Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CLENBUTEROL HYDROCHLORIDE
DUOPHARMA (M) SDN. BHD.
CLENBUTEROL HYDROCHLORIDE
1000 Tablet Tablets; 500 Tablet Tablets; 250 Tablet Tablets; 100 Tablet Tablets
DUOPHARMA (M) SDN. BHD.
_Consumer Medication Information Leaflet (RIMUP) _ MAVILEX TABLET Clenbuterol hydrochloride 0.02mg WHAT IS IN THE LEAFLET? 1. What MAVILEX is used for 2. How MAVILEX works 3. Before you use MAVILEX 4. How to use MAVILEX 5. While you are using it 6. Side effects 7. Storage and Disposal of MAVILEX 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT MAVILEX IS USED FOR MAVILEX is used in people with asthma, bronchitis (inflammation or swelling of bronchial tubes) and other breathing problem. Ask your doctor if you have any questions about why MAVILEX has been prescribed for you. Your doctor may prescribe it for another reason. HOW MAVILEX WORKS MAVILEX contains clenbuterol hydrochloride. Clenbuterol is a bronchodilator and belongs to a group of medicines called beta-2- agonists. MAVILEX is used to open up the airways so that you can breathe more easily. BEFORE YOU USE MAVILEX _When you must not use it _ Do not take MAVILEX if you have ever had an allergic reaction to: • any medicine containing clenbuterol or any other medicines used to treat breathing problems. • any of the ingredients listed at the end of this leaflet. Do not take MAVILEX after the expiry date (EXP) printed on the pack. Do not take it if the bottle shows signs of having been tampered with. If you are not sure whether you should start using this medicine, talk to your doctor or pharmacist. _Before you start to use it _ Tell your doctor if you are allergic to any other medicines or any foods, dyes or preservatives. Tell your doctor if you have any of the following medical conditions: • heart problems • hypertension (high blood pressure) • diabetes • thyroid problems It may not be safe for you to take MAVILEX if you have any of these conditions. Tell your doctor if you are pregnant or plan to become pregnant, or breastfeeding. Your doctor will advise you of the risks and benefits of using MAVILEX during pregnancy and while breastfeeding. If you have not told your doctor about any of these things Baca dokumen lengkap
MAVILEX TABLET 0.02 MG [DUOPHARMA (M) SDN BHD] DESCRIPTION: MAVILEX TABLET 0.02 MG: An oval, scored tablet, white in colour with markings ‘DUO’ and ‘861’. COMPOSITION: MAVILEX TABLET 0.02 MG: Each tablet contains Clenbuterol HCl 0.02 mg. PHARMACODYNAMICS: It is a broncholytic agent which acts through selective stimulation of the β2-receptors. It differs from other β2-specific sympathomimetics by its low dose, long biological half-life and rapid and complete absorption by oral administration. It has no significant effects on β1-cardiac receptors. PHARMACOKINETICS: Invasion half-life of Clenbuterol is 1 hour the distribution corresponds to an open two compartment model with a side-compartment. Elimination from plasma takes place in 2 phases, the half-life of the α-phase being 1 hour and that of β-phase 34 hours. Elimination is primarily renal (87% after 168 hours) 43% of Clenbuterol is recovered unchanged in the urine. Dose intervals of 12 hours suffice to maintain a plasma level. Five metabolites have been found in humans. INDICATIONS: Prophylaxis and therapy of bronchospasm in bronchial asthma, acute and chronic bronchitis associated with emphysema. RECOMMENDED DOSAGE: The recommended total daily dose for adults and children over 12 years is 0.04 mg / day. In severe bronchospasm the dose may be increased to 0.08 mg / day twice daily; as therapy continues, the dose may often be reduced to 0.02 mg / day. The recommended total daily dose for children is 0.0012 mg / kg body weight, ranging from 0.0008 – 0.0015 mg Mavilex. TABLET: _ADULTS AND CHILDREN OVER 12 YEARS: _0.02 mg twice daily. Twice daily doses morning and evening provide for constant blood levels. The duration of treatment depends upon the symptoms and there is no objection to long-term treatment. ROUTE OF ADMINISTRATION: Oral CONTRAINDICATIONS: Thyrotoxicosis, idiopathic hypertrophic subvalvular aortic stenosis, tachycardia, tachyarrhythmia. Known sensitivity to sympathomimetic amines. WARNINGS AND PRECAUTIONS: Care must be exercised when a Baca dokumen lengkap