ประเทศ: มอลตา
ภาษา: อังกฤษ
แหล่งที่มา: Malta Medicines Authority
BOTULINUM TOXIN, TYPE A
Merz Pharmaceuticals GmbH Eckenheimer Landstrasse 100, D-60318 Frankfurt am Main, Germany
M03AX01
BOTULINUM TOXIN TYPE A 50 U
POWDER FOR SOLUTION FOR INJECTION
BOTULINUM TOXIN TYPE A 50 U
POM
MUSCLE RELAXANTS
Authorised
2019-01-09
Page 1 of 9 PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER BOCOUTURE 50 UNITS POWDER FOR SOLUTION FOR INJECTION BOCOUTURE 100 UNITS POWDER FOR SOLUTION FOR INJECTION Botulinum toxin type A (150 kD), free from complexing proteins 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. • 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 BOCOUTURE is and what it is used for 2. What you need to know before BOCOUTURE is used 3. How to use BOCOUTURE 4. Possible side effects 5. How to store BOCOUTURE 6. Contents of the pack and other information 1. WHAT BOCOUTURE IS AND WHAT IT IS USED FOR BOCOUTURE is a medicine that contains the active substance Botulinum toxin type A which relaxes the injected muscles. BOCOUTURE is used for temporary improvement of upper facial lines in adults under 65 years of age when the severity of these lines has an important psychological impact for the patient: • moderate to severe vertical lines between the eyebrows seen at maximum frown and/or • moderate to severe lateral periorbital lines seen at maximum smile and/or • moderate to severe horizontal forehead lines seen at maximum contraction 2. WHAT YOU NEED TO KNOW BEFORE BOCOUTURE IS USED DO NOT USE BOCOUTURE • if you are allergic to Botulinum neurotoxin type A or any of the other ingredients of this medicine (listed in section 6) • if you suffer from a generalised disorder of muscle activity (e.g. myasthenia gravis, Lambert- Eaton syndrome) • if you have an infection or inflammation at the proposed injection site. WARNINGS AND PRECAUTIONS Side effects may occur from misplaced injections of Botulinum neurotoxin type A temporarily paralysing nearby muscle groups. There have been very ra อ่านเอกสารฉบับเต็ม
Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT BOCOUTURE 50 units powder for solution for injection BOCOUTURE 100 units powder for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _BOCOUTURE 50 units _ One vial contains 50 units of Botulinum toxin type A (150 kD), free from complexing proteins*. _BOCOUTURE 100 units _ One vial contains 100 units of Botulinum toxin type A (150 kD), free from complexing proteins*. _* _ _Botulinumtoxin type A, purified from cultures of Clostridium Botulinum (Hall strain)_ For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for injection (powder for injection) White powder 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS BOCOUTURE is indicated for the temporary improvement in the appearance of upper facial lines in adults below 65 years when the severity of these lines has an important psychological impact for the patient: • moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar frown lines) and/or • moderate to severe lateral periorbital lines seen at maximum smile (crow’s feet lines) and/or • moderate to severe horizontal forehead lines seen at maximum contraction 4.2 POSOLOGY AND METHOD OF ADMINISTRATION DUE TO UNIT DIFFERENCES IN THE POTENCY ASSAY, UNIT DOSES FOR BOCOUTURE ARE NOT INTERCHANGEABLE WITH THOSE FOR OTHER PREPARATIONS OF BOTULINUM TOXIN TYPE A. For detailed information regarding clinical studies with BOCOUTURE in comparison to conventional Botulinum toxin type A complex (900 kD), see section 5.1. GENERAL BOCOUTURE may only be administered by physicians with suitable qualifications and the requisite experience in the application of Botulinum toxin type A. POSOLOGY _VERTICAL LINES BETWEEN THE EYEBROWS SEEN AT MAXIMUM FROWN (GLABELLAR FROWN LINES) _ After reconstitution of BOCOUTURE a dose of 4 units is injected into each of the 5 injection sites: two injections in each corrugator muscle and one injection in the procerus muscle, which c อ่านเอกสารฉบับเต็ม