ALPHAGAN Eye drops, solution (2022)
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Περιεχόμενα
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. <u>Excipient with known effect:</u> Contains benzalkonium chloride 0.05 mg/ml. For the full list of excipients, ...
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
Posology 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 ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Neonates and infants (less than 2 years of age) (see section 4.8). Patients receiving monoamine oxidase (MAO) ...
Special warnings and precautions for use
Paediatric population 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 ...
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
Pregnancy 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 ...
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
<b>Pharmacotherapeutic group:</b> Sympathomimetics in glaucoma therapy <b>ATC code:</b> S01EA05 Brimonidine is an alpha<sub>2</sub>-adrenergic receptor agonist that is 1000-fold more selective for the ...
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
<u>Before first opening:</u> 2 years for the 2.5 ml container. 3 years for the 5 ml and 10 ml containers. <u>After first opening:</u> 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
AbbVie Ltd., Maidenhead, SL6 4UB, UK
Marketing authorization number(s)
PL 41042/0052
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
01/04/2022
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