Riik: Austraalia
keel: inglise
Allikas: Department of Health (Therapeutic Goods Administration)
gemcitabine hydrochloride, Quantity: 228 mg (Equivalent: gemcitabine, Qty 200 mg)
Medis Pharma Pty Ltd
Gemcitabine hydrochloride
Injection, powder for
Excipient Ingredients: mannitol; sodium hydroxide; sodium acetate trihydrate
Intravenous Infusion
1 X 10 mL vial
(S4) Prescription Only Medicine
Treatment of patients with locally advanced or metastatic non-small cell lung cancer. Treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. Treatment of patients with FU refractory pancreatic cancer. Treatment of patients with bladder cancer, alone or in combination with cisplatin. Treatment, in combination with paclitaxel, 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. Treatment, in combination with carboplatin, of patients with recurrent epithelial ovarian carcinoma, who have relapsed >six months following platinum based therapy.
Visual Identification: White or almost white lyophilisate; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2009-07-28
GEMCITABINE ACTAVIS/130307/CMI-1 1 GEMCITABINE ACTAVIS _contains the active ingredient gemcitabine (as hydrochloride) _ CONSUMER MEDICINE INFORMATION What is in this leaflet This leaflet answers some common questions about GEMCITABINE ACTAVIS. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you being given GEMCITABINE ACTAVIS against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. Keep this leaflet with your medicine. You may need to read it again. What GEMCITABINE ACTAVIS is used for GEMCITABINE ACTAVIS is used to treat patients with: lung cancer cancer of the pancreas bladder cancer breast cancer ovarian cancer. GEMCITABINE ACTAVIS works by killing cancer cells and preventing cancer cells from growing and multiplying. GEMCITABINE ACTAVIS belongs to a group of medicines called antineoplastic or cytotoxic medicines. You may also hear of these being called chemotherapy medicines. Your doctor may have prescribed GEMCITABINE ACTAVIS for another reason. Ask your doctor if you have any questions about why GEMCITABINE ACTAVIS has been prescribed for you. GEMCITABINE ACTAVIS may be used in combination with other cytotoxic medicines to treat cancer. Before you are given GEMCITABINE ACTAVIS _WHEN YOU MUST NOT TAKE IT _ YOU MUST NOT BE GIVEN GEMCITABINE ACTAVIS IF YOU ARE ALLERGIC TO MEDICINES CONTAINING GEMCITABINE OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. YOU MUST NOT BE GIVEN GEMCITABINE ACTAVIS IF YOU HAVE: liver problems kidney problems. YOU MUST NOT BE GIVEN GEMCITABINE ACTAVIS IF THE EXPIRY DATE (EXP.) PRINTED ON THE PACK HAS PASSED. YOU MUST NOT BE GIVEN GEMCITABINE ACTAVIS IF THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING. _BEFORE YOU START TO TAKE IT _ TELL YOUR DOCTOR IF YOU ARE ALLERGIC TO ANY OTHER MEDICINES, FOODS, DYES OR PRES Lugege kogu dokumenti
Gemcitabine Actavis POWDER FOR INJECTION PRODUCT INFORMATION NAME OF THE MEDICINE Gemcitabine (as hydrochloride). The chemical name for gemcitabine hydrochloride is 4-Amino-1- (2-Deoxy-2,2-difluoro-ß-D-_erythro_-pentofuranosyl)pyrimidin-2(1_H_)-one hydrochloride. Its structural formula is: C 9 H 11 F 2 N 3 O 4 .HCl Molecular weight: 299.7 CAS No.: 122111-03-9. DESCRIPTION Gemcitabine hydrochloride is a white or almost white powder, which is soluble in water. The pH value is 2 to 3 in aqueous solution at 10 mg/mL, and the pKa is 3.6. GEMCITABINE ACTAVIS comes in three strengths of powder for injection and contains either 200 mg, 1000 mg or 2000 mg of gemcitabine (as hydrochloride). It also contains mannitol, sodium acetate and sodium hydroxide may be added to adjust pH 3.0 ± 0.2. PHARMACOLOGY Gemcitabine exhibits significant cytotoxic activity against a variety of cultured murine and human tumour cells. It exhibits cell phase specificity, primarily killing cells undergoing DNA synthesis (S- phase) and, under certain conditions blocking progression of cells through the GI/S-phase boundary. _In vitro_, the cytotoxic action of gemcitabine is both concentration and time dependent. In animal tumour models, the antitumour activity of gemcitabine is schedule dependent. When administered daily gemcitabine causes death in animals with minimal antitumour activity. However, when an every third or fourth day dosing schedule is used, gemcitabine can be given at non-lethal doses and have excellent antitumour activity against a broad range of mouse tumours. Mechanism of Action: Gemcitabine (dFdC) is metabolised intracellularly by nucleoside kinase to the active diphosphate (dFdCDP) and triphosphate (dFdCTP) nucleosides. The cytotoxic action of gemcitabine appears to be due to inhibition of DNA synthesis by two actions of dFdCDP and dFdCTP. First, dFdCDP inhibits ribonucleotide reductase which is uniquely responsible for catalysing the reactions that generate the deoxynucleoside triphosphates for DNA synthesis. Inhibition of th Lugege kogu dokumenti