Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
Galcanezumab
Eli Lilly Nederland B.V.
N02
galcanezumab
Analgesics, galcanezumab
Migraine Disorders
Emgality is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.
Revision: 10
Authorised
2018-11-14
39 B. PACKAGE LEAFLET 40 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT EMGALITY 120 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN galcanezumab . 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 Emgality is and what it is used for 2. What you need to know before you use Emgality 3. How to use Emgality 4. Possible side effects 5. How to store Emgality 6. Contents of the pack and other information 1. WHAT EMGALITY IS AND WHAT IT IS USED FOR Emgality contains galcanezumab, a medicine that stops the activity of a naturally occurring substance in the body called calcitonin gene-related peptide (CGRP). People with migraine may have increased levels of CGRP. Emgality is used to prevent migraine in adult patients who have at least 4 migraines days per month. Emgality can reduce the frequency of migraine headache and improve your quality of life. It starts working in about a week. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE EMGALITY _ _ DO NOT USE EMGALITY: - if you are allergic to galcanezumab or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before or during treatment with Emgality if: - you have a serious cardiovascular disease. Emgality has not been studied in patients with serious cardiovascular diseases. LOOK OUT FOR ALLERGIC REACTIONS Emgality can potentially cause serious allergic reactions. Serious allergic reactions happen mainly within 1 day after having taken Emgality, but some reactions can be delayed Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Emgality 120 mg solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled pen contains 120 mg of galcanezumab in 1 mL. Galcanezumab is a recombinant humanised monoclonal antibody produced in Chinese Hamster Ovary cells. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). The solution is clear and colourless to slightly yellow. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Emgality is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated by physicians experienced in the diagnosis and treatment of migraine. Posology The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose. Patients should be instructed to inject a missed dose as soon as possible and then resume monthly dosing. 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. _ _ _Elderly (_ ≥ _ 65 years) _ There is limited information in subjects aged ≥ 65 years. No dose adjustment is required as the pharmacokinetics of galcanezumab are not affected by age. _ _ _ _ _Renal impairment/hepatic impairment _ No dose adjustment is required in patients with mild to moderate renal impairment or hepatic impairment (see section 5.2). _Paediatric population _ The safety and efficacy of galcanezumab in children aged 6 to 18 years have not yet been established. No data are available. 3 There is no relevant use of galcanezumab in children below the age of 6 years for the prevention of migraine. Method of administration Subcutaneous use. A patient may self-inject galcanezumab by following the Instructi Pročitajte cijeli dokument