Hyoscine Injection BP 400 micrograms/ml, Solution for Injection

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Hyoscine hydrobromide

Verfügbar ab:

Martindale Pharmaceuticals Ltd

ATC-Code:

A04AD

INN (Internationale Bezeichnung):

Hyoscine hydrobromide

Dosierung:

400 microgram(s)/millilitre

Darreichungsform:

Solution for injection

Verschreibungstyp:

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

Therapiebereich:

Other antiemetics

Berechtigungsstatus:

Marketed

Berechtigungsdatum:

2005-08-26

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hyoscine Injection BP 400 micrograms/ml, Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml contains 400 micrograms of Hyoscine Hydrobromide.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection
A clear colourless solution in clear glass ampoules.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1. Nausea, vomiting, vertigo, labyrinthine disorders, motion sickness.
2. To prevent excessive bronchial salivary secretions during the use
of general anaesthesia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
By subcutaneous or intramuscular injection.
ADULTS AND THE ELDERLY
1. 200 micrograms as a single dose.
2. 200 – 600 micrograms, 30 – 60 minutes before induction of
anaesthesia.
CHILDREN (OVER 4 MONTHS)
1. 6 micrograms/ kg as a single dose.
2. 15 micrograms/ kg , 30 – 60 minutes before induction of
anaesthesia.
CHILDREN (UNDER 4 MONTHS)
Not recommended.
4.3 CONTRAINDICATIONS
Known hypersensitivity, glaucoma, acute porphyria and the onset of
labour.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
In some patients, especially the elderly, it may cause central
anticholinergic syndrome (excitement, ataxia,
hallucinations, behavioural abnormalities and drowsiness), urinary
retention, cardiovascular disease, paralytic ileus and
pyloric stenosis. Caution is required in patients with asthma, hepatic
or renal impairment, gastrointestinal obstruction,
epilepsy and thyrotoxicosis.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
The depressant actions of hyoscine may be enhanced by other CNS
depressants such as alcohol, anaesthetics,
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