Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
Clostridium botulinum type a toxin haemagglutinin complex, Quantity: 500 U
Ipsen Pty Ltd
Clostridium botulinum type a toxin haemagglutinin complex
Injection, powder for
Excipient Ingredients: Albumin; lactose monohydrate
Intramuscular
1 vial, 2 vials
(S4) Prescription Only Medicine
Dysport is indicated for symptomatic treatment of focal spasticity of: ? Upper limbs in adults ? Lower limbs in adults ? Upper limbs in children aged 2 years and older ? Lower limbs in children aged 2 years and older,Dysport is indicated in adults for the treatment of: ? Spasmodic torticollis ? Blepharospasm ? Hemifacial spasm ? Moderate to severe glabellar lines and / or lateral canthal lines (crow?s feet)
Visual Identification: White lyophilised powder.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
2000-06-16
DYSPORT ® _(Clostridium botulinum type A toxin-haemagglutinin complex)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Dysport. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Dysport against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT IS DYSPORT Dysport is a muscle relaxant produced by Clostridium botulinum bacteria. It acts on the junctions between the nerves and muscles, preventing the release of one of the chemical messengers called acetylcholine from the nerve endings that 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. WHAT DYSPORT IS USED FOR Dysport is used for the treatment of • upper limb spasticity in adults. Upper limb spasticity is an increased stiffness in the arm and/ or hand muscles that develops in many patients after a stroke, for example, and can lead to restricted use of the arm or hand. • lower limb spasticity in adults. Lower limb spasticity is an increased stiffness in the leg and/ or foot muscles that develops in many patients after a stroke, for example, and can lead to restricted use of the leg or foot. • spasmodic torticollis in adults. Spasmodic torticollis is where there is a turning movement of the neck leading to an unusual head and shoulder position • upper and lower limb spasticity in children (2 years of age and older) which may be due to cerebral palsy. Cerebral palsy spasticity is a disorder in which some muscles become stiff and movement is difficult • blepharospasm or hemifacial spasm in adults. Blepharospasm is a condition affecting the eye lid muscles c Læs hele dokumentet
Dysport Product Information: Version 8, 20 October 2021 1 AUSTRALIAN PRODUCT INFORMATION DYSPORT _CLOSTRIDIUM BOTULINUM_ TYPE A TOXIN - HAEMAGGLUTININ COMPLEX POWDER FOR INJECTION VIAL 1 NAME OF THE MEDICINE _clostridium botulinum_ type A toxin - haemagglutinin complex 2 QUALITATIVE AND QUANTITATIVE COMPOSITION DYSPORT Powder for Injection contains 125, 300 or 500 IPSEN UNITS per vial of _clostridium botulinum_ type A toxin-haemagglutinin complex, 125 microgram human serum albumin and 2.5 mg lactose in a sterile, lyophilised form without a preservative. ONE IPSEN UNIT is not equivalent to ONE UNIT of any other botulinum toxin preparation. From now on in this Product Information the term Ipsen unit will simply be replaced by the term unit. _Clostridium botulinum_ type A toxin-haemagglutinin complex has a molecular weight of about 900,000D and is a complex of proteins. For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM DYSPORT 125U, 300U, or 500U is a white lyophilised powder for injection in a clear glass vial 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 • Upper limbs in children aged 2 years and older • Lower limbs in children aged 2 years and older Dysport is indicated in adults for the treatment of: • Spasmodic torticollis • Blepharospasm • Hemifacial spasm • Moderate to severe glabellar lines and / or lateral canthal lines (crow’s feet) Dysport Product Information: Version 8, 20 October 2021 2 4.2 DOSE AND METHOD OF ADMINISTRATION THE UNITS OF DYSPORT ARE SPECIFIC TO THE PREPARATION AND ARE NOT INTERCHANGEABLE WITH OTHER PREPARATIONS OF BOTULINUM TYPE A TOXIN. TRAINING : DYSPORT should only be administered by appropriately trained physicians. The product distributor can facilitate training in administration of DYSPORT injections. _FOCAL SPASTICITY AFFECTING THE UPPER LIMBS IN ADULTS _ Dosing in initial and sequential treatment ses Læs hele dokumentet