Land: Malta
Språk: engelska
Källa: Medicines Authority
CLOSTRIDIUM BOTULINUM, TOXIN TYPE, A
Merz Pharmaceuticals GmbH Eckenheimer Landstrasse 100, D-60318 Frankfurt am Main, Germany
M03AX01
CLOSTRIDIUM BOTULINUM TOXIN TYPE A 200 U
POWDER FOR SOLUTION FOR INJECTION
CLOSTRIDIUM BOTULINUM TOXIN TYPE A 200 U
POM
MUSCLE RELAXANTS
Authorised
2016-04-11
PACKAGE LEAFLET: INFORMATION FOR THE USER XEOMIN 50 UNITS POWDER FOR SOLUTION FOR INJECTION XEOMIN 100 UNITS POWDER FOR SOLUTION FOR INJECTION XEOMIN 200 UNITS POWDER FOR SOLUTION FOR INJECTION Clostridium Botulinum neurotoxin type A (150 kD), free from complexing proteins READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU RECEIVE 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 XEOMIN is and what it is used for 2. What you need to know before XEOMIN is used 3. How to use XEOMIN 4. Possible side effects 5. How to store XEOMIN 6. Contents of the pack and other information 1. WHAT XEOMIN IS AND WHAT IT IS USED FOR XEOMIN is a medicine that contains the active substance Botulinum Neurotoxin Type A which relaxes the injected muscles or decreases the salivary flow at the respective administration site. XEOMIN is used for the treatment of the following conditions in adults • eyelid spasm (blepharospasm) and spasms affecting one side of the face (hemifacial spasm) • twisted neck (spasmodic torticollis) • increased muscle tension/uncontrollable muscle stiffness in shoulders, arms and/or hands (spasticity of the upper limb) • chronic drooling (sialorrhea) due to neurological disorders. XEOMIN is used in children and adolescents aged 2 to 17 years and weighing ≥ 12 kg for the treatment of • chronic drooling (sialorrhea) due to neurological / neurodevelopmental disorders. 2. WHAT YOU NEED TO KNOW BEFORE XEOMIN IS USED DO NOT USE XEOMIN • 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 hav Läs hela dokumentet
1. NAME OF THE MEDICINAL PRODUCT XEOMIN 50 units powder for solution for injection XEOMIN 100 units powder for solution for injection XEOMIN 200 units powder for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _XEOMIN 50 units powder for solution for injection _ One vial contains 50 units of Clostridium Botulinum neurotoxin type A (150 kD), free from complexing proteins*. _XEOMIN 100 units powder for solution for injection _ One vial contains 100 units of Clostridium Botulinum neurotoxin type A (150 kD), free from complexing proteins*. _XEOMIN 200 units powder for solution for injection _ One vial contains 200 units of Clostridium Botulinum neurotoxin type A (150 kD), free from complexing proteins*. _* _ _Botulinum neurotoxin 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 White powder 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS XEOMIN is indicated for the symptomatic treatment in adults of • blepharospasm and hemifacial spasm, • cervical dystonia of a predominantly rotational form (spasmodic torticollis), • spasticity of the upper limb, • chronic sialorrhea due to neurological disorders. XEOMIN is indicated for the symptomatic treatment in children and adolescents aged 2 to 17 years and weighing ≥ 12 kg of • chronic sialorrhea due to neurological / neurodevelopmental disorders. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION DUE TO UNIT DIFFERENCES IN THE POTENCY ASSAY, UNIT DOSES FOR XEOMIN ARE NOT INTERCHANGEABLE WITH THOSE FOR OTHER PREPARATIONS OF BOTULINUM TOXIN TYPE A. For detailed information regarding clinical studies with XEOMIN in comparison to conventional Botulinum toxin type A complex (900 kD), see section 5.1. XEOMIN may only be administered by physicians with suitable qualifications and the requisite experience in the application of Botulinum toxin type A. The optimum dose, frequency and number of injection sites should be determined by Läs hela dokumentet