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EPHEDRINE HYDROCHLORIDE Solution for injection (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Ephedrine Hydrochloride 30 mg/ml Solution for Injection.

Qualitative and quantitative composition

Each 1 ml of solution for injection contains 30 mg ephedrine hydrochloride. For the full list of excipients, see section 6.1.

Pharmaceutical form

Solution for injection. Clear, colourless and free of visible particles.

Therapeutic indications

Reversal of hypotension from spinal or epidural anaesthesia.

Posology and method of administration

Posology Adults and the elderly Up to 30 mg in increments of 3-7.5 mg. After the development of hypotension, by slow intravenous injection. Paediatric population Ephedrine Hydrochloride 30 mg/ml Solution ...

Contraindications

Ephedrine Hydrochloride 30 mg/ml Solution for Injection should not be used in case of: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. In combination with other ...

Special warnings and precautions for use

Warnings Ephedrine should be used with caution in patients who may be particularly susceptible to their effects, particularly those with hyperthyroidism. Great care is also needed in patients with cardiovascular ...

Interaction with other medicinal products and other forms of interaction

Contraindicated combinations Indirect sympathomimetic agents (phenylpropanolamine, pseudoephedrine, phenylephrine, methylphenidate): Risk of vasoconstriction and/or of acute episodes of hypertension. ...

Fertility, pregnancy and lactation

Pregnancy Studies in animals have shown a teratogenic effect. Clinical data from epidemiological studies on a limited number of women appear to indicate no particular effects of ephedrine with respect ...

Effects on ability to drive and use machines

Not relevant.

Undesirable effects

Very common: ≥1/10; Common: ≥1/100, <1/10; Uncommon: ≥1/1,000, <1/100; Rare: ≥1/10,000, <1/1,000; Very rare: <1/10,000; Not known: cannot be estimated from the available data Blood and lymphatic system ...

Overdose

Symptoms In the event of overdose, the occurrence of nausea, vomiting, fever, paranoid psychosis, ventricular and supraventricular arrhythmias, hypertension, respiratory depression, convulsions and coma ...

Pharmacodynamic properties

Pharmacotherapeutic group: Adrenergic and dopaminergic agents ATC code: C01CA26 Ephedrine is a sympathomimetic amine acting directly on the alpha and beta receptors and indirectly by increasing the release ...

Pharmacokinetic properties

After intravenous administration, ephedrine is completely biologically available, and after oral administration, the bioavailability of ephedrine has been reported to be above 90%. Excretion depends on ...

Preclinical safety data

There is no pre-clinical data of relevance to the prescriber which is additional to that already included in other sections of the SmPC.

List of excipients

Water for injections

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

Shelf life

<u>Unopened:</u> 3 years. <u>Diluted solution:</u> Chemical and physical in-use stability has been demonstrated for 72 hours at 25°C. From a microbiological point of view, the product should be used immediately. ...

Special precautions for storage

This medicinal product does not require any special temperature storage conditions. Keep the container in the outer carton in order to protect from light. For storage conditions after dilution of the medicinal ...

Nature and contents of container

1 ml colourless glass one-point-cut (OPC) ampoules, type I containing 1 ml solution for injection. Packed into cartons of 5 or 10 ampoules. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

For single use only. Ephedrine hydrochloride is compatible with sodium chloride 9 mg/ml (0.9%), Ringers lactate solution and glucose 50 mg/ml (5%). The drug product should be examined visually and should ...

Marketing authorization holder

hameln pharmaceuticals ltd, Nexus, Gloucester Business Park, Gloucester, GL3 4AG, United Kingdom

Marketing authorization number(s)

PL 01502/0103

Date of first authorization / renewal of the authorization

08/06/2018

Date of revision of the text

02/11/2018

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