Země: Malajsie
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LABETALOL HYDROCHLORIDE
Aspen Medical Products Malaysia Sdn Bhd
LABETALOL HYDROCHLORIDE
50 Tablet Tablets
Aspen Bad Oldesloe GmbH
_Consumer Medication Information Leaflet (RIMUP) _ 1 TRANDATE TABLETS 100MG Labetalol hydrochloride (100mg) WHAT IS IN THE LEAFLET? 1. What Trandate Tablet is used for 2. How Trandate Tablet works 3. Before you use Trandate Tablet 4. How to use Trandate Tablet 5. While you are using it 6. Side effects 7. Storage and Disposal of Trandate Tablet 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT TRANDATE TABLET IS USED FOR Trandate Tablet is used for the treatment of all degrees of hypertension. Hypertension is a condition marked by high blood pressure. HOW TRANDATE TABLET WORKS Trandate Tablet contains a medicine called labetalol hydrochloride. This belongs to a group of medicines called beta-blockers. It works by changing the body’s response to some nerve impulses. Therefore, it widens the blood vessels in the body, causing the blood pressure to fall. Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason. BEFORE YOU USE TRANDATE TABLET - _When you must not take it _ Do not take this medicine if you have an allergy to: • labetalol hydrochloride, the active ingredient • any of the other ingredients listed at the end of this leaflet Do not take Trandate Tablet if • you suffer from second or third degree heart block (unless pacemaker is in situ), cardiogenic shock and other conditions accompanied by severe and prolonged hypertension or bradycardia. • you suffer from asthma or from airways obstruction. • you suffer from uncompensated heart failure • you suffer from unstable / uncontrolled heart insufficiency • you suffer from sick sinus syndrome (including sinus atrial block) unless pacemaker is in situ. • you suffer from prinzmetal angina. • you suffer from sinus node dysfunction. Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, retur Přečtěte si celý dokument
1 TRANDATE LABETALOL HYDROCHLORIDE QUALITATIVE AND QUANTITATIVE COMPOSITION TRANDATE Injection is a clear, colourless solution, practically free from visible particles, containing 5mg of Labetalol Hydrochloride per ml and supplied in 5ml ampoule. TRANDATE Tablets are orange, round, biconvex film-coated tablets, engraved TT01 on one face. Each tablet contains 100mg of Labetalol Hydrochloride. PHARMACEUTICAL FORM Solution for injection. Film-coated tablets. CLINICAL INFORMATION INDICATIONS _INJECTION IS INDICATED FOR: _ • Severe hypertension, including severe hypertension of pregnancy, when rapid control of blood pressure is essential. • May be used to achieve controlled hypotension during anaesthesia. _ _ _TABLET IS INDICATED FOR: _ • Mild, moderate or severe hypertension. • Hypertensions in pregnancy. • Angina pectoris with coexisting hypertension. DOSAGE AND ADMINISTRATION _INJECTION: _ POSOLOGY Labetalol injection is intended for i.v. use in hospitalised patients. POPULATIONS • ADULTS INDICATION DOSE SEVERE HYPERTENSION Bolus Injection: If it is essential to reduce the blood pressure quickly a dose of 50 mg should be given by I.V. injection (over a period of at least 1 min) and, if necessary, repeated at 5 min intervals until a satisfactory response occurs. The total dose should not exceed 200 mg. 2 The maximum effect usually occurs within 5 min and the duration of action is usually about 6 h but may be as long as 18 h. Intravenous Infusion: _ _ A 1 mg/ml solution of labetalol should be used, i.e. the contents of eight 5 ml ampoules (200 mg) diluted to 200 ml with Sodium Chloride and Dextrose Injection BP or 5% Dextrose Intravenous Infusion BP. The infusion rate should normally be about 160 mg/h but may be adjusted according to the response at the discretion of the physician. The effective dose is usually 50 to 200 mg but infusion should be continued until a satisfactory response is obtained and larger doses may be needed, especially in patients with phaeochromocytoma. In case of severe hypertension Přečtěte si celý dokument