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Βιβλιογραφική αναφορά

Προτάσεις

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

Εκδότης

Εκδότης Mercury Pharma Group
Διεύθυνση No. 1 Croydon, 12 - 16 Addiscombe Road, Croydon, Surrey, CR0 0XT, UK
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Περιεχόμενα

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 ...

Posology and method of administration

The solution must be diluted before administration. Alkaline solutions such as 5% sodium bicarbonate ...

Contraindications

Dopamine should not be used in patients with: Hypersensitivity to dopamine or any of the excipients. ...

Special warnings and precautions for use

The solution contains an antioxidant, sodium metabisulphite, a sulphite that may cause allergic-type ...

Interaction with other medicinal products and other forms of interaction

Anaesthetics The myocardium is sensitised by the effect of dopamine, cyclopropane or halogenated hydrocarbon ...

Pregnancy and lactation

Use in Pregnancy Animal studies have shown no evidence of teratogenic effects with dopamine. However, ...

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 ...

Overdose

Excessive elevation of blood pressure and vasoconstriction can occur due to the alpha adrenergic actions ...

Pharmacodynamic properties

Dopamine (3,4-dihydroxyphenylethylamine) is the third naturally occurring catecholamine and is a metabolic ...

Pharmacokinetic properties

Dopamine is inactive when taken orally and its vasoconstrictor properties preclude its administration ...

Preclinical safety data

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

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 ...

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 ...

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
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.