Indications

Acute moderate or intense post-surgery or post-traumatic pain, colicky-type or from tumoral origin. High fever that does not respond to other therapeutic measures including first choice antipyretics. Parenteral administration is only indicated in acute intense pain if enteral administration is not considered appropriate.

Dosage and Administration

Usage:I.V./I.M.

In children and adolescents up to 14 years old, 8–16 mg metamizole per kg body weight can be given as a single dose. In the case of fever, a dose of 10 mg metamizole per kilogram body weight is generally enough for children. Adults and adolescents from 15 years of age (>53 kg) can be administered up to 1,000 mg as a single dose.

Precautions & Warning:

1.Severe hematologic reactions (such as agranulocytosis or pancytopenia)

2.Anaphylactic/anaphylactoid reactions and anaphylactic shock

3.Severe hypotensive reactions

4.Severe skin reactions

5.Gastrointestinal bleeding

Contraindications:

- Agranulocytosis in the medical history induced by metamizole, other pyrazolones or pyrazolidines

- Impaired bone marrow function or diseases of the hematopoietic system

- patients who have shown prior hypersensitivity reactions or haematological reactions to medicinal products containing metamizole, other pyrazolones or pyrazolidines (isopropylaminophenazone, propyphenazone, phenazone or phenylbutazone), as well as patients with hypersensitivity to any of the excipients

- patients with known analgesic-induced asthma syndrome or known analgesic intolerance of the urticarial-angioedema type, i.e. patients who develop bronchospasm or other anaphylactoid reactions in response to salicylates, paracetamol or other non-narcotic analgesics such as diclofenac, ibuprofen, indomethacin or naproxen - patients with acute intermittent hepatic porphyria (risk of triggering a porphyria attack).

- patients with genetic glucose-6-phosphate-dehydrogenase deficiency (risk of haemolysis).

Adverse Reactions:

1. Blood and lymphatic system disorders Rare leukopenia very rare agranulocytosis (including fatal cases), thrombocytopenia frequency not known sepsis, aplastic anaemia, pancytopenia (including fatal cases) These are presumably immunological reactions. They can occur even if metamizole was administered on previous occasions without complications. Agranulocytosis is manifested in the form of pyrexia, chills, oropharyngeal pain, dysphagia, stomatitis, rhinitis, pharyngitis, genital tract inflammation, and anal inflammation. These signs or symptoms may be minimal in patients on antibiotics. There is little or no lymphadenopathy or splenomegaly. The sedimentation rate is markedly increased, and granulocytes are considerably reduced or absent altogether. Haemoglobin, red blood cell count and platelet counts may be abnormal.

2. Immune system disorders, skin and subcutaneous tissue disorders

3. Cardiac disorders

4.Vascular disorders

Drug interactions:

1.Methotrexate and other antineoplastic

Concomitant administration of metamizole with methotrexate or other antineoplastic may increase blood toxicity of antineoplastic particularly in elderly patients. Therefore, this combination should be avoided.

2. Chlorpromazine

Concomitant use of metamizole and chlorpromazine can cause severe hypothermia.

3. Acetylsalicylic acid

Metamizole can reduce the antiplatelet effect of acetylsalicylic acid if administered concomitantly. Therefore, metamizole sodium injection should be used with caution in patients taking low doses of acetylsalicylic acid as a cardioprotective agent.

Storage instructions:

Keep in a cool, dry place and away from children.