Țară: Australia
Limbă: engleză
Sursă: Department of Health (Therapeutic Goods Administration)
vinflunine ditartrate
Pierre Fabre Australia Pty Ltd
Vinflunine ditartrate
Registered
CONSUMER MEDICINE INFORMATION Version: A04-090818 1 Supercedes: A03-0914 JAVLOR 25 MG/ML CONCENTRATED INJECTION _vinflunine ditartrate _ _ _ _ _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Javlor. It does not contain all 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 taking Javlor against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT JAVLOR IS USED FOR Javlor is used to treat cancer of the bladder and urinary tract at an advanced stage. Javlor is given if previous therapy with a platinum-containing medicine has failed. Javlor belongs to a group of medicines called antineoplastic or cytotoxic medicines. You may also hear of these medicines being called chemotherapy. Javlor contains the medicine, vinflunine which belongs to a family of medicines called vinca alkaloids. Javlor works by stopping cancer cells from growing and multiplying causing the cells to die. Your doctor may have prescribed Javlor for another purpose. Ask your doctor if you have any questions about why Javlor has been prescribed for you. This medicine is available only with a doctor’s prescription. BEFORE YOU ARE GIVEN JAVLOR _WHEN YOU MUST NOT BE _ _GIVEN IT _ DO NOT TAKE JAVLOR IF YOU HAVE AN ALLERGY TO THE ACTIVE SUBSTANCE, VINFLUNINE OR TO THE OTHER VINCA ALKALOIDS, (VINBLASTINE, VINCRISTINE, VINDESINE, VINORELBINE). Symptoms of an allergic reaction to Javlor may include: • shortness of breath • wheezing, difficulty breathing or a tight feeling in your chest • swelling of the face, lips, tongue or other parts of the body • rash, itching, hives or flushed, red skin. DO NOT TAKE JAVLOR IF YOU HAVE OR HAVE HAD (WITHIN THE LAST TWO WEEKS), A SEVERE INFECTION. Tell your doctor if you have or have had a severe infection i Citiți documentul complet
Version: A06-090818 Page 1 of 21 Supercedes: A05-0914 PRODUCT INFORMATION JAVLOR ® 25 MG/ML CONCENTRATED INJECTION NAME OF THE MEDICINE vinflunine ditartrate N H N F N H H N C H 3 OCOCH 3 OH F H H 3 COOC COOCH 3 CH 3 O . 2 (C 4 H 6 O 6 ) CAS number: 194468-36-5 DESCRIPTION Vinflunine ditartrate is a white to off-white powder with the molecular formula C 53 H 66 F 2 N 4 O 20 and a molecular weight of 1117.09. Vinflunine ditartrate is freely soluble in water, soluble in ethanol and practically insoluble in dichloromethane. It is very hygroscopic with a pKa value of 5.67 and 8.17 in water at 26 o C – 27 o C. Javlor Concentrated Injection is presented as a clear, colourless to pale yellow solution. It is supplied as a sterile, endotoxin-free aqueous solution intended for dilution with a suitable parenteral fluid (sodium chloride 0.9% solution or glucose 5% solution). One mL of Javlor contains 25 mg of vinflunine (as vinflunine ditartrate). Javlor also contains the excipient, water for injections. PHARMACOLOGY PHARMACODYNAMICS Vinflunine is an antineoplastic drug. Vinflunine binds to tubulin at or near to the vinca binding sites inhibiting its polymerisation into microtubules, which results in treadmilling suppression, disruption of microtubule dynamics, mitotic arrest and apoptotic cell death. Version: A06-090818 Page 2 of 21 Supercedes: A05-0914 _In vivo_, vinflunine displays significant antitumour activity against a broad spectrum of human xenografts in mice both in terms of survival prolongation and tumour growth inhibition. PHARMACOKINETICS Vinflunine pharmacokinetics is linear up to 400 mg/m 2 in cancer patients. Blood exposure to vinflunine (AUC) significantly correlated with severity of leucopenia, neutropenia and fatigue. Distribution Vinflunine is moderately bound to human plasma protein (67.2 ± 1.1%) with a plasma/blood concentration ratio of 0.80 ± 0.12. Protein binding mainly involves high density lipoproteins and serum albumin and is non-saturable in the range of vinflunine concentrations observed i Citiți documentul complet