MIOZAC

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DOBUTAMINE AS HYDROCHLORIDE

Available from:

RAZ PHARMACEUTICS LTD, ISRAEL

ATC code:

C01CA07

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

DOBUTAMINE AS HYDROCHLORIDE 12.5 MG/ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

FISIOPHARMA S.R.L., ITALY

Therapeutic area:

DOBUTAMINE

Therapeutic indications:

Dobutamine is indicated for patients who require a positive inotropic support in the short term treatment of adults with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures, especially when a low cardiac output is associated with raised pulmonary pressure.

Authorization date:

2023-08-10

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
MIOZAC
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of 20 ml contains:
Active ingredient:
Dobutamine hydrochloride
280.28 mg
(Equivalent to Dobutamine
250.0 mg)
(each ml contains 12.5 mg of Dobutamine)
Excipient with known effect:
Sodium metabisulphite 4.4 mg
For the full list of the excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Sterile concentrated solution for intravenous infusion.
Clear and colourless solution.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Dobutamine is indicated for patients who require a positive inotropic
support in the short term treatment of
adults with cardiac decompensation due to depressed contractility
resulting either from organic heart disease
or from cardiac surgical procedures, especially when a low cardiac
output is associated with raised
pulmonary pressure.
NOTE
In case of cardiogenic shock characterized by cardiac failure and
severe hypotension and in case of septic
shock dopamine is the drug of first-choice after correction of
possible hypovolemia.
In patients who have atrial fibrillation with rapid ventricular
response, a digitalis preparation should be used
prior to institution of therapy with Dobutamine 12.5 mg/ml.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Just before administration Dobutamine concentrate for solution for
infusion MUST be further diluted to AT
LEAST 50 ML prior to administration in a container for intravenous use
and according to the table below with
one of the intravenous solutions listed in section 6.6.
The concentration used depends on the dosage and fluid requirements of
the patient. The dilution should not
be more concentrated than 5 mg/ml (5,000 µg/ml). Most patients will
respond satisfactorily to doses from 2.5
to 10 µg/kg/min. Occasionally, however, a dose as low as 0.5
µg/kg/min will be effective. Rarely, a dose as
high as 40 µg/kg/min has been required.
The table below is a directive for the rate of infusion:
DRUG DELIVERY RATE
INFUSION DELIVERY RATE
(ML