Enalaprilat-BP (inj)

Enalaprilatum

One ampoule (1 ml) of solution for injection/infusion contains enalaprilat 1.25 mg. Excipients with known effect: benzyl alcohol (9 mg/ml), sodium (2.5 mg/ml). Clear, colourless solution for injection.

Indication: Hypertension, when oral treatment is not possible.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications - Hypersensitivity to enalapril, enalaprilat, other ACE inhibitors, or to any of the excipients listed in section 6.1. - History of angioneurotic oedema following treatment with other ACE inhibitors. - Hereditary angioneurotic oedema or angioneurotic oedema of any cause. - Second and third trimesters of pregnancy (see sections 4.4 and 4.6). - Concomitant use with medicines containing aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m²) (see sections 4.5 and 5.1).

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use Dual blockade of the renin-angiotensin-aldosterone system (RAAS) There is evidence that concomitant use of ACE inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure). Therefore, dual blockade of the RAAS through the concomitant use of ACE inhibitors, angiotensin II receptor blockers or aliskiren is not recommended (see sections 4.5 and 5.1). If dual blockade therapy is considered absolutely necessary, it should be carried out only under the supervision of a specialist physician, with close and frequent monitoring of renal function, electrolytes and blood pressure. ACE inhibitors and angiotensin II receptor blockers should not […]