Země: Austrálie
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
gemcitabine hydrochloride
Pfizer Australia Pty Ltd
Gemcitabine hydrochloride
Registered
DBL ™ GEMCITABINE FOR INJECTION Gemcitabine Hydrochloride (_jem-sie-ta-been) _ CONSUMER MEDICINE INFORMATION_ _ _Date of Dispensing _ _Consumer Name _ _Pharmacist Name _ _Consumer Address _ _Pharmacist Address _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about DBL ™ Gemcitabine for Injection. 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 DBL ™ Gemcitabine for Injection against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT DBL ™ GEMCITABINE FOR INJECTION IS USED FOR This medicine is used to treat the following types of cancer: • lung cancer • pancreatic cancer • bladder cancer • breast cancer • ovarian cancer. This medicine belongs to a group of medicines called antineoplastic or cytotoxic medicines. You may also hear of these being called chemotherapy medicines. This medicine works by killing cancer cells and stopping cancer cells from growing and 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. DBL ™ Gemcitabine for Injection may be used alone or in combination with other medicines to treat cancer. This medicine is not addictive. This medicine is available only with a doctor’s prescription. BEFORE YOU ARE GIVEN DBL ™ GEMCITABINE FOR INJECTION _WHEN YOU MUST NOT BE _ _GIVEN IT _ YOU MUST NOT BE GIVEN DBL ™ GEMCITABINE FOR INJECTION IF YOU HAVE AN ALLERGY TO: • any medicine containing gemcitabine hydrochloride • any of the ingredients listed at the end of this leaflet • if the packaging is torn or shows sign of tampering. Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of Přečtěte si celý dokument
Version: pfpgempv10919 Supersedes: Version 4 Page 1 of 20 AUSTRALIAN PRODUCT INFORMATION – DBL TM GEMCITABINE FOR INJECTION (GEMCITABINE HYDROCHLORIDE) POWDER FOR INJECTION 1. NAME OF THE MEDICINE Gemcitabine hydrochloride 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 200 mg/ vial in single packs 1 g/ vial in single packs 2 g/ vial in single packs For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS . 3. PHARMACEUTICAL FORM DBL™ Gemcitabine for Injection is a white to off-white lyophilized powder in a clear glass vial. DBL TM Gemcitabine for Injection is a white to off-white lyophilised powder to be reconstituted for intravenous use. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DBL TM Gemcitabine Injection is indicated: • for treatment of patients with locally advanced or metastatic non-small cell lung cancer. • for treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. • for treatment of patients with Fluorouracil refractory pancreatic cancer. • alone or in combination with cisplatin, is indicated for treatment of patients with bladder cancer. • in combination with paclitaxel, for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. Prior chemotherapy should have included an anthracycline unless clinically contraindicated. • in combination with carboplatin, for the treatment of patients with recurrent epithelial ovarian carcinoma, who have relapsed > 6 months following platinum-based therapy. Version: pfpgempv10919 Supersedes: Version 4 Page 2 of 20 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE NON-SMALL CELL LUNG CANCER: _Single-agent use (Adults) _ The optimum dose schedule for gemcitabine has not been determined. The recommended dose of gemcitabine is 1,000 mg/m 2 , given by 30 minute intravenous infusion. This should be repeated once weekly for three weeks, followed by a one week rest period. This four week cycle is then repeated. Dosage re Přečtěte si celý dokument