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SPC, UK: Alphagan (2012)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Allergan Ltd
Διεύθυνση :
Marlow International, The Parkway, Marlow, Bucks, SL7 1YL, UK
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Name of the medicinal product

Alphagan 0.2% w/v (2 mg/ml) eye drops, solution.

Qualitative and quantitative composition

One ml solution contains 2.0 mg brimonidine tartrate, equivalent to 1.3 mg of brimonidine. Excipient(s): Contains benzalkonium chloride 0.05 mg/ml. For a full list of excipients, see section 6.1.

Pharmaceutical form

Eye drops, solution. Clear, greenish-yellow to light greenish-yellow solution.

Therapeutic indications

Reduction of elevated intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension. As monotherapy in patients in whom topical beta-blocker therapy is contraindicated. As adjunctive ...

Posology and method of administration

Recommended dosage in adults (including the elderly) The recommended dose is one drop of Alphagan in the affected eye(s) twice daily, approximately 12 hours apart. No dosage adjustment is required for ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Neonates and infants (see section 4.8). Patients receiving monoamine oxidase (MAO) inhibitor therapy and patients on antidepressants ...

Special warnings and precautions for use

Children of 2 years of age and above, especially those in the 2-7 age range and/or weighing ≤ 20 Kg, should be treated with caution and closely monitored due to the high incidence and severity of somnolence ...

Interaction with other medicinal products and other forms of interaction

Alphagan is contraindicated in patients receiving monoamine oxidase (MAO) inhibitor therapy and patients on antidepressants which affect noradrenagic transmission (e.g. tricyclic antidepressants and miaserin), ...

Pregnancy and lactation

The safety of use during human pregnancy has not been established. In animal studies, brimonidine tartrate did not cause any teratogenic effects. In rabbits, brimonidine tartrate, at plasma levels higher ...

Effects on ability to drive and use machines

Alphagan may cause fatigue and/or drowsiness, which may impair the ability to drive or operate machinery. Alphagan may cause blurred and/or abnormal vision, which may impair the ability to drive or to ...

Undesirable effects

The most commonly reported ADRs are oral dryness, ocular hyperaemia and burning/stinging, all occurring in 22 to 25% of patients. They are usually transient and not commonly of a severity requiring discontinuation ...

Overdose

Ophthalmic overdose (Adults) In those cases received, the events reported have generally been those already listed as adverse reactions. Systemic overdose resulting from accidental ingestion (Adults) ...

Pharmacodynamic properties

Pharmacotherapeutic group: Sympathomimetics in glaucoma therapy ATC code: S01EA05 Brimonidine is an alpha-2 adrenergic receptor agonist that is 1000-fold more selective for the alpha-2 adrenoceptor than ...

Pharmacokinetic properties

a) General characteristics After ocular administration of a 0.2% solution twice daily for 10 days, plasma concentrations were low (mean C<sub>max</sub> was 0.06 ng/ml). There was a slight accumulation ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.

List of excipients

Benzalkonium Chloride Poly(vinyl alcohol) Sodium chloride Sodium citrate Citric acid monohydrate Purified water Hydrochloric acid (for pH-adjustment) or Sodium hydroxide (for pH-adjustment)

Incompatibilities

Not applicable.

Shelf life

Before first opening: 2 years for the 2.5 ml container 3 years for the 5 ml and 10 ml containers After first opening: Use within 28 days.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

White low density polyethylene dropper bottles with a 35 microlitre tip. The cap is either a conventional polystyrene screw cap or a Compliance Cap (C-Cap). 2.5 ml, 5 ml and 10 ml bottles in packs of 1, ...

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Allergan Ltd 1st Floor Marlow International The Parkway Marlow Buckinghamshire SL7 1YL UK

Marketing authorization number(s)

PL 00426/0088

Date of first authorization / renewal of the authorization

Date of first authorisation: 18 March 1997 Date of last renewal: 17 September 2006

Date of revision of the text

2 September 2010