Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
Trastuzumab, Quantity: 150 mg
Roche Products Pty Ltd
Injection, powder for
Excipient Ingredients: histidine; histidine hydrochloride monohydrate; trehalose dihydrate; polysorbate 20
Intravenous
1 vial
(S4) Prescription Only Medicine
Early Breast Cancer. HERCEPTIN is indicated for the treatment of patients with HER2 positive localised breast cancer following surgery, and in assocoation with chemotherapy and, if applicable, radiotherapy. Locally Advanced Breast Cancer.Herceptin is indicated for the treatment of HER2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant HERCEPTIN. Metastatic Breast Cancer. HERCEPTIN 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. HERCEPTIN 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: Lyophilised powder: white to pale yellow in colour. Reconstituted solution: colourless to pale yellow, clear to slightly opalescent liquid.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 4 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
2000-09-14
HERCEPTIN ® _INTRAVENOUS INFUSION_ _Contains the active ingredient trastuzumab (rch)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Herceptin. 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 Herceptin 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. HERCEPTIN IS ALSO AVAILABLE AS A SUBCUTANEOUS (SC) INJECTION. FOR MORE INFORMATION ON HERCEPTIN SC PRODUCT PLEASE REFER TO THE SEPARATE CMI FOR HERCEPTIN SC OR SPEAK WITH YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT HERCEPTIN IS GIVEN FOR Herceptin contains an active ingredient called trastuzumab. Herceptin belongs to a group of medicines known as anti-neoplastic (or anti-cancer) agents. There are many different classes of anti- neoplastic agents. Herceptin 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. Herceptin 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 Herceptin binds to HER2 it stops the growth and spread of the cancer cells. Herceptin is used to treat breast and gastric cancer It is only used in patients whose tumour has tested positive to HER2. Herceptin 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 Herceptin is used with chemotherapy medicines cisplatin and capecitabine (or 5FU). For further information about the other medicines you are receiving with Herceptin, plea Soma hati kamili
herceptin20210507 1 AUSTRALIAN PRODUCT INFORMATION HERCEPTIN (TRASTUZUMAB) POWDER FOR INJECTION 1. NAME OF THE MEDICINE Trastuzumab 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Herceptin 150 mg vial contains 150mg of trastuzumab Herceptin 60mg vial contains 60 mg trastuzumab The reconstituted Herceptin solution contains 21 mg/mL of trastuzumab. For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Powder for IV infusion. Sterile, preservative-free lyophilized white to pale yellow powder. _Herceptin solution for subcutaneous (SC) injection (Herceptin SC) is a colourless to yellowish, clear to _ _opalescent and contains 600 mg/5mL of trastuzumab (see separate Herceptin SC Product Information). _ 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS EARLY BREAST CANCER Herceptin 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 Herceptin is indicated for the treatment of HER2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant Herceptin. METASTATIC BREAST CANCER Herceptin 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 Herceptin 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 Soma hati kamili