Država: Avstralija
Jezik: angleščina
Source: Department of Health (Therapeutic Goods Administration)
pemetrexed disodium
Sandoz Pty Ltd
pemetrexed disodium
Registered
PEMETREXED SANDOZ ® _pemetrexed disodium_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Pemetrexed Sandoz ® . 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 has weighed the risks of you taking this medicine 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. You may need to read it again. WHAT PEMETREXED SANDOZ ® IS USED FOR This medicine is used to treat: • mesothelioma, a rare cancer of the lungs often related to exposure to asbestos • non-small cell lung cancer, a type of lung cancer. It belongs to a group of medicines called cytotoxic or antineoplastic agents. They may also be called chemotherapy medicines. It affects enzymes within cancer cells to kill cancer cells or prevent them growing and multiplying. Your doctor may have prescribed it for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. Pemetrexed Sandoz ® may be used in combination with other chemotherapy drugs. BEFORE YOU ARE GIVEN PEMETREXED SANDOZ ® _WHEN YOU MUST NOT BE GIVEN_ _IT_ DO NOT TAKE THIS MEDICINE IS IF YOU HAVE AN ALLERGY TO: • any medicine containing pemetrexed disodium • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin. IF YOU ARE NOT SURE WHETHER YOU SHOULD BE GIVEN THIS MEDICINE, TALK TO YOUR DOCTOR. _BEFORE YOU ARE GIVEN IT_ TELL YOUR DOCTOR IF YOU HAVE OR HAVE HAD ANY OF THE FOLLOWING MEDICAL CONDITIONS: • kidney problems TELL YOUR DOCTOR IF YOU ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE Preberite celoten dokument
_Product Information _ _Page 1 _ _Pemetrexed Sandoz 500mg powder for injection _ _03/2015 _ _Sandoz Pty Ltd _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _Version 01 _ _ _ PPRODUCT INFORMATION PEMETREXED SANDOZ ® 500MG POWDER FOR INJECTION NAME OF THE MEDICINE pemetrexed disodium N-[4-[2-(2-Amino-4, 7-dihydro-4-oxo-1H-pyrrolo [2,3d] pyrimidin-5-yl) ethyl] benzoyl]- L-glutamic acid disodium salt 2.5 hydrate Disodium (2S)-2-[[4-[2-(2-amino-4-oxo-4,7-dihydro-1H-pyrrolo-[2,3-d]pyrimidin-5-yl) ethyl]benzoyl]amin]pentanedioate 2.5 hydrate CAS [357166-30-4 (2.5 hydrate)] Empirical formula: C 20 H 19 N 5 Na 2 O 6 2.5 H 2 O MW: 516.42 DESCRIPTION Pemetrexed disodium is a white to almost white solid. Pemetrexed Sandoz is supplied as a sterile lyophilised powder for intravenous infusion available in single dose vials. The product is a white or off-white lyophilised solid. Pemetrexed Sandoz is supplied in 500 mg vials. Each 500 mg vial of Pemetrexted Sandoz contains pemetrexed disodium equivalent to 515 mg pemetrexed and 515 mg of mannitol. Hydrochloric acid and/or sodium hydroxide may have been added to adjust pH. Pemetrexed is freely soluble in water and in 0.1 mol/L sodium hydroxide; sparingly soluble in methanol; very slightly soluble in 0.1 mol/L hydrochloric acid, practically insoluble or insoluble in N,N-dimethylformamide, in ethyl acetate, in alcohol and in acetone and pKa of: ≤ 3.5, 6.24, 7.61 and > 13. _Product Information _ _Page 2 _ _Pemetrexed Sandoz 500mg powder for injection _ _03/2015 _ _Sandoz Pty Ltd _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _Version 01 _ _ _ PHARMACOLOGY PHARMACODYNAMIC PROPERTIES Pemetrexed is an antifolate antineoplastic agent. _ In vitro_ studies have shown that pemetrexed behaves as a multitargeted antifolate by inhibiting thymidylate synthase (TS), dihydrofolate reductase (DHFR) and glycinamide ribonucleotide formyltransferase (GARFT), which are key folate-dependent enzymes for the de novo biosynthesis of thymidine and purine nucleotides that are essential for cell replication. Both the reduce Preberite celoten dokument