DOBUTAMINE-HAMELN 250 MG/ 50 ML VIAL 5 Mg/Ml Solution for Infusion
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
02-05-2024
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Active ingredient:
DOBUTAMINE HYDROCHLORIDE
Available from:
Hameln Pharmaceuticals GmbH
INN (International Name):
DOBUTAMINE HYDROCHLORIDE
Dosage:
5 Mg/Ml
Pharmaceutical form:
Solution for Infusion
Authorization status:
Withdrawn
Authorization date:
2008-11-04
Summary of Product characteristics
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dobutamine-hameln 250 mg/ 50 ml vial, solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1ml of solution contains 5mg Dobutamine equivalent to 5.6mg
Dobutamine HCl. Each 50ml vial 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: Dobutamine Hameln 250 mg/50 ml may not be mixed with
5 % sodium bicarbonate solution or any other
strong alkaline solution. Due to the risk of incompatibility
Dobutamine Hameln 250 mg/50 ml is not recommended
to be mixed in the same infusion as other medical substances.
Dobutamine Hameln 250 mg/50 ml should not be used in
solutions for intravenous infusion containing both
sodium metabisulphite and ethanol. Sulphite is a very
reactive substance. Other drugs may not be added to
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