国家: 南非
语言: 英文
来源: South African Health Products Regulatory Authority (SAHPRA)
Abbvie (Pty) Ltd
See ingredients
SOLUTION
EACH 1,0 ml SOLUTION CONTAINS BRIMONIDINE TARTRATE 1,5 mg
Registered
2007-05-10
Allergan Pharmaceuticals (Pty) Ltd Alphagan ® Purite ® Brimonidine tartrate 1,5 mg/ml Ophthalmic solution 1.3.2 Patient Information Leaflet Page 1 Submitted: 13 Jul 2016; Ref: mcc-80.2016; Approved: 18 Oct 2016 (SR-PIN) PATIENT INFORMATION LEAFLET SCHEDULING STATUS Schedule 3 PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM ALPHAGAN ® PURITE ® , BRIMONIDINE TARTRATE 1,5 mg/ml ophthalmic solution READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING ALPHAGAN ® PURITE ® • Keep this leaflet. You may need to read it again. • If you have further questions, please ask your doctor or your pharmacist. • ALPHAGAN ® Purite ® has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours. 1. WHAT ALPHAGAN ® PURITE ® CONTAINS • The active substance is brimonidine tartrate • The other ingredients are boric acid, calcium chloride, magnesium chloride, potassium chloride, purified water, sodium borate, sodium carboxymethylcellulose, sodium chloride and Purite ® (stabilised oxychloro complex) 0,005 % m/v_ _as preservative. 2. WHAT ALPHAGAN ® PURITE ® IS USED FOR ALPHAGAN ® Purite ® ophthalmic solution helps fluid flow out of the eye chamber and also decreases the fluid produced by the eye. This lowers the pressure in the eye. ALPHAGAN ® Purite ® can be used either alone or with another eye drop which lowers pressure in the eye for the treatment of high pressure in the eye in glaucoma or ocular hypertension. 3. BEFORE YOU USE ALPHAGAN ® PURITE ® DO NOT USE ALPHAGAN ® PURITE ® • If you are hypersensitive (allergic) to brimonidine tartrate or any of the ingredients of ALPHAGAN ® Purite ® . ALPHAGAN ® Purite ® should not be used in neonates and infants under the age of 2 years. TAKE SPECIAL CARE WITH ALPHAGAN ® PURITE ® • If you have any diseases associated with the heart. • If you have any diseases that affect the kidney or liver. • If you suffer or have suffered from depression, reduced 阅读完整的文件
Allergan Pharmaceuticals (Pty) Ltd Alphagan ® Purite ® Brimonidine tartrate 1,5 mg/ml Ophthalmic solution 1.3.1.1 Package Insert Page 1 Submitted: 13 Jul 2016; Ref: mcc-80.2016; Approved: 18 Oct 2016 (SR-PIN) SCHEDULING STATUS Schedule 3 PROPRIETARY NAME AND DOSAGE FORM ALPHAGAN ® PURITE ® Ophthalmic solution COMPOSITION Each ml contains: Brimonidine tartrate 1,5 mg Excipients: Boric acid, calcium chloride dehydrate, magnesium chloride hexahydrate; potassium chloride, purified water, sodium borate decahydrate, sodium carboxymethylcellulose, sodium chloride. Preservative: Purite ® (stabilised oxychloro complex) 0,005 % m/v PHARMACOLOGICAL CLASSIFICATION A.15.4 Ophthalmic preparations. Other. PHARMACOLOGICAL ACTION PHARMACODYNAMIC PROPERTIES Brimonidine tartrate is a selective alpha-2-adrenergic receptor agonist. Topical administration of brimonidine decreases intraocular pressure (IOP) in humans with a peak ocular hypotensive effect occurring at two hours post-dosing. Fluorophotometric studies in animals and humans suggest that brimonidine tartrate has a dual mechanism of action by reducing aqueous humour production and increasing uveoscleral outflow. . PHARMACOKINETIC PROPERTIES _Absorption _ After ocular administration of either a 0,1 % or 0,2 % solution, plasma concentrations peaked within 0,5 to 2,5 hours and declined with a systemic half-life of approximately 2 hours. _Distribution _ The protein binding of brimonidine has not been studied. _Metabolism _ In humans brimonidine is extensively metabolised by the liver. _Elimination _ Urinary excretion is the major route of elimination of the medicine and its metabolites. Approximately 87 % of an orally-administered radioactive dose was eliminated within 120 hours, with 74 % found in the urine. INDICATIONS ALPHAGAN ® Purite ® is indicated for the lowering of intraocular pressure in patients with open- Allergan Pharmaceuticals (Pty) Ltd Alphagan ® Purite ® Brimonidine tartrate 1,5 mg/ml Ophthalmic solution 1.3.1.1 Package Insert Page 2 Submitted: 13 Jul 20 阅读完整的文件