Страна: Європейський Союз
мова: англійська
Джерело: EMA (European Medicines Agency)
Obinutuzumab
Roche Registration GmbH
L01XC15
obinutuzumab
Antineoplastic agents
Leukemia, Lymphocytic, Chronic, B-Cell
Chronic Lymphocytic Leukaemia (CLL)Gazyvaro in combination with chlorambucil is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) and with comorbidities making them unsuitable for full-dose fludarabine based therapy (see section 5.1).Follicular Lymphoma (FL)Gazyvaro in combination with chemotherapy, followed by Gazyvaro maintenance therapy in patients achieving a response, is indicated for the treatment of patients with previously untreated advanced follicular lymphoma.Gazyvaro in combination with bendamustine followed by Gazyvaro maintenance is indicated for the treatment of patients with follicular lymphoma (FL) who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen.
Revision: 16
Authorised
2014-07-22
48 B. PACKAGE LEAFLET 49 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT GAZYVARO 1,000 MG CONCENTRATE FOR SOLUTION FOR INFUSION obinutuzumab READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 nurse. • If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Gazyvaro is and what it is used for 2. What you need to know before you are given Gazyvaro 3. How Gazyvaro is given _ _ 4. Possible side effects 5. How to store Gazyvaro _ _ 6. Content of the pack and other information 1. WHAT GAZYVARO IS AND WHAT IT IS USED FOR WHAT GAZYVARO IS Gazyvaro contains the active substance obinutuzumab, which belongs to a group of medicines called “monoclonal antibodies”. Antibodies work by attaching themselves to specific targets in your body. WHAT GAZYVARO IS USED FOR Gazyvaro can be used in adults to treat two different types of cancer • CHRONIC LYMPHOCYTIC LEUKAEMIA (also called “CLL”) - Gazyvaro is used in patients who have not had any treatment for CLL before and who have other illnesses which make it unlikely that they would be able to tolerate a full dose of a different medicine used to treat CLL called fludarabine. - Gazyvaro is used together with another medicine for cancer called chlorambucil. • FOLLICULAR LYMPHOMA (also called “FL”) - Gazyvaro is used in patients who have not had any treatment for FL - Gazyvaro is used in patients who have had at least one treatment with a medicine called rituximab before and whose FL has come back or got worse during or after this treatment. - At the start of treatment for FL, Gazyvaro is used together with other medicines for cancer. - Gazyvaro can then be used on its own for up to 2 years as a “maintenance treatment”. HOW GAZYVARO WORKS • CLL and FL are types of cance Прочитайте повний документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Gazyvaro 1,000 mg concentrate for solution for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial of 40 mL concentrate contains 1,000 mg obinutuzumab, corresponding to a concentration before dilution of 25 mg/mL. Obinutuzumab is a Type II humanised anti-CD20 monoclonal antibody of the IgG1 subclass derived by humanisation of the parental B-Ly1 mouse antibody and produced in the Chinese Hamster Ovary cell line by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear, colourless to slightly brownish liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Chronic lymphocytic leukaemia (CLL) Gazyvaro in combination with chlorambucil is indicated for the treatment of adult patients with previously untreated CLL and with comorbidities making them unsuitable for full-dose fludarabine based therapy (see section 5.1). Follicular lymphoma (FL) Gazyvaro in combination with chemotherapy, followed by Gazyvaro maintenance therapy in patients achieving a response, is indicated for the treatment of patients with previously untreated advanced FL (see section 5.1) Gazyvaro in combination with bendamustine followed by Gazyvaro maintenance is indicated for the treatment of patients with FL who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Gazyvaro should be administered under the close supervision of an experienced physician and in an environment where full resuscitation facilities are immediately available. Posology _Prophylaxis and premedication for tumour lysis syndrome (TLS) _ Patients with a high tumour burden and/or a high circulating lymphocyte count (> 25 x 10 9 /L) and/or renal impairment (CrCl < 70 mL/min) are considered at risk of TLS and should receive prophylaxis. 3 Prophylaxis should consist of adequate hydration an Прочитайте повний документ