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DOPAMINE HYDROCHLORIDE Concentrate for solution for infusion (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Dopamine Hydrochloride 40mg/ml Concentrate for Solution for Infusion.

Qualitative and quantitative composition

Each ml contains 40 mg dopamine hydrochloride. Each 5 ml ampoule contains 200mg Dopamine hydrochloride Excipient(s) with known effect: Each 5mL ampoule contains 50 mg sodium metabisulfite. Each 5mL ampoule ...

Pharmaceutical form

Concentrate for solution for infusion. Clear, colourless or pale yellow solution.

Therapeutic indications

For the correction of haemodynamic imbalances in low-perfusion circulatory insufficiency associated with myocardial infarction, trauma, septicaemia, cardiac failure and open heart surgery.

Posology and method of administration

Posology Adults Use as large a vein as possible for infusion. The initial rate of infusion is 2 to 5 micrograms per kilogram bodyweight per minute and this may be increased gradually by increments of 5 ...

Contraindications

Dopamine should not be used in patients with – Hypersensitivity to dopamine or any of the excipients listed in section 6.1. Phaeochromocytoma or hyperthyroidism. Dopamine should not be used in the presence ...

Special warnings and precautions for use

Warnings Patients who have been treated with MAO inhibitors prior to dopamine should be given reduced doses; the starting dose should be one tenth (1/10<sup>th</sup>) of the usual dose. Excess administration ...

Interaction with other medicinal products and other forms of interaction

Anaesthetics The myocardium is sensitised by the effect of dopamine, cyclopropane or halogenated hydrocarbon anaesthetics, and these should be avoided. This interaction applies both to pressor activity ...

Fertility, pregnancy and lactation

Pregnancy Animal studies have shown no evidence of teratogenic effects with dopamine. However, the effect of dopamine on the human foetus is unknown. Therefore the drug should be used in pregnant women ...

Effects on ability to drive and use machines

Not applicable in view of the indications for use and the short half-life of the drug.

Undesirable effects

Adverse reactions to dopamine are related to its pharmacological action. The following adverse reactions are classified by system organ class and ranked under heading of frequency: Common (>1/100 to <1/10; ...

Overdose

Excessive elevation of blood pressure and vasoconstriction can occur due to the alpha adrenergic actions of dopamine, especially in patients with a history of occlusive vascular disease. If desired, this ...

Pharmacodynamic properties

Pharmacotherapeutic group: adrenergic and dopaminergic agents ATC code: C01CA04 Dopamine (3,4-dihydroxyphenylethylamine) is the third naturally occurring catecholamine and is a metabolic precursor of noradrenaline ...

Pharmacokinetic properties

Dopamine is inactive when taken orally and its vasoconstrictor properties preclude its administration by subcutaneous or intramuscular injection. Dopamine hydrochloride is administered by intravenous infusion ...

Preclinical safety data

No further relevant information other than that which is included in other sections of the Summary of Product Characteristics.

List of excipients

Sodium metabisulfite Water for injections

Incompatibilities

Iron salts, alkalis or oxidising agents. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Shelf life

36 months. For single use only If only part of an ampoule is used, discard the remaining solution. Diluted solutions should be used immediately. Discard any remaining solution

Special precautions for storage

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

Nature and contents of container

5 ml clear glass one point-cut (OPC) ampoules, glass Type I Ph Eur. borosilicate glass ampoules packed in cardboard cartons to contain 10 5ml ampoules.

Special precautions for disposal and other handling

This solution must be diluted before use. Do not dilute with alkaline solution. Inspect the solution before use. Do not use the injection if it is darker than slightly yellow or discoloured in any other ...

Marketing authorization holder

Mercury Pharma International Ltd, 4045, Kingswood Road, City West Business Park, Co Dublin, Ireland

Marketing authorization number(s)

PL 02848/0130

Date of first authorization / renewal of the authorization

14 September 1989 / 19 March 2008

Date of revision of the text

17/09/2019

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