PRIMACOR INJECTION

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

MILRINONE

Tilgjengelig fra:

SANOFI ISRAEL LTD

ATC-kode:

C01CE02

Legemiddelform:

SOLUTION FOR INJECTION

Sammensetning:

MILRINONE 1 MG/ML

Administreringsrute:

I.V

Resept typen:

Required

Produsert av:

DELPHARM DIJON, FRANCE

Terapeutisk gruppe:

MILRINONE

Terapeutisk område:

MILRINONE

Indikasjoner:

For the treatment of refractory heart failure immediately (up to 72 hours) following cardiac surgery. For the short term ( up to 48 hours) intravenous therapy of severe refractory congestive heart failure.In pediatric population Primacor is indicated for the short-term treatment (up to 35 hours) of severe congestive heart failure unresponsive to conventional maintenance therapy (glycosides, diuretics, vasodilators and/or angiotensin converting enzyme (ACE) inhibitors), and for the short-term treatment (up to 35 hours) of pediatric patients with acute heart failure, including low output states following cardiac surgery.

Autorisasjon dato:

2022-11-30

Informasjon til brukeren

.תשפיחש המ תא ונאצמ אל
הנוכנ תנזהש תבותכה םא קודבל יאדכ
תבותכב עייסל חמשנ
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Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
PRIMACOR INJECTION
1
NAME OF THE MEDICINAL PRODUCT
Primacor Injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule contains 1 mg/ml of the active substance Milrinone.
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Solution for Injection.
Clear, colourless to pale yellow liquid.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Primacor Injection is indicated for treatment of refractory heart
failure
immediately (up to 72 hours) following cardiac surgery.
For the short-term (up to 48 hours) intravenous therapy of severe
refractory
congestive heart failure.
In pediatric population Primacor is indicated for the short-term
treatment
(up to 35 hours) of severe congestive heart failure unresponsive to
conventional maintenance therapy (glycosides, diuretics, vasodilators
and/or
angiotensin converting enzyme (ACE) inhibitors), and for the
short-term
treatment (up to 35 hours) of pediatric patients with acute heart
failure,
including low output states following cardiac surgery.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For intravenous administration.
_Adults:_ Primacor Injection should be given as a loading dose of 50
µg/kg
administered over a period of 10 minutes usually followed by a
continuous
infusion at a dosage titrated between 0.375 µg/kg/min and 0.75
µg/kg/
min according to haemodynamic and clinical response, but should not
exceed 1.13 mg/kg/day total dose.
The following provides a guide to maintenance infusion delivery rate
based
upon a solution containing milrinone 200 µg/ml prepared by adding 40
ml
diluent per 10 ml ampoule (400 ml diluent per 100 ml Primacor
Injection).
0.45% saline, 0.9% saline or 5% dextrose may be used as diluents.
PRIMACOR INJECTION DOSE
(ΜG/KG/MIN)
INFUSION
DELIVERY RATE (ML/KG/H)
0.375
0.400
0.500
0.600
0.700
0.750
0.11
0.12
0.15
0.18
0.21
0.22
Solutions of different concentrations may be used according to patient
fluid
requirements. The duration of therapy should depend upon the
patient’s
response. In congestive