Država: Malezija
Jezik: engleski
Izvor: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BRIMONIDINE TARTRATE; TIMOLOL MALEATE
Allergan Malaysia Sdn Bhd
BRIMONIDINE TARTRATE; TIMOLOL MALEATE
5ml mL
ALLERGAN PHARMACEUTICALS IRELAND
COMBIGAN™ EYE DROPS brimonidine tartrate/timolol (2mg/5mg per 1ml) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What COMBIGAN™ is used for 2. How COMBIGAN™ works 3. Before you use COMBIGAN™ 4. How to use COMBIGAN™ 5. While you are using it 6. Side effects 7. Storage and Disposal of COMBIGAN™ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT COMBIGAN™ IS USED FOR COMBIGAN™ is prescribed to reduce high pressure in the eye of people with glaucoma or high pressure in the eye when other medicines like beta-blocker eye drops used alone are not enough. HOW COMBIGAN™ WORKS COMBIGAN™ works by reducing the production of liquid in the eye and increasing the amount of liquid that is drained away. This reduces the eye pressure. BEFORE YOU USE COMBIGAN™ - _When you must not use it_ _ _ _ _ Do not use COMBIGAN™ : - If you are allergic (hypersensitive to brimonidine tartrate, timolol, beta- blockers, or any of the other ingredients of COMBIGAN™ . (for a full list of ingredients, see section “PRODUCT DESCRIPTION”). Symptoms of an allergic reaction may include swelling of the face, lips and throat, wheeziness, feeling faint, shortness of breath, itching or redness around the eye. - if you have now or have had in the past breathing problems such as asthma or severe chronic obstructive lung disease. - if you have heart problems such as low heart rate, heart failure, heart beat disorders (unless controlled by a pacemaker). - if you are taking monoamine oxidase (MAO) inhibitors or certain other antidepressant medicines. If you think any of these points apply to you, do not use COMBIGAN™ until you have talked again to your doctor. - _Pregnancy and lactation _ Ask your doctor or pharmacist for advice before taking any medicine. Tell your doctor if you are pregnant or planning to become pregnant. Do not use COMBIGAN™ if you are pregnant unless your doctor considers it necessary. Do not use COMBIGAN™ if you are breast-feedi Pročitajte cijeli dokument
* 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:71803MY11 Drawing Number: 0144701 Page: 1 of 2 COMBIGAN ® eye drops brimonidine tartrate 2 mg/mL and timolol 5 mg/mL 71803MY11 DESCRIPTION AND COMPOSITION Each mL contains: 2.0 mg brimonidine tartrate (equivalent to 1.3 mg of brimonidine) and 5.0 mg timolol (equivalent to 6.8 mg of timolol maleate) with benzalkonium chloride, sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, hydrochloric acid or sodium hydroxide to adjust pH, and purified water. COMBIGAN® is a clear, greenish-yellow to light greenish-yellow solution. CLINICAL PHARMACOLOGY Pharmacodynamic properties Pharmacotherapeutic group:Ophthalmological – antiglaucoma preparations and miotics -beta blocking agents - timolol, combinations ATC code: SO1ED 51 Mechanism of action:COMBIGAN® consists of two active substances: brimonidine tartrate and timolol maleate. These two components decrease elevated intraocular pressure (IOP) by complementary mechanisms of action and the combined effect results in additional IOP reduction compared to either compound administered alone. COMBIGAN® has a rapid onset of action. Brimonidine tartrate is an alpha-2 adrenergic receptor agonist that is 1000-fold more selective for the alpha-2 adrenoreceptor than the alpha-1 adrenoreceptor. This selectivity results in no mydriasis and the absence of vasoconstriction in microvessels associated with human retinal xenografts. It is thought that brimonidine tartrate lowers IOP by suppressing aqueous humour inflow and enhancing uveoscleral outflow. Timolol is a beta 1 and beta 2 non-selective adrenergic receptor blocking agent that does not have significant intrinsic sympathomimetic, direct myocardial depressant, or local anaesthetic (membrane-stabilising) activity. Timolol lowers IOP by reducing aqueous humour formation. The precise mechanism of action is not clearly established, bu Pročitajte cijeli dokument