Country: Ավստրալիա
language: անգլերեն
source: Department of Health (Therapeutic Goods Administration)
paclitaxel, Quantity: 250 mg
Abraxis Bioscience Australia Pty Ltd
Injection, powder for
Excipient Ingredients: Albumin; sodium octanoate; sodium acetyltryptophanate
Intravenous
1 x 100mL vial
(S4) Prescription Only Medicine
Metastatic Breast Cancer ABRAXANE is indicated for the treatment of metastatic carcinoma of the breast after failure of anthracycline therapy. Non-small Cell Lung Cancer ABRAXANE, in combination with carboplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation. Metastatic Adenocarcinoma of the Pancreas ABRAXANE, in combination with gemcitabine, is indicated for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas.
Visual Identification: White to yellow, lyophilised powder.; Container Type: Vial; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2018-12-07
November 2018 CMI FOR ABRAXANE ________________________________________________________________________________ 20181127_ABX_CMI_AUNZ_Cat1-250mg_Approved 1 ABRAXANE Ò Paclitaxel (pak-li-TAX-el) CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ABRAXANE. 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 ABRAXANE against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR. YOUR DOCTOR OR PHARMACIST CAN PROVIDE YOU WITH MORE INFORMATION ABOUT ABRAXANE. KEEP THIS LEAFLET You may need to read it again. WHAT ABRAXANE IS USED FOR This medicine is used to treat: • Breast cancer • Lung Cancer • Pancreatic Cancer This medicine belongs to a group of medicines called antineoplastic or cytotoxic medicines. You may also hear of these being called chemotherapy medicines. It works by killing cancer cells and stopping them from multiplying. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is not addictive. This medicine is available only with a doctor’s prescription . BEFORE YOU ARE GIVEN ABRAXANE WHEN YOU MUST NOT BE GIVEN IT YOU MUST NOT BE GIVEN ABRAXANE IF YOU HAVE AN ALLERGY TO: • any medicine containing paclitaxel • any of the ingredients listed at the end of this leaflet Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin. YOU MUST NOT BE GIVEN THIS MEDICINE IF YOU HAVE A VERY LOW WHITE BLOOD CELL (WBC) COUNT. TELL YOUR DOCTOR IF YOU HAVE AN INFECTION OR HIGH TEMPERATURE. Your doctor may decide to delay your treatment until the infection is gone. A mild illness, su read_full_document
20200609_ABX_PI_AU_SRR(CCDSv17)_final 1 PRODUCT INFORMATION ABRAXANE (NANOPARTICLE ALBUMIN-BOUND PACLITAXEL) 1 NAME OF THE MEDICINE nanoparticle albumin-bound paclitaxel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ABRAXANE (nanoparticle albumin-bound paclitaxel) powder for injection (suspension) is an albumin nanoparticle form of paclitaxel with a mean particle size of approximately 130 nanometres. Paclitaxel exists in the nanoparticles in a non-crystalline, amorphous state. Each vial of ABRAXANE contains paclitaxel and human albumin in the ratio of 1:9. The paclitaxel is contained within nanoparticles that consist of a majority of paclitaxel bound to human albumin. Each single-use vial contains the following: Paclitaxel 100 mg or 250 mg. ABRAXANE is free of solvents. 100 mg vial: The reconstituted medicinal product contains approximately 85 mg sodium per vial when reconstituted with 0.9% sodium chloride. 250 mg vial: The reconstituted medicinal product contains approximately 213 mg sodium per vial when reconstituted with 0.9% sodium chloride. The active agent in ABRAXANE is paclitaxel, a natural product with antitumour activity. Paclitaxel is obtained from Taxus media . Excipient(s) with known effect Not applicable. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM ABRAXANE is supplied as a white to yellow, sterile, lyophilised powder in the following presentations: 100 mg paclitaxel in a 50 mL glass vial 250 mg paclitaxel in a 100 mL glass vial 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS METASTATIC BREAST CANCER ABRAXANE is indicated for the treatment of metastatic carcinoma of the breast after failure of anthracycline therapy. NON-SMALL CELL LUNG CANCER ABRAXANE, in combination with carboplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation. METASTATIC ADENOCARCINOMA OF THE PANCREAS ABRAXANE, in combination with gemcitabine, is indicated for the first-li read_full_document