Country: Ástralía
Tungumál: enska
Heimild: Department of Health (Therapeutic Goods Administration)
dacarbazine
Sandoz Pty Ltd
Dacarbazine
Registered
Dacarbazine Sandoz ® 1 _ _ DACARBAZINE SANDOZ _ _ DACARBAZINE POWDER FOR INJECTION CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Dacarbazine Sandoz. It does not contain all the available information. It does not take the place of talking to your doctor and pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET . You may need to read it again. WHAT DACARBAZINE SANDOZ IS USED FOR This medicine is used to treat some types of melanomas (skin cancers) and a type of cancer called sarcoma. It contains the active ingredient, dacarbazine. 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 also belongs to a group of cytotoxics known as “alkylating agents”. It 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. This medicine may be used in combination with other medicines to treat cancer. This medicine is not addictive. This medicine is available only with a doctor’s prescription. Dacarbazine Sandoz ® 2 _ _ 2 BEFORE YOU ARE GIVEN DACARBAZINE SANDOZ _WHEN YOU MUST NOT BE GIVEN IT _ YOU MUST NOT BE GIVEN THIS MEDICINE IF YOU HAVE AN ALLERGY TO: dacarbazine, the active ingredient, or to any of the ingredients listed at the end of this leaflet under Product Description Some of the symptoms of an allergic reaction may include: shortness of breath wheezing or difficulty breathing or swallowing swelling of the face, lips, tongue or other parts of the body rash, itching or hives on the skin YOU MUST NOT BE GIVEN THIS MEDICINE IF YOU HAVE OR HAVE Lestu allt skjalið
_Product Information _ _ _ _ Page _1_ _ _Dacarbazine Sandoz 200 mg powder for injection _ _December 2015 _ _ _ _ _ _Sandoz Pty Ltd _ _ _ _ Version 4 _ PRODUCT INFORMATION DACARBAZINE SANDOZ ® 200 MG POWDER FOR INJECTION NAME OF THE MEDICINE Dacarbazine Sandoz powder for injection contains the active ingredient dacarbazine. _Chemical Name: _ _ _ _ _ 5-(3,3-dimethyltriazeno)imidazole-4-carboxamide _Structural Formula: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _Molecular Formula:_ C 6 H 10 N 6 O _Molecular Weight:_ 182.2 _CAS Number_: 4342-03-4 _ _ _ _ DESCRIPTION Each vial of Dacarbazine Sandoz powder for injection contains dacarbazine, which occurs as a white or very pale yellow crystalline powder. Dacarbazine is light sensitive and is slightly soluble in water and alcohol. The reconstituted solution appears as a clear, pale yellow to colourless solution and has a pH of 3.0 to 4.0. Dacarbazine Sandoz powder for injection also contains citric acid and mannitol as excipients. PHARMACOLOGY Pharmacological Actions Dacarbazine inhibits cell replication by an unknown mechanism. However, the following three possible mechanisms have been postulated. 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 biosynthesis. This appears to be true at high concentrations of the drug, but low concentrations appear to enhance DNA, RNA and protein biosynthesis. One metabolite of dacarbazine, diazomethane, is an alkylating agent and may act in the same way as the nitrogen mustards. _Product Information _ _ _ _ Page _ _Dacarbazine Sandoz _ _200 mg powder for injection _ _December 2015 _ _Sandoz Pty Ltd_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _Version 4_ 2 The drug might act as a sulfydryl 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 tract, which could result in unp Lestu allt skjalið