DOBUTAMINE-HAMELN 250 MG/50 ML AMPOULE
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
21-03-2023
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Active ingredient:
DOBUTAMINE HYDROCHLORIDE
Available from:
Hameln Pharmaceuticals GmbH
Dosage:
5 Mg/Ml
Pharmaceutical form:
Solution for Infusion
Authorization date:
2003-11-04
Summary of Product characteristics
License
Part II
Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Dobutamine-hameln 250 mg/50 ml ampoule, solution for infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1ml of solution contains 5mg Dobutamine equivalent to 5.6mg Dobutamine HCl. Each 50ml ampoule contains
250mg Dobutamine equivalent to 280mg Dobutamine Hydrochloride.
For excipients, see 6.1
3 PHARMACEUTICAL FORM
Solution for infusion.
A clear, colourless or almost colourless solution
4 CLINICAL PARTICULARS
4.1 Therapeutic Indications
Dobutamine is indicated for adults who require inotropic support in the treatment of low output cardiac failure
associated with myocardial infarction, open heart surgery or cardiomyopathies. Dobutamine is also indicated for
adults with cardiogenic or septic shock who are not severely hypotensive. Dobutamine can increase or maintain
cardiac output during positive end expiratory pressure (PEEP) ventilation.
Dobutamine may also be used for cardiac stress testing in cases where exercise stress testing is not feasible or
inadequate.
4.2 Posology and method of adminstration
Due to its short half-life dobutamine has to be administered by continuous intravenous infusion.
Dobutamine Hameln 250 mg/50 ml may be diluted if wanted. Diluents may be 5 % glucose solution, 0.9 % sodium
chloride solution, Ringer-lactate or 0.45 % sodium chloride in 5 % glucose solution.
Note: Dobu
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