Minox 50

Minox 50 may be available in the countries listed below.

Ingredient matches for Minox 50

Minocycline

Minocycline is reported as an ingredient of Minox 50 in the following countries:

• Ireland

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Hidropharm

Hidropharm may be available in the countries listed below.

Ingredient matches for Hidropharm

Chlortalidone

Chlortalidone is reported as an ingredient of Hidropharm in the following countries:

• Mexico

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Amxol

Amxol may be available in the countries listed below.

Ingredient matches for Amxol

Ambroxol

Ambroxol hydrochloride (a derivative of Ambroxol) is reported as an ingredient of Amxol in the following countries:

• Singapore

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Gasvan

Gasvan may be available in the countries listed below.

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Dimeticone

Dimeticone is reported as an ingredient of Gasvan in the following countries:

• Serbia

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Febuprol

Scheme

Rec.INN

CAS registry number (Chemical Abstracts Service)

0003102-00-9

Chemical Formula

C13-H20-O3

Molecular Weight

224

Therapeutic Category

Choleretic

Chemical Name

2-Propanol, 1-butoxy-3-phenoxy-

Foreign Names

• Febuprolum (Latin)
• Febuprol (German)
• Fébuprol (French)
• Febuprol (Spanish)

Generic Names

• Fébuprol (OS: DCF)
• H 33 (IS)
• K 10033 (IS)

Brand Name

• Valbil
  CPH, Portugal

International Drug Name Search

Glossary

DCF	Dénomination Commune Française
IS	Inofficial Synonym
OS	Official Synonym
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

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Tripta

Tripta may be available in the countries listed below.

Ingredient matches for Tripta

Amitriptyline

Amitriptyline hydrochloride (a derivative of Amitriptyline) is reported as an ingredient of Tripta in the following countries:

• Myanmar


• Singapore

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Allopurinol EG

Allopurinol EG may be available in the countries listed below.

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Allopurinol

Allopurinol is reported as an ingredient of Allopurinol EG in the following countries:

• Belgium


• France

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Telnidine

Telnidine may be available in the countries listed below.

Ingredient matches for Telnidine

Povidone Iodine

Povidone-Iodine is reported as an ingredient of Telnidine in the following countries:

• Japan

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Tessifol

Tessifol may be available in the countries listed below.

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Atenolol

Atenolol is reported as an ingredient of Tessifol in the following countries:

• Portugal

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Anazo

Anazo may be available in the countries listed below.

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Anastrozole

Anastrozole is reported as an ingredient of Anazo in the following countries:

• Taiwan

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Allilestrenolo

Allilestrenolo may be available in the countries listed below.

Ingredient matches for Allilestrenolo

Allylestrenol

Allilestrenolo (DCIT) is also known as Allylestrenol (Rec.INN)

International Drug Name Search

Glossary

DCIT	Denominazione Comune Italiana
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

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Ciprofloxacin Arcana

Ciprofloxacin Arcana may be available in the countries listed below.

Ingredient matches for Ciprofloxacin Arcana

Ciprofloxacin

Ciprofloxacin hydrochloride (a derivative of Ciprofloxacin) is reported as an ingredient of Ciprofloxacin Arcana in the following countries:

• Austria

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Pantacid

Pantacid may be available in the countries listed below.

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Pantoprazole

Pantoprazole sodium (a derivative of Pantoprazole) is reported as an ingredient of Pantacid in the following countries:

• Hungary

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Ferran Fol

Ferran Fol may be available in the countries listed below.

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Folic Acid

Folic Acid is reported as an ingredient of Ferran Fol in the following countries:

• Peru

Iron Polymaltose

Iron Polymaltose is reported as an ingredient of Ferran Fol in the following countries:

• Peru

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Phenpro AbZ

Phenpro AbZ may be available in the countries listed below.

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Phenprocoumon

Phenprocoumon is reported as an ingredient of Phenpro AbZ in the following countries:

• Germany

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Iovone

Iovone may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

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Povidone Iodine

Povidone-Iodine is reported as an ingredient of Iovone in the following countries:

• Australia

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Lopéramide Sandoz Conseil

Lopéramide Sandoz Conseil may be available in the countries listed below.

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Loperamide

Loperamide hydrochloride (a derivative of Loperamide) is reported as an ingredient of Lopéramide Sandoz Conseil in the following countries:

• France

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Rythmical

Rythmical may be available in the countries listed below.

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Disopyramide

Disopyramide phosphate (a derivative of Disopyramide) is reported as an ingredient of Rythmical in the following countries:

• Israel

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Ritmenal

Ritmenal may be available in the countries listed below.

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Gabapentin

Gabapentin is reported as an ingredient of Ritmenal in the following countries:

• Chile

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Tiamvet

Tiamvet may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Tiamvet

Tiamulin

Tiamulin fumarate (a derivative of Tiamulin) is reported as an ingredient of Tiamvet in the following countries:

• France


• Germany


• Italy

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Tricoxane

Tricoxane may be available in the countries listed below.

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Minoxidil

Minoxidil is reported as an ingredient of Tricoxane in the following countries:

• Chile

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Aflogol

Aflogol may be available in the countries listed below.

Ingredient matches for Aflogol

Aminobenzoic Acid

Aminobenzoic Acid calcium salt (a derivative of Aminobenzoic Acid) is reported as an ingredient of Aflogol in the following countries:

• Chile

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Plurivers

Plurivers may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

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Piperazine

Piperazine adipate (a derivative of Piperazine) is reported as an ingredient of Plurivers in the following countries:

• France

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Mevastan

Mevastan may be available in the countries listed below.

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Pravastatin

Pravastatin sodium salt (a derivative of Pravastatin) is reported as an ingredient of Mevastan in the following countries:

• Japan

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Lofat

Lofat may be available in the countries listed below.

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Fenofibrate

Fenofibrate is reported as an ingredient of Lofat in the following countries:

• Bangladesh

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Clobexpro

Clobexpro may be available in the countries listed below.

Ingredient matches for Clobexpro

Clobetasol

Clobetasol 17α-propionate (a derivative of Clobetasol) is reported as an ingredient of Clobexpro in the following countries:

• Mexico

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Acelopam

Acelopam may be available in the countries listed below.

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Citalopram

Citalopram is reported as an ingredient of Acelopam in the following countries:

• Greece

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Pertinar

Pertinar may be available in the countries listed below.

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Glucosamine

Glucosamine sulfate (a derivative of Glucosamine) is reported as an ingredient of Pertinar in the following countries:

• Argentina

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Pethidini HCl PCH

Pethidini HCl PCH may be available in the countries listed below.

Ingredient matches for Pethidini HCl PCH

Pethidine

Pethidine hydrochloride (a derivative of Pethidine) is reported as an ingredient of Pethidini HCl PCH in the following countries:

• Netherlands

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Carbinib

Carbinib may be available in the countries listed below.

Ingredient matches for Carbinib

Acetazolamide

Acetazolamide is reported as an ingredient of Carbinib in the following countries:

• Portugal

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Furobactina

Furobactina may be available in the countries listed below.

Ingredient matches for Furobactina

Nitrofurantoin

Nitrofurantoin is reported as an ingredient of Furobactina in the following countries:

• Spain

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Epirax

Epirax may be available in the countries listed below.

Ingredient matches for Epirax

Chlordiazepoxide

Chlordiazepoxide is reported as an ingredient of Epirax in the following countries:

• Ethiopia

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Cortimycin

Cortimycin may be available in the countries listed below.

Ingredient matches for Cortimycin

Hydrocortisone

Hydrocortisone 21-acetate (a derivative of Hydrocortisone) is reported as an ingredient of Cortimycin in the following countries:

• Georgia

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Froxime

Froxime may be available in the countries listed below.

Ingredient matches for Froxime

Cefuroxime

Cefuroxime axetil (a derivative of Cefuroxime) is reported as an ingredient of Froxime in the following countries:

• Bahrain


• Iraq


• Jordan


• Kuwait


• Lebanon


• Libya


• Nigeria


• Qatar


• Saudi Arabia


• Somalia


• Sudan


• United Arab Emirates


• Yemen

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Glimépiride EG

Glimépiride EG may be available in the countries listed below.

Ingredient matches for Glimépiride EG

Glimepiride

Glimepiride is reported as an ingredient of Glimépiride EG in the following countries:

• France

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Fungosten

Fungosten may be available in the countries listed below.

Ingredient matches for Fungosten

Clotrimazole

Clotrimazole is reported as an ingredient of Fungosten in the following countries:

• Turkey

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Calcipotriol Sandoz

Calcipotriol Sandoz may be available in the countries listed below.

Ingredient matches for Calcipotriol Sandoz

Calcipotriol

Calcipotriol is reported as an ingredient of Calcipotriol Sandoz in the following countries:

• Austria


• Estonia


• Germany


• Latvia

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Electro-K

Electro-K may be available in the countries listed below.

Ingredient matches for Electro-K

Potassium Chloride

Potassium Chloride is reported as an ingredient of Electro-K in the following countries:

• Bangladesh

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Chloromycetin Palmitate

Chloromycetin Palmitate may be available in the countries listed below.

Ingredient matches for Chloromycetin Palmitate

Chloramphenicol

Chloramphenicol palmitate (a derivative of Chloramphenicol) is reported as an ingredient of Chloromycetin Palmitate in the following countries:

• Japan

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Xalacom eye drops, solution (Pfizer Limited)

1. Name Of The Medicinal Product

Xalacom 50 microgram/ml and 5 mg/ml eye drops, solution.

2. Qualitative And Quantitative Composition

1ml solution contains latanoprost 50 micrograms and timolol maleate 6.8 mg equivalent to 5 mg timolol.

Excipient: Benzalkonium chloride 200 microgram/ml.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Eye drops, solution

The solution is a clear colourless liquid.

4. Clinical Particulars

4.1 Therapeutic Indications

Reduction of intraocular pressure (IOP) in patients with open angle glaucoma and ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues.

4.2 Posology And Method Of Administration

Recommended dosage for adults (including the elderly):

Recommended therapy is one eye drop in the affected eye(s) once daily.

If one dose is missed, treatment should continue with the next dose as planned. The dose should not exceed one drop in the affected eye(s) daily.

Administration:

Contact lenses should be removed before instillation of the eye drops and may be reinserted after 15 minutes (see section 4.4).

If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart.

Use in children and adolescents:

Safety and effectiveness in children and adolescents has not been established.

4.3 Contraindications

Xalacom is contraindicated in patients with:

- Reactive airway disease including bronchial asthma or a history of bronchial asthma, severe chronic obstructive pulmonary disease.

- Sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock.

- Hypersensitivity to the active substances or to any of the excipients.

4.4 Special Warnings And Precautions For Use

Systemic effects

Like other topically applied ophthalmic agents, Xalacom may be absorbed systemically. Due to the beta-adrenergic component timolol, the same types of cardiovascular and pulmonary adverse reactions as seen with systemic beta-blockers may occur.

In patients with cardiovascular diseases (e.g. coronary heart disease, sick sinus syndrome, peripheral circulatory disturbances - hypotension, Prinzmetal's Angina, cardiac failure) the therapy with beta-blockers should be critically assessed and the therapy with other active substances should be considered. Patients with cardiovascular diseases should be watched for signs of deterioration of these diseases and of adverse reactions.

Respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma and, rarely, death in association with cardiac failures, have been reported following administration of timolol maleate.

Beta-blockers should be administered with caution in patients subject to spontaneous hypoglycaemia or to patients with labile insulin-dependant diabetes, as beta-blockers may mask the signs and symptoms of acute hypoglycaemia. Beta-blockers may also mask the signs of hyperthyroidism.

Anaphylactic reactions

While taking beta-blockers, patients with a history of atopy or a history of severe anaphylactic reaction to a variety of allergens may be unresponsive to the usual doses of adrenaline used to treat anaphylactic reactions.

Concomitant therapy

Timolol may interact with other drugs, see 4.5 Interaction with other medicinal products and other forms of interaction.

The effect on intraocular pressure or the known effects of systemic beta-blockade may be potentiated when Xalacom is given to patients already receiving an oral beta-blocking agent. The use of two local beta-blockers or two local prostaglandins is not recommended.

Ocular effects

Latanoprost may gradually change the eye colour by increasing the amount of brown pigment in the iris. Similar to experience with latanoprost eye drops, increased iris pigmentation was seen in 16-20% of all patients treated with Xalacom for up to one year (based on photographs). This effect has predominantly been seen in patients with mixed coloured irides, i.e. green-brown, yellow-brown or blue/grey-brown, and is due to increased melanin content in the stromal melanocytes of the iris. Typically the brown pigmentation around the pupil spreads concentrically towards the periphery in affected eyes, but the entire iris or parts of it may become more brownish. In patients with homogeneously blue, grey, green or brown eyes, the change has only rarely been seen during two years of treatment in clinical trials with latanoprost.

The change in iris colour occurs slowly and may not be noticeable for several months to years and it has not been associated with any symptom or pathological changes.

No further increase in brown iris pigment has been observed after discontinuation of treatment, but the resultant colour change may be permanent.

Neither naevi nor freckles of the iris have been affected by treatment.

Accumulation of pigment in the trabecular meshwork or elsewhere in the anterior chamber has not been observed but patients should be examined regularly and, depending on the clinical situation, treatment may be stopped if increased iris pigmentation ensues.

Before treatment is instituted patients should be informed of the possibility of a change in eye colour. Unilateral treatment can result in permanent heterochromia.

There is no documented experience with latanoprost in inflammatory, neovascular, chronic angle closure or congenital glaucoma, in open angle glaucoma of pseudophakic patients and in pigmentary glaucoma.

Latanoprost has no or little effect on the pupil but there is no documented experience in acute attacks of closed angle glaucoma. It is recommended, therefore, that Xalacom should be used with caution in these conditions until more experience is obtained.

Latanoprost should be used with caution in patients with a history of herpetic keratitis, and should be avoided in cases of active herpes simplex keratitis and in patients with a history of recurrent herpetic keratitis specifically associated with prostaglandin analogues.

Macular oedema, including cystoid macular oedema, has been reported during treatment with latanoprost. These reports have mainly occurred in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular oedema. Xalacom should be used with caution in these patients.

Choroidal detachment has been reported with administration of aqueous suppressant therapy (e.g. timolol, acetazolamide) after filtration procedures.

Use of contact lenses

Xalcom contains benzalkonium chloride, which is commonly used as a preservative in ophthalmic products. Benzalkonium chloride has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy, may cause eye irritation and is known to discolour soft contact lenses. Close monitoring is required with frequent or prolonged use of Xalcom in dry eye patients, or in conditions where the cornea is compromised. Contact lenses may absorb benzalkonium chloride and these should be removed before applying Xalcom but may be reinserted after 15 minutes (see section 4.2 Posology and Method of Administration).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Specific medicinal product interaction studies have not been performed with Xalacom.

There have been reports of paradoxical elevations in intraocular pressure following the concomitant ophthalmic administration of two prostaglandin analogues. Therefore, the use of two or more prostaglandins, prostaglandin analogues, or prostaglandin derivatives is not recommended.

The effect on intraocular pressure or the known effects of systemic beta-blockade may be potentiated when Xalacom is given to patients already receiving an oral beta-adrenergic blocking agent, and the use of two or more topical beta-adrenergic blocking agents is not recommended.

Mydriasis has occasionally been reported when timolol was given with epinephrine.

There is a potential for additive effects resulting in hypotension and/or marked bradycardia when eye drops with timolol are administered concomitantly with oral calcium channel blockers, guanethidine or beta-blocking agents, antiarrhythmics, digitalis glycosides or parasympathomimetics.

The hypertensive reaction to sudden withdrawal of clonidine can be potentiated when taking beta-blockers.

Beta-blockers may increase the hypoglycaemic effect of antidiabetic agents. Beta-blockers can mask the signs and symptoms of hypoglycaemia (see 4.4, Special warnings and special precautions for use).

4.6 Pregnancy And Lactation

PREGNANCY

Latanoprost:

There are no adequate data from the use of lantanoprost in pregnant women. Studies in animals have shown reproductive toxicity (see 5.3). The potential risk for humans is unknown.

Timolol:

Well controlled epidemiological studies with systemic use of beta-blockers did not indicate malformative effects, but some pharmacological effects such as bradycardia have already been observed in foetuses or neonates.

Consequently Xalacom should not be used during pregnancy (see 5.3).

LACTATION

Timolol is excreted into breast milk. Latanoprost and its metabolites may pass into breast milk. Xalacom should therefore not be used in women who are breast-feeding.

4.7 Effects On Ability To Drive And Use Machines

Instillation of eye drops may cause transient blurring of vision. Until this is resolved, patients should not drive or use machines.

4.8 Undesirable Effects

For latanoprost, the majority of adverse events relate to the ocular system. In data from the extension phase of the Xalacom pivotal trials, 16 - 20% of patients developed increased iris pigmentation, which may be permanent. In an open 5 year latanoprost safety study, 33% of patients developed iris pigmentation (see 4.4). Other ocular adverse events are generally transient and occur on dose administration. For timolol, the most serious adverse events are systemic in nature, including bradycardia, arrhythmia, congestive heart failure, bronchospasm and allergic reactions.

Treatment related adverse events seen in clinical trials with Xalacom are listed below.

Adverse events are categorized by frequency as follows: very common (

Nervous System Disorders:

Uncommon: Headache.

Eye Disorders:

Very common: Increased iris pigmentation.

Common: Eye irritation (including stinging, burning and itching), Eye pain.

Uncommon: Eye hyperaemia, Conjunctivitis, Vision blurred, Lacrimation increased, Blepharitis, Corneal disorders.

Skin and Subcutaneous Tissue Disorders:

Uncommon: Skin rash, Pruritus.

Additional adverse events have been reported specific to the use of the individual components of Xalacom in either in clinical studies, spontaneous reports or in the available literature.

For latanoprost, these are:

Infections and Infestations:

Herpetic keratitis

Nervous System Disorders:

Dizziness.

Eye Disorders:

Eyelash and vellus hair changes (increased length, thickness, pigmentation, and number), Punctate epithelial erosions, periorbital oedema, iritis/uveitis, macular oedema (in aphakic, pseudophakic patients with torn posterior lens capsules or in patients with known risk factors for macular oedema), dry eye, keratitis, corneal oedema and erosions, misdirected eyelashes sometimes resulting in eye irritation and iris cyst.

Cardiac Disorders:

Aggravation of angina in patients with pre-existing disease, Palpitations.

Respiratory, Thoracic and Mediastinal Disorders

Asthma, Asthma aggravation, Dysponea.

Skin and Subcutaneous Tissue Disorders:

Darkening of palpebral skin.

Musculoskeletal, Connective Tissue and Bone Disorders:

Joint pain, Muscle pain.

General disorders and Administration Site Conditions:

Chest pain

For timolol, these are:

Immune System Disorders:

Signs and symptoms of systemic allergic reactions including angioedema, urticaria, and localized and generalized rash.

Psychiatric Disorders:

Depression, Memory loss, Decreased libido, Insomnia, Nightmares.

Nervous System Disorders:

Dizziness, Paraesthesia, Cerebral ischemia, Cerebrovascular accident, Increase in signs and symptoms of myasthenia gravis, Syncope.

Eye Disorders:

Signs and symptoms of ocular irritation including keratitis, decreased corneal sensitivity and dry eyes, Visual disturbances including refractive changes (due to withdrawal of miotic therapy in some cases), Diplopia, Ptosis, Choroidal detachment (following filtration surgery),

Ear and Labyrinth Disorders:

Tinnitus

Cardiac Disorders:

Palpitation, Arrhythmia, Bradycardia, Cardiac arrest, Heart block, Congestive heart failure.

Vascular Disorders:

Hypotension, Raynaud's phenomenon, Cold hands and feet.

Respiratory, Thoracic and Mediastinal Disorders:

bronchospasm (predominantly in patients with pre-existing bronchospastic disease), Dyspnoea, Cough.

Gastrointestinal Disorders:

Nausea, Diarrhoea, Dyspepsia, Dry mouth.

Skin and Subcutaneous Tissue Disorders:

Alopecia, Psoriasiform rash or exacerbation of psoriasis.

General Disorders and Administration Site Conditions:

Asthenia/fatigue, Chest pain, Oedema.

4.9 Overdose

No data are available in humans with regard to overdose with Xalacom.

Symptoms of systemic timolol overdose are: bradycardia, hypotension, bronchospasm and cardiac arrest. If such symptoms occur the treatment should be symptomatic and supportive. Studies have shown that timolol does not dialyse readily.

Apart from ocular irritation and conjunctival hyperaemia no other ocular or systemic side effects are known if latanoprost is overdosed.

If latanoprost is accidentally ingested orally the following information may be useful: Treatment: Gastric lavage if needed. Symptomatic treatment. Latanoprost is extensively metabolised during the first pass through the liver. Intravenous infusion of 3 micrograms/kg in healthy volunteers induced no symptoms but a dose of 5.5-10 micrograms/kg caused nausea, abdominal pain, dizziness, fatigue, hot flushes and sweating. These events were mild to moderate in severity and resolved without treatment, within 4 hours after terminating the infusion.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group:

Ophthalmological-betablocking agents - timolol, combinations

ATC code: S01ED51

Mechanism of action

Xalacom consists of two components: latanoprost and timolol maleate. These two components decrease elevated intraocular pressure (IOP) by different mechanisms of action and the combined effect results in additional IOP reduction compared to either compound administered alone.

Latanoprost, a prostaglandin F_2alpha analogue, is a selective prostanoid FP receptor agonist that reduces the IOP by increasing the outflow of aqueous humour. The main mechanism of action is increased uveoscleral outflow. Additionally, some increase in outflow facility (decrease in trabecular outflow resistance) has been reported in man. Latanoprost has no significant effect on the production of aqueous humour, the blood-aqueous barrier or the intraocular blood circulation. Chronic treatment with latanoprost in monkey eyes, which had undergone extracapsular lens extraction, did not affect the retinal blood vessels as determined by fluorescein angiography. Latanoprost has not induced fluorescein leakage in the posterior segment of pseudophakic human eyes during short-term treatment.

Timolol is a beta-1 and beta-2 (non-selective) adrenergic receptor blocking agent that has no significant intrinsic sympathomimetic, direct myocardial depressant or membrane-stabilising activity. Timolol lowers IOP by decreasing the formation of aqueous in the ciliary epithelium. The precise mechanism of action is not clearly established, but inhibition of the increased cyclic AMP synthesis caused by endogenous beta-adrenergic stimulation is probable. Timolol has not been found to significantly affect the permeability of the blood-aqueous barrier to plasma proteins. In rabbits, timolol was without effect on the regional ocular blood flow after chronic treatment.

Pharmacodynamic effects

Clinical effects

In dose finding studies, Xalacom produced significantly greater decreases in mean diurnal IOP compared to latanoprost and timolol administered once daily as monotherapy. In two well controlled, double masked six-month clinical studies the IOP reducing effect of Xalacom was compared with latanoprost and timolol monotherapy in patients with an IOP of at least 25 mm Hg or greater. Following a 2-4 week run-in with timolol (mean decrease in IOP from enrollment of 5 mm Hg), additional decreases in mean diurnal IOP of 3.1, 2.0 and 0.6 mm Hg were observed after 6 months of treatment for Xalacom, latanoprost and timolol (twice daily), respectively. The IOP lowering effect of Xalacom was maintained in 6 month open label extensions of these studies.

Existing data suggest that evening dosing may be more effective in IOP lowering than morning dosing. However, when considering a recommendation of either morning or evening dosing, sufficient consideration should be given to the lifestyle of the patient and their likely compliance.

It should be kept in mind that in case of insufficient efficacy of the fixed combination, results from studies indicate that the use of unfixed administration of Timolol bid and latanoprost once a day might be still efficient.

Onset of action of Xalacom is within one hour and maximal effect occurs within six to eight hours. Adequate IOP reducing effect has been shown to be present up to 24 hours post dosage after multiple treatments.

5.2 Pharmacokinetic Properties

Latanoprost

Latanoprost is an isopropyl ester prodrug, which per se is inactive, but after hydrolysis by esterases in the cornea to the acid of latanoprost, becomes biologically active. The prodrug is well absorbed through the cornea and all drug that enters the aqueous humor is hydrolysed during the passage through the cornea. Studies in man indicate that the maximum concentration in the aqueous humour, approximately 15-30 ng/ml, is reached about 2 hours after topical administration of latanoprost alone. After topical application in monkeys latanoprost is distributed primarily in the anterior segment, the conjunctiva and the eyelids.

The acid of latanoprost has a plasma clearance of 0.40 l/h/kg and a small volume of distribution, 0.16 l/kg, resulting in a rapid half life in plasma, 17 minutes. After topical ocular administration the systemic bioavailability of the acid of latanoprost is 45%. The acid of latanoprost has a plasma protein binding of 87%.

There is practically no metabolism of the acid of latanoprost in the eye. The main metabolism occurs in the liver. The main metabolites, the 1,2-dinor and 1,2,3,4- tetranor metabolites, exert no or only weak biological activity in animal studies and are excreted primarily in the urine.

Timolol

The maximum concentration of timolol in the aqueous humor is reached about 1 hour after topical administration of eye drops. Part of the dose is absorbed systemically and a maximum plasma concentration of 1 ng/ml is reached 10-20 minutes after topical administration of one eye drop to each eye once daily (300 micrograms/day). The half life of timolol in plasma is about 6 hours. Timolol is extensively metabolised in the liver. The metabolites are excreted in the urine together with some unchanged timolol.

Xalacom

No pharmacokinetic interactions between latanoprost and timolol were observed although there was an approximate 2-fold increased concentration of the acid of latanoprost in aqueous humour 1-4 hours after administration of Xalacom compared to monotherapy.

5.3 Preclinical Safety Data

The ocular and systemic safety profile of the individual components is well established. No adverse ocular or systemic effects were seen in rabbits treated topically with the fixed combination or with concomitantly administered latanoprost and timolol ophthalmic solutions. Safety pharmacology, genotoxicity and carcinogenicity studies with each of the components revealed no special hazards for humans. Latanoprost did not affect corneal wound healing in the rabbit eye, whereas timolol inhibited the process in the rabbit and the monkey eye when administered more frequently than once a day.

For latanoprost, no effects on male and female fertility in rats and no teratogenic potential in rats and rabbits have been established. No embryotoxicity was observed in rats after intravenous doses of up to 250 micrograms/kg/day. Latanoprost, however, caused embryofetal toxicity, characterised by increased incidence of late resorption and abortion and by reduced foetal weight, in rabbits at intravenous doses of 5 micrograms/kg/day (approximately 100 times the clinical dose) and above. Timolol showed no effects on male and female fertility in rats or teratogenic potential in mice, rats and rabbits.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sodium chloride

Benzalkonium chloride

Sodium dihydrogen phosphate monohydrate

Disodium phosphate anhydrous

Hydrochloric acid solution (for adjustment to pH 6.0)

Sodium hydroxide solution (for adjustment to pH 6.0)

Water for injections

6.2 Incompatibilities

In vitro studies have shown that precipitation occurs when eye drops containing thiomersal are mixed with Xalatan. If such drugs are used concomitantly with Xalacom, the eye drops should be administered with an interval of at least five minutes.

6.3 Shelf Life

2 years

After opening of container: 4 weeks

6.4 Special Precautions For Storage

Store in a refrigerator (2°C - 8°C).

Opened bottle: Do not store above 25 °C.

Keep the bottle in the outer carton.

6.5 Nature And Contents Of Container

LDPE bottle (5 ml) and dropper applicator (dropper tip), HDPE screw cap, tamper evident LDPE overcap.

Each bottle contains 2.5 ml eye drop solution

Pack sizes:	1 x 2.5 ml
	3 x 2.5 ml
	6 x 2.5 ml

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

The tamper evident overcap should be removed before use.

Administrative Data

7. Marketing Authorisation Holder

Pfizer Limited

Ramsgate Road, Sandwich

Kent

CT 13 9NJ

United Kingdom

8. Marketing Authorisation Number(S)

PL 00057/1056

9. Date Of First Authorisation/Renewal Of The Authorisation

16^th February 2007

10. Date Of Revision Of The Text

June 2011

XM 14_0 UK

Epufen

Epufen may be available in the countries listed below.

Ingredient matches for Epufen

Fentanyl

Fentanyl is reported as an ingredient of Epufen in the following countries:

• Slovenia

International Drug Name Search

Bioshirubbing

Bioshirubbing may be available in the countries listed below.

Ingredient matches for Bioshirubbing

Benzalkonium Chloride

Benzalkonium chloride (a derivative of Benzalkonium) is reported as an ingredient of Bioshirubbing in the following countries:

• Japan

International Drug Name Search

Rixapen

Rixapen may be available in the countries listed below.

Ingredient matches for Rixapen

Clometocillin

Clometocillin potassium salt (a derivative of Clometocillin) is reported as an ingredient of Rixapen in the following countries:

• Belgium


• Luxembourg

International Drug Name Search

Glibenclamida

Glibenclamida may be available in the countries listed below.

Ingredient matches for Glibenclamida

Glibenclamide

Glibenclamide is reported as an ingredient of Glibenclamida in the following countries:

• Chile


• Colombia


• Ecuador


• Venezuela

International Drug Name Search

Calcitonina Sandoz

Calcitonina Sandoz may be available in the countries listed below.

Ingredient matches for Calcitonina Sandoz

Calcitonin

Calcitonin is reported as an ingredient of Calcitonina Sandoz in the following countries:

• Argentina


• Italy

International Drug Name Search

Kemicetine

Kemicetine may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

UK matches:

• Kemicetine Succinate Injection (SPC)

Ingredient matches for Kemicetine

Chloramphenicol

Chloramphenicol is reported as an ingredient of Kemicetine in the following countries:

• India


• Indonesia


• Philippines


• Turkey

Chloramphenicol succinate sodium (a derivative of Chloramphenicol) is reported as an ingredient of Kemicetine in the following countries:

• Hong Kong


• Indonesia


• United Kingdom

International Drug Name Search

Glossary

SPC	Summary of Product Characteristics (UK)

Click for further information on drug naming conventions and International Nonproprietary Names.

PMS-Paroxetine

PMS-Paroxetine may be available in the countries listed below.

Ingredient matches for PMS-Paroxetine

Paroxetine

Paroxetine hydrochloride (a derivative of Paroxetine) is reported as an ingredient of PMS-Paroxetine in the following countries:

• Canada

International Drug Name Search

Mevlor

Mevlor may be available in the countries listed below.

Ingredient matches for Mevlor

Lovastatin

Lovastatin is reported as an ingredient of Mevlor in the following countries:

• Argentina


• Portugal

International Drug Name Search

Trizina

Trizina may be available in the countries listed below.

Ingredient matches for Trizina

Cefatrizine

Cefatrizine comp. with propylene glycole (a derivative of Cefatrizine) is reported as an ingredient of Trizina in the following countries:

• Italy

International Drug Name Search

Fluoricare

Fluoricare may be available in the countries listed below.

Ingredient matches for Fluoricare

Sodium Fluoride

Sodium Fluoride is reported as an ingredient of Fluoricare in the following countries:

• Indonesia

International Drug Name Search

Humalog Mix 75 / 25

In the US, Humalog Mix 75/25 (insulin lispro/insulin lispro protamine systemic) is a member of the drug class insulin and is used to treat Diabetes - Type 1 and Diabetes - Type 2.

US matches:

• HumaLog Mix 75/25 Vials


• Humalog Mix 75/25 Pens


• Humalog Mix 75/25


• Humalog Mix 75/25 KwikPen


• Humalog Mix 75/25 Pen

Ingredient matches for Humalog Mix 75/25

Insulin Lispro

Insulin Lispro biphasic (a derivative of Insulin Lispro) is reported as an ingredient of Humalog Mix 75/25 in the following countries:

• United States

International Drug Name Search

Artricom

Artricom may be available in the countries listed below.

Ingredient matches for Artricom

Tenoxicam

Tenoxicam is reported as an ingredient of Artricom in the following countries:

• Indonesia

International Drug Name Search

Apurone

Apurone may be available in the countries listed below.

Ingredient matches for Apurone

Flumequine

Flumequine is reported as an ingredient of Apurone in the following countries:

• France

International Drug Name Search

Prostin F2

Prostin F2 may be available in the countries listed below.

Ingredient matches for Prostin F2

Dinoprost

Dinoprost tromethamine (a derivative of Dinoprost) is reported as an ingredient of Prostin F2 in the following countries:

• Israel

International Drug Name Search

Piroxicam AbZ

Piroxicam AbZ may be available in the countries listed below.

Ingredient matches for Piroxicam AbZ

Piroxicam

Piroxicam is reported as an ingredient of Piroxicam AbZ in the following countries:

• Germany

International Drug Name Search

Epirubicin Mayne

Epirubicin Mayne may be available in the countries listed below.

Ingredient matches for Epirubicin Mayne

Epirubicin

Epirubicin hydrochloride (a derivative of Epirubicin) is reported as an ingredient of Epirubicin Mayne in the following countries:

• Estonia


• Latvia


• Norway

International Drug Name Search

Theradia

Theradia may be available in the countries listed below.

Ingredient matches for Theradia

Sulfadiazine

Sulfadiazine is reported as an ingredient of Theradia in the following countries:

• Japan

International Drug Name Search

Invigen

Invigen may be available in the countries listed below.

Ingredient matches for Invigen

Gentamicin

Gentamicin sulfate (a derivative of Gentamicin) is reported as an ingredient of Invigen in the following countries:

• Bangladesh

International Drug Name Search

Adavin

Adavin may be available in the countries listed below.

Ingredient matches for Adavin

Nicergoline

Nicergoline is reported as an ingredient of Adavin in the following countries:

• Bosnia & Herzegowina


• Poland

International Drug Name Search

Cardiazol Paracodina

Cardiazol Paracodina may be available in the countries listed below.

Ingredient matches for Cardiazol Paracodina

Dihydrocodeine

Dihydrocodeine is reported as an ingredient of Cardiazol Paracodina in the following countries:

• Italy

International Drug Name Search

Bicarbonato Sodico Braun

Bicarbonato Sodico Braun may be available in the countries listed below.

Ingredient matches for Bicarbonato Sodico Braun

Sodium Bicarbonate

Sodium Bicarbonate is reported as an ingredient of Bicarbonato Sodico Braun in the following countries:

• Spain

International Drug Name Search

Risperidone Instasolv

Risperidone Instasolv may be available in the countries listed below.

Ingredient matches for Risperidone Instasolv

Risperidone

Risperidone is reported as an ingredient of Risperidone Instasolv in the following countries:

• Luxembourg

International Drug Name Search

Limpet

Limpet may be available in the countries listed below.

Ingredient matches for Limpet

Glimepiride

Glimepiride is reported as an ingredient of Limpet in the following countries:

• Bangladesh

International Drug Name Search

Piperacilina-Tazobactam Northia

Piperacilina-Tazobactam Northia may be available in the countries listed below.

Ingredient matches for Piperacilina-Tazobactam Northia

Piperacillin

Piperacillin is reported as an ingredient of Piperacilina-Tazobactam Northia in the following countries:

• Argentina

Tazobactam

Tazobactam is reported as an ingredient of Piperacilina-Tazobactam Northia in the following countries:

• Argentina

International Drug Name Search

Lactinol

In the US, Lactinol (lactic acid topical) is a member of the drug class miscellaneous topical agents and is used to treat Dry Skin and Pityriasis rubra pilaris.

US matches:

• Lactinol Lotion


• Lactinol-E

Ingredient matches for Lactinol

Lactic Acid

Lactic Acid is reported as an ingredient of Lactinol in the following countries:

• United States

International Drug Name Search

Fulgram

Fulgram may be available in the countries listed below.

Ingredient matches for Fulgram

Amoxicillin

Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Fulgram in the following countries:

• Venezuela

Clavulanate

Clavulanic Acid potassium (a derivative of Clavulanic Acid) is reported as an ingredient of Fulgram in the following countries:

• Venezuela

Norfloxacin

Norfloxacin is reported as an ingredient of Fulgram in the following countries:

• Chile

International Drug Name Search

Fenemal Recip

Fenemal Recip may be available in the countries listed below.

Ingredient matches for Fenemal Recip

Phenobarbital

Phenobarbital is reported as an ingredient of Fenemal Recip in the following countries:

• Iceland


• Sweden

International Drug Name Search

Flutamid-ratiopharm

Flutamid-ratiopharm may be available in the countries listed below.

Ingredient matches for Flutamid-ratiopharm

Flutamide

Flutamide is reported as an ingredient of Flutamid-ratiopharm in the following countries:

• Germany

International Drug Name Search

Minims Gentamycine

Minims Gentamycine may be available in the countries listed below.

Ingredient matches for Minims Gentamycine

Gentamicin

Gentamicin is reported as an ingredient of Minims Gentamycine in the following countries:

• Netherlands

International Drug Name Search

Cefatame

Cefatame may be available in the countries listed below.

Ingredient matches for Cefatame

Cefalexin

Cefalexin is reported as an ingredient of Cefatame in the following countries:

• Vietnam

International Drug Name Search

Amiloride HCl and Hydrochlorothiazide

Ingredient matches for Amiloride HCl and Hydrochlorothiazide

Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of Amiloride HCl and Hydrochlorothiazide in the following countries:

• United States

International Drug Name Search

Trimexazol

Trimexazol may be available in the countries listed below.

Ingredient matches for Trimexazol

Sulfamethoxazole

Sulfamethoxazole is reported as an ingredient of Trimexazol in the following countries:

• Brazil


• Mexico

Trimethoprim

Trimethoprim is reported as an ingredient of Trimexazol in the following countries:

• Brazil


• Mexico

International Drug Name Search

Betametha

Betametha may be available in the countries listed below.

Ingredient matches for Betametha

Betamethasone

Betamethasone is reported as an ingredient of Betametha in the following countries:

• Japan

International Drug Name Search

Clonid-Ophtal

Clonid-Ophtal may be available in the countries listed below.

Ingredient matches for Clonid-Ophtal

Clonidine

Clonidine hydrochloride (a derivative of Clonidine) is reported as an ingredient of Clonid-Ophtal in the following countries:

• Germany

International Drug Name Search

Euglucon 5

Euglucon 5 may be available in the countries listed below.

Ingredient matches for Euglucon 5

Glibenclamide

Glibenclamide is reported as an ingredient of Euglucon 5 in the following countries:

• Argentina


• Aruba


• Bahrain


• Bosnia & Herzegowina


• Colombia


• Costa Rica


• Czech Republic


• Dominican Republic


• Ecuador


• El Salvador


• Ethiopia


• Finland


• Guatemala


• Honduras


• Hong Kong


• India


• Kenya


• Kuwait


• Luxembourg


• Malaysia


• Mexico


• Oman


• Panama


• Philippines


• Portugal


• Saudi Arabia


• Singapore


• Sri Lanka


• Taiwan


• Tanzania


• Thailand


• Uganda


• United Arab Emirates


• Uruguay


• Venezuela


• Zambia


• Zimbabwe

International Drug Name Search

Resulin

Resulin may be available in the countries listed below.

Ingredient matches for Resulin

Nimesulide

Nimesulide is reported as an ingredient of Resulin in the following countries:

• Italy

International Drug Name Search

CiL

CiL may be available in the countries listed below.

Ingredient matches for CiL

Fenofibrate

Fenofibrate is reported as an ingredient of CiL in the following countries:

• Germany

International Drug Name Search

Alphacutanée

Alphacutanée may be available in the countries listed below.

Ingredient matches for Alphacutanée

Chymotrypsin

Chymotrypsin is reported as an ingredient of Alphacutanée in the following countries:

• Luxembourg

International Drug Name Search

Karmarte

Karmarte may be available in the countries listed below.

Ingredient matches for Karmarte

Epirizole

Epirizole is reported as an ingredient of Karmarte in the following countries:

• Japan

International Drug Name Search

Betlol SR

Betlol SR may be available in the countries listed below.

Ingredient matches for Betlol SR

Bezafibrate

Bezafibrate is reported as an ingredient of Betlol SR in the following countries:

• Japan

International Drug Name Search

Humex rhume des foins a la béclométasone

Humex rhume des foins a la béclométasone may be available in the countries listed below.

Ingredient matches for Humex rhume des foins a la béclométasone

Beclometasone

Beclometasone 17α,21-dipropionate (a derivative of Beclometasone) is reported as an ingredient of Humex rhume des foins a la béclométasone in the following countries:

• France

International Drug Name Search

Atenentoin

Atenentoin may be available in the countries listed below.

Ingredient matches for Atenentoin

Aldioxa

Aldioxa is reported as an ingredient of Atenentoin in the following countries:

• Japan

International Drug Name Search

Bicalutamid Aristo

Bicalutamid Aristo may be available in the countries listed below.

Ingredient matches for Bicalutamid Aristo

Bicalutamide

Bicalutamide is reported as an ingredient of Bicalutamid Aristo in the following countries:

• Germany

International Drug Name Search

Carvedilol Labesfal

Carvedilol Labesfal may be available in the countries listed below.

Ingredient matches for Carvedilol Labesfal

Carvedilol

Carvedilol is reported as an ingredient of Carvedilol Labesfal in the following countries:

• Portugal

International Drug Name Search

Caid

Caid may be available in the countries listed below.

Ingredient matches for Caid

Aspirin

Acetylsalicylic Acid is reported as an ingredient of Caid in the following countries:

• Bangladesh

International Drug Name Search

Rifoldin

Rifoldin may be available in the countries listed below.

Ingredient matches for Rifoldin

Rifampicin

Rifampicin is reported as an ingredient of Rifoldin in the following countries:

• Austria

International Drug Name Search

Alerfast

Alerfast may be available in the countries listed below.

Ingredient matches for Alerfast

Ketotifen

Ketotifen is reported as an ingredient of Alerfast in the following countries:

• Georgia

Loratadine

Loratadine is reported as an ingredient of Alerfast in the following countries:

• Peru

International Drug Name Search

Farbovil

Farbovil may be available in the countries listed below.

Ingredient matches for Farbovil

Ketoprofen

Ketoprofen is reported as an ingredient of Farbovil in the following countries:

• Greece

International Drug Name Search

Indo-CT

Indo-CT may be available in the countries listed below.

Ingredient matches for Indo-CT

Indometacin

Indometacin is reported as an ingredient of Indo-CT in the following countries:

• Germany

International Drug Name Search

Forlax Junior

Forlax Junior may be available in the countries listed below.

Ingredient matches for Forlax Junior

Macrogol

Macrogol 4000 (a derivative of Macrogol) is reported as an ingredient of Forlax Junior in the following countries:

• Belgium


• Luxembourg


• Netherlands

International Drug Name Search

Mirtazapina Agen

Mirtazapina Agen may be available in the countries listed below.

Ingredient matches for Mirtazapina Agen

Mirtazapine

Mirtazapine is reported as an ingredient of Mirtazapina Agen in the following countries:

• Spain

International Drug Name Search

Feranin

Feranin may be available in the countries listed below.

Ingredient matches for Feranin

Iron Polymaltose

Iron Polymaltose is reported as an ingredient of Feranin in the following countries:

• Peru

International Drug Name Search

Accretropin

In the US, Accretropin (somatropin systemic) is a member of the drug class growth hormones and is used to treat Burns - Nitrogen Retention, Cachexia, Hypopituitarism, Pediatric Growth Hormone Deficiency, Short Bowel Syndrome, Short Stature for Age and Turner's Syndrome.

US matches:

• Accretropin

Ingredient matches for Accretropin

Somatropine

Somatropine is reported as an ingredient of Accretropin in the following countries:

• United States

International Drug Name Search

Tetroxy

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Tetroxy

Oxytetracycline

Oxytetracycline is reported as an ingredient of Tetroxy in the following countries:

• United Kingdom

Oxytetracycline dihydrate (a derivative of Oxytetracycline) is reported as an ingredient of Tetroxy in the following countries:

• Ireland


• Sweden

Oxytetracycline hydrochloride (a derivative of Oxytetracycline) is reported as an ingredient of Tetroxy in the following countries:

• Ireland


• United States

Oxytetracycline magnesiumoxyethylammonium (a derivative of Oxytetracycline) is reported as an ingredient of Tetroxy in the following countries:

• United Kingdom

International Drug Name Search

Chlorprothixen Zentiva

Chlorprothixen Zentiva may be available in the countries listed below.

Ingredient matches for Chlorprothixen Zentiva

Chlorprothixene

Chlorprothixene hydrochloride (a derivative of Chlorprothixene) is reported as an ingredient of Chlorprothixen Zentiva in the following countries:

• Bulgaria

International Drug Name Search

Myodura

Myodura may be available in the countries listed below.

Ingredient matches for Myodura

Amlodipine

Amlodipine besilate (a derivative of Amlodipine) is reported as an ingredient of Myodura in the following countries:

• India

International Drug Name Search

Cloruro Potasico Grifols

Cloruro Potasico Grifols may be available in the countries listed below.

Ingredient matches for Cloruro Potasico Grifols

Potassium Chloride

Potassium Chloride is reported as an ingredient of Cloruro Potasico Grifols in the following countries:

• Spain

International Drug Name Search

Etacortilen

Etacortilen may be available in the countries listed below.

Ingredient matches for Etacortilen

Dexamethasone

Dexamethasone 21-(disodium phosphate) (a derivative of Dexamethasone) is reported as an ingredient of Etacortilen in the following countries:

• Italy

International Drug Name Search

Gentagil Fortius

Gentagil Fortius may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Gentagil Fortius

Gentamicin

Gentamicin sulfate (a derivative of Gentamicin) is reported as an ingredient of Gentagil Fortius in the following countries:

• Italy

International Drug Name Search

Keta-S

Keta-S may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Keta-S

Ketamine

Ketamine hydrochloride (a derivative of Ketamine) is reported as an ingredient of Keta-S in the following countries:

• Switzerland

International Drug Name Search

Epinephrine

In some countries, this medicine may only be approved for veterinary use.

In the US, Epinephrine (epinephrine systemic) is a member of the following drug classes: adrenergic bronchodilators, catecholamines, vasopressors and is used to treat Adams-Stokes Syndrome, Allergic Reactions, Asthma - acute, Asystole, AV Heart Block, COPD - Acute, Electromechanical Dissociation and Shock.

US matches:

• Epinephrine Aerosol


• Epinephrine Auto-Injector


• Epinephrine Nebulizer Solution


• Epinephrine Solution


• Epinephrine/Lidocaine Iontophoretic Patch


• Epinephrine and pilocarpine ophthalmic


• Epinephrine injection


• Epinephrine ophthalmic


• Epinephrine y pilocarpine ophthalmic


• Epinephrine

UK matches:

• Epinephrine (Adrenaline) Injection 1:10,000 (International Medication Systems) (SPC)
• Epinephrine (Adrenaline) Injection 1:1000 Minijet (International Medication Systems) (SPC)

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

A01AD01,B02BC09,C01CA24,R01AA14,R03AA01,S01EA01

CAS registry number (Chemical Abstracts Service)

0000051-43-4

Chemical Formula

C9-H13-N-O3

Molecular Weight

183

Therapeutic Category

α-Sympathomimetic agent

Chemical Names

(R)-1-(3,4-Dihydroxyphenyl)-2-(methylamino)ethanol (IUPAC)

(-)-α-3,4-Dihydroxyphenyl)-ß-methylaminoethanol (WHO)

Foreign Names

• Epinephrinum (Latin)
• Epinephrin (German)
• Epinéphrine (French)
• Epinefrina (Spanish)

Generic Names

• Adrenalina (OS: DCIT)
• Adrenaline (OS: BAN)
• Adrénaline (OS: DCF)
• Epinephrine (OS: BAN)
• Paranephrin (IS)
• Adrenaline (PH: Ph. Eur. 6, BP 2010, JP XV)
• Adrenalinum (PH: Ph. Eur. 6)
• Epinephrine (PH: Ph. Int. 4, USP 32, BP 2010)
• Epinephrinum (PH: Ph. Int. 4)
• Adrenaline Acid Tartrate (OS: BANM)
• Epinephrine Acid Tartrate (OS: BANM)
• Epinephrine Tartrate (IS)
• Adrénaline (tatrate d') (PH: Ph. Eur. 6)
• Adrenaline Acid Tartrate (PH: BP 2010)
• Adrenaline tartrate (PH: Ph. Eur. 6)
• Adrenalini tartras (PH: Ph. Eur. 6)
• Epinephrine Acid Tartrate (PH: BP 2010)
• Epinephrine Bitartrate (PH: USP 32)
• Epinephrine Hydrogen Tartrate (PH: Ph. Int. 4)
• Epinephrinhydrogentartrat (PH: Ph. Eur. 6)
• Epinephrini hydrogenotartras (PH: Ph. Int. 4)
• Epinephrine Hydrochloride (PH: JP VIII)

Brand Names

• Adreject
  Alk, Spain



• Adrenalin Carino
  Carinopharm, Germany



• Adrenalin
  Biofarma, Bosnia & Herzegowina; Biofarma, Turkey; Braun, Luxembourg; Briz, Latvia; Drogsan, Turkey; Galen, Turkey; Leiras, Finland; Memphis Co., Egypt; Osel, Turkey; Terapia, Bulgaria



• Adrenalina B Braun
  Braun, Spain



• Adrenalina Biol
  Biol, Argentina



• Adrenalina Biologici
  Biologici, Italy



• Adrenalina Cloruro
  Roemmers, Venezuela



• Adrenalina Fada
  Fada, Argentina



• Adrenalina Galenica
  Galenica, Italy



• Adrenalina Inyectable
  Ecar, Colombia



• Adrenalina Larjan
  Veinfar, Argentina



• Adrenalina Monico
  Monico, Italy



• Adrenalina Salf
  Salf, Italy



• Adrenalina WZF
  Polfa Lódz, Poland



• Adrenalina
  Medifarm, Venezuela; Pifano, Venezuela; Ponce & Benzo, Venezuela



• Adrenalinã
  Terapia, Romania



• Adrénaline Aguettant
  Aguettant, France; Aguettant, Malta



• Adrénaline Renaudin
  Renaudin, France



• Adrenaline
  Aguettant, Tunisia; Gedeon Richter, Ethiopia; Renaudin, Tunisia; Teva, Israel



• Adrenalinum
  Polfa Warszawa, Lithuania



• Adrenotone
  Merck Generics, South Africa



• Alfacaina (Epinephrine and Atricaine)
  Dentsply, Italy



• Anapen Junior
  Lincoln, Netherlands; Owen Mumford, Bulgaria; UCB, Ireland



• Anapen Junior (pediatric)
  Lincoln, Austria



• Anapen
  AllergyCare, Switzerland; CSP, France; Decomed, Portugal; Lincoln, Austria; Lincoln, Czech Republic; Lincoln, Luxembourg; Lincoln, Netherlands; Lincoln, Poland; Lincoln Medical, United Kingdom; Lincoln Medical, Hungary; Medeca, Sweden; Owen Mumford, Bulgaria; Owen Mumford, Romania; UCB, United Arab Emirates; UCB, Bahrain; UCB, Egypt; UCB, Ireland; UCB, Iraq; UCB, Iran; UCB, Jordan; UCB, Lebanon; UCB, Oman; UCB, Qatar; UCB, Saudi Arabia; UCB, Syria; UCB, Yemen



• Anapen Junior
  Dr. Beckmann, Germany



• Anapen Junior (pediatric)
  AllergyCare, Switzerland; Lincoln Medical, United Kingdom; Medeca, Sweden



• Anestesia Topica Braun Con Adrenalina (Epinephrine and Tetracaine)
  Braun, Spain



• Aspen Adrenaline
  Aspen, Australia



• Biodicaine Adrenalinée (Epinephrine and Lidocaine)
  Biodica, France



• Bosmin
  Daiichi, Taiwan; Daiichi Sankyo, Japan



• Bucanest (Epinephrine and Articaine)
  Biodica, Australia



• Bupivacaine Hydrochloride and Epinephrine (Epinephrine and Bupivacaine hydrochloride)
  APP, United States



• Carbocain adrenalin (Epinephrine and Mepivacaine)
  AstraZeneca, Sweden



• Deltazine (Epinephrine and Articaine)
  Ato Zizine, Australia



• Epiject
  Alk, Spain



• Epinefrina Dany
  Dany, Peru



• Epinefrina GP Pharm
  GP Pharm, Peru



• Epinefrina Sanderson
  Sanderson, Peru



• Epinefrina
  Biosano, Chile; Farmionni, Colombia; Sanderson, Chile



• Epinephrine Injection
  Alveda Pharma, Canada



• Epinephrine Mist
  Armstrong, United States; Cardinal Health, United States



• Epinephrine
  Armstrong, United States; Hospira, Canada; International Medication Systems, United Kingdom; Terumo, Japan



• EpiPen
  ALK, United Arab Emirates; ALK, Austria; ALK, Bahrain; ALK, Czech Republic; ALK, Egypt; ALK, Finland; ALK, United Kingdom; ALK, Hungary; ALK, Iraq; ALK, Iran; ALK, Iceland; ALK, Jordan; ALK, Kuwait; ALK, Lebanon; ALK, Netherlands; ALK, Qatar; ALK, Saudi Arabia; ALK, Sweden; ALK Abelló, Denmark; Alk-Abelló, Switzerland; Alk-Abelló, Poland; CSL Biotherapies, New Zealand; Dey, United States; Euro, Netherlands; King Pharma, Canada; Merck, Singapore; Merck Serono, South Africa; Meridian, United States; Trupharm, Israel



• EpiPen Jr
  King Pharma, Canada



• EpiPen Jr (pediatric)
  ALK, Norway; ALK, Sweden; Merck, Singapore



• EpiPen Junior (pediatric)
  ALK, Austria; Alk-Abelló, Switzerland



• Fastject
  Allergopharma, Luxembourg



• Fastjekt
  Merck, Italy



• Giancaina (Epinephrine and Lidocaine)
  Gianfarma, Peru



• Injectio Adrenalini
  Polfa Warszawa, Poland



• Isocain (Epinephrine and Procaine (veterinary use))
  Selecta, Germany



• L-Adrenalin Fresenius
  Fresenius Kabi, Austria



• Lidocaina Dany (Epinephrine and Lidocaine)
  Dany, Peru



• Lidocaine Hydrochloride and Epinephrine (Epinephrine and Lidocaine)
  Alveda Pharma, Canada; Eastman Kodak, United States; Graham, United States; Hospira, United States



• Lidocain-Epinephrin Streuli (Epinephrine and Lidocain)
  Streuli Pharma, Switzerland



• Lidocaton (Epinephrine and Lidocaine)
  Pharmaton, United States



• Lidocom Epinefrina (Epinephrine and Lidocaine)
  Comiesa Druc, Peru



• Lignospan (Epinephrine and Lidocaine)
  Nippon Shika YakuhinDental Pharm, Japan



• Lignospan S (Epinephrine and Lidocaine)
  Nippon Shika YakuhinDental Pharm, Japan



• Marcain Dental (Epinephrine and Bupivacaine)
  AstraZeneca, New Zealand; Dentsply, Australia



• Marcain with Adrenalin (Epinephrine and Bupivacaine)
  AstraZeneca, Australia



• Marcain adrenalin (Epinephrine and Bupivacaine)
  AstraZeneca, Sweden



• Meganest (Epinephrine and Articaine)
  Clarben, Spain



• Mepi Mynol (Epinephrine and Mepivacaine)
  Curaden, Italy



• Mepivac (Epinephrine and Mepivacaine)
  Comiesa Druc, Peru



• Noradren
  Demo, Greece



• Nurocain (Epinephrine and Lidocaine)
  Dentsply, Australia



• Octocaine (Epinephrine and Lidocaine)
  Clarben, Spain; Septodont, United States



• Pehacain (Epinephrine and Lidocaine)
  Phapros Tbk, Indonesia



• Posumin
  Metro, Taiwan



• Primatene
  Wyeth, United States



• Scandonest (Epinephrine and Mepivacaine)
  Septodont, Bulgaria



• Scandonest-Adrenalin (Epinephrine and Mepivacaine)
  Septodont, Denmark



• Sensorcaine with Epinephrine (Epinephrine and Bupivacaine)
  AstraZeneca, Canada



• Septanest (Epinephrine and Articaine)
  Specialites Septodont, Australia



• Septocaine (Epinephrine and Articaine)
  Septodont, Norway



• Tonogen
  Gedeon Richter, Hungary



• Twinject
  Paladin, Canada; Shionogi, United States; Verus, United States



• Ubistesin (Epinephrine and Articaine)
  3M, New Zealand; 3M ESPE AG, Denmark; ESPE, Slovenia



• Ultracain D-S (Epinephrine and Articaine)
  Sanofi-Aventis, Slovenia



• Xylanaest mit Epinephrin (Epinephrine and Lidocain)
  Gebro, Austria



• Xylestesin A (Epinephrine and Lidocaine)
  3M, Japan



• Xylocain Dental adrenalin (Epinephrine and Lidocaine)
  Dentsply, Norway



• Xylocain-Adrenalin (Epinephrine and Lidocaine)
  AstraZeneca, Norway



• Xylocaine with Adrenaline (Epinephrine and Lidocaine)
  AstraZeneca, United Kingdom; AstraZeneca, New Zealand; Dentsply, New Zealand



• Xylocaine (Epinephrine and Lidocaine)
  AstraZeneca, Japan; Dentsply, Australia



• Xylocaine with Epinephrine (Epinephrine and Lidocaine)
  AstraZeneca, Canada



• Xylocaine-Epinephrine (Epinephrine and Lidocaine)
  APP, United States



• Xylodont z adrenalina (Epinephrine and Lidocain)
  L.Molteni, Poland



• Adrenalin Amino
  Amino, Switzerland



• Adrenalin Dak
  Nycomed, Denmark



• Adrenalin Jenapharm
  Mibe Jena, Germany



• Adrenalin Mylan
  Mylan, Sweden



• Adrenalin SAD
  Amgros, Denmark



• Adrenalin
  Leiras, Finland; Nycomed, Norway



• Adrenalin (veterinary use)
  Nycomed Vet, Norway



• Adrenaline Acid Tartare Injection
  AstraZeneca, New Zealand



• Adrenaline Atlantic
  Atlantic, Singapore



• Adrenaline Injection Demo
  Demo, Estonia; Demo, Greece



• Adrenaline Injection
  AstraZeneca, Australia



• Adrenaline
  Antigen, Bahrain; Antigen, Malta; Antigen, Oman; Demo, Latvia; Hameln, United Kingdom; Hospira, New Zealand; IMS, Oman; Margalit, Israel; UCB, United Arab Emirates; UCB, Egypt; UCB, Iraq; UCB, Iran; UCB, Jordan; UCB, Kuwait; UCB, Qatar; UCB, Saudi Arabia; UCB, Syria; UCB, Yemen



• Adrenaline (veterinary use)
  Alfasan, Netherlands; Kombivet, Netherlands



• Adrenaline-Fresenius
  Bodene, South Africa



• Adrenalinum
  Warsaw Pharmaceutical Works, Latvia



• Adrilan (veterinary use)
  Sorologico, Portugal



• Adrin
  Gaco, Bangladesh



• Articadent (Epinephrine and Articaine)
  Dentsply, France



• Articaina con Adrenalina (Epinephrine and Articaine)
  Pierrel, Italy



• Articaine hydrochloride with Epinephrine (Epinephrine and Articaine)
  Pierrel, United States



• Artinibsa (Epinephrine and Articaine)
  Inibsa, Spain



• Aspen Adrenaline
  Aspen, New Zealand



• Bronitin Mist
  Wyeth, United States



• Bucanest Adrenalinée (Epinephrine and Articaine)
  Biodica, France



• Bupicain + Adrenalina (Epinephrine and Bupicacaine)
  Monico, Italy



• Bupiforan + Adrenalina (Epinephrine and Bupicacaine)
  Baxter-RM, Italy



• Bupisen + Adrenalina (Epinephrine and Bupivacaine)
  Galenica Senese, Italy



• Bupisolver + Adrenalina (Epinephrine and Bupivacaine)
  Altaselect, Italy



• Bupivacain Jenapharm mit Epinephrin (Epinephrine and Bupivacaine)
  Mibe Jena, Germany



• Bupivacaïne Aguettant Adrenaline (Epinephrine and Bupivacaine)
  Aguettant, France



• Bupivacaine Hydrochloride and Epinephrine (Epinephrine and Bupivacaine hydrochloride)
  Hospira, United States



• Carbocain-Adrenalin (Epinephrine and Mepivacaine)
  AstraZeneca, Denmark



• Carboplyina + Adrenalina (Epinephrine and Mepivacaine)
  Dentsply, Italy



• Carbosen + Adrenalina (Epinephrine and Mepivacaine)
  Galenica Senese, Italy



• Cartidont (Epinephrine and Articaine)
  Curaden, Italy



• Citanest Forte (Epinephrine and Prilocaine)
  Dentsply, United States



• Citanest (Epinephrine and Prilocaine)
  Dentsply-Sankin, Japan



• Citocartin (Epinephrine and Articaine)
  Molteni, Italy



• Déltazine Adrénalinée (Epinephrine and Articaine)
  A.T.O. Zizine, France



• Dentacaine (Epinephrine and Lidocaine)
  Shiono Kemikaru, Japan



• Ecocain (Epinephrine and Lidocaine)
  Julphar, Oman



• Epinefrine CF
  Centrafarm, Netherlands



• InfectoKrupp Inhal
  Infectopharm, Germany



• Lidocaina + Adrenalina Pierrel (Epinephrine and Lidocaine)
  Pierrel, Italy



• Lidocaina Epinefrina Diasa (Epinephrine and Lidocaine)
  Diasa, Spain



• Lidocaina Epinefrina Normon (Epinephrine and Lidocaine)
  Normon, Spain



• Lidocaïne Adrénaline Aguettant (Epinephrine and Lidocaine)
  Aguettant, France



• Lidokain-adrenalin SAS (Epinephrine and Lidocaine)
  SAD, Denmark



• Lidokain-adrenalin (Epinephrine and Lidocaine)
  Belupo, Croatia (Hrvatska)



• Lidokel-Adrenalin (Epinephrine and Lidocaine (veterinary use))
  Kela, Norway



• Lidonet (Epinephrine and Lidocaine)
  A.DH. Pharm, Greece



• Lignocaine (Epinephrine and Lidocaine (veterinary use))
  Ilium Veterinary Products, Australia



• Lignospan (Epinephrine and Lidocaine)
  Deproco, United States; Specialites Septodont, Australia



• Marcain with Adrenalin (Epinephrine and Bupivacaine)
  AstraZeneca, Denmark; AstraZeneca, New Zealand



• Marcain-Adrenalin (Epinephrine and Bupivacaine)
  AstraZeneca, Norway



• Mepiforan + Adrenalina (Epinephrine and Mepivacaine)
  Baxter-RM, Italy



• Mepisolver + Adrenalina (Epinephrine and Mepivacaine)
  Altaselect, Italy



• Mepivacaina + Adrenalina Angelini (Epinephrine and Mepivacaine)
  Angelini, Italy



• Mepivacaina + Adrenalina Pierrel (Epinephrine and Mepivacaine)
  Pierrel, Italy



• Ora (Epinephrine and Lidocaine)
  Showa Yakuhin Kako, Japan



• Scandinibsa C Epinefrina (Epinephrine and Mepivacaine)
  Inibsa, Spain



• Scandonest (Epinephrine and Mepivacaine)
  Wild, Switzerland



• Sensorcaine with Epinephrine (Epinephrine and Bupivacaine)
  APP, United States



• Septanest (Epinephrine and Articaine)
  Septodont, Bulgaria; Septodont, Netherlands; Wild, Switzerland



• Septocaine (Epinephrine and Articaine)
  Deproco, United States



• Sopira Citocartin mit Epinephrin (Epinephrine and Articaine)
  Heraeus Medical, Germany



• Xilonibsa Con Epinefrina (Epinephrine and Lidocaine)
  Inibsa, Spain



• Xylocain Adrenalin (Epinephrine and Lidocaine)
  AstraZeneca, Switzerland; AstraZeneca, Sweden



• Xylocain mit Adrenalin (Epinephrine and Lidocaine)
  AstraZeneca, Germany; Dentsply, Germany



• Xylocain-Adrenalin (Epinephrine and Lidocaine)
  AstraZeneca, Denmark



• Xylocaine with Adrenaline (Epinephrine and Lidocaine)
  AstraZeneca, Australia



• Xylocaine avec Adrenaline (Epinephrine and Lidocaine)
  AstraZeneca, Belgium



• Xylocitin mit Epinephrin (Epinephrine and Lidocaine)
  Mibe Jena, Germany



• Xylonest mit Adrenalin (Epinephrine and Prilocaine)
  AstraZeneca, Germany



• Xyloplyin Dental Adrenalin (Epinephrine and Lidocaine)
  Dentsply Ltd.GB, Denmark



• Adrenalin HCl
  Jugoremedija, Serbia



• Adrenalin Leciva
  Leciva, Czech Republic; Zentiva, Slovakia



• Adrenalin Sintetica
  Sintetica, Switzerland



• Adrenalin
  Braun Melsungen, Luxembourg; King, United States



• Adrenalina Apolo
  Apolo, Argentina



• Adrenalina Level
  Ern, Spain



• Adrenalin-Braun
  Braun, Luxembourg



• Adrenaline Hydrochloride Injection
  CSL, Australia



• Adrenaline Xinhua Pharm
  Xinhua, China



• Adrenaline
  CSL Biotherapies, New Zealand



• Alfacaina (Epinephrine and Atricaine)
  Dentsply, Italy



• Alphacaïne (Epinephrine and Articaine)
  Dentsply, France; Heck Pharma, Switzerland



• Anapen
  Dr. Beckmann, Germany



• Articaina Epinefrina Diasa (Epinephrine and Articaine)
  Diasa, Spain



• Citocartin (Epinephrine and Articaine)
  Molteni, Poland



• Clorhidrato de adrenalina Richmond
  Richmond, Argentina



• Ephedrin HCl Bichsel
  Bichsel, Switzerland



• Epifrin
  Allergan, United States



• Epinefrina Life
  Life, Ecuador



• Epinephrine Hydrochloride
  Abbott, United States; Hospira, United States; IMS, United States



• Epinephrine Injection
  AstraZeneca, United States; IMS, United States



• EpiPen
  ALK, Belgium; ALK, Norway; CSL, Australia; Dey, United States; Merck, Portugal



• EpiPen Jr (pediatric)
  CSL, Australia



• Fastjekt
  Allergopharma, Germany; Allergopharma, Poland



• Glaucon
  Alcon, United States



• Haymine (Epinephrine and Chlorphenamine)
  Chemidex, United Kingdom



• Lignospan (Epinephrine and Lidocaine)
  Septodont, Netherlands



• Neo-Xylestesin (Epinephrine and Lidocaine)
  3M, Austria



• Rapidocain mit Epinephrin (Epinephrine and Lidocaine)
  Sintetica, Switzerland



• Rudocain (Epinephrine and Articaine)
  Streuli Pharma, Switzerland



• Septanest (Epinephrine and Articaine)
  Septodont, Austria; Septodont, Denmark



• Septanest z adrenalin (Epinephrine and Articain)
  Septodont, Poland



• Septocaine (Epinephrine and Articaine)
  Septodont, Denmark



• Supracaine (Epinephrine and Articaine)
  Richter Gedeon RT, Slovakia



• Suprarenin
  Aventis, Slovenia; Sanofi-Aventis, Austria; Sanofi-Aventis, Germany



• Ubistesin (Epinephrine and Articaine)
  3M, Austria; 3M, Switzerland; 3M ESPE, Germany; 3M ESPE, Poland; 3M Svenska, Sweden



• Ultracain Epinefrina (Epinephrine and Articaine)
  Normon, Spain



• Ultracain (Epinephrine and Articaine)
  Sanofi-Aventis, Austria



• Ultracain D-S (Epinephrine and Articaine)
  Sanofi-Aventis, Switzerland; Sanofi-Aventis, Germany; Sanofi-Aventis, Netherlands



• Ultracain Suprarenin (Epinephrine and Articaine)
  Sanofi-Aventis, Germany



• Xylocaine-Adrenaline (Epinephrine and Lidocaine Hydrochloride)
  AstraZeneca, Ethiopia



• Xylocaine-Epinephrine (Epinephrine and Lidocaine)
  AstraZeneca, Netherlands

International Drug Name Search

Glossary

BAN	British Approved Name
BANM	British Approved Name (Modified)
DCF	Dénomination Commune Française
DCIT	Denominazione Comune Italiana
IUPAC	International Union of Pure and Applied Chemistry
IS	Inofficial Synonym
OS	Official Synonym
PH	Pharmacopoeia Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
SPC	Summary of Product Characteristics (UK)
WHO	World Health Organization

Click for further information on drug naming conventions and International Nonproprietary Names.