País: Nova Zelanda
Idioma: anglès
Font: Medsafe (Medicines Safety Authority)
Paclitaxel 100mg (nanoparticle albumin-bound);
Celgene Limited
Paclitaxel 100 mg (nanoparticle albumin-bound)
100 mg
Powder for injection
Active: Paclitaxel 100mg (nanoparticle albumin-bound) Excipient: Albumin
Vial, glass, 50 mL Type I 20 mm with bromobutyl rubber stopper and flip-cap aluminium crimp seal, 1 dose unit
Prescription
Prescription
ScinoPharm Taiwan Ltd
Abraxane is indicated for the treatment of metastatic carcinoma of the breast after failure of anthracycline therapy.
Package - Contents - Shelf Life: Vial, glass, 50 mL Type I 20 mm with chlorobutyl rubber stopper and flip-cap aluminium crimp seal - 1 dose units - 36 months from date of manufacture stored at or below 25°C protect from light 8 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Should be used immediately but can be stored if required - Vial, glass, 50 mL Type I 20 mm with bromobutyl rubber stopper and flip-cap aluminium crimp seal - 1 dose units - 36 months from date of manufacture stored at or below 25°C protect from light 8 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Should be used immediately but can be stored if required
2009-06-11
20221215_ABX_CMI_AUNZ 1 ABRAXANE _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, such as a cold, is not usually a reason to delay treatment. YOU MUST NOT BE GIVEN THIS MEDICINE IF YOU HAVE SEVERE LIVER DAMAGE. Llegiu el document complet
20230518_ABX_PI_NZ 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 ABRAXANE is free of solvents. The reconstituted medicinal product contains approximately 85 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 a 50 mL glass vial. Paclitaxel is a white to off-white crystalline powder with a molecular weight of 853.91. It is highly lipophilic, insoluble in water. 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-line treatment of patients with metastatic adenocarcinoma of the pancreas. 4.2 D OSE AND METHOD OF ADMINISTRATION The reconstituted s Llegiu el document complet