Country: Australia
Bahasa: Inggeris
Sumber: Department of Health (Therapeutic Goods Administration)
pemetrexed disodium hemipentahydrate, Quantity: 604.05 mg (Equivalent: pemetrexed, Qty 500 mg)
Juno Pharmaceuticals Pty Ltd
pemetrexed disodium hemipentahydrate
Injection, powder for
Excipient Ingredients: mannitol; hydrochloric acid; nitrogen; sodium hydroxide
Intravenous Infusion
1 vial
(S4) Prescription Only Medicine
PEMETREXED JUNO, in combination with cisplatin, is indicated for the treatment of patients with malignant pleural mesothelioma. Non-Small Cell lung Cancer PEMETREXED JUNO 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 JUNO 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-yellow or green-yellow lyophilized powder or cake.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2015-05-21
PEMETREXED JUNO 1 PEMETREXED JUNO _pemetrexed disodium hemipentahydrate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about PEMETREXED JUNO. 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. All medicines have risks and benefits. Your doctor has weighed the risks of you taking PEMETREXED JUNO against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT PEMETREXED JUNO IS USED FOR PEMETREXED JUNO 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 JUNO may be used in combination with other chemotherapy drugs. BEFORE YOU ARE GIVEN PEMETREXED JUNO _ _ _ _ _WHEN YOU MUST NOT BE GIVEN _ _IT_ DO NOT TAKE PEMETREXED JUNO IF YOU HAVE AN ALLERGY TO: • any medicine containing pemetrexed disodium hemipentahydrate • 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 bo Baca dokumen lengkap
Juno Pharmaceuticals Pty Ltd Australian Product Information Pemetrexed Juno PI Page | 1 AUSTRALIAN PRODUCT INFORMATION PEMETREXED JUNO _(PEMETREXED DISODIUM HEMIPENTAHYDRATE) _ _ _ 1 NAME OF THE MEDICINE Pemetrexed disodium hemipentahydrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION PEMETREXED JUNO is supplied in 500 mg and 100 mg vials. Each 500 mg vial of PEMETREXED JUNO contains pemetrexed disodium hemipentahydrate equivalent to 500 mg pemetrexed. Each 100 mg vial of PEMETREXED JUNO contains pemetrexed disodium hemipentahydrate equivalent to 100 mg pemetrexed. For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM PEMETREXED JUNO 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 lyophilized powder or cake. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _MALIGNANT PLEURAL MESOTHELIOMA _ PEMETREXED JUNO, in combination with cisplatin, is indicated for the treatment of patients with malignant pleural mesothelioma. _NON-SMALL CELL LUNG CANCER _ PEMETREXED JUNO 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 JUNO 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 PEMETREXED JUNO should be administered under the supervision of a qualified physician experienced in the use of antineoplastic agents. PEMETREXED JUNO in combination use with cisplatin: e003055 Product information - clean 1.3.1.1 Pg. 1 Juno Pharmaceuticals Pty Ltd Australian Product Information Pemetrexed Juno PI Page | 2 Adults - The recommended dose of PEMETREXED JUNO injection is 500 mg/m 2 as body surface area (BSA) administered as an intravenous infusion ove Baca dokumen lengkap