Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
Dacarbazine
Hospira Australia Pty Ltd
Medicine Registered
DBL ™ Dacarbazine for Injection CMI Page 1 DBL ™ DACARBAZINE FOR INJECTION Dacarbazine _(da-CAR-ba-zeen)_ 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 ™ Dacarbazine 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 or pharmacist has weighed the risks of you being given DBL ™ Dacarbazine for Injection against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET IN A SAFE PLACE. You may need to read it again. WHAT DBL ™ DACARBAZINE FOR INJECTION IS USED FOR Dacarbazine belongs to a group of medicines known as antineoplastic or cytotoxic agents. You may also hear it referred to as a chemotherapy medicine. Dacarbazine belongs to a group of cytotoxics known as ‘alkylating agents’. Dacarbazine works by killing cancer cells and stopping cancer cells from growing and multiplying. DBL ™ Dacarbazine for Injection is used to treat some types of melanomas (skin cancers) and a type of cancer called sarcoma. Your doctor may have prescribed DBL ™ Dacarbazine for Injection for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY DBL ™ DACARBAZINE FOR INJECTION HAS BEEN PRESCRIBED FOR YOU. This medicine may be used in combination with other medicines to treat cancer. DBL ™ Dacarbazine for Injection is available only with a doctor’s prescription. BEFORE YOU ARE GIVEN DBL ™ DACARBAZINE FOR INJECTION _WHEN YOU MUST NO Soma hati kamili
Product Information - Australia Version 5.0 Page 1 DBL™ DACARBAZINE FOR INJECTION NAME OF MEDICINE Dacarbazine The molecular formula of dacarbazine is C 6 H 10 N 6 O. Its molecular weight is 182.2. The CAS Registry number of dacarbazine is 4342-03-4. The structural formula of dacarbazine appears below: HN N CONH 2 N N N Me Me DESCRIPTION Dacarbazine is a colourless to pale yellow solid, sensitive to light. It is slightly soluble in water and alcohol. DBL™ Dacarbazine for Injection is a sterile parenteral dosage form for reconstitution. When reconstituted as directed each mL of the solution in the 200 milligram vial contains dacarbazine 10 milligrams, citric acid 10 milligrams and mannitol 3.75 milligrams. The pH of the reconstituted solution is 3.0 – 4.0. PHARMACOLOGY Relationship to other drugs: Dacarbazine is a structural analogue of 5-amino-imidazole-4- carboxamide which is an intermediate in purine biosynthesis. Site and mode of action: This drug inhibits cell replication by an unknown mechanism. However, three possible mechanisms have been postulated: 1. Since dacarbazine is an analogue of 5-amino-imidazole-4-carboxamide, an intermediate in the de novo biosynthesis of purine, it might interfere with purine biosynthesis and hence DNA bio- synthesis. This appears to be true at high concentrations of the drug, but low concentrations appear to enhance DNA, RNA and protein biosynthesis. 2. One metabolite of dacarbazine, diazomethane, is an alkylating agent and may act in the same way as the nitrogen mustards. 3. The drug might act as a sulphydryl reagent since the inhibition of bacterial growth by dacarbazine can be prevented by glutathione. PHARMACOKINETICS ABSORPTION: Dacarbazine is poorly and erratically absorbed from the gastrointestinal tra Soma hati kamili