Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
pemetrexed disodium hemipentahydrate
Menarini International Operations Luxembourg S.A.
L01BA04
pemetrexed
Antineoplastic agents
Carcinoma, Non-Small-Cell Lung; Mesothelioma
Malignant pleural mesothelioma Ciambra in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Ciambra in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. Ciambra is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. Ciambra is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.,
Revision: 6
Authorised
2015-12-02
48 B. PACKAGE LEAFLET 49 PACKAGE LEAFLET: INFORMATION FOR THE USER CIAMBRA 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION CIAMBRA 500 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION pemetrexed READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START RECEIVING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What CIAMBRA is and what it is used for 2. What you need to know before you use CIAMBRA 3. How to use CIAMBRA 4. Possible side effects 5. How to store CIAMBRA 6. Contents of the pack and other information 1. WHAT CIAMBRA IS AND WHAT IT IS USED FOR CIAMBRA is a medicine used in the treatment of cancer. CIAMBRA is given in combination with cisplatin, another anti-cancer medicine, as treatment for malignant pleural mesothelioma, a form of cancer that affects the lining of the lung, to patients who have not received prior chemotherapy. CIAMBRA is also given in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer. CIAMBRA can be prescribed to you if you have lung cancer at an advanced stage if your disease has responded to treatment or it remains largely unchanged after initial chemotherapy. CIAMBRA is also a treatment for patients with advanced stage of lung cancer whose disease has progressed after other initial chemotherapy has been used. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE CIAMBRA _ _ DO NOT USE CIAMBRA - if you are allergic (hypersensitive) to pemetrexed or any of the other ingredients of CIAMBRA (listed in section 6). - if you are breast-feeding; you must discontinue breast-feeding during treatment with CIAMBRA. - if you have recently received or are about to receive a vaccine against yellow fever. 50 WARNINGS AND PRECAUTIONS Talk to your doctor Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT CIAMBRA 100 mg powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial of powder contains 100 mg of pemetrexed (as pemetrexed disodium hemipentahydrate). After reconstitution (see section 6.6), each vial contains 25 mg/ml of pemetrexed. Excipient with known effect Each vial contains approximately 11 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion. White to almost white lyophilised powder. The pH of the reconstituted solution is between 6.6 and 7.8. The Osmolality of the reconstituted solution is 230-270 mOsmol/kg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Malignant pleural mesothelioma CIAMBRA in combination with cisplatin is indicated for the treatment of chemotherapy naive patients with unresectable malignant pleural mesothelioma. Non- small cell lung cancer CIAMBRA in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1). CIAMBRA is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy (see section 5.1). CIAMBRA is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION CIAMBRA must only be administered under the supervision of a physician qualified in the use of anti-cancer chemotherapy. 3 Posology _CIAMBRA in combination with cisplatin _ The recommended dose of CIAMBRA is 500 mg/m 2 of body surface area (BSA) administered as an intravenous infusion over 1 Pročitajte cijeli dokument