Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
PROMETHAZINE HYDROCHLORIDE
Sanofi-Aventis Ireland Limited
2.5 %w/v
Solution for Injection
2005-10-28
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 Baca dokumen lengkap