Страна: Малайзия
Язык: английский
Источник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BRIMONIDINE TARTRATE
Allergan Malaysia Sdn Bhd
BRIMONIDINE TARTRATE
3ml mL; 5ml mL; 10ml mL; 15ml mL
Allergan Sales, LLC
ALPHAGAN ® P OPHTHALMIC SOLUTION brimonidine tartrate (0.15% w/v) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What ALPHAGAN ® P is used for 2. How ALPHAGAN ® P works 3. Before you use ALPHAGAN ® P 4. How to use ALPHAGAN ® P 5. While you are using it 6. Side effects 7. Storage and Disposal of ALPHAGAN ® P 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT ALPHAGAN ® P IS USED FOR ALPHAGAN ® P is used to lower pressure in the eye of people with glaucoma or high pressure in the eye. HOW ALPHAGAN ® P WORKS ALPHAGAN ® P is an eye drop solution that reduces the amount of fluid flowing into the eye and increases the amount of fluid flowing out of the eye. This reduces the pressure inside the eye. BEFORE YOU USE ALPHAGAN ® P _ _ - _When you must not use it_ _ _ _ _ Do not use ALPHAGAN ® P : - If you are allergic (hypersensitive to brimonidine tartrate, or any of the other ingredients of ALPHAGAN ® P . (for a full list of ingredients, see section “PRODUCT DESCRIPTION”). - If you are taking monoamine oxidase antidepressant medication (MAO) - For neonates and infants (children under the age of 2 years) If you are not sure whether you should start using ALPHAGAN ® P , talk to your doctor. - _Pregnancy and lactation _ Discuss with your doctor the possible risks and benefits of using ALPHAGAN ® P during pregnancy. Discuss with your doctor the possible risks and benefits of using ALPHAGAN ® P when breast-feeding. - _Children _ The safe and effective use of ALPHAGAN ® P in children under the age of 2 has not been established. - _Before you start use it _ Tell your doctor if: 1. You have had an allergy to any other medicines or any other substances, such as foods, preservatives or dyes. 2. You have or have had any medical conditions, especially the following: - Liver or kidney disease - Severe, uncontrolled heart disease, poor blood flow to the heart or recurring inflammation and clotting of small and medium blood vessels of the Прочитать полный документ
* ARTWORK IS ACTUAL SIZE * DROP NOTES AND TEMPLATE BEFORE PROCESSING * IF REQUIRED, BARCODE AND CONTROL BAR(S) WILL BE ADDED BY SUPPLIER * PERFORATION REQUIRED: NO Part Number: 91773MY_INT_01 Drawing Number: 0196601 Page: 1 of 2 Date of Revision: 15 MARCH 2017 DESCRIPTION ALPHAGAN® P (brimonidine tartrate ophthalmic solution) 0.15% is a relatively selective alpha-2 adrenergic agonist for ophthalmic use. The chemical name of brimonidine tartrate is 5-bromo- 6- (2-imidazolidinylideneamino) quinoxaline L-tartrate. It is an off-white to pale yellow powder. It has a molecular weight of 442.24 as the tartrate salt, and is both soluble in water (1.5 mg/mL) and in the product vehicle (3.0 mg/mL) at pH 7.2. The structural formula is: Formula: C 11H10BrN5•C4H6O6 CAS Number: 59803-98-4 In solution, ALPHAGAN® P (brimonidine tartrate ophthalmic solution) 0.15% has a clear, greenish-yellow color. It has an osmolality of 250-350 mOsmol/kg and a pH of 6.6-7.4. Each mL of ALPHAGAN® P contains: Active ingredient: brimonidine tartrate 0.15% (1.5 mg/mL) Preservative: PURITE® 0.005% (0.05mg/mL) CLINICAL PHARMACOLOGY Mechanism of action: ALPHAGAN® P is an alpha adrenergic receptor agonist. It has 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 humor production and increasing uveoscleral outflow. Pharmacokinetics: 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. In humans, systemic metabolism of brimonidine is extensive. It is metabolized primarily by the liver. Urinary excretion is the major route of elimination of the drug and its metabolites. Approximately 87% of an orally-administered radioactive dose was eliminated within 120 hours, with 74% found in the urine. Clinical Evaluations: Elevated IOP presents a major risk factor in glaucomatous fie Прочитать полный документ