ALPHAGAN 0.2 %w/v Ear Drops Solution
Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Tabia za bidhaa
(SPC)
30-05-2024
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Viambatanisho vya kazi:
BRIMONIDINE TARTRATE
Inapatikana kutoka:
LTT Pharma Limited
INN (Jina la Kimataifa):
BRIMONIDINE TARTRATE
Kipimo:
0.2 %w/v
Dawa fomu:
Ear Drops Solution
Dawa ya aina:
Product subject to prescription which may be renewed (B)
Idhini hali ya:
Authorised
Idhini ya tarehe:
0000-00-00
Tabia za bidhaa
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Alphagan 0.2% w/v (2 mg/ml) eye drops, solution
2 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
3 PHARMACEUTICAL FORM
Eye drops, solution.
_Product imported from the UK_
Clear, greenish-yellow to light greenish-yellow solution.
4 CLINICAL PARTICULARS
4.1 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 therapy to other intraocular pressure lowering medications when the target IOP is not achieved with a
single agent (see Section 5.1).
4.2 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 the use in elderly patients.
As with any eye drops, to reduce possible systemic absorption, it is recommended that the lachrymal sac be compressed
at the medial canthus (punctal occlusion) for one minute. This should be performed immediately following the
instillation of each drop.
If more than one topical ophthalmic drug is to be used, the different drugs should be instilled 5-15 minutes apart.
_Use in renal and hepatic impairment_
Alphagan has not been studied in patients with hepatic or renal impairment (see section 4.4).
_Use in paediatric subjects_
No clinical studies have been performed in adolescents (12 to 17 years).
Alphagan is not recommended for use in children bel
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