Pays: Nouvelle-Zélande
Langue: anglais
Source: Medsafe (Medicines Safety Authority)
Galcanezumab 120 mg/mL
Eli Lilly and Company (NZ) Limited
120 mg/mL
Solution for injection
Active: Galcanezumab 120 mg/mL Excipient: Histidine Histidine hydrochloride monohydrate Polysorbate 80 Sodium chloride Water for injection
Prescription
EMGALITY is indicated for the prophylaxis of migraine in adults
Package - Contents - Shelf Life: Syringe, glass, pre-fitted into a pen injector (1 mL fill) - 1 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 7 days not refrigerated stored at or below 30°C protect from light. do not freeze, no return to refrigeration - Syringe, glass, pre-fitted into a pen injector (1 mL fill) - 2 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 7 days not refrigerated stored at or below 30°C protect from light. do not freeze, no return to refrigeration - Syringe, glass, pre-fitted into a pen injector (1 mL fill) - 3 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 7 days not refrigerated stored at or below 30°C protect from light. do not freeze, no return to refrigeration
2019-09-06
EMGALITY Page 1 of 4 EMGALITY ® _PREFILLED PEN (AUTOINJECTOR) AND PREFILLED SYRINGE _ _Galcanezumab _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about EMGALITY. It does not contain all the available information. It should not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking EMGALITY against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT EMGALITY IS USED FOR EMGALITY is used to prevent migraine in adult patients. Migraine is a disease affecting the nervous system where patients suffer with repeated headaches, often only affecting one side of the head. The headaches are commonly associated with feeling nauseous, or actually vomiting, and patients can also be very sensitive to light and sound. The active ingredient in EMGALITY is galcanezumab. Galcanezumab belongs to a group of preventative medicines that stop the activity of a naturally occurring substance in the body called calcitonin-gene-related peptide (CGRP). Increased levels of CGRP have been associated with migraine. EMGALITY has been shown to improve quality of life by significantly reducing the frequency of migraine headache, with an onset of effect as early as one week after starting treatment. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY EMGALITY HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. EMGALITY is available only with a doctor's prescription. .EMGALITY could have a minor effect on your ability to drive and use machines. Some patients have had vertigo whilst using EMGALITY. EMGALITY has not been studied in patients under 18 years of age. BEFORE YOU TAKE EMGALITY _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE EMGALITY IF YOU HAVE AN ALLERGY TO: • Galcanezumab • Any of the ingredients listed at the end of Lire le document complet
NEW ZEALAND DATA SHEET VA1.0_03Sep20 Page 1 of 15 1. PRODUCT NAME EMGALITY® 120mg/mL prefilled pen EMGALITY® 120mg/mL prefilled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each prefilled pen (autoinjector) or prefilled syringe contains 120 mg of galcanezumab in 1 mL. EMGALITY solution is sterile and preservative-free. Galcanezumab is a humanised monoclonal antibody (IgG4) produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. It is composed of two identical immunoglobulin kappa light chains and two identical immunoglobulin gamma heavy chains (Molecular Weight = 144,084 Da non-glycosylated, disulfide linked). EMGALITY is administered as a subcutaneous injection. EXCIPIENT WITH KNOWN EFFECT Each 1mL of product contains approximately 3.5 mg sodium. For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Solution for injection in pre-filled pen (autoinjector). Solution for injection in pre-filled syringe. 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. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE Emgality should be initiated by physicians experienced in the diagnosis and treatment of migraine. VA1.0_03Sep20 Page 2 of 15 The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose. Treatment response for galcanezumab should be evaluated by the prescriber after 8-12 weeks as recommended by the current American Headache Society Consensus Statement 1 . 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. Instruct patients to inject a missed dose as soon as possible. Thereafter, resume monthly dosing. METHOD OF ADMINISTRATION EMGALITY is for subcutaneous administration. A patient may self-inject EMGALITY by following the instructions for use. Site Lire le document complet