Riik: Austraalia
keel: inglise
Allikas: Department of Health (Therapeutic Goods Administration)
pemetrexed disodium hemipentahydrate, Quantity: 120.82 mg (Equivalent: pemetrexed, Qty 100 mg)
AFT Pharmaceuticals Pty Ltd
Injection, powder for
Excipient Ingredients: sodium hydroxide; mannitol; hydrochloric acid
Intravenous
1 x vial
(S4) Prescription Only Medicine
Malignant Pleural Mesothelioma -Pemetrexed-AFT, in combination with cisplatin, is indicated for the treatment of patients with malignant pleural mesothelioma. Non-Small Cell lung Cancer - Pemetrexed-AFT 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-AFT 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 faint yellow loose mass or powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2020-02-25
1 PEMETREXED-AFT _pemetrexed (as disodium)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about PEMETREXED-AFT. 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- AFT 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-AFT 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- AFT IS USED FOR PEMETREXED-AFT is used to treat: • mesothelioma, a rare cancer of the lungs o ften related to exposure to asb estos • non-small cell lung cancer, a type of lung can cer. 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-AFT may be used in combination with other chemotherapy drugs. BEFORE YOU ARE GIVEN PEMETREXED-AFT _WHEN YOU MUST NOT BE GIVEN _ _IT_ DO NOT TAKE PEMETREXED-AFT IF YOU HAVE AN ALLERGY TO: • any medicine containing pemetrexed dis odium • any of the ingredients listed at the end of this le aflet. Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face Lugege kogu dokumenti
Page 1 of 22 AUSTRALIAN PRODUCT INFORMATION – PEMETREXED-AFT (PEMETREXED (AS DISODIUM)) POWDER FOR INJECTION 1 NAME OF THE MEDICINE Pemetrexed (as disodium) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION PEMETREXED-AFT is supplied in 500 mg and 100 mg vials. Each 500 mg vial of PEMETREXED-AFT contains pemetrexed (as disodium) equivalent to 500 mg pemetrexed and 500 mg of mannitol. Hydrochloric acid and/or sodium hydroxide may have been added to adjust pH. Each 100 mg vial of PEMETREXED-AFT contains pemetrexed (as disodium) equivalent to 100 mg pemetrexed and 106.4 mg of mannitol. Hydrochloric acid and/or sodium hydroxide may have been added to adjust pH. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Pemetrexed (as disodium) is a white to almost white solid. PEMETREXED-AFT 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 T HERAPEUTIC INDICATIONS Malignant Pleural Mesothelioma PEMETREXED-AFT, in combination with cisplatin, is indicated for the treatment of patients with malignant pleural mesothelioma. Non-small cell lung cancer PEMETREXED-AFT 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-AFT 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-AFT should be administered under the supervision of a qualified physician experienced in the use of antineoplastic agents. PEMETREXED-AFT IN COMBINATION USE WITH CISPLATIN: Adults - The recommended dose of PEMETREXED-AFT is 500 mg/m 2 as body surface area (BSA) administered as an intravenous infusion over 10 minutes on t Lugege kogu dokumenti