EPHEDRINE HYDROCHLORIDE Solution for injection (2018)
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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