Analgin-BP (inj.)

Metamizol sodic

1 ml solution for injection contains metamizole sodium 500 mg (1 ampoule of 2 ml contains metamizole sodium 1000 mg). Excipients with known effect: sodium metabisulfite, sodium.

Indication: Post-traumatic and post-operative pain, colic, pain syndrome in oncology patients, and fever not controlled by other antipyretics; parenteral administration is used only when oral administration of metamizole sodium is not possible.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications − Hypersensitivity to the active substance or to other pyrazolone or pyrazolidine derivatives or to any other components of the medicine listed in section 6.1; − patients with a history of analgesic-induced asthma syndrome or analgesic intolerance (urticaria, angioneurotic oedema), i.e. patients who develop bronchospasm or other forms of anaphylactoid reactions to salicylates, paracetamol or other non-opioid analgesics such as diclofenac, ibuprofen, indomethacin or naproxen; − history of agranulocytosis induced by metamizole, other pyrazolones or pyrazolidines; − impaired bone marrow function or diseases of the haematopoietic system; − hereditary glucose-6-phosphate dehydrogenase deficiency (risk of haemolysis); − acute intermittent hepatic porphyria (risk of a porphyric attack); − third trimester of pregnancy; − hypotension and/or haemodynamic instability.

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use This medicine contains a pyrazolone derivative - metamizole - which can cause rare but life-threatening adverse reactions, including shock and agranulocytosis. Agranulocytosis Treatment with metamizole may cause agranulocytosis, which can be fatal (see section 4.8). It can occur even after metamizole has previously been used without complications. Metamizole-induced agranulocytosis is an idiosyncratic adverse reaction. It is not dose-dependent and can occur at any time during treatment, even shortly after treatment discontinuation. Patients must be instructed to stop treatment and seek medical attention immediately if symptoms suggestive of agranulocytosis occur (e.g. fever, chills, sore throat and painful mucosal lesions), particularly […]