Ülke: İsveç
Dil: İsveççe
Kaynak: Läkemedelsverket (Medical Products Agency)
brimonidintartrat
BIOGARAN
S01EA05
brimonidine tartrate
2 mg/ml
Ögondroppar, lösning
brimonidintartrat 2 mg Aktiv substans; bensalkoniumklorid Hjälpämne
Receptbelagt
Förpacknings: Flaska, 5 ml; Flaska, 3 x 5 ml; Flaska, 6 x 5 ml
Avregistrerad
2017-10-25
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BRIMONIDINE BIOGARAN 2 MG/ML EYE DROPS, SOLUTION 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 Brimonidine Biogaran is and what it is used for 2. What you need to know before you use Brimonidine Biogaran 3. How to use Brimonidine Biogaran 4. Possible side effects 5. How to store Brimonidine Biogaran 6. Contents of the pack and other information 1. WHAT BRIMONIDINE BIOGARAN IS AND WHAT IT IS USED FOR The active ingredient in Brimonidine Biogaran is brimonidine tartrate which belongs to a group of medicines called sympathomimetics. It works by reducing pressure within the eyeball in the conditions open angle glaucoma or ocular hypertension. It can be used either alone or with another eye drop, if a single medicine is not enough to lower the increased pressure in the eye. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE BRIMONIDINE BIOGARAN DO NOT USE BRIMONIDINE BIOGARAN: If you are allergic to brimonidine or any of the other ingredients of this medicine (listed in section 6). If you are taking monoamine oxidase (MAO) inhibitors or certain antidepressants. You must inform your doctor if you are taking any antidepressant drug. In infants/babies (from birth until 2 years). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Brimonidine Biogaran 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 o Belgenin tamamını okuyun
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Brimonidine Biogaran 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) with known effect: Contains benzalkonium chloride 0.05 mg/ml. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, solution. Clear and slightly greenish-yellow solution, pH 5.5-6.5, and osmolality 275-350 mOsm/kg. 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 Posology _Recommended dosage in adults (including the elderly) _ The recommended dose is one drop of brimonidine tartrate 2 mg/ml eye drops, solution 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 tartrate 2 mg/ml eye drops, solution has not been studied in patients with hepatic or renal impairment (see section 4.4). _Paediatric population_ No clinical studies have been performed in adolescents (12 to 17 years). 2 Brimonidine tartrate 2 mg/ml eye drops, solution is not recommended for use in children below 12 years and is contraindicated in neonates and infants (less than 2 years o Belgenin tamamını okuyun