Država: Australija
Jezik: engleski
Izvor: Department of Health (Therapeutic Goods Administration)
gemcitabine hydrochloride, Quantity: 1138.6 mg (Equivalent: gemcitabine, Qty 1000 mg)
Fresenius Kabi Australia Pty Ltd
Gemcitabine hydrochloride
Injection, concentrated
Excipient Ingredients: sodium hydroxide; hydrochloric acid; water for injections
Intravenous
1000 mg/26.3 mL - 1's
(S4) Prescription Only Medicine
Gemcitabine Kabi is indicated for treatment of patients with locally advance or metastatic non-small cell lung cancer. Gemcitabine Kabi is indicated for treatment of patients with locally advance or metastatic adenocarcinoma of the pancreas. Gemcitabine is also indicated for patients with 5-FU refractory pancreatic cancer. Gemcitabine Kabi, alone or in combination with cisplatin, is indicated for treatment of patients with bladder cancer. Gemcitabine Kabi, in combination with paclitaxel, is indicated 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. Gemcitabine Kabi, in combinatin with carboplatin, is indicated for the treatment of patients with recurrent epithelial ovarian carcinoma, who have relapsed > 6 months following platinum-based therapy.
Visual Identification: A clear, colourless to slightly yellow solution; Container Type: Vial; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
2014-10-21
CMI for Gemcitabine Kabi May, 2013 Page 1 of 4 GEMCITABINE KABI Gemcitabine hydrochloride CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Gemcitabine Kabi Injection. It does not contain all the available information. It does not take the place of talking to your doctor. All medicines have benefits and risks. Your doctor has weighed the risks of using Gemcitabine Kabi against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR HEALTH CARE PROFESSIONAL. KEEP THIS LEAFLET. You may need to read it again. WHAT GEMCITABINE KABI IS USED FOR Gemcitabine Kabi is used to treat patients with: • lung cancer • cancer of the pancreas • bladder cancer • breast cancer • ovarian cancer Gemcitabine Kabi belongs to a group of anticancer drugs known as antineoplastic or cytotoxic medicines. It works by killing cancer cells and preventing cancer cells from growing and multiplying, and is used for different types of cancer. The active ingredient in Gemcitabine Kabi is gemcitabine hydrochloride. Your doctor will be able to tell you about the specific condition for which you have been prescribed Gemcitabine Kabi. Ask your doctor or health care professional if you have any questions why it has been prescribed for you. Gemcitabine is only available on a prescription from your doctor. Your doctors have decided to treat you with Gemcitabine because they believe that the benefit of Gemcitabine treatment will be greater than any unwanted side effects. Many of the side effects from anti cancer drugs are predictable and can be prevented or lessened. Your doctor and other staff will take all of the precautions needed to reduce the unwanted effects of treatment. BEFORE YOU ARE GIVEN GEMCITABINE KABI _WHEN YOU MUST NOT RECEIVE IT _ DO NOT USE GEMCITABINE KABI IF: • you have an allergy to Gemcitabine or any of the ingredients listed at the end of this leaflet • you have kidney disease or poor kidney function • you Pročitajte cijeli dokument
Page 1 of 21 PRODUCT INFORMATION Product Name: GEMCITABINE KABI NAME OF THE MEDICINE Gemcitabine hydrochloride Gemcitabine is an antineoplastic agent that inhibits ribonucleotide reductase. Gemcitabine is described chemically as 2'-deoxy-2', 2' - difluorocytidine monohydrochloride (ß-isomer). Gemcitabine hydrochloride has the following chemical structure: Empirical formula: C 9 H 11 F 2 N 3 O 4 .HCl Molecular weight: 299.7 CAS Number: 122111-03-9 DESCRIPTION Gemcitabine hydrochloride is a white to off-white lyophilised powder soluble in water, slightly soluble in methanol and practically insoluble in ethanol and polar organic solvents. Gemcitabine Kabi 38 mg/mL concentrated injection contains 38 mg/mL gemcitabine (as the hydrochloride) as well as the excipients sodium hydroxide, hydrochloric acid and water for injections. Gemcitabine Kabi 200 mg, 1000 mg and 2000 mg powder for injection contains gemcitabine hydrochloride as well as the excipients mannitol, sodium acetate, hydrochloric acid and sodium hydroxide. PHARMACOLOGY Pharmacodynamics Cytotoxic activity in cell cultures Gemcitabine exhibits significant cytotoxic effects against a variety of cultured murine and human tumour cells. Its action is phase specific such that gemcitabine primarily kills cells that are undergoing DNA synthesis (S-phase) and, under certain circumstances, blocks the progression of cells through the GI/S-phase boundary. _In vitro _the cytotoxic action of gemcitabine is dependent on both concentration and time. Page 2 of 21 Antitumoral activity in preclinical models In animal tumour models, the antitumour activity of gemcitabine is schedule- dependent. When gemcitabine is administered daily, high mortality among the animals but minimal antitumour activity is observed. If, however, gemcitabine is given every third or fourth day, it can be administered in non-lethal doses with substantial antitumoural activity against a broad spectrum of mouse tumours. Mechanism of Action: Gemcitabine (dFdC), which is a pyrimidine antimetabolite, is meta Pročitajte cijeli dokument