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āĻāĻžāĻˇāĻž: āĻāĻāĻ°ā§āĻāĻŋ
āĻ¸ā§āĻ¤ā§āĻ°: JFDA (Jordan Food & Drug Administration - اŲŲ ؤØŗØŗØŠ اŲؚاŲ ØŠ ŲŲØēØ°Ø§ØĄ ŲاŲدŲØ§ØĄ)
Bevacizumab 100 mg/4ml
Ų ØŗØĒŲدؚ ادŲŲØŠ شاŲŲ Ų ØąØ´ŲداØĒ Ų Ų ØŗŲاØĒ - Shawi & Rushedat Drug Store
L01XC07
Bevacizumab 100 mg/4ml
100 mg/4ml
1 Vial
F.Hoffmann La- Roche, kaiseraugst (ØŗŲŲØŗØąØ§)
March 2021 Product Information GCC Ro 487-6646 Avastin _ _ 1 / 37 AVASTIN ÂŽ Bevacizumab ANTINEOPLASTIC AGENT COMPOSITION _Active substances _ Bevacizumab (manufactured by recombinant DNA technology using CHO [Chinese hamster ovary] cells). _Excipients _ Îą,Îą-Trehalose dihydrate, sodium dihydrogen phosphate monohydrate, anhydrous disodium phosphate, polysorbate 20, water for injection. 1 ml of concentrate contains 1.35 mg sodium, i.e. 5.42 mg or 21.67 mg per vial. PHARMACEUTICAL FORM AND ACTIVE SUBSTANCE QUANTITY PER UNIT Concentrate for solution for infusion. Clear to slightly opalescent, colourless to pale brown sterile fluid for intravenous infusion. Each 4 ml vial contains 100 mg bevacizumab. Each 16 ml vial contains 400 mg bevacizumab. INDICATIONS/USES _Metastatic colorectal cancer _ Avastin (bevacizumab) is indicated for first-line treatment of patients with metastatic carcinoma of the colon or rectum in combination with the following chemotherapies: ī 5-fluorouracil/folinic acid ī 5-fluorouracil/folinic acid/irinotecan ī capecitabine/oxaliplatin (XELOX) Avastin is indicated as second-line therapy in combination with an irinotecan- or oxaliplatin-based chemotherapy regimen in patients with metastatic colorectal cancer with prior oxaliplatin- or irinotecan- based chemotherapy with or without Avastin. _Metastatic breast cancer _ Avastin (bevacizumab) is indicated in combination with paclitaxel for first-line treatment of patients with HER2-negative, metastatic breast cancer. _Advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) _ First-line therapy in combination with cisplatin- and gemcitabine-containing chemotherapy in unresectable, advanced, metastatic or recurrent, non-squamous non-small cell lung cancer (NSCLC). March 2021 Product Information GCC Ro 487-6646 Avastin _ _ 2 / 37 _Advanced and/or metastatic renal cell cancer _ Avastin in combination with interferon alfa-2a is indicated for first-line treatment of nephrectomised patients with advanced and/or metastatic renal cell cance āĻ¸āĻŽā§āĻĒā§āĻ°ā§āĻŖ āĻ¨āĻĨāĻŋ āĻĒāĻĄāĻŧā§āĻ¨