Země: Malajsie
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ISOSORBIDE DINITRATE
GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.
ISOSORBIDE DINITRATE
10ml mL
EVER Pharma Jena GmbH
Not Applicable Přečtěte si celý dokument
ISOKET AMPOULE 10MG/10ML ISOSORBIDE DINITRATE (SOLUTION FOR INFUSION OR INJECTION) NAME OF THE MEDICINAL PRODUCT Isosorbide dinitrate, 1mg/ml, solution for infusion or injection QUALITATIVE AND QUANTITATIVE COMPOSITION Isoket is a concentrated solution of Isosorbide dinitrate 1mg/1ml (0.1%) in sterile isotonic saline. It is supplied in 10 ml ampoules. The solution contains no alcohol or potassium. EXCIPIENTS Sodium chloride, water for injections, sodium hydroxide (for pH-adjustment), hydrochloric acid (for pH-adjustment). PHARMACEUTICAL FORM The solution is clear, colourless liquid. CLINICAL INFORMATION INDICATIONS Isoket is indicated in the treatment of unresponsive left ventricular failure secondary to acute myocardial infarction, unresponsive left ventricular failure of various aetiology and severe or unstable angina pectoris. DOSAGE AND ADMINISTRATION This medicinal product is a concentrated solution and must be diluted prior use. The diluted solution should never be injected directly in the form of a bolus. Isosorbide dinitrate solution for infusion or injection, can be administered as an intravenous admixture with a suitable vehicle ( _see Section Use and Handling_ ). Prepared isosorbide dinitrate admixtures should be given by intravenous infusion or with the aid of a syringe pump incorporating a glass or rigid plastic syringe. During administration, the patient’s blood pressure and pulse should be closely monitored and dose adjusted according to the patient’s response. ROUTE OF ADMINISTRATION For intravenous use. ADULTS A dose of between 2 mg and 12 mg per hour is usually satisfactory. However, dosages up to 20 mg per hour administered should be adjusted to the patient response. CHILDREN The safety and efficacy of isosorbide dinitrate solution for infusion or injection has not yet been established in children. ELDERLY No dose adjustment is necessary. RENAL AND HEPATIC IMPAIRMENT Isosorbide dinitrate should be used with caution in patients with severely impaired renal or hepatic function _(see Section W Přečtěte si celý dokument