Land: Israel
Språk: engelska
Källa: Ministry of Health
BOTULINUM TOXIN TYPE A
MEDISON PHARMA LTD
M03AX01
POWDER FOR SOLUTION FOR INJECTION
BOTULINUM TOXIN TYPE A 300 U/VIAL
S.C, I.M
Required
IPSEN BIOPHARM LTD, UK
BOTULINUM TOXIN
Dysport is indicated for symptomatic treatment of focal spasticity of:- Upper limbs in adults due to stroke or traumatic brain injury- 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 pediatric cerebral palsy patients, two years of age or older.Dysport is indicated in adults for symptomatic treatment of:- Spasmodic torticollis- Blepharospasm- Hemifacial spasm.Dysport is indicated for symptomatic treatment of persistent severe primary hyperhidrosis of the axillae, which interferes with the activities of daily living and is resistant to topical treatment.Dysport is indicated for the temporary improvement in the appearance of moderate to severe:- glabellar lines (vertical lines between the eyebrows) seen at 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.
2020-01-31
DYSP-PIL-0222-V1 Page 1 of 12 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only DYSPORT 300 DYSPORT 500 POWDER FOR SOLUTION FOR INJECTION ACTIVE INGREDIENT AND ITS QUANTITY: Botulinum A toxin _(Clostridium botulinum_ _type A_ _toxin_ haemagglutinin complex) _ _ Dysport 300 Each vial contains 300 units of Botulinum A toxin Dysport 500 Each vial contains 500 units of Botulinum A toxin _ _ For the list of inactive ingredients - see section 6 "ADDITIONAL INFORMATION". READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? Dysport contains a toxin produced by the bacterium _Clostridium botulinum_. Dysport is a muscle relaxant. It works by preventing the release of a chemical which acts between the nerves and muscles that makes the muscles contract. This helps to reduce abnormal muscle contractions known as spasms. Dysport is also used to prevent contraction of the muscles causing lines on the forehead, appearing upon frowning, and at the outer corner of the eye. This muscle relaxation is temporary and gradually wears off. Some people are distressed when lines appear on their face. Dysport is indicated for symptomatic treatment of focal spasticity: - of upper limbs in adults due to stroke or traumatic brain injury. - of lower limbs in adults affecting the ankle joint due to stroke or traumatic brain injury. - For treatment of pediatric cerebral palsy patients (two years of age or older) who can walk, to treat foot deformity caused by persistent muscle spasms in the legs. - of upper limbs in pediatric cerebral palsy patients two years of age or older Dysport is indicated in AD Läs hela dokumentet
DYSP-SPC-1121-V1 Page 1 of 27 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dysport 300 Dysport 500 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Dysport 300: _ Clostridium botulinum _ type A toxin-haemagglutinin complex 300 units Dysport 500: _Clostridium botulinum _ type A toxin-haemagglutinin complex 500 units 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 due to stroke or traumatic brain injury. - 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 pediatric cerebral palsy patients, two years of age or older. Dysport is indicated in adults for symptomatic treatment of: - Spasmodic torticollis - Blepharospasm - Hemifacial spasm Dysport is indicated for symptomatic treatment of persistent severe primary hyperhidrosis of the axillae, which interferes with the activities of daily living and is resistant to topical treatment. Dysport is indicated for the temporary improvement in the appearance of moderate to severe: - Glabellar lines (vertical lines between the eyebrows) seen at 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 an appropriately qualified healthcare practitioner with expertise in the treatment of the relevant indication and the use of the required equipment, in accordance with national guidelines. _ _ For instructions on reconstitution of the powder for solution for Läs hela dokumentet