国家: 亚美尼亚
语言: 英文
来源: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
enalaprilat
KRKA d.d.
առկա չէ (C09AA)
enalaprilat
1,25mg/ml
solution for injection
(5) ampoules 1ml, in blister
Prescription
Registered
2017-09-05
PI_Text019983_1 – Updated: Page 1 of 14 1. NAME OF THE MEDICINAL PRODUCT Enap ® 1.25 mg/ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of solution for injection (one ampoule) contains 1.25 mg enalaprilat. Excipients: 1 ml of solution for injection (one ampoule) contains 9 mg benzyl alcohol and 2.5 mg sodium. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection The solution for injection is clear, colourless, practically free from particles. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Arterial hypertension in cases when oral treatment is impossible. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The usual dose for the treatment of hypertension is 1 ampoule (1.25 mg) every 6 hours. When switching from treatment with enalapril to treatment with enalaprilat, the usual dose is 1 ampoule (1.25 mg) every 6 hours. For patients on diuretic therapy, the initial dose is ½ ampoule (0.625 mg). If after one hour there is an inadequate clinical response, the same dose may be repeated and treatment continued with the full dose after 6 hours (1 ampoule every 6 hours). Treatment with enalaprilat usually lasts for 48 hours. Thereafter, treatment should be continued with enalapril. When switching from parenteral treatment with enalaprilat to oral treatment with enalapril, the recommended initial dose is 5 mg a day for patients having received 1 ampoule (1.25 mg) of enalaprilat every 6 hours. If necessary, the dose may be increased. For patients initially treated with half the dose of enalaprilat (0.625 mg), the recommended dose when switching to oral treatment is 2.5 mg enalapril a day. _Dosage in renal insufficiency_ For patients with a creatinine clearance >0.5 ml/s (30 ml/min, serum creatinine up to 265 µmol/l), the initial dose is 1 ampoule (1.25 mg) every 6 hours. For patients with a creatinine clearance <0.5 ml/s (30 ml/min, serum creatinine >265 µmol/l), the initial dose is ½ ampoule (0.625 mg). If after one hour there is an inadequate cli 阅读完整的文件