Source: Web Search Revision Year: 2017 Publisher: Manufactured by Sanofi Egypt S.A.E under license from Sanofi-Aventis Germany
Parenteral use is indicated only where enteric administration cannot be considered.
Not used as routine analgesic.
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 given unless strictly indicated.
| age (body weight) | Single dose |
|---|---|
| 3–11 months (5–8 kg) | 0.1–0.2 ml Novalgin (equivalent to 50–100 mg metamizole sodium ) i. m. only |
| 1–3 years (9–15 kg) | 0.2–0.5 ml Novalgin (equivalent to 100–250mg metamizole sodium) |
| 4–6 years (16–23 kg) | 0.3–0.8 ml Novalgin (equivalent to 150–400mg metamizole sodium) |
| 7–9 years (24–30 kg) | 0.4–1 ml Novalgin (equivalent to 200–500 mg metamizole sodium) |
| 10–12 years (31–45 kg) | 0.5–1 ml Novalgin (equivalent to 250–500 mg metamizole sodium) |
| 13–14 years (46–53 kg) | 0.8–1.8 ml Novalgin (equivalent to 400–900 mg |
| Adults and young people from 15 years of age (>53 kg) | (1–2 ml*) Novalgin (equivalent to 500–1,000 mg metamizole sodium) |
* If necessary the single dose may be increased to 5 ml (equivalent to 2,500 mg metamizole sodium) and the daily dose to 10 ml (equivalent to 5,000 mg metamizole sodium).
In elderly patients the dose should be reduced, as elimination of the products of metabolism of Novalgin may be delayed.
In patients with impaired general health and reduced creatinine clearance, the dose should be reduced as elimination of the products of metabolism of Novalgin may be delayed.
Since the rate of elimination is reduced in patients with an impaired renal or hepatic function, repeated high doses should be avoided. Only in short-term use is no dose reduction necessary. No experience is available in respect of long-term administration.
The method of administration depends on the therapeutic effect desired and the condition of the patient. In many cases oral administration is adequate to achieve a satisfactory effect. If rapid onset of the effect is necessary or if oral or rectal administration is not indicated, intravenous or intramuscular injection of Novalgin is recommended. When selecting the method of administration it must be borne in mind that parenteral administration of the drug is associated with an increased risk of anaphylactic or anaphylactoid reactions.
Novalgin is injected by the intravenous or intramuscular route but in infants (3–11 months) by the intramuscular route only. The intramuscular injection should always be given in a solution at body heat. In view of the possibility of incompatibility, Novalgin solution for injection should not be injected or infused together with other medications.
The duration of administration depends on the nature and severity of the disease. During longer-term treatment with Novalgin, regular blood counts should be performed, including a differential blood count.
A single dose of more than 2 ml Novalgin (equivalent to 1,000 mg metamizole sodium) requires particularly careful verification of the indication, as it is suspected that non-allergic critical falls in blood pressure are dose-related.
For parenteral administration of Novalgin, the patient must be lying down and closely monitored by medical staff.
To minimise the risk of a hypotensive reaction and to ensure that the injection can be discontinued at the first signs of an anaphylactic or anaphylactoid reaction, the intravenous injection should be given very slowly, i.e. at a rate of not more than 1 ml (equivalent to 500 mg metamizole sodium) per minute.
In the event of acute overdose, nausea, vomiting, abdominal pain, impaired renal function/acute renal failure (e.g. in the form of interstitial nephritis) and – more rarely – central nervous symptoms (dizziness, somnolence, coma, seizures) and hypotension or even shock and tachycardia have been reported.
After very high doses the elimination of rubazonic acid can cause red discolouration of the urine.
No specific antidote is known for metamizole. If the metamizole has been taken recently, an attempt may be made to limit uptake in the body by primary detoxification (e. g. gastric lavage) or by means of measures to reduce absorption (e.g. activated carbon). The main metabolite (4 N-methyl-amino-antipyrine) can be eliminated by dialysis, haemofiltration, haemoperfusion or plasma filtration.
The treatment of poisoning and the prevention of serious complications may require general and specific intensive medical monitoring and treatment.
At the first sings (e.g. cutaneous reactions such as urticaria and ushing, restlessness, headache, sweating, nausea), discontinue the injection. Leave the cannula in the vein or create a venous access. In addition to the usual emergency measures involving lowering the head and upper body, maintaining the airway and administration of oxygen, the administration of sympathomimetics, volume replacement or glucocorticoids may be necessary.
3 years.
Refer to outer pack.
Novalgin 1 g solution for injection:
Brown, cylindrical glass vials supplied in packs of 5 × 2 ml and 10 × 2 ml and
hospital packs of 96 × 2 ml and 100 × 2 ml.
Brown, cylindrical glass vials supplied in packs of 4 × 5 ml, 6 × 5 ml and
hospital packs of 20 × 5 ml and 24 × 5 ml.
Not all pack sizes may be marketed.
No special requirements.
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