METAMIZOLE SODIUM / NOVALGIN INJECTION 500 mg/5 mL

Metamizole is a precise mechanism of action is unknown, although it is believed that inhibiting brain and spinal cord prostaglandin (fat-like molecules that are involved in inflammation, pain and fever) synthesis might be involved.

COMPOSITION:

Each 5 mL contains 500 mg Metamizole sodium.

PHARMACOLOGICAL ACTION:

Its precise mechanism of action is unknown, although it is believed that inhibiting brain and spinal cord prostaglandin (fat-like molecules that are involved in inflammation, pain and fever) synthesis might be involved 

INDICATIONS:

Colic of the billiary,gastro-intestinal and urinary tracts.Dysmenorrhoea,Mittelschmerz.

CONTRA-INDICATIONS:

Previous hypersensitivity (such as agranulocytosis or anaphylaxis) to metamizole or any of the excipients (e.g. lactose) in the preparation used, acute porphyria, impaired haematopoiesis (such as due to treatment with chemotherapy agents), third trimester of pregnancy (potential for adverse effects in the newborn), lactation, children with a body weight below 16 kg, history of aspirin-induced asthma and other hypersensitivity reactions to analgesics.

WARNING

Its use in pregnancy is advised against, although animal studies are reassuring in that they show minimal risk of birth defects; its use in the elderly or those with liver/kidney impairment is advised against, but if these groups of people must be treated a lower dose and caution is usually advised; its use in lactation is advised against as it is excreted in breast milk.

DOSAGE AND DIRECTIONS FOR USE:

SIDE EFFECTS AND SPECIAL PRECAUTIONS:

It is known to cause minimal side effects in most people given it; serious side effects include agranulocytosis,aplastic anaemia, hypersensitivity reactions (like anaphylaxis and bronchospasm), toxic epidermal necrolysis and it may provoke acute attacks of porphyria, as it is chemically related to sulfonamides.

he relative risk for agranulocytosis appears to greatly vary according to the country of estimates on said rate and opinion on the risk is strongly divided.

STORAGE INSTRUCTIONS: 
Store below 25°C. 
KEEP OUT OF REACH OF CHILDREN.