Land: Verenigd Koninkrijk
Taal: Engels
Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)
Botulinum toxin type A
Ipsen Ltd
M03AX01
Botulinum toxin type A
500unit
Powder for solution for injection
Subcutaneous; Intramuscular
No Controlled Drug Status
Valid as a prescribable product
BNF: 04090300; GTIN: 5036611000028
Page 1 of 8 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 ARE GIVEN 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: Around the eyes In the face In the neck In the arm and shoulders In the leg Dysport is also used in adults to treat: Hyperhidrosis. This is a condition where there is excess sweating of the armpits, which interferes with daily living. CHILDREN: Dysport is used in children (aged two years or older) with cerebral palsy to treat muscle spasms in the legs, 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 8 muscles that makes the muscles contract. This helps to reduce abnormal muscle contractions known as spasms. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DYSPORT DO NOT USE DYSPORT: If you are allergic Lees het volledige document
OBJECT 1 DYSPORT 500U Summary of Product Characteristics Updated 24-Jul-2017 | Ipsen Ltd 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. For a full list of excipients, see section 6.1. 3. Pharmaceutical form Powder for solution for injection 4. Clinical particulars 4.1 Therapeutic indications Dysport is indicated for symptomatic treatment of focal spasticity of: - Upper limbs in adults - Lower limbs in adults affecting the ankle joint due to stroke or traumatic brain injury (TBI) - Dynamic equinus foot deformity in ambulant paediatric cerebral palsy patients, two years of age or older. Dysport is indicated in adults for symptomatic treatment of: - Spasmodic torticollis - Blepharospasm - Hemifacial spasm - Severe primary hyperhidrosis of the axillae, which does not respond to topical treatment with antiperspirants or antihidrotics. 4.2 Posology and method of administration THE UNITS OF DYSPORT ARE SPECIFIC TO THE PREPARATION AND ARE NOT INTERCHANGEABLE WITH OTHER PREPARATIONS OF BOTULINUM TOXIN. Training: Dysport should only be administered by appropriately trained physicians. Ipsen can facilitate training in administration of Dysport injections. For instructions on reconstitution of the powder for solution for injection, handling and disposal of vials please refer to section 6.6. FOCAL SPASTICITY IN ADULTS _UPPER LIMB:_ Posology Dosing in initial and sequential treatment sessions should be tailored to the individual based on the size, number and location of muscles involved, severity of spasticity, the presence of local muscle weakness, the patient's response to previous treatment, and/or adverse event history with Dysport. In clinical trials, doses of 500 units and 1000 units were divided among selected muscles at a given treatment session as shown below. No more than 1 ml should generall Lees het volledige document