Enap solution for injection

Maa: Armenia

Kieli: englanti

Lähde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiivinen ainesosa:

enalaprilat

Saatavilla:

KRKA d.d.

ATC-koodi:

առկա չէ (C09AA)

INN (Kansainvälinen yleisnimi):

enalaprilat

Annos:

1,25mg/ml

Lääkemuoto:

solution for injection

Kpl paketissa:

(5) ampoules 1ml, in blister

Prescription tyyppi:

Prescription

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

2017-09-05

Valmisteyhteenveto

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