Land: Egypt
Språk: engelsk
Kilde: EDA (Egyptian Drug Authority)
SANOFI AVENTIS-GERMANY
50 mg/ml
syrup
100 ml
SANOFI AVENTIS-EGYPT
2006-09-06
1. NAME OF THE MEDICINAL PRODUCTS Novalgin 1 g solution for injection 2. QUALITIVE AND QUANTITATIVE COMPOSITION Novalgin 1 g solution for injection 1 ml solution for injection contains 500 mg metamizole sodium Each vial with 2 ml solution for injection contains 1 g metamizole sodium For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection, nearly colourless to yellow 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Acute severe pain after injury or surgery -Colic, - Tumour pain, - Other acute or chronic severe pain, where other therapeutic measures are not indicated, - High fever not responding to other measures. Parenteral use is indicated only where enteric administration cannot be considered. Not used as routine analgesic 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose depends on the severity of the pain or fever and the sensitivity of the individual’s reaction to Novalgin. Essentially the lowest dose effective in controlling the pain and fever should be selected. In fever, a dose of 10 mg metamizole per kilogram body weight is generally adequate in children. A clear effect can be expected 30 to 60 minutes after oral use and approx. 30 minutes after parenteral administration. For children and adolescents up to 14 years of age, the single dose is 8 to 16 mg metamizole sodium per kilogram body weight. Adults and young people aged 15 and over (> 53 kg) can take up to 1000 mg per single dose. In the event of inadequate efficacy the single dose may be given up to 4 times a day, depending on the maximum daily dose. The recommended single doses and maximum daily doses are shown in the dosage table below. The single dose usually given by parenteral administration is 6 mg to 16 mg metamizole per kilogram body weight. Infants from 3 months of age to 1 year are given Novalgin solution for injection by the intramuscular route only. As hypotensive reactions to the injection may possibly be dose-related, single parenteral doses of more than 1 g Novalgin must not be giv Les hele dokumentet