Kraj: Nowa Zelandia
Język: angielski
Źródło: Medsafe (Medicines Safety Authority)
Hydralazine hydrochloride 25mg
AFT Pharmaceuticals Ltd
Hydralazine hydrochloride 25 mg
25 mg
Tablet
Active: Hydralazine hydrochloride 25mg Excipient: Colloidal silicon dioxide Dispersed Yellow 15093, coat Copovidone Hypromellose Macrogol 8000 Magnesium stearate Microcrystalline cellulose Opacode brown S-1-26593 Povidone Purified talc Sucrose Titanium dioxide Wheat starch
Bottle, plastic, 1 x 100, 100 tablets
Prescription
Prescription
Sumitomo Chemical Company Limited
For the treatment of moderate to severe hypertension as an adjunct to other anti-hypertensive agents e.g. beta-blockers and diuretics.
Package - Contents - Shelf Life: Bottle, plastic, 1 x 100 - 100 tablets - 48 months from date of manufacture stored at or below 30°C
1969-12-31
NEW ZEALAND DATA SHEET 1 APRESOLINE ® (20 MG/ML POWDER FOR INJECTION ) APRESOLINE ® 20 mg/mL powder for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Hydralazine hydrochloride 20 mg/mL 3 PHARMACEUTICAL FORM White to yellowish lyophilisate 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertensive crisis, especially during late pregnancy (pre-eclampsia and eclampsia) 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE ADULTS The initial dose is 5-10 mg, administered by slow intravenous injection in order to avoid precipitous fall in mean arterial pressure with a critical reduction in cerebral or utero- placental perfusion. If it is necessary to repeat the injection, this should be done after an interval of 20-30 min, throughout which the blood pressure and heart rate should be monitored. A satisfactory response can be defined as a decrease in diastolic blood pressure to 90-100 mmHg. Apresoline may also be given by continuous intravenous infusion, beginning with a flow rate of 200-300 µg/min. Maintenance flow rates must be determined individually and are usually within the range 50-150 µg/min. Prior to injection, the powdered active substance should be completely dissolved in 1 mL distilled water for injection and the freshly prepared solution should be used immediately. For the preparation of infusion solutions, this fresh solution should be diluted with physiological saline or with 5% sorbitol solution. CHILDREN In the rare cases where rapid treatment proves indispensable in a child, Apresoline ampoules should be used with extreme caution. The initial dose is 0.1-0.5 mg/kg body weight administered intravenously over 1-2 min with repeat doses every 30-90 min as required, up to a maximum daily dose of 3.5 mg/kg body weight. METHOD OF ADMINISTRATION Parenteral treatment with Apresoline should always be carried out cautiously and under strict medical surveillance (if possible in hospital). 4.3 CONTRAINDICATIONS Known hypersensitivity to hydralazine or dihydralazine or to any of the excipients Idiopathi Przeczytaj cały dokument