देश: यूरोपीय संघ
भाषा: अंग्रेज़ी
स्रोत: EMA (European Medicines Agency)
fremanezumab
Teva GmbH
N02CD03
fremanezumab
Calcitonin gene-related peptide (CGRP) antagonists
Migraine Disorders
Ajovy is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month.
Revision: 10
Authorised
2019-03-28
26 B. PACKAGE LEAFLET 27 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AJOVY 225 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE fremanezumab 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, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What AJOVY is and what it is used for 2. What you need to know before you use AJOVY 3. How to use AJOVY 4. Possible side effects 5. How to store AJOVY 6. Contents of the pack and other information 1. WHAT AJOVY IS AND WHAT IT IS USED FOR WHAT AJOVY IS AJOVY is a medicine containing the active substance fremanezumab, a monoclonal antibody, a type of protein that recognises and attaches to a specific target in the body. HOW AJOVY WORKS A substance in the body called calcitonin gene-related peptide (CGRP) plays an important role in migraine. Fremanezumab attaches to CGRP and prevents it from working. This reduction in CGRP's activity reduces migraine attacks. WHAT AJOVY IS USED FOR AJOVY is used to prevent migraine in adults who have at least 4 migraine days per month. WHAT ARE THE BENEFITS OF USING AJOVY AJOVY reduces the frequency of migraine attacks and days with headache. This medicine also decreases the disability associated with migraine and it reduces the need for medicines used to treat migraine attacks. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE AJOVY _ _ DO NOT USE AJOVY Do not use this medicine if you are allergic to fremanezumab or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse immediately if you get any signs पूरा दस्तावेज़ पढ़ें
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT AJOVY 225 mg solution for injection in pre-filled syringe AJOVY 225 mg solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Pre-filled syringe One pre-filled syringe contains 225 mg fremanezumab. Pre-filled pen One pre-filled pen contains 225 mg fremanezumab. Fremanezumab is a humanised monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection) Clear to opalescent, colourless to slightly yellow solution with a pH of 5.5 and an osmolality of 300-450 mOsm/kg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS AJOVY is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The treatment should be initiated by a physician experienced in the diagnosis and treatment of migraine. Posology Two dosing options are available: • 225 mg once monthly (monthly dosing) or • 675 mg every three months (quarterly dosing) When switching dosing regimens, the first dose of the new regimen should be administered on the next scheduled dosing date of the prior regimen. When initiating treatment with fremanezumab, concomitant migraine preventive treatment may be continued, if considered necessary by the prescriber (see section 5.1). The treatment benefit should be assessed within 3 months after initiation of treatment. Any further decision to continue treatment should be taken on an individual patient basis. Evaluation of the need to continue treatment is recommended regularly thereafter. 3 _Missed dose _ If a fremanezumab injection is missed on the planned date, dosing should resume as soon as possible on the indicated dose and regimen. A double dose must not be administered to make up for a missed dose. Special populations _Elderly _ There is limited data available on the use of fremanezumab in patie पूरा दस्तावेज़ पढ़ें