Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Trastuzumab, Quantity: 150 mg
Celltrion Healthcare Australia Pty Ltd
Injection, powder for
Excipient Ingredients: histidine hydrochloride; polysorbate 20; histidine; trehalose dihydrate
Intravenous
Single-dose 150 mg vial
(S4) Prescription Only Medicine
Early Breast Cancer,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,Indicated for the treatment of HER2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant therapy.,Metastatic Breast Cancer,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,Indicated in combination with cisplatin and either capecitabine or 5-FU for the treatmen
Visual Identification: SIMABTRA is a sterile, white to pale yellow, preservative-free lyophilized powder for IV infusion.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 72 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2018-07-17
-Celltrion Healthcare Australia Pty Ltd CONSUMER MEDICINE INFORMATION SIMABTRA® trastuzumab 150 mg Powder for Injection for Intravenous (IV) Infusion SIMABTRA ® _POWDER FOR INJECTION FOR INTRAVENOUS (IV) INFUSION _ _ _ _Contains the active ingredient trastuzumab (rch) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about SIMABTRA. 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 SIMABTRA 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 SIMABTRA IS GIVEN FOR SIMABTRA contains the active ingredient called trastuzumab. SIMABTRA belongs to a group of medicines known as anti-neoplastic (or anti-cancer) agents. There are many different classes of anti- neoplastic agents. SIMABTRA 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. SIMABTRA 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 SIMABTRA binds to HER2 it stops the growth and spread of the cancer cells. SIMABTRA is used to treat breast and gastric cancer. It is only used in patients whose tumour has tested positive to HER2. SIMABTRA 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 SIMABTRA is used with chemotherapy medicines cisplatin and capecitabine (or 5FU). For further information about the other medicines you are receiving with SIMABTRA, please ask your doctor, n Read the complete document
SIMABTRA ® (trastuzumab (rch)) 2021-08 v7.0 Page 1 of 39 AUSTRALIAN PI – SIMABTRA ® (TRASTUZUMAB (RCH)) POWDER FOR INJECTION FOR INTRAVENOUS (IV) INFUSION 1 NAME OF THE MEDICINE SIMABTRA ® (trastuzumab (rch)) Trastuzumab 150 mg and 440 mg powder for injection for intravenous (IV) infusion SIMABTRA ® is a biosimilar medicine to the reference biological medicine HERCEPTIN ®. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION SIMABTRA ® 150 mg vial contains 150 mg of trastuzumab. SIMABTRA ® 440 mg vial contains 440 mg of trastuzumab. The reconstituted SIMABTRA ® 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 Injection for Intravenous (IV) Infusion. SIMABTRA ® is a sterile, white to pale yellow lyophilised powder. The solvent is a clear to slightly opalescent liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Early Breast Cancer SIMABTRA ® 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 SIMABTRA ® is indicated for the treatment of HER2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant SIMABTRA ® . Metastatic Breast Cancer SIMABTRA ® 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. SIMABTRA ® (trastuzumab (rch)) 2021-08 v7.0 Page 2 of 39 Advanced Gastric Cancer SIMABTRA ® is indicated in combination with cisplatin and either capecitabine Read the complete document