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SPC, UK: Dopamine Hydrochloride 40mg/ml Concentrate for Solution for Infusion (2012)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Mercury Pharma Group
Διεύθυνση :
No. 1 Croydon, 12 - 16 Addiscombe Road, Croydon, Surrey, CR0 0XT, UK
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Name of the medicinal product

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

Qualitative and quantitative composition

Dopamine hydrochloride USP, 200mg in 5ml.

Pharmaceutical form

Clear, colourless or pale yellow sterile solution intended for parenteral administration to human beings.

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

The solution must be diluted before administration. Alkaline solutions such as 5% sodium bicarbonate should NOT be added to dopamine hydrochloride because the drug will be inactivated. The usual dilution ...

Contraindications

Dopamine should not be used in patients with: Hypersensitivity to dopamine or any of the excipients. Phaeochromocytoma or hyperthyroidism Dopamine should not be used in the presence of uncorrected atrial ...

Special warnings and precautions for use

The solution contains an antioxidant, sodium metabisulphite, a sulphite that may cause allergic-type reactions including bronchospasm, anaphylaxis and life-threatening episodes in certain susceptible individuals. ...

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 ...

Pregnancy and lactation

Use in 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 ...

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. More common reactions include Cardiovascular: Ectopic heart beats, tachycardia, anginal pain, palpitation, hypotension, vasoconstriction. ...

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

Dopamine (3,4-dihydroxyphenylethylamine) is the third naturally occurring catecholamine and is a metabolic precursor of noradrenaline and adrenaline. Dopamine is used therapeutically as the hydrochloride ...

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 Metabisulphite BP Water for Injections BP

Incompatibilities

Iron salts, alkalis or oxidising agents.

Shelf life

36 months * If only part of an ampoule is used, discard the 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. Do not use the injection if it is darker than slightly yellow or discoloured in any other way. For the preparation of Dopamine ...

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 / 25 July 2000

Date of revision of the text

23/08/2012