Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Clostridium botulinum toxin type a haemagglutinin complex
Ipsen Pharma
M03AX; M03AX01
Clostridium botulinum toxin type a haemagglutinin complex
125 Speywood
Powder for solution for injection
Product subject to prescription which may not be renewed (A)
Other muscle relaxants, peripherally acting agents; botulinum toxin
Marketed
2010-03-26
____________________________________________________________________________________________________________ Document name: 54_AZZ_IE Reason for change: National Phase submission following EOP for Type II Variation addition of ADRs in post marketing experience - FR/H/0341/001/II/061 Document replaced: 50_AZZ_UKIE Preparation date:09/06/2022 Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER AZZALURE, 125 SPEYWOOD UNITS, POWDER FOR SOLUTION FOR INJECTION _(botulinum _ toxin type A) _ _ 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. If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See Section 4. IN THIS LEAFLET: 1. What Azzalure is and what it is used for 2. What you need to know before you use Azzalure 3. How to use Azzalure 4. Possible side effects 5. How to store Azzalure 6. Contents of the pack and other information 1. WHAT AZZALURE IS AND WHAT IT IS USED FOR Azzalure contains a substance, botulinum toxin A, which causes muscles to relax. Azzalure acts at the junction between the nerves and muscle to prevent the release of a chemical messenger called acetylcholine from the nerve endings. This prevents muscles from contracting. The muscle relaxation is temporary and gradually wears off. Some people are distressed when lines appear on their face. Azzalure can be used in adults under 65 years to temporarily improve the appearance of any moderate to severe glabellar lines (the vertical frown lines between the eyebrows) and lateral canthal lines (crow’s feet lines). 2. WHAT YOU NEED TO KNOW BEFORE YOU USE AZZALURE DO NOT HAVE AN AZZALURE INJECTION IF: You are allergic to _Clostridium botulinum _ toxin A or any of the other ingredients of this medicine (listed in section 6) You have an infection at the proposed site of injection You have myasth Baca dokumen lengkapnya
Health Products Regulatory Authority 20 July 2022 CRN00CPS6 Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Azzalure, 125 Speywood units, powder for solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Botulinum toxin type A* Quantity corresponding to 125 Speywood units (U)** for one vial. *_Clostridium botulinum_ toxin A haemagglutinin complex ** The Speywood units of Azzalure are specific to the preparation and are not interchangeable with other preparations of botulinum toxin. For the full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for injection. The powder is white. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Azzalure is indicated for the temporary improvement in the appearance of moderate to severe: ● Glabellar lines (vertical lines between the eyebrows) seen at maximum frown and/or ● Lateral canthal lines (crow’s feet lines) seen at maximum smile in adult patients under 65 years, when the severity of these lines has an important psychological impact on the patient. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: Botulinum toxin units are different depending on the medicinal products. The Speywood units of Azzalure are specific to the preparation and are not interchangeable with other preparations of botulinum toxin. Paediatric population The safety and efficacy of Azzalure in individuals aged up to 18 years have not been established. The use of Azzalure is not recommended in subjects under 18 years. Method of administration: Azzalure should only be administered by physicians with appropriate qualifications and expertise in this treatment and having the required equipment. Once reconstituted, Azzalure should only be used to treat a single patient, during a single session. For instructions on reconstitution of the medicinal product before administration, see section 6.6. Remove any make-up and disinfect the skin with a local antiseptic. Intramuscular injections should be performed using a sterile 29 - 30 gauge need Baca dokumen lengkapnya