Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
docetaxel, Quantity: 80 mg
Accord Healthcare Pty Ltd
Docetaxel
Injection, concentrated
Excipient Ingredients: polysorbate 80; ethanol absolute; citric acid
Intravenous
Pack of 1 vial
(S4) Prescription Only Medicine
Breast cancer Docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer in whom previous chemotherapy has failed. Docetaxel in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy. Docetaxel in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease Adjuvant treatment of breast cancer Docetaxel in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with node-positive breast cancer. Doxorubicin and cyclophosphamide followed by Docetaxel in combination with trastuzumab (AC-TH) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress HER2. Docetaxel in combination with carboplatin and trastuzumab (TCH) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress HER2 Docetaxel in combination with cyclophosphamide is indicated for the adjuvant treatment of operable breast cancer with a primary tumour of = 1 cm and < 7 cm. Non small cell lung cancer Docetaxel is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer, including those who have failed platinum-based chemotherapy. Ovarian cancer Docetaxel is indicated for the treatment of metastatic carcinoma of the ovary after failure of first-line or subsequent chemotherapy. Prostate cancer Docetaxel is indicated for the treatment of patients with androgen independent (hormone refractory) prostate cancer. Head and neck cancer Docetaxel in combination with cisplatin and fluorouracil, is indicated as induction treatment prior to chemoradiotherapy, for the treatment of patients with locally advanced, squamous cell carcinoma of the head and neck, who have low probability of surgical cure, require organ preservation or where the tumour is technically unresectable.
Visual Identification: Supplied in single-dose vials as a sterile, pyrogen-free, non-aqueous,pale yellow to brownish-yellow solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2015-02-17
Version 3.0 Page 1 of 4 DOCETAXEL ACCORD _Docetaxel Concentrated Injection 20 mg/1 mL, 80 mg/4 mL and 160 mg/8 mL _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Docetaxel Accord. It does not contain all the available information. It does not take the place of talking to your doctor, nurse or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you being given this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR, NURSE OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT DOCETAXEL ACCORD IS USED FOR Docetaxel Accord is used to treat breast cancer, ovarian cancer, some types of lung cancer, head and neck cancer and prostate cancer. Docetaxel Accord works by stopping cells from growing and multiplying. Docetaxel Accord belongs to a group of medicines called antineoplastic or cytotoxic medicines. You may also hear of these being called chemotherapy medicines. Your doctor, however, may prescribe Docetaxel Accord for another purpose. ASK YOUR DOCTOR, NURSE OR PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT WHY DOCETAXEL ACCORD HAS BEEN PRESCRIBED FOR YOU. You may have probably taken another medicine to treat your breast, ovarian, lung, head and neck or prostate cancer. However, your doctor has now decided to treat you with Docetaxel Accord. Docetaxel Accord may be used alone or in combination with other medicines to treat cancer. This medicine is only available with a doctor's prescription. Docetaxel Accord is not addictive. BEFORE YOU ARE GIVEN IT _WHEN YOU MUST NOT BE _ _GIVEN IT _ Docetaxel Accord is not recommended for use in children. DO NOT RECEIVE DOCETAXEL ACCORD IF YOU HAVE AN ALLERGY TO DOCETAXEL, PACLITAXEL OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Symptoms of an allergic reaction include: • shortness of breath, wheezing, difficulty breathing or a tight feeling in your chest • Prečítajte si celý dokument
Page 1 of 39 AUSTRALIAN PRODUCT INFORMATION DOCETAXEL ACCORD (DOCETAXEL) CONCENTRATED INJECTION 1 NAME OF THE MEDICINE Docetaxel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of docetaxel solution contains 20 mg docetaxel. Docetaxel is a white to off white powder and it is highly lipophilic and practically insoluble in water. Single-dose vials of Docetaxel Concentrated Injection containing 20 mg or 80 mg or 160 mg of docetaxel per 1.0 mL, 4.0 mL or 8.0 mL respectively. The sterile pyrogen-free viscous solution contains 20 mg/mL docetaxel (anhydrous). Each mL of docetaxel solution also contains 395 mg absolute ethanol. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS . 3 PHARMACEUTICAL FORM Docetaxel Accord is a sterile pyrogen-free non-aqueous pale yellow to brownish-yellow solution for injection. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS BREAST CANCER Docetaxel Accord is indicated for the treatment of patients with locally advanced or metastatic breast cancer in whom previous chemotherapy has failed. Docetaxel Accord in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy. Docetaxel Accord in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease ADJUVANT TREATMENT OF BREAST CANCER Docetaxel Accord in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with node-positive breast cancer. Doxorubicin and cyclophosphamide followed by Docetaxel Accord in combination with trastuzumab (AC-TH) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress HER2. Docetaxel Accord in combination with carboplatin and trastuzumab (TCH) is indicated for the adjuvant treatment of patients with operable breast cancer whose tum Prečítajte si celý dokument