PROLIA 60 MG / 1 ML 1 SYRINGE

** Prolia (denosumab 60 mg) solution for injection in a pre-filled syringe x1. Subcutaneous use.

** One pre-filled syringe with automatic needle guard.

** 1 ml pre-filled syringe containing 60 mg of denosumab (60 mg/ml).
Glacial acetic acid, sodium hydroxide, sorbitol (E420), polysorbate 20 and water for injections.

** Indications:
Osteoporosis && prevent skeletal event associted with bone metastase from solid tumour.
– Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture
– Treatment To Increase Bone Mass In Men With Osteoporosis
– Treatment of Bone Loss in Women Receiving Adjuvant Aromatase Inhibitor Therapy for Breast Cancer
– Treatment Of Bone Loss In Men Receiving Androgen Deprivation Therapy For Prostate Cancer

** Recommended Dosage:
– Prolia should be administered by a healthcare professional.
– The recommended dose of Prolia is 60 mg administered as a single subcutaneous injection once every 6 months.
– Administer Prolia via subcutaneous injection in the upper arm, the upper thigh, or the abdomen.
– Patients must be adequately supplemented with calcium 1000 mg daily and vitamin D 400 IU daily.
– If a dose of Prolia is missed, administer the injection as soon as the patient is available. Thereafter, schedule injections every 6 months from the date of the last injection.

** Pharmacotherapeutic group:
Drugs for the treatment of bone diseases – Other drugs affecting bone structure and mineralization, ATC code: M05BX04

** Mechanism of action:
Denosumab is a human monoclonal antibody (IgG2) that targets and binds with high affinity and specificity to RANKL, preventing activation of its receptor, RANK, on the surface of osteoclast precursors and osteoclasts. Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function and survival, thereby decreasing bone resorption in cortical and trabecular bone.

** Do not shake excessively.

** List I. Prescription only. Medicinal product subject to medical prescription.
Read the package leaflet before use.
Follow the prescribed doses.
** 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.
Minervum 7061, 4817 ZK Breda
The Netherlands
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