Ephedrine Hydrochloride 30mg in 1ml Solution for Injection

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Ephedrine hydrochloride

Verfügbar ab:

Martindale Pharmaceuticals Ltd

ATC-Code:

C01CA26

INN (Internationale Bezeichnung):

Ephedrine hydrochloride

Dosierung:

30 milligram(s)/millilitre

Darreichungsform:

Solution for injection

Verschreibungstyp:

Product subject to prescription which may not be renewed (A)

Therapiebereich:

ephedrine

Berechtigungsstatus:

Marketed

Berechtigungsdatum:

2004-11-26

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ephedrine Hydrochloride 30mg in 1ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml ampoule contains 30mg of ephedrine hydrochloride.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection
A clear colourless sterile solution for injection
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
To reduce hypotension during spinal anaesthesia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For single patient use only:
Adults and the elderly
Up to 30 mg in increments of 3 - 7.5 mg.
After the development of hypotension, by slow intravenous
administration.
Children
0.5 - 0.75 mg / kg body weight or 17 - 25 mg / m
2
body surface.
After the development of hypotension, by slow intravenous
administration.
4.3 CONTRAINDICATIONS
Patients receiving treatment with monoamine oxidase inhibitors (or
within 2 weeks of their withdrawal). Coronary
thrombosis, diabetes mellitus, ischaemic heart disease, hypertension,
thyrotoxicosis, closed angle glaucoma or, in the
case of elderly patients prostatic hypertrophy.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Cardiovacular effects may be seen with sympathomimetic drugs including
Ephedrine Hydrochloride 30 mg in 1 ml
Solution for Injection. There is some evidence from post-marketing
data and published literature of rare occurrences of
myocardial ischaemia associated with beta agonists. Patients with
underlying severe heart disease (e.g. ischaemic heart
disease, arrhythmia or severe heart failure) who are receiving
Ephedrine Hydrochloride 30 mg in 1 ml Solution for
Injection should be warned to seek medical advice if they experience
chest pain or other symptoms of worsening heart
disease. Attention should be paid to assessment of symptoms such as
dyspnoea and chest pain, as they may be of either
respiratory or cardiac origin.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Patients receiving treatment with monoamine oxidase inhibitors (or