NOVALGIN Solution for injection (2017)

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1. Name of the medicinal product

Novalgin 1 g solution for injection.

2. Qualitative 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, ...

3. Pharmaceutical form

Solution for injection, nearly colourless to yellow.

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 ...

4.2. Posology and method of administration

Posology The dose depends on the severity of the pain or fever and the sensitivity of the individuals reaction to Novalgin. Essentially the lowest dose effective in controlling the pain and fever should ...

4.3. Contraindications

Hypersensitivity to the active substance or other pyrazolones or pyrazolidines (this also includes patients who have reacted, for example, with agranulocytosis after using these substances) or to any of ...

4.4. Special warnings and precautions for use

Novalgin contains the pyrazolone derivative metamizole and carries the rare but life-threatening risk of shock and agranulocytosis (see section 4.8). Patients who show anaphylactoid reactions to Novalgin ...

4.5. Interaction with other medicinal products and other forms of interaction

Metamizole may lead to a reduction in serum cyclosporin levels. These must therefore be monitored if Novalgin is used concomitantly. During concomitant use of Novalgin and chlorpromazine, severe hypothermia ...

4.6. Pregnancy and lactation

Pregnancy No adequate data is available on the use of Novalgin in pregnant women. Metamizole crosses the placental barrier. In animal experimental studies metamizole showed no teratogenic effects (see ...

4.7. Effects on ability to drive and use machines

No impairment of concentration and the ability to react is known in the normal dose range. As a precautionary measure, however, at least at higher doses, the possibility of impairment should be considered ...

4.8. Undesirable effects

The incidences of undesirable effects are based on the following categories: very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1,000 to <1/100), rare (>1/10,000 to <1/1,000), very rare (<1/10,000), ...

4.9. Overdose

Symptoms of an overdose 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 ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: analgesics, other analgesics and antipyretics, pyrazolones ATC code: N02BB02 Metamizole is a pyrazolone derivative and has analgesic, antipyretic and spasmolytic ...

5.2. Pharmacokinetic properties

Metamizole is completely hydrolysed after oral administration to the pharmacologically active 4 N methyl-amino-antipyrine (MAA). The bioavailability of MAA is approx. 90% and is slightly higher after oral ...

5.3. Preclinical safety data

Subchronic and chronic toxicity investigations have been performed in various animal species. Rats were given 100 to 900 mg metamizole per kg BW orally for 6 months. At the highest dose (900 mg per kg ...

6.1. List of excipients

Water for injection

6.2. Incompatibilities

In view of the possibility of incompatibility, it is recommended that the solution for injection should not be mixed with other therapeutic agents for injection or infusion (with respect to miscibility ...

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Refer to outer pack.

6.5. Nature and contents of container

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 ...

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

Manufactured by Sanofi Egypt S.A.E under license from Sanofi-Aventis Germany

8. Marketing authorization number(s)

Novalgin 1 g solution for injection: 619647.00.03 : 619647.01.03

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 31 March 1998 Date of latest renewal: 07 August 2006

10. Date of revision of the text

March 2017