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SPC, UK: Dobutamine 5 mg/ml, solution for infusion (2011)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Hameln pharmaceuticals ltd
Διεύθυνση :
Nexus, Gloucester Business Park, Gloucester, GL3 4AG
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Name of the medicinal product

Dobutamine 5 mg/ml solution for infusion.

Qualitative and quantitative composition

Each ampoule/vial Dobutamine contains dobutamine hydrochloride corresponding to 250 mg dobutamine. 50 ml ampoule/vial. 1 ml contains 5 mg dobutamine. For a full list of excipients, see section 6.1.

Pharmaceutical form

Solution for infusion. The product is a clear, colourless or almost colourless solution.

Therapeutic indications

Dobutamine is indicated for patients who require a positive inotropic support in the treatment of cardiac decompensation due to depressed contractility. In cardiogenic shock characterised by heart failure ...

Posology and method of administration

Dobutamine doses must be individually adjusted. The required rate of infusion depends on the patients response to therapy and the adverse reactions experienced. Dosage in adults According to experience, ...

Contraindications

Dobutamine must not be used in the case of: known hypersensitivity to dobutamine or to any of the excipients, mechanical obstruction of ventricular filling and/or of outflow, such as pericardial tamponade, ...

Special warnings and precautions for use

Dobutamine must not be used for the treatment of patients with bronchial asthma who are hypersensitive to sulphites. A local increase or decrease of coronary blood flow, which may have an impact on the ...

Interaction with other medicinal products and other forms of interaction

Via competitive receptor inhibition, the sympathomimetic effect of dobutamine can be reduced by simultaneous administration of a beta receptor blocker. In addition, the alpha agonistic effects may cause ...

Fertility, pregnancy and lactation

As there is no adequate data on the safety of dobutamine in human pregnancy and it is not known whether dobutamine crosses the placenta, dobutamine should not be used during pregnancy unless potential ...

Effects on ability to drive and use machines

Not relevant.

Undesirable effects

Evaluation of undesirable effects is based on the following frequency scale: Very common: ≥ 1/10 Common: ≥ 1/100 to 1/10 Uncommon: ≥ 1/1,000 to 1/100 Rare: ≥ 1/10,000 to 1/1,000 Very rare: < 1/10,000 ...

Overdose

Symptoms of overdose Symptoms are generally caused by excessive stimulation of beta-receptors. Symptoms may include nausea, vomiting, anorexia, tremor, anxiety, palpitations, headache, anginal pain and ...

Pharmacodynamic properties

Pharmacotherapeutic group: Adrenergic and dopaminergic agents ATC Code: C01CA07 Dobutamine is a synthetic, sympathomimetic amine, structurally related to isoproterenol and dopamine, and is administered ...

Pharmacokinetic properties

Onset of action is 1 2 minutes after the start of infusion; during continuing infusion, steady-state plasma levels are only reached after 10 12 minutes. Steady-state plasma levels increase dose-dependently ...

Preclinical safety data

Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and repeated dose toxicity. There are no studies concerning the mutagenic and carcinogenic potential ...

List of excipients

Sodium metabisulphite (E 223) Sodium chloride Hydrochloric acid Water for injections

Incompatibilities

Dobutamine solutions have proven to be incompatible with: alkaline solutions (e. g. sodium hydrogen carbonate), solutions containing both sodium metabisulphite and ethanol, aciclovir, alteplase, aminophylline, ...

Shelf life

In an un-opened container: 3 years. Once opened or following dilution: Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C. From a microbiological point of view, the product ...

Special precautions for storage

Do not store above 25°C. Keep the ampoules/vials in the outer carton in order to protect from light. Do not refrigerate or freeze.

Nature and contents of container

Dobutamine 5 mg/ml (250 mg in 50 ml) ampoules made of colourless, neutral glass, type I Ph.Eur. 1,5 and 10 ampoules with 50 ml solution for infusion. Dobutamine 5 mg/ml (250 mg in 50 ml) vials made of ...

Special precautions for disposal and other handling

In case of dilution the solution for infusion should be diluted immediately before use. For dilution, a compatible infusion solution should be used. Chemical and physical compatibility have been demonstrated ...

Marketing authorization holder

Hameln pharma plus gmbh Langes Feld 13 31789 Hameln Germany

Marketing authorization number(s)

PL 25215/0004

Date of first authorization / renewal of the authorization

13/02/2011

Date of revision of the text

13/02/2011