Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
necitumumab
Eli Lilly Nederland B.V.
L01
necitumumab
Antineoplastic agents
Carcinoma, Non-Small-Cell Lung
Portrazza in combination with gemcitabine and cisplatin chemotherapy is indicated for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) expressing squamous non-small cell lung cancer who have not received prior chemotherapy for this condition.
Revision: 3
Withdrawn
2016-02-15
26 B. PACKAGE LEAFLET Medicinal product no longer authorised 27 PACKAGE LEAFLET: INFORMATION FOR THE USER PORTRAZZA 800 MG CONCENTRATE FOR SOLUTION FOR INFUSION necitumumab This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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. - If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Portrazza is and what it is used for 2. What you need to know before you are given Portrazza 3. How you are given Portrazza 4. Possible side effects 5. How to store Portrazza 6. Contents of the pack and other information 1. WHAT PORTRAZZA IS AND WHAT IT IS USED FOR Portrazza contains the active substance necitumumab, which belongs to a group of substances called monoclonal antibodies. Necitumumab recognises and binds specifically to a protein on the surface of some cancer cells. The protein is known as epidermal growth factor receptor (EGFR). Other body proteins (called growth factors) can attach to the EGFR and stimulate the cancer cell to grow and divide. Necitumumab hinders other proteins from binding to the EGFR and thus prevents the cancer cell from growth and division. Portrazza is used in combination with other anti-cancer medicines for the treatment of adults with certain type of lung cancer at an advanced stage (squamous non-small cell lung cancer), whose cancer cells have the EGFR protein on their surface. The anti-cancer medicines it is combined with are gemcitabine and cisplatin. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PORTRAZZA _ _ YOU MUST NOT BE GIVEN PORTRAZZA - if you have ever had a severe allergic reaction to Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Portrazza 800 mg concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 50 mL vial contains 800 mg of necitumumab. Each mL of concentrate for solution for infusion contains 16 mg of necitumumab. The concentrate must be diluted before use (see section 6.6). Necitumumab is a human IgG1 monoclonal antibody produced in murine (NS0) cells by recombinant DNA technology. Excipient with known effect Each 50 mL vial contains approximately 76 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate). Clear to slightly opalescent and colourless to slightly yellow liquid, with pH 6.0. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Portrazza in combination with gemcitabine and cisplatin chemotherapy is indicated for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) expressing squamous non-small cell lung cancer who have not received prior chemotherapy for this condition. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Necitumumab therapy must be administered under the supervision of a physician qualified in the use of anti-cancer chemotherapy. Appropriate medical resources for the treatment of severe infusion reactions should be available during necitumumab infusions. Availability of resuscitation equipment must be ensured. Posology _ _ Portrazza is administered in addition to gemcitabine and cisplatin-based chemotherapy for up to 6 cycles of treatment followed by Portrazza as a single agent in patients whose disease has not progressed, until disease progression or unacceptable toxicity. Lesen Sie das vollständige Dokument