Nazione: Sudafrica
Lingua: inglese
Fonte: South African Health Products Regulatory Authority (SAHPRA)
Cipla Medpro (Pty) Ltd
See ingredients
INJECTION
EACH VIAL CONTAINS ZOLEDRONATE TRISODIUM EQUIVALENT TO ZOLEDRONIC ACID 4,0 mg
Registered
2012-02-03
Cipla Medpro (Pty) Ltd Cipla Zoledronic Acid 1.3.2 Page 1 of 8 Approved PIL 23-04-2015 PATIENT INFORMATION LEAFLET INFORMATION FOR THE PATIENT ABOUT CIPLA ZOLEDRONIC ACID INJECTION SCHEDULING STATUS: S4 PROPRIETARY NAME (AND DOSAGE FORM): CIPLA ZOLEDRONIC ACID (Injection) WHAT CIPLA ZOLEDRONIC ACID CONTAINS: The active substance in CIPLA ZOLEDRONIC ACID is zoledronic acid. Zoledronic acid belongs to a class of medicines known as bisphosphonates, which primarily acts on bone. It prevents the breakdown of bone tissue. Each vial of CIPLA ZOLEDRONIC ACID contains zoledronic acid monohydrate equivalent to zoledronic acid anhydrous 4 mg. The inactive ingredients include mannitol and sodium citrate. WHAT CIPLA ZOLEDRONIC ACID IS USED FOR: CIPLA ZOLEDRONIC ACID is indicated for the treatment of: READ THIS ENTIRE LEAFLET CAREFULLY BEFORE YOU RECEIVE CIPLA ZOLEDRONIC ACID. - KEEP THIS LEAFLET, YOU MAY NEED TO READ IT AGAIN. - IF YOU HAVE FURTHER QUESTIONS PLEASE ASK YOUR DOCTOR OR YOUR PHARMACIST. Cipla Medpro (Pty) Ltd Cipla Zoledronic Acid 1.3.2 Page 2 of 8 Approved PIL 23-04-2015 High blood levels of calcium due to cancer. Bone lesions resulting from multiple myeloma (a cancer that originates in bone marrow) in combination with standard therapy for this condition. Breast cancer that has spread to the bone in combination with appropriate anticancer therapy. Prostate cancer that has spread to the bone in patients who have increased levels of prostate specific antigen (PSA) despite hormone treatment. Your oncologist (doctor specialising in the treatment of cancer) will decide whether you qualify for treatment with CIPLA ZOLEDRONIC ACID and what other therapy you should be receiving in combination with it. BEFORE YOU RECEIVE CIPLA ZOLEDRONIC ACID: DO NOT RECEIVE CIPLA ZOLEDRONIC ACID IF YOU: Are known to be hypersensitive (allergic) to CIPLA ZOLEDRONIC ACID, any other bisphosphonates, or to any components of the formulation. Suffer from severely impaired kidney function. Suffer from severely impa Leggi il documento completo
Cipla Medpro (Pty) Ltd Cipla Zoledronic Acid 1.3.1.1 Page 1 of 11 Approved PI 23-04-2015 PACKAGE INSERT FOR CIPLA ZOLEDRONIC ACID SCHEDULING STATUS: S4 PROPRIETARY NAME (AND DOSAGE FORM): CIPLA ZOLEDRONIC ACID (Injection) COMPOSITION: Each vial contains zoledronic acid monohydrate equivalent to zoledronic acid anhydrous 4 mg. PHARMACOLOGICAL CLASSIFICATION: A 3.5 Others PHARMACOLOGICAL ACTION: Zoledronic acid is a bisphosphonate which primarily acts on the bone by inhibiting bone resorption without adversely affecting the formation, mineralisation or mechanical properties of bone. The selective action of zoledronic acid on bone is based on the affinity for mineralised bone, but the precise molecular mechanism leading to the inhibition of osteoclastic activity is still unclear. In addition to inhibiting osteoclastic bone resorption, zoledronic acid exerts direct anti-tumour effects on cultured human myeloma and breast cancer cells, inhibiting proliferation and inducing apoptosis. It also inhibits human endothelial cell proliferation _in vitro_. Cipla Medpro (Pty) Ltd Cipla Zoledronic Acid 1.3.1.1 Page 2 of 11 Approved PI 23-04-2015 Zoledronic acid reduces the invasion of human breast cancer cells through extracellular matrix _in vitro_, indicating that it may have anti-metastatic properties. INDICATIONS: CIPLA ZOLEDRONIC ACID is indicated for: Treatment of tumour-induced hypercalcaemia (HCM). Osteolytic lesions of multiple myeloma, in conjunction with standard antineoplastic therapy. Breast carcinoma with metastatic bone lesions in combination with appropriate anticancer therapy. Prostate carcinoma in patients with bone metastases who have increased prostate specific antigen (PSA) levels despite hormonal therapy. CONTRA-INDICATIONS: CIPLA ZOLEDRONIC ACID is contra-indicated in the following: Patients with clinically significant hypersensitivity to zoledronic acid, other bisphosphonates or any of the excipients in the formulation of CIPLA ZOLEDRONIC ACID. Severe impairment of renal function. Leggi il documento completo