NOVALGIN 50mg/ml syrup

البلد: مصر

اللغة: الإنجليزية

المصدر: EDA (Egyptian Drug Authority)

متاح من:

SANOFI AVENTIS-GERMANY

جرعة:

50 mg/ml

الشكل الصيدلاني:

syrup

الوحدات في الحزمة:

100 ml

المصنعة من قبل:

SANOFI AVENTIS-EGYPT

تاريخ الترخيص:

2006-09-06

خصائص المنتج

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