MILHARDT

Land: Israel

Sprache: Englisch

Quelle: Ministry of Health

Wirkstoff:

MILRINONE

Verfügbar ab:

PROPHARM LTD

ATC-Code:

C01CE02

Darreichungsform:

SOLUTION FOR INJECTION / INFUSION

Zusammensetzung:

MILRINONE 1 MG / 1 ML

Verabreichungsweg:

I.V

Verschreibungstyp:

Required

Hergestellt von:

CP PHARMACEUTICALS LTD, U.K.

Therapiebereich:

MILRINONE

Anwendungsgebiete:

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 Milhardt 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

Berechtigungsdatum:

2020-09-30

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
MILHARDT
1
NAME OF THE MEDICINAL PRODUCT
Milhardt
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule contains 1 mg/ml of the active substance milrinone.
Excipient with known effect:
Sodium (this medicinal product contains less than 1 mmol sodium (23
mg) per dose)
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Solution for Injection/infusion.
Clear, colourless to pale yellow solution, practically free from
particles.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Milhardt Injection is indicated 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 Milhardt 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: _Milhardt 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
Milhardt).
0.45% saline, 0.9% saline or 5% glucose may be used as diluents.
MILHARDT 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 pat