Quốc gia: New Zealand
Ngôn ngữ: Tiếng Anh
Nguồn: Medsafe (Medicines Safety Authority)
Clostridium botulinum type A toxin haemagglutinin complex 300 U
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Clostridium botulinum type A toxin haemagglutinin complex 300 U
300 U
Powder for injection
Active: Clostridium botulinum type A toxin haemagglutinin complex 300 U Excipient: Albumin Lactose monohydrate
Prescription
Ipsen Biopharm Limited
Dysport is also indicated for the symptomatic treatment of axillary hyperhidrosis (excessive sweating)
Package - Contents - Shelf Life: Vial, glass, - 300 U - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)
2013-07-24
DYSPORT ® 1 DYSPORT ® _(Clostridium botulinum type A toxin-haemagglutinin complex) _ NEW ZEALAND 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 affecti Đọc toàn bộ tài liệu
NEW ZEALAND DATASHEET 1 PRODUCT NAME DYSPORT ® 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Clostridium botulinum type A toxin-haemagglutinin complex 3 PHARMACEUTICAL FORM DYSPORT Powder for Injection contains 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 another 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. DYSPORT is a white lyophilised powder for reconstitution contained in Type 1 glass vials 3 mL of capacity, with 13 mm bromobutyl freeze-drying closures oversealed by 13 mm aluminium overseals with centre hole, crimped over. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications DYSPORT is indicated for the 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 is also indicated for the symptomatic treatment of axillary hyperhidrosis (excessive sweating). 2 4.2 Dosage 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. The exposed central portion of the rubber stopper should be cleaned with alcohol and allowed to dry immediately prior to piercing the septum. Sterile needles of a suitable gauge should be used for drawing up and administering the product. Reconstitution with preservative-free Đọc toàn bộ tài liệu