Страна: Малайзія
мова: англійська
Джерело: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TIMOLOL MALEATE; LATANOPROST
Generic Partners (M) Sdn Bhd
TIMOLOL MALEATE; LATANOPROST
2.5ml x 1 bottle BOTTLE
S.C. ROMPHARM COMPANY S.R.L.
_Consumer Medication Information Leaflet (RiMUP) _ XALANOTIM EYE DROPS latanoprost 50 micrograms/ml and timolol (as timolol maleate) 5 mg/ml 1 WHAT IS IN THIS LEAFLET 1. What XALANOTIM is used for 2. How XALANOTIM works 3. Before you use XALANOTIM 4. How to use XALANOTIM 5. While you are using XALANOTIM 6. Side Effects 7. Storage and disposal of XALANOTIM 8. Product description 9. Manufacturer 1. WHAT XALANOTIM IS USED FOR Reduction of intraocular pressure (lOP) in patients with open angle glaucoma and ocular hypertension who are insufficiently responsive to topical beta-blockers. 2. HOW XALANOTIM WORKS XALANOTIM contains two medicines: latanoprost and timolol. Latanoprost belongs to a group of medicines known as prostaglandin analogues. Timolol belongs to a group of medicines known as beta- blockers. Latanoprost works by increasing the natural outflow of fluid from the eye into the bloodstream. Timolol works by slowing the formation of fluid in the eye. XALANOTIM is used to reduce the pressure in your eye if you have conditions known as open angle glaucoma or ocular hypertension. Both these conditions are linked to an increase in the pressure within your eye, eventually affecting your eyesight. Your doctor will usually prescribe you XALANOTIM when other medicines have not worked adequately. 3. BEFORE YOU USE XALANOTIM XALANOTIM can be used in adult men and women (including the elderly), but is not recommended for use if you are less than 18 years of age. _WHEN YOU MUST NOT USE IT: _ When you must not use it: Do not use XALANOTIM: - if you are allergic (hypersensitive) to either of the medicines in XALANOTIM (latanoprost or timolol), beta-blockers, or any of the other ingredients of XALANOTIM (see Section 10 Product Description). - if you have not or have had in the past respiratory problems such as asthma, severe chronic obstructive bronchitis (severe lung disease which may cause wheeziness, difficulty in breathing and/or long- standing cough) - if you have serious heart problems or heart rhythm disorders - Прочитайте повний документ
1 XALANOTIM EYE DROPS, SOLUTION BRAND OR PRODUCT NAME _Xalanotim _Eye Drops, solution NAME AND STRENGTH OF ACTIVE SUBSTANCE(S) Latanoprost 0.05 mg/mL (0.005 % w/v) Timolol maleate 6.83mg/ml equivalent to timolol 5.0 mg/mL (0.5% w/v) PRODUCT DESCRIPTION The solution is a clear and colourless liquid, filled in a transparent low density polyethylene (LDPE) bottles, equipped with transparent LDPE dropper, and a white HDPE screw cap. _ _ PHARMACODYNAMICS Latanoprost/timolol eye drops consist of two components; latanoprost and timolol maleate. These two components decrease elevated intraocular pressure (IOP) by different mechanisms of action and the combined effect results in additional IOP reduction compared to either compound administered alone. Latanoprost is a prostaglandin F 2-alpha analogue and a selective FP prostanoid receptor agonist. It reduces intraocular pressure by increasing the outflow of aqueous humor. Studies suggest that the main mechanism of action is increased uveoscleral outflow. Timolol maleate is a beta1 and beta2 (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 decreasing the formation of aqueous humour in the ciliary epithelium. The precise mechanism of action is not clearly established. PHARMACOKINETICS _Absorption_ Latanoprost is absorbed through the cornea where the isopropyl ester prodrug is hydrolyzed to the acid form to become biologically active. The peak concentration of latanoprost in the aqueous humor is reached about two hours after topical administration. The maximum concentration of timolol in the aqueous humour is reached about 1 hour after topical administration of eye drops. Part of the dose is absorbed systemically and a maximum plasma concentration of 1 ng/mL is reached 10-20 minutes after topical administration of one eye drop to each eye once daily (300 µg/day). _Distribution_ Latanoprost: Active metabolite has Прочитайте повний документ