Երկիր: Սինգապուր
Լեզու: անգլերեն
Աղբյուրը: HSA (Health Sciences Authority)
LABETALOL HCl
DCH AURIGA SINGAPORE
C07AG01
100 mg/20 ml
INJECTION
LABETALOL HCl 100 mg/20 ml
INTRAVENOUS
Prescription Only
UBI Pharma Inc
ACTIVE
1988-07-14
CONFIDENTIAL 1 Proposed Package Insert severe hypertension, including severe hypertension of pregnancy, when rapid control of blood pressure is essential TRANDATE™ LABETALOL QUALITATIVE AND QUANTITATIVE COMPOSITION 5 mg/ml labetalol hydrochloride solution for injection in a 20 ml or a 5 ml ampoule. PHARMACEUTICAL FORM Solution for injection. CLINICAL PARTICULARS INDICATIONS _TRANDATE injection is indicated for: _ anaesthesia when a hypotensive technique is indicated hypertensive episodes following acute myocardial infarction. DOSAGE AND ADMINISTRATION _TRANDATE_ injection is intended for i.v. use in hospitalised patients. Patients should always receive the drug whilst in the supine or left lateral position. Raising the patient into the upright position within 3 h of i.v. _TRANDATE_ administration should be avoided since excessive postural hypotension may occur. It is desirable to monitor the blood pressure and heart rate after injection and during infusion. In most patients, there is a small decrease in the heart rate; severe bradycardia is unusual but may be controlled by injecting atropine 1 to 2 mg intravenously. Respiratory function should be observed particularly in patients with any known impairment. _TRANDATE_ injection has been administered to patients with uncontrolled hypertension already receiving other hypotensive agents, including beta-blocking drugs, without adverse effects. • ADULTS _TRANDATE INJECTION: _ FOR 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. The maximum effect usually occurs Կարդացեք ամբողջական փաստաթուղթը
1 TRANDATE TM LABETALOL QUALITATIVE AND QUANTITATIVE COMPOSITION 5 mg/ml labetalol hydrochloride solution for injection in a 20 ml or a 5 ml ampoule. PHARMACEUTICAL FORM Solution for injection. CLINICAL PARTICULARS INDICATIONS _TRANDATE injection is indicated for: _ _ _ severe hypertension, including severe hypertension of pregnancy, when rapid control of blood pressure is essential May be used to achieve control hypotension during anaesthesia DOSAGE AND ADMINISTRATION _TRANDATE _injection is intended for i.v. use in hospitalised patients. Patients should always receive the drug whilst in the supine or left lateral position. Raising the patient into the upright position within 3 h of i.v. _TRANDATE _administration should be avoided since excessive postural hypotension may occur. It is desirable to monitor the blood pressure and heart rate after injection and during infusion. In most patients, there is a small decrease in the heart rate; severe bradycardia is unusual but may be controlled by injecting atropine 1 to 2 mg intravenously. Respiratory function should be observed particularly in patients with any known impairment. _TRANDATE _injection has been administered to patients with uncontrolled hypertension already receiving other hypotensive agents, including beta-blocking drugs, without adverse effects. POPULATIONS • ADULTS INTERACTION 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 2 response occurs. The total dose should not exceed 200 mg. 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 TRANDATE should be used, i.e. the contents of two 20 ml ampoules or eight 5 ml ampoules (200 mg) diluted to 200 ml with Sodium Chloride and Dextrose Injection BP or 5% Dextrose Intravenous Infusion BP. Կարդացեք ամբողջական փաստաթուղթը