Страна: Новая Зеландия
Язык: английский
Источник: Medsafe (Medicines Safety Authority)
Trastuzumab 150mg
Samsung Bioepis NZ Limited
150 mg
Powder for infusion concentrate
Active: Trastuzumab 150mg Excipient: Histidine Histidine hydrochloride monohydrate Polysorbate 20 Trehalose dihydrate
Prescription
Metastatic breast cancer Ontruzant is indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress HER2: · as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease; or · in combination with taxanes for the treatment of those patients who have not received chemotherapy for their metastatic disease; or · in combination with an aromatase inhibitor for the treatment of post-menopausal patients with hormone-receptor positive metastatic breast cancer.
Package - Contents - Shelf Life: Vial, glass, single dose, Type 1, bromobutyl rubber stopper, aluminium and polypropylene flip-off cap - 150 mg - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)
2021-08-23
CONSUMER MEDICINE INFORMATION ONTRUZANT ® TRASTUZUMAB 150 MG POWDER FOR CONCENTRATE, SOLUTION FOR INTRAVENOUS INFUSION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Ontruzant 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 being given ONTRUZANT against the benefits expected 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 ONTRUZANT IS USED FOR ONTRUZANT contains the active ingredient trastuzumab. ONTRUZANT belongs to a group of medicines known as antineoplastic (or anti-cancer) agents. There are many different classes of antineoplastic agents. ONTRUZANT 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. ONTRUZANT 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 ONTRUZANT binds to HER2 it stops the growth and spread of the cancer cells. ONTRUZANT is used to treat breast and gastric cancer. It is only used in patients whose tumours has tested positive to HER2. ONTRUZANT 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, ONTRUZANT is used with the chemotherapy medicines cisplatin and capecitabine (or 5FU). For further information about other medicines you are receiving with ONTRUZANT, please ask your doctor, nurse or pharmacist for the Consumer medicine Information (CMI) leaflet. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS WHY ONTRUZANT HAS BEEN PRESCRIBED FOR YOU. This medicine is available only Прочитать полный документ
1 NEW ZEALAND DATA SHEET ONTRUZANT (TRASTUZUMAB) 1. PRODUCT NAME Ontruzant 150 mg powder for concentrate for solution for infusion Ontruzant is a biosimilar medicine 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains 150 mg trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by several chromatography steps including specific viral inactivation and removal procedures. The reconstituted Ontruzant solution contains 21 mg/mL of trastuzumab. For the full list of excipients, see section 6.1. The prescribing physician should be involved in any decision regarding interchangeability (unless the product is known to be non-interchangeable), and a reference to this webpage for further information (www.medsafe.govt.nz/profs/RIss/Biosimilars.asp) Comparability of Ontruzant with reference product (Herceptin ® ) is stated in “5. Pharmacological Properties” section of this datasheet. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion. White to pale yellow lyophilised powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS METASTATIC BREAST CANCER Ontruzant is indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress HER2: • as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease; or • in combination with taxanes for the treatment of those patients who have not received chemotherapy for their metastatic disease; or • in combination with an aromatase inhibitor for the treatment of post-menopausal patients with hormone-receptor positive metastatic breast cancer. EARLY BREAST CANCER Ontruzant is indicated for the treatment of patients with: • HER2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy, followed by adjuvant Ontruzant; or • HER2-positive early breast cancer following surgery, sequentially or concurrently with chemotherapy and, if applicable Прочитать полный документ