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Βιβλιογραφική αναφορά

Προτάσεις

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

Εκδότης

Εκδότης Hameln pharmaceuticals ltd
Διεύθυνση Nexus, Gloucester Business Park, Gloucester, GL3 4AG
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Περιεχόμενα

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 ...

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 ...

Posology and method of administration

Dobutamine doses must be individually adjusted. The required rate of infusion depends on the patient ...

Contraindications

Dobutamine must not be used in the case of: known hypersensitivity to dobutamine or to any of the excipients, ...

Special warnings and precautions for use

Dobutamine must not be used for the treatment of patients with bronchial asthma who are hypersensitive ...

Interaction with other medicinal products and other forms of interaction

Via competitive receptor inhibition, the sympathomimetic effect of dobutamine can be reduced by simultaneous ...

Fertility, pregnancy and lactation

As there is no adequate data on the safety of dobutamine in human pregnancy and it is not known whether ...

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: ...

Overdose

Symptoms of overdose Symptoms are generally caused by excessive stimulation of beta-receptors. Symptoms ...

Pharmacodynamic properties

Pharmacotherapeutic group: Adrenergic and dopaminergic agents ATC Code: C01CA07 Dobutamine is a synthetic, ...

Pharmacokinetic properties

Onset of action is 1 2 minutes after the start of infusion; during continuing infusion, steady-state ...

Preclinical safety data

Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology ...

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), ...

Shelf life

In an un-opened container: 3 years. Once opened or following dilution: Chemical and physical in-use stability ...

Special precautions for storage

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

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 ...

Special precautions for disposal and other handling

In case of dilution the solution for infusion should be diluted immediately before use. For dilution, ...

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
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.