** XGEVA® (denosumab) 120 mg solution for injection. 1 single use vial. Subcutaneous use.
** Each vial contains 120 mg of denosumab in 1.7 ml of solution (70 mg/ml)
Acetic acid glacial, sodium hydroxide, sorbitol (E420) and water for injections.
** Therapeutic indications
– Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from solid tumours.
– Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
** Pharmacotherapeutic group:
Drugs for the treatment of bone diseases – other drugs affecting bone structure and mineralisation, ATC code: M05BX04
** Mechanism Of Action
Xgeva binds to RANKL, a transmembrane or soluble protein essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption, thereby modulating calcium release from bone. Increased osteoclast activity, stimulated by RANKL, is a mediator of bone pathology in solid tumors with osseous metastases. Similarly, giant cell tumors of bone consist of stromal cells expressing RANKL and osteoclast-like giant cells expressing RANK receptor, and signaling through the RANK receptor contributes to osteolysis and tumor growth. Xgeva prevents RANKL from activating its receptor, RANK, on the surface of osteoclasts, their precursors, and osteoclast-like giant cells.
** Do not shake excessively.
** Read the package leaflet before use.
** Medicinal product subject to medical prescription. Follow the prescribed doses.
** List I. Prescription only.
** Store in a refrigerator (2-8 degrees C). Do not freeze. Store in the original carton in order to protect from light.
Keep out of the reach and sight of children.
** AMGEN® Europe B.V.
48017 ZK Breda,
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