Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
CLOSTRIDIUM BOTULINUM TOXIN TYPE A HAEMAGGLUTININ COMPLEX
Ipsen Biopharm Limited
J06AA04
CLOSTRIDIUM BOTULINUM TOXIN TYPE A HAEMAGGLUTININ COMPLEX
500 Units/ml
Pdr for Soln for Injection
Product subject to prescription which may not be renewed (A)
Immune sera
Authorised
2014-01-31
Page 1 of 9 PACKAGE LEAFLET: INFORMATION FOR THE USER DYSPORT ® 500 UNITS POWDER FOR SOLUTION FOR INJECTION _Clostridium botulinum_ type A toxin-haemagglutinin complex 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 further questions, ask your doctor, pharmacist or nurse. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. 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 DYSPORT IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE DYSPORT 3. HOW DYSPORT IS GIVEN 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE DYSPORT 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT DYSPORT IS AND WHAT IT IS USED FOR Dysport contains the active substance_ Clostridium botulinum _type A toxin-haemagglutinin complex. WHAT DYSPORT IS USED FOR: ADULTS Dysport is used in adults to treat muscle spasms: In the arm and shoulders In the lower leg affecting the ankle joint In the neck Around the eyes In the face. Dysport is also used in adults to treat: Hyperhidrosis. This is a condition where the body produces excessive sweating of the armpits, which interferes with daily living. CHILDREN Dysport is used to treat muscle spasms in the legs of children (aged two years or older) with cerebral palsy, to improve their walking. HOW DYSPORT WORKS Dysport contains a toxin produced by the bacterium _Clostridium botulinum. _It works by stopping your muscles contracting. It does this by stopping the release of a chemical which acts between the nerves and Page 2 of 9 muscles that makes the muscles contract. This helps to reduce abnormal muscle contractions known as spasms. Dysport injected into the underarm areas will block the nerve Pročitajte cijeli dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dysport 500 units Powder for solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION _Clostridium botulinum_ type A toxin-haemagglutinin complex 500 units* *One unit (U) is defined as the median lethal intraperitoneal dose in mice. During the development of botulinum type A toxin haemagglutinin complex, the activity was commonly expressed in terms of a nominal weight, based upon a standard specific activity of 4x 10 7 units/mg. Any reference to this product expressed in nanograms, whether in the literature or elsewhere, may therefore be readily converted into units using the formula 1 ng = 40U. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for injection Uncoloured Type I glass vial containing a sterile white lyophilised powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dysport is indicated for focal spasticity including the: - Symptomatic treatment of focal spasticity affecting the upper limbs in adults - Symptomatic treatment of focal spasticity in adults affecting the ankle joint due to stroke or traumatic brain injury (TBI) - Treatment of dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients, two years of age or older. Dysport is also indicated for the following treatments: - Spasmodic torticollis - Blepharospasm - Hemifacial spasm - Persistent severe primary hyperhidrosis of the axillae, which interferes with the activities of daily living and is resistant to topical treatment. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _ Pročitajte cijeli dokument