Land: Australien
Språk: engelska
Källa: Department of Health (Therapeutic Goods Administration)
Trastuzumab, Quantity: 60 mg
Pfizer Australia Pty Ltd
Injection, powder for
Excipient Ingredients: histidine hydrochloride monohydrate; histidine; polysorbate 20; sucrose
Intravenous
1
(S4) Prescription Only Medicine
Early Breast Cancer ,TRAZIMERA 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 ,TRAZIMERA is indicated for the treatment of HER2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant TRAZIMERA. ,Metastatic Breast Cancer ,TRAZIMERA 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 ,TRAZIMERA is indicated in combination
Visual Identification: a sterile, white, preservative-free lyophilized powder or cake for IV infusion.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 48 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2019-08-19
TRAZIMERA™ T R A Z I M E R A ™ CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING TRAZIMERA? TRAZIMERA contains the active ingredient trastuzumab. TRAZIMERA is used to treat breast and gastric cancer. It is only used in patients whose tumour has tested positive to HER2. For more information, see Section 1. Why am I using TRAZIMERA? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE TRAZIMERA? Do not use if you have ever had an allergic reaction to any medicine containing trastuzumab, any protein of Chinese hamster origin or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use TRAZIMERA? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with TRAZIMERA and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE TRAZIMERA? TRAZIMERA must be prepared by a healthcare professional and will be given in a hospital or clinic by a doctor or nurse. TRAZIMERA is given by "drip" into a vein (intravenous (IV) infusion). The first TRAZIMERA infusion is given over 90 minutes. If the first infusion is well tolerated, your drip time may be shortened to 30 minutes. For the treatment of breast cancer, TRAZIMERA is given either once a week or once every three weeks. It may be given alone or in combination with other medicines used to treat breast cancer. For the treatment of gastric cancer TRAZIMERA is given every three weeks in combination with other medicines used to treat gastric cancer. More instructions can be found in Section 4. How do I use TRAZIMERA? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING TRAZIMERA? THINGS YOU SHOULD DO • Remind any doctor Läs hela dokumentet
Version: pfptrazv11121 Supersedes: pfptrazv10720 Page 1 of 36 AUSTRALIAN PRODUCT INFORMATION – TRAZIMERA TM (TRASTUZUMAB) 1 NAME OF THE MEDICINE Trastuzumab TRAZIMERA is a biosimilar medicine to the reference biological medicine HERCEPTIN ® . 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 60 mg or 150 mg trastuzumab. The humanized antibody against HER2 is produced by recombinant mammalian cells (Chinese hamster ovary (rch)) in suspension culture in a nutrient medium and purified by affinity chromatography and ion exchange, including specific viral inactivation and removal procedures. For the full list of excipients, see section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Powder for injection for infusion. TRAZIMERA is a sterile, white preservative-free lyophilized powder or cake for IV infusion. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS EARLY BREAST CANCER TRAZIMERA 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 TRAZIMERA is indicated for the treatment of HER2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant TRAZIMERA. METASTATIC BREAST CANCER TRAZIMERA 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 Version: pfptrazv11121 Supersedes: pfptrazv10720 Page 2 of 36 c) in combination with an aromatase inhibitor for the treatment of post-menopausal patients with hormone-receptor positive metastatic breast cancer. ADVANCED GASTRIC CANCER TRAZIMERA is indicated in combination with cisplatin and either capecitabine or 5-FU for the treatment of patients with HER2 positi Läs hela dokumentet