Kraj: Malezja
Język: angielski
Źródło: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LEVOCETIRIZINE DIHYDROCHLORIDE
UNIMED SDN BHD
LEVOCETIRIZINE DIHYDROCHLORIDE
200Tablet Tablets; 50 Tablets
FDC LIMITED
LEVOZIN (LEVOCETIRIZINE DIHYDROCHLORIDE CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) TABLETS USP 5MG) WHAT IS IN THIS LEAFLET 1. What LEVOZIN is used for 2. How LEVOZIN works 3. Before you use LEVOZIN 4. How to use LEVOZIN 5. While you are using it 6. Side effects 7. Storage and Disposal of LEVOZIN 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT LEVOZIN IS USED FOR LEVOZIN is an anti-allergic agent. It is used to treat symptoms associated with allergic conditions, such hronic unknown cause of hives. allergic rhinitis (inflammation of the lining inside the nose) HOW LEVOZIN WORKS LEVOZIN helps to relieve allergic symptoms by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. BEFORE YOU USE LEVOZIN - When you must not use it Do not take LEVOZIN if You are allergic (hypersensitive) to LEVOZIN, or any other related substance, or any of the other ingredients of LEVOZIN contains. You have severe kidney impairment You have been told by your doctor that you have intolerance to some sugars - Before you start to use it Check with your doctor of pharmacist before taking LEVOZIN : If you suffer from kidney impairment, you may require a lower dosage and should discuss your situation with your doctor. PREGNANCY AND BREAST-FEEDING No information is available on the safe use of LEVOZIN during pregnancy or breast-feeding. When you are pregnant or breast-feeding you should only use LEVOZIN if there is a clear benefit outweighing the possible risks. Your doctor will make this decision for you. - Taking other medicines Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop. Other medicines may be affected by LEVOZIN. They, in turn, may affect how well LEVOZIN works. HOW TO USE LEVOZIN - How much to use Always use LEVOZIN exactly as your doctor has told you. You should check with your doctor or pharmacist. Adults Przeczytaj cały dokument
For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory. (LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS USP 5 MG / LEVOCETIRIZINE DIHYDROCHLORIDE SYRUP) LEVOZIN TABLETS 5 MG LEVOZIN SYRUP 2.5 MG/5ML (LEVOCETIRIZINE DIHYDROCHLORIDE SYRUP 2.5MG/5ML): DESCRIPTION AND COMPOSITION: Orange coloured syrup pleasantly flavoured having a sweet taste and no sediment filled in amber colour bottle, sealed with ROPP cap labeled and placed in a printed carton. Each 5ml contains: Levocetirizine Dihydrochloride 2.5mg and sunset yellow as permitted colour. LEVOCETIRIZINE TABLETS 5MG (LEVOCETIRIZINE DIHYDROCHLORIDE TABLET 5MG): DESCRIPTION AND COMPOSITION: Yellow coloured circular, biconvex film coated tablets plain on both sides. Each film coated tablet contains: Levocetirizine Dihydrochloride 5mg, Titanium dioxide and Quinoline yellow as colouring agents. PHANNACODYNAMICS Levocetirizine is the active component of Cetirizine. It is a selective competitive inhibitor for the H 1- histamine receptor, both in vitro and in vivo. There is no evidence of any binding with other receptors at concentrations 500 fold higher than those displacing a H1- ligand. It is effective in antagonizing histamine effects in both cutaneous and pulmonary models after IV and PO administration of 0.1-0.2 mg/kg. As with cetirzine safety pharmacology studies indicate a high margin of safety for adverse effects on the CNS, GI, immune and cardiovascular systems. Levocetirizine is unlikely to be involved in torsades de pointes or other arrhythmias. In addition, as levocetirizine is mainly excreted unchanged in man and does not inhibit the major GYP isoforms in human liver microsomes, cardiac and other adverse effects due to pharmacokinetic interactions are also unlikely. PHANNACOKINETICS The pharmacokinetic profile of levocetirizine is linear and time-independent with low inter-subject variability. The clearance of levocetirizine differs slightly in men and women. This difference is clearance, however, does not necessitate the use of a differ Przeczytaj cały dokument