ประเทศ: เนเธอร์แลนด์
ภาษา: ดัตช์
แหล่งที่มา: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
BRIMONIDINETARTRAAT SAMENSTELLING overeenkomend met ; BRIMONIDINE
Medana Pharma Spólka Akcyjna
S01EA05
Brimonidine tartrate COMPOSITION corresponding to ; BRIMONIDINE
Oogdruppels, oplossing
BENZALKONIUMCHLORIDE ; CITROENZUUR 1-WATER (E 330) ; NATRIUMCHLORIDE ; NATRIUMHYDROXIDE (E 524) ; POLYVINYLALCOHOL (E1203) ; TRINATRIUMCITRAAT 2-WATER (E 331) ; WATER, GEZUIVERD ; ZOUTZUUR (E 507),
Oculair gebruik
Brimonidine
Hulpstoffen: BENZALKONIUMCHLORIDE; CITROENZUUR 1-WATER (E 330); NATRIUMCHLORIDE; NATRIUMHYDROXIDE (E 524); POLYVINYLALCOHOL (E1203); TRINATRIUMCITRAAT 2-WATER (E 331); WATER, GEZUIVERD; ZOUTZUUR (E 507);
2012-10-24
1 PACKAGE LEAFLET: INFORMATION FOR THE USER BRIGLAU 2 MG/ML, OOGDRUPPELS, OPLOSSING Brimonidine tartrate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Briglau is and what it is used for 2. What you need to know before you use Briglau 3. How to use Briglau 4. Possible side effects 5. How to store Briglau 6. Contents of the pack and other information 1. WHAT BRIGLAU IS AND WHAT IT IS USED FOR Briglau is used to reduce pressure within the eye. It can be used either alone or with another eye drop to lower the increased pressure in the eye which occurs in open angle glaucoma or ocular hypertension. The active ingredient in Briglau is brimonidine tartrate, which works by reducing pressure within the eyeball. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE BRIGLAU DO NOT USE BRIGLAU: - if you are allergic to brimonidine tartrate or any of the other ingredients of this medicine (listed in section 6). - if you are taking monoamine oxidase (MAO) inhibitors or certain antidepressants, for example tricyclic antidepressants or mianserin. If you are already taking an antidepressant drug, ask your doctor if you can use Briglau. - if you are breast-feeding. - in infants/babies (from birth until 2 years). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Briglau if you: - suffer or have suffered from depression, reduced mental capacity, reduced blood supply to the brain, heart problems, a disturbed blood supply of the limbs or a blood pressure disorder. - have or have had in the past kidney or li อ่านเอกสารฉบับเต็ม
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Briglau 2 mg/ml, oogdruppels, oplossing 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml solution contains 2.0 mg brimonidine tartrate, equivalent to 1.3 mg of brimonidine. Excipient with known effect: benzalkonium chloride. Each ml contains 0.05 mg benzalkonium chloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, solution Clear and yellowish-green liquid Osmolality: 280~330 mOsmol/kg pH: 5.7 - 6.5 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 _ _ Pasology _Adults (including the elderly) _ The recommended dose is one drop of Briglau 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 _ Brimonidine has not been studied in patients with hepatic or renal impairment (see section 4.4). 2 _Paediatric population _ No clinical studies have been performed in adolescents (12 to 17 years). Briglau is not recommended for use in children below 12 years and is contraindicated in neonates and infants (less than 2 years of age) (see sections 4.3, 4.4 and 4.9). It is known that severe adverse reactions can occur in neonates. The safety and efficacy of br อ่านเอกสารฉบับเต็ม