Țară: Australia
Limbă: engleză
Sursă: Department of Health (Therapeutic Goods Administration)
pemetrexed disodium heptahydrate, Quantity: 151.7 mg
Eli Lilly Australia Pty Ltd
Pemetrexed disodium heptahydrate
Injection, powder for
Excipient Ingredients: hydrochloric acid; mannitol; water for injections; sodium hydroxide
Intravenous
1 vial
(S4) Prescription Only Medicine
Malignant Pleural Mesothelioma. ALIMTA, in combination with cisplatin, is indicated for the treatment of patients with malignant pleural mesothelioma. Non-Small Cell lung Cancer. Alimta in combination with cisplatin is indicated for initial treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. Alimta as monotherapy is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer other than predominantly squamous cell histology after prior platinum-based chemotherapy.
Visual Identification: White to either light yellowish or green-yellowish lyophilized solid.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2007-11-08
ALIMTA ® _pemetrexed disodium heptahydrate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ALIMTA. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date shown on the final page. More recent information on this medicine may be available. Make sure you speak to your pharmacist, nurse or doctor to obtain the most up to date information on this medicine. You can also download the most up to date leaflet from www.lilly.com.au. The updated leaflet may contain important information about ALIMTA and its use that you should be aware of. All medicines have risks and benefits. Your doctor has weighed the risks of you taking ALIMTA 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 ALIMTA IS USED FOR ALIMTA 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. ALIMTA may be used in combination with other chemotherapy drugs. BEFORE YOU ARE GIVEN ALIMTA _WHEN YOU MUST NOT BE GIVEN_ _IT_ DO NOT TAKE ALIMTA IF YOU HAVE AN ALLERGY TO: • any medicine containing pemetrexed disodium heptahydrate • 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; swell Citiți documentul complet
vA15_Nov2019 Page 1 of 26 AUSTRALIAN PRODUCT INFORMATION – ALIMTA ® (PEMETREXED DISODIUM HEPTAHYDRATE) POWDER FOR SOLUTION FOR INFUSION 1. NAME OF THE MEDICINE pemetrexed disodium heptahydrate. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ALIMTA is supplied in 500 mg and 100 mg vials. Each 500 mg vial of ALIMTA contains pemetrexed disodium heptahydrate equivalent to 500 mg pemetrexed. Each 100 mg vial of ALIMTA contains pemetrexed disodium heptahydrate equivalent to 100 mg pemetrexed. For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM ALIMTA is supplied as a sterile lyophilised powder for intravenous infusion available in single dose vials. The product is a white to either light yellow or green yellow lyophilised solid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS MALIGNANT PLEURAL MESOTHELIOMA ALIMTA, in combination with cisplatin, is indicated for the treatment of patients with malignant pleural mesothelioma. NON-SMALL CELL LUNG CANCER ALIMTA in combination with cisplatin is indicated for initial treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. ALIMTA as monotherapy is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology after prior platinum-based chemotherapy. 4.2 DOSE AND METHOD OF ADMINISTRATION ALIMTA should be administered under the supervision of a qualified physician experienced in the use of antineoplastic agents. vA15_Nov2019 Page 2 of 26 ALIMTA in combination use with cisplatin: Adults - The recommended dose of ALIMTA is 500 mg/m2 as body surface area (BSA) administered as an intravenous infusion over 10 minutes on the first day of each 21 day cycle. The recommended dose of cisplatin is 75 mg/m2 BSA infused over 2 hours approximately 30 minutes after completion of the ALIMTA infusion on the first day of each 21 day cycle. Patients must receive adequate anti-emetic treatm Citiți documentul complet