País: Armenia
Idioma: inglés
Fuente: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
clostridium botulinum type A toxin-haemagglutinin complex
Ipsen Biopharm Limited
M03AX01
clostridium botulinum type A toxin-haemagglutinin complex
500U
powder lyophilized for solution for injection
(1) glass vial
Prescription
Registered
2016-06-08
Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dysport 300 units Dysport 500 units 2 QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ _Clostridium botulinum_ type A toxin-haemagglutinin complex 300 units* or _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 - 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 - Axillary hyperhidrosis - The temporary improvement in the appearance of moderate to severe glabellar lines (vertical lines between the eyebrows) seen at frown, 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. 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. Page 2 of 17 FOCAL SPASTICITY AFFECTING THE UPPER LIMBS 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 select Leer el documento completo