国家: 新加坡
语言: 英文
来源: HSA (Health Sciences Authority)
CLOSTRIDIUM BOTULINUM TYPE A TOXIN-HAEMAGGLUTININ COMPLEX
IPSEN PHARMA SINGAPORE PTE. LTD.
M03AX01
500 U/Vial
INJECTION, POWDER, FOR SOLUTION
CLOSTRIDIUM BOTULINUM TYPE A TOXIN-HAEMAGGLUTININ COMPLEX 500 U/Vial
SUBCUTANEOUS, INTRAMUSCULAR
Prescription Only
IPSEN BIOPHARM LTD
ACTIVE
1999-05-31
PATIENT INFORMATION LEAFLET INFORMATION FOR THE PATIENT Please read this leaflet carefully. It provides some information about this medicine. If there are any questions, please ask the doctor. The name of this medicine is Dysport. Its active ingredient is _Clostridium botulinum _type A toxin-haemagglutinin complex. Dysport also contains albumin and lactose, and is presented as a powder. For the injection, Dysport will be dissolved in Sodium Chloride for Injection. PACK SIZE Each pack contains 1 or 2 vials of Dysport, although not all pack sizes may be marketed. WHAT IS DYSPORT? Dysport is a toxin produced by _Clostridium botulinum _bacteria. The toxin acts on the junctions between the nerves and muscles, preventing the release of one of the chemical messengers called acetylcholine from the nerve endings which would normally cause the muscle to contract. If the messenger is prevented from being released this results in a weakened muscle and helps to reduce some of the abnormal muscle contractions. It can also be used to prevent muscles which cause frown lines and crow’s feet lines from contracting. This muscle relaxation is temporary and gradually wears off. Each vial of Dysport contains 500 units of the toxin complex. These units apply to Dysport only and are not the same for other medicines containing botulinum toxin. Dysport is also available in 300 units vial. WHO MAKES DYSPORT? Dysport is manufactured by: Ipsen Biopharm Limited, Ash Road, Wrexham Industrial Estate, Wrexham LL13 9UF, UK. The product licence holder is: A. Menarini Singapore Pte Ltd 30 Pasir Panjang Road, #08-32 Mapletree Business City Singapore 117440 WHAT IS DYSPORT USED FOR? Dysport is used to manage the symptoms of upper limbs and lower limbs spasticity in adults as well as equinus foot deformity due to spasticity in children (2 years of age or older) with cerebral palsy. Dysport is also used for the treatment of spasmodic torticollis, blepharospasm, hemifacial spasm and axillary hyperhidrosis in adults. Upper limbs and lower limbs spastic 阅读完整的文件
DYSPORT_ _ _Clostridium botulinum _ type A toxin-haemagglutinin complex INFORMATION FOR THE DOCTOR 1. NAME OF THE MEDICINAL PRODUCT Dysport 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Clostridium botulinum _ type A toxin-haemagglutinin complex 500 units* _Clostridium botulinum _ type A toxin-haemagglutinin complex 300 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 - Upper limbs in paediatric cerebral palsy patients, two years of age or older Dysport is indicated in adults for symptomatic treatment of: - Spasmodic torticollis - Blepharospasm - Hemifacial spasm - Axillary hyperhidrosis Dysport is indicated for the temporary improvement in the appearance of moderate to severe: - Glabellar lines (vertical lines between the eyebrows) seen at maximum frown and/or - Lateral canthal lines (crow’s feet lines) seen at maximum smile in adult patients under 65 years, when the severity of these lines has an important psychological impact on the patient. 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. Dysport should only be administered by appropriately trained physicians. For the treatment of focal spasticity, Dysport can also be administered by healthcare professionals having received appropriate training and qualification in accordance with national guidelines (e.g., Royal College of Physicians). For instructions on reconstitution of the powder for solution for injection, handling and disposal of vials, please refer to se 阅读完整的文件