Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
pemetrexed disodium, Quantity: 1102.9 mg (Equivalent: pemetrexed, Qty 1000 mg)
Accord Healthcare Pty Ltd
pemetrexed disodium
Injection, powder for
Excipient Ingredients: hydrochloric acid; mannitol; sodium hydroxide
Intravenous
1 vial per carton
(S4) Prescription Only Medicine
Malignant Pleural Mesothelioma,Pemetrexed, in combination with cisplatin, is indicated for the treatment of patients with malignant pleural mesothelioma.,Non-Small Cell lung Cancer,Pemetrexed 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.,Pemetrexed 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: A white to either light yellow or greenish yellow lyophilized solid in a clear glass vial; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2015-05-28
v 2.0 1 PEMETREXED ACCORD POWDER FOR INJECTION pemetrexed (as disodium) CONSUMER MEDICINES INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Pemetrexed Accord. 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. The updated leaflet may contain important information about Pemetrexed Accord and its use that you should be aware of. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Pemetrexed Accord 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 ACCORD IS USED FOR Pemetrexed Accord 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 Accord may be used in combination with other chemotherapy drugs. BEFORE YOU ARE GIVEN PEMETREXED ACCORD _WHEN YOU MUST NOT BE GIVEN IT _ DO NOT TAKE PEMETREXED ACCORD 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 o Prečítajte si celý dokument
Page 1 of 20 AUSTRALIAN PRODUCT INFORMATION PEMETREXED ACCORD (PEMETREXED) POWDER FOR INJECTION 1 NAME OF THE MEDICINE Pemetrexed disodium 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 vial contains 100 mg, 500 mg or 1000 mg of pemetrexed. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Pemetrexed Accord pemetrexed (as disodium) powder for Injection. Pemetrexed Accord is supplied as a sterile lyophilised powder for intravenous infusion available in single dose clear glass vials. The product is a white to either light yellow or green-yellow lyophilised solid. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS MALIGNANT PLEURAL MESOTHELIOMA Pemetrexed, in combination with cisplatin, is indicated for the treatment of patients with malignant pleural mesothelioma. NON-SMALL CELL LUNG CANCER Pemetrexed 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. Pemetrexed 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 D OSE AND METHOD OF ADMINISTRATION Pemetrexed Accord should be administered under the supervision of a qualified physician experienced in the use of antineoplastic agents. PEMETREXED ACCORD IN COMBINATION USE WITH CISPLATIN ADULTS - The recommended dose of Pemetrexed Accord is 500 mg/m 2 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/m 2 BSA infused over 2 hours approximately 30 minutes after completion of the Pemetrexed Accord infusion on the first day of each 21-day cycle. Patients must receive adequate anti-emetic treatment and appropriate hydration prior to and/or after receiving cisplatin. See cisplatin Product Information document for specific dosin Prečítajte si celý dokument