País: Australia
Idioma: inglés
Fuente: Department of Health (Therapeutic Goods Administration)
Trastuzumab, Quantity: 150 mg
Maxx Pharma Pty Ltd
Powder
Excipient Ingredients: histidine; sorbitol; histidine hydrochloride monohydrate; macrogol 3350; sodium hydroxide; hydrochloric acid
Intravenous
1 vial
(S4) Prescription Only Medicine
? Early Breast Cancer,OGIVRI is indicated for the treatment of HER2-positive early breast cancer following surgery, and in association with chemotherapy and, if applicable, radiotherapy.,? Locally Advanced Breast Cancer,OGIVRI is indicated for the treatment of HER2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant OGIVRI.,? Metastatic Breast Cancer,OGIVRI is indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress HER2:,a) as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease;,b) in combination with taxanes for the treatment of those patients who have not received chemotherapy for their metastatic disease; or,c) in combination with an aromatase inhibitor for the treatment of post-menopausal patients with hormone-receptor positive metastatic breast cancer.,? Advanced Gastric Cancer,OGIVRI is indicated in combination with cisplatin and either capecitabine or 5-FU for the treatment of patients with HER2 positive advanced adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.
Visual Identification: Lyophilized powder, off-white to pale yellow in colour. Reconstituted solution - colourless to pale yellow clear to slightly opalescent solution practically free of visible particles.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 48 Months; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
2018-12-11
OGIVRI _contains the active ingredient trastuzumab (rch)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about OGIVRI. 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 being given OGIVRI against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST.. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT OGIVRI IS USED FOR OGIVRI contains an active ingredient called trastuzumab. OGIVRI belongs to a group of medicines known as anti-neoplastic (or anti-cancer) agents. There are many different classes of antineoplastic agents. OGIVRI belongs to a class called monoclonal antibodies Monoclonal antibodies are proteins made in a laboratory. These proteins are designed to recognise and bind to other unique proteins in the body. OGIVRI binds selectively to a protein called human epidermal growth factor receptor 2 (HER2). HER2 is found in large amounts on the surface of some cancer cells. When OGIVRI binds to HER2 it stops the growth and spread of the cancer cells. OGIVRI is used to treat breast and gastric cancer. It is only used in patients whose tumor has tested positive to HER2. OGIVRI may be used alone or with other medicines that treat breast cancer, such as an aromatase inhibitor (hormone receptor positive breast cancer) or a taxane (e.g. paclitaxel or docetaxel). For the treatment of gastric cancer OGIVRI is used with chemotherapy medicines cisplatin and capecitabine (or 5FU). For further information about the other medicines you are receiving with OGIVRI, please ask your doctor, nurse or pharmacist for the Consumer Medicine Information (CMI) leaflet. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS WHY OGIVRI HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor’s prescription. BEFORE YOU ARE GIVEN OGIVRI Leer el documento completo
AUSTRALIAN PRODUCT INFORMATION OGIVRI _trastuzumab (rch) powder for injection _ 1 NAME OF THE MEDICINE Trastuzumab. OGIVRI is a biosimilar medicine to Herceptin. The evidence for comparability supports the use of OGIVRI for the listed indications. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION OGIVRI contains trastuzumab as the active ingredient. Each OGIVRI 150 mg single-dose vial contains 150 mg of trastuzumab. Each OGIVRI 440 mg Pharmacy Bulk Pack contains 440 mg of trastuzumab. Excipients with known effect: Sorbitol OGIVRI contains 0.77 mg sorbitol/ 1.00 mg trastuzumab. There is 115.2 mg of sorbitol in the 150 mg vial and 337.9 mg of sorbitol in the 440 mg Pharmacy Bulk Pack. Reconstitution of the 150 mg vial with 7.2 mL of sterile water for injection yields 7.4 mL of a single-dose solution containing approximately 21 mg/mL trastuzumab, at a pH of approximately 6.0. A volume overage of 4% ensures that the labelled dose can be withdrawn from each vial. Reconstitution of the 440 mg vial with 20 mL of bacteriostatic water for injection yields a multiple-dose solution containing approximately 21 mg/mL trastuzumab, at a pH of approximately 6.0. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Powder for IV infusion. OGIVRI is a sterile, white to pale yellow, preservative-free lyophilized powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS EARLY BREAST CANCER OGIVRI is indicated for the treatment of HER2-positive early breast cancer following surgery, and in association with chemotherapy and, if applicable, radiotherapy. LOCALLY ADVANCED BREAST CANCER OGIVRI is indicated for the treatment of HER2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant OGIVRI. METASTATIC BREAST CANCER OGIVRI is indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress HER2: a) as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metast Leer el documento completo