Ország: Új-Zéland
Nyelv: angol
Forrás: Medsafe (Medicines Safety Authority)
Botulinum toxin type A 100 Units equivalent to incobotulinumtoxinA (USAN), purified botulinum toxin type A
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Botulinum toxin type A 100 Units (= incobotulinumtoxinA (USAN), purified botulinum toxin type A)
100 Units
Powder for injection
Active: Botulinum toxin type A 100 Units equivalent to incobotulinumtoxinA (USAN), purified botulinum toxin type A Excipient: Albumin Sucrose
Prescription
Merz Pharma GmbH & Co KGaA
Xeomin is indicated in adults for the treatment of: · Cervical dystonia · Blepharospasm · Spasticity of the upper limb · Upper facial lines -Glabellar frown lines -Lateral periorbital lines (crow's feet) - Horizontal forehead lines
Package - Contents - Shelf Life: Vial, glass, single dose, Type 1 clear, with West bromobutyl rubber stopper - 1 dose units - 36 months from date of manufacture stored at or below 30°C
2014-05-06
Xeomin New Zealand Consumer Medicine Information July 2023 Page 1 of 4 XEOMIN ® (ZEE-oh-min) _incobotulinumtoxinA _ _Purified Botulinum toxin type A free from complexing proteins _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Xeomin. It does not contain all 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 using this medicine against the benefits they expect it will have for you. IF' YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT XEOMIN IS USED FOR The medicine is used: • To treat the abnormal head position and neck pain that happens with cervical dystonia in adults, • To treat abnormal spasm of the eyelids (blepharospasm) in adults, • Spasticity of the upper limbs in adults, • To improve the look of upper facial lines including frown lines between the eyebrows (glabellar lines), wrinkles at the side of eyes (crow’s feet) and horizontal forehead lines in adults. The medicine contains incobotulinumtoxinA, purified neurotoxin free from complexing proteins. This belongs to a family of medicines called peripheral muscle relaxants. Xeomin is injected into the muscles where it blocks passage of signals from nerves to the muscle. This causes a reduction in the ability of the muscle to contract. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is not addictive. This medicine is available only with a doctor's prescription. XEOMIN HAS ONLY BEEN EXAMINED FOR SAFETY AND EFFECTIVENESS IN ADULTS. IT IS NOT RECOMMENDED FOR USE IN CHILDREN. BEFORE YOU ARE GIVEN XEOMIN _WHEN YOU MUST NOT USE IT _ DO NOT USE THE MEDICINE IF YOU HAVE AN ALLERGY TO: • any medicine containing incobotulinumtoxinA, • any of the ingredients listed at the end o Olvassa el a teljes dokumentumot
Version 4.0, May 2021 Page 1 of 29 NEW ZEALAND DATA SHEET 1. XEOMIN (POWDER FOR INJECTION) XEOMIN ® 50 units or 100 units powder for solution for injection IncobotulinumtoxinA, purified Botulinum toxin type A, free from complexing proteins 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of Xeomin powder for solution for injection contains 50 or 100 units of incobotulinumtoxinA. Native Botulinum toxin type A is a high molecular weight complex, which, in addition to the toxin (150 kD), contains other bacterial non-toxic proteins, like haemagglutinins and non-haemagglutinins. In contrast to conventional preparations containing the botulinum toxin A complex, Xeomin contains pure (150 kD) toxin since it is free from complexing proteins and thus has a low foreign protein content. The foreign protein content administered is considered as one of the factors for secondary therapy failure. IncobotulinumtoxinA is produced from the fermentation of Clostridium botulinum and is subsequently purified to remove complexing proteins. It consists of the purified neurotoxin which has been separated from complexing proteins (haemagglutinins and a non-toxic non-haemagglutinating protein) during production. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for injection. White to off-white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Xeomin is indicated in adults for the treatment of: • Cervical dystonia • Blepharospasm • Spasticity of the upper limb • Upper facial lines o Glabellar frown lines o Lateral periorbital lines (crow’s feet) o Horizontal forehead lines 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE Xeomin may only be administered by health care professionals with suitable qualifications and proven experience in the application of botulinum toxin and in the use of the necessary equipment Version 4.0, May 2021 Page 2 of 29 DUE TO UNIT DIFFERENCES IN THE POTENCY ASSAY, XEOMIN UNITS ARE SPECIFIC TO XEOMIN. THEREFORE, UNIT DOSES RECOMMENDED FOR XEOMIN ARE NOT Olvassa el a teljes dokumentumot