Država: Avstralija
Jezik: angleščina
Source: Department of Health (Therapeutic Goods Administration)
Bevacizumab, Quantity: 100 mg
Maxx Pharma Pty Ltd
Injection, concentrated
Excipient Ingredients: dibasic sodium phosphate; polysorbate 20; monobasic sodium phosphate dihydrate; water for injections; trehalose dihydrate; sodium hydroxide; phosphoric acid
Intravenous Infusion
1 vial
(S4) Prescription Only Medicine
Metastatic Colorectal Cancer,ABEVMY (bevacizumab) in combination with fluoropyrimidine-based chemotherapy is indicated for the treatment of patients with metastatic colorectal cancer.,Locally recurrent or metastatic Breast Cancer,ABEVMY (bevacizumab) in combination with paclitaxel is indicated for the first-line treatment of metastatic breast cancer in patients in whom an anthracycline-based therapy is contraindicated (see section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical Trials).,Advanced, metastatic or recurrent non-squamous Non-Small Cell Lung Cancer (NSCLC),ABEVMY (bevacizumab), in combination with carboplatin and paclitaxel, is indicated for firstline treatment of patients with unresectable advanced, metastatic or recurrent, non-squamous, non- small cell lung cancer.,Advanced and/or metastatic Renal Cell Cancer,ABEVMY (bevacizumab) in combination with interferon alfa-2a is indicated for treatment of patients with advanced and/or metastatic renal cell cancer.,Grade IV Glioma,ABEVMY (bevacizumab) as a single agent, is indicated for the treatment of patients with Grade IV glioma after relapse or disease progression after standard therapy, including chemotherapy.,Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer,ABEVMY (bevacizumab) in combination with carboplatin and paclitaxel, is indicated for firstline treatment of patients with advanced (FIGO stages IIIB, IIIC and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer.,Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer,ABEVMY (bevacizumab) in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, is indicated for the treatment of patients with first recurrence of platinum-sensitive, epithelial ovarian, fallopian tube, or primary peritoneal cancer who have not received prior bevacizumab or other VEGF-targeted angiogenesis inhibitors.,ABEVMY (bevacizumab) in combination with paclitaxel, topotecan or pegylated liposomal doxorubicin is indicated for the treatment of patients with recurrent, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received no more than two prior chemotherapy regimens, and have not received any prior anti-angiogenic therapy including bevacizumab.,Cervical Cancer,ABEVMY (bevacizumab) in combination with paclitaxel and cisplatin is indicated for the treatment of persistent, recurrent or metastatic carcinoma of the cervix. ABEVMY (bevacizumab) in combination with paclitaxel and topotecan is an acceptable alternative where cisplatin is not tolerated or not indicated.
Visual Identification: A clear to slightly opalescent, colourless to pale brown, sterile solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 30 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2021-09-06
ABEVMY ® _bevacizumab (rch)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ABEVMY infusion. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking ABEVMY against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ABEVMY IS USED FOR ABEVMY is used to treat; • brain tumours resistant to previous treatments • metastatic (spreading) cancer of the large bowel (i.e. in the colon or rectum), breast or cervix in combination with chemotherapy agents • lung cancer and cancer of the ovaries and fallopian tubes (which can extend to the lining of surrounding organs such as stomach, liver) in combination with chemotherapy agents • kidney cancer (renal cell cancer) in combination with interferon therapy (Roferon-A ® ). ABEVMY contains the active ingredient bevacizumab. ABEVMY belongs to a group of medicines known as anti-neoplastic (or anti-cancer) agents. There are many different classes of anti- neoplastic agents. ABEVMY belongs to a class known as anti-angiogenic agents. Anti-angiogenic agents inhibit angiogenesis (the process of forming new blood vessels in your body). ABEVMY selectively binds to vascular endothelial growth factor (VEGF), a protein found on the cells that line blood vessels. Tumours produce high levels of VEGF, which stimulates blood vessels to grow, thereby providing the tumour with nutrients and oxygen. When ABEVMY blocks VEGF it disrupts the blood supply to the tumour, stopping or slowing down its growth. There are many different types of medicines used to treat brain tumours and metastatic cancer of the large bowel, breast, lung, kidney and cervix. Your doctor may have prescribed ABEVMY for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY Preberite celoten dokument
AUSTRALIAN PRODUCT INFORMATION ABEVMY ® _Bevacizumab (rch) Injection_ _ _ _ _ _ _ 1 NAME OF THE MEDICINE Bevacizumab (rch). ABEVMY is a biosimilar medicine to Avastin. The evidence for comparability supports the use of ABEVMY for the listed indications. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Bevacizumab is the active ingredient. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS . 3 PHARMACEUTICAL FORM ABEVMY (bevacizumab) is available in 100 mg and 400 mg single dose vials containing 4 mL and 16 mL, respectively, of bevacizumab (25 mg/mL). ABEVMY is a clear to slightly opalescent, colourless to pale brown, sterile solution for intravenous (IV) infusion. ABEVMY is not formulated for intravitreal use (see SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE , SEVERE EYE INFECTIONS FOLLOWING COMPOUNDING FOR UNAPPROVED INTRAVITREAL USE ). 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS METASTATIC COLORECTAL CANCER ABEVMY (bevacizumab) in combination with fluoropyrimidine-based chemotherapy is indicated for the treatment of patients with metastatic colorectal cancer. LOCALLY RECURRENT OR METASTATIC BREAST CANCER ABEVMY (bevacizumab) in combination with paclitaxel is indicated for the first-line treatment of metastatic breast cancer in patients in whom an anthracycline-based therapy is contraindicated (see SECTION 5.1 PHARMACODYNAMIC PROPERTIES, CLINICAL TRIALS ). ADVANCED, METASTATIC OR RECURRENT NON-SQUAMOUS NON-SMALL CELL LUNG CANCER (NSCLC) ABEVMY (bevacizumab), in combination with carboplatin and paclitaxel, is indicated for first-line treatment of patients with unresectable advanced, metastatic or recurrent, non-squamous, non- small cell lung cancer. ADVANCED AND/OR METASTATIC RENAL CELL CANCER ABEVMY (bevacizumab) in combination with interferon alfa-2a is indicated for treatment of patients with advanced and/or metastatic renal cell cancer. ABEVMY ® – PRODUCT INFORMATION 2 GRADE IV GLIOMA ABEVMY (bevacizumab) as a single agent, is indicated for the treatment of patients with Grade IV Preberite celoten dokument