PHENERGAN Solution for Injection 2.5 %w/v
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
27-04-2024
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Active ingredient:
PROMETHAZINE HYDROCHLORIDE
Available from:
Sanofi-Aventis Ireland Limited
Dosage:
2.5 %w/v
Pharmaceutical form:
Solution for Injection
Authorization date:
2005-10-28
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Phenergan 2.5% w/v Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml ampoule contains Promethazine Hydrochloride 25 mg.
Excipients: Contains Sodium Sulphite (E221) 0.5mg and Sodium Metabisulphite (E223) 0.7mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection
Clear, bright, almost colourless, solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the treatment of allergic conditions and reactions.
As an antiemetic.
As a tranquilliser.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: Intramuscular or Intravenous.
INTRAMUSCULAR:
ADULTS:
The usual daily dose is 25-50 mg by deep intramuscular injection. A maximum dose of 100mg parenterally should not
be exceeded.
CHILDREN:
Children 5-10 years only:
6.25 - 12.5 mg daily be deep intramuscular injection.
ELDERLY:
No specific dosage recommendations.
INTRAVENOUS:
ADULTS ONLY:
In an emergency, the usual dose is 25-50mg after dilution to 10 times the volume with water for injection. A maximum
dose of 100mg parenterally should not be exceeded.
ELDERLY:
No specific dosage recommendations.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 25/04/2012_
_CRN 2114730_
_page number: 1_
4.3 CONTRAINDICATIONS
Phenergan should not be used in patients in pre-coma states, in a coma or suffering from CNS depression of any cause.
It must not be given to neonates or premature infants.
Phenergan should not be given to patients with a known hypersensitivity to promethazine or to any of the excipients.
Phenergan should be avoided in patients with blood dycrasias and in patients taking monoamine oxidase inhibitors up
to 14 days
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