Država: Malta
Jezik: engleski
Izvor: Medicines Authority
CROMA-PHARMA GmbH Industriezeile 6 2100 Leobendorf , Austria
M03AX01
BOTULINUM TOXIN TYPE A 50 U
POWDER FOR SOLUTION FOR INJECTION
BOTULINUM TOXIN TYPE A 50 U
POM
MUSCLE RELAXANTS
Licence number in the source country: NOT APPLICAPABLE
Authorised
2022-10-07
1 PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER LETYBO 50 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 or pharmacist. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Letybo is and what it is used for 2. What you need to know before you use Letybo 3. How to use Letybo 4. Possible side effects 5. How to store Letybo 6. Contents of the pack and other information 1. WHAT LETYBO IS AND WHAT IT IS USED FOR Letybo contains the active substance botulinum toxin type A. It works by blocking nerve impulses to the muscles in which it has been injected. It prevents muscles from contracting, leading to a temporary paralysis. Letybo is used in adults less than 75 years of age to temporarily improve moderate to severe VERTICAL LINES BETWEEN THE EYEBROWS, when their presence has a significant psychological impact on them. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE LETYBO DO NOT USE LETYBO: • if you are allergic to botulinum toxin type A or any of the other ingredients of this medicine (listed in section 6) • if you have muscle activity disorders, such as myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis • if you have acute infection or inflammation at the proposed injection sites WARNINGS AND PRECAUTIONS Talk to your doctor before using Letybo if you have: • any disorder affecting muscles and/or their direct nervous system control • difficulties swallowing or breathing, or have had these in the past • a bleeding disorder If you have a history of these problems, Letybo is not recommended for you. 2 Needle-related pain and/or fear of injections can lead to feeling faint due to a sudden drop in blood pressure. S Pročitajte cijeli dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Letybo 50 units powder for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains 50 units botulinum toxin type A produced by _Clostridium botulinum_ . After reconstitution each 0.1 mL of the solution contains 4 units. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for injection. White powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Letybo is indicated for the temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows in adults <75 years old seen at maximum frown (glabellar lines), when the severity of the facial lines has an important psychological impact. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Letybo should only be administered by physicians with appropriate qualifications and expertise in this treatment and use of the required equipment. Posology The recommended dose is a total of 20 units divided into five injections of 4 units (0.1 mL) each: 2 injections in each _corrugator supercilii_ muscle and 1 injection in the _procerus_ muscle. Botulinum toxin units are not interchangeable from one product to another. Doses recommended are different from other botulinum toxin preparations. Treatment interval should not be more frequent than every three months. In the absence of any undesirable effects secondary to the previous treatment session, initiation of a further treatment session with at least a three-month interval between the treatment sessions is possible. In case of treatment failure one month after a previous treatment session, i.e. in the absence of significant improvement from baseline, the following approaches may be considered: • Analysis of the causes of failure, e.g. incorrect muscles injected, injection technique, formation of toxin neutralising antibodies, insufficient dose. • Re-evaluation of the relevance of treatment with botulinum toxin type A. _ _ The efficacy and safety of repeat injections of L Pročitajte cijeli dokument