Krajina: Nový Zéland
Jazyk: angličtina
Zdroj: Medsafe (Medicines Safety Authority)
Botulinum toxin type A 50 U
AbbVie Limited
Botulinum toxin type A 50 U
50 U
Powder for injection
Active: Botulinum toxin type A 50 U Excipient: Albumin Sodium chloride
Vial, glass, 50 U
Prescription
Prescription
Allergan Inc
· For the prophylaxis of headaches in adults with chronic migraine (headaches on at least 15 days per month with headache lasting 4 hours a day or longer, of which at least 8 days are with migraine)
Package - Contents - Shelf Life: Vial, glass, - 50 U - 36 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). Single use only
2012-01-31
BOTOX ® BOTULINUM TOXIN TYPE A INJECTION NZ CMI V14.0, DS V16.0 PAGE 1 OF 9 CONSUMER MEDICINE INFORMATION BOTOX ® (botulinum toxin, type A) purified neurotoxin complex _The information in this leaflet is ONLY a summary and is not a complete statement about BOTOX_ _®_ _ injection. Your _ _doctor has more detailed information relating to you, your medical history and the product and should be consulted _ _so that you will be informed about all aspects of BOTOX_ _®_ _ injection as it relates to you. _ PLEASE READ THIS LEAFLET CAREFULLY BEFORE RECEIVING BOTOX ® INJECTION AND KEEP THIS LEAFLET HANDY AS YOU MAY WANT TO REFER TO IT IN THE FUTURE. IF YOU HAVE ANY CONCERNS ABOUT RECEIVING THIS MEDICINE, ASK YOUR DOCTOR. All medicines have benefits and risks. Your doctor has weighed the risks of using BOTOX ® injection against the benefits expected from using it for you. 1. PRODUCT DESCRIPTION WHAT IS BOTOX ® INJECTION? The injection contains a muscle relaxant obtained from the bacterium _Clostridium botulinum._ WHAT IS IN BOTOX ® INJECTION? Each vial contains either 50 units (U),100 units (U) or 200 units (U) of _Clostridium botulinum_ toxin type A-haemagglutinin complex as the active ingredient. It also contains human albumin and sodium chloride. WHAT IT LOOKS LIKE The injection is supplied as a sterile white vacuum-dried powder in a clear glass vial. It is diluted before use with 0.9% sterile non-preserved sodium chloride injection. 2. WHAT BOTOX ® INJECTION IS USED FOR HOW BOTOX ® INJECTION WORKS BOTOX ® works by temporarily relaxing overactive or spastic (contracting) muscles. BOTOX ® injection can also block signals to the sweat glands thus reducing excessive sweating (hyperhidrosis), and can also block the release of chemicals in the brain associated with the cause of pain (chronic migraine). When injected into the bladder wall, BOTOX works on the bladder muscle to prevent leakage of urine (urinary incontinence). It is used to treat medical conditions associated with overactive muscles: - causing exc Prečítajte si celý dokument
BOTOX ® Botulinum Toxin Type A Data Sheet Version 16 CCDS Version 22.0 Page 1 of 37 NEW ZEALAND DATA SHEET 1. PRODUCT NAME BOTOX ® (botulinum toxin type A) purified neurotoxin complex 50 units (U), 100 units (U) or 200 units (U) powder for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of BOTOX ® injection contains either 50 units (U), 100 units (U) or 200 units (U) of botulinum toxin type A as a haemagglutinin complex. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM A sterile, vacuum-dried preparation. Powder for injection. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS BOTOX ® (botulinum toxin type A) purified neurotoxin complex is indicated: • for the treatment of overactive bladder with symptoms of urinary incontinence, urgency and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication • for the treatment of urinary incontinence due to neurogenic detrusor overactivity (e.g. spinal cord injury or multiple sclerosis) in adults who have an inadequate response to or are intolerant of an anticholinergic medication • for the prophylaxis of headaches in adults with chronic migraine (headaches on at least 15 days per month with headache lasting 4 hours a day or longer, of which at least 8 days are with migraine) • for the treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VIIth nerve disorders in patients 12 years of age and above • to reduce the subjective symptoms and objective signs of spasmodic torticollis (cervical dystonia) in adults • treatment of focal spasticity in children two years and older • for the treatment of primary hyperhidrosis of the axillae • for the treatment of focal spasticity in adults • for the treatment of upper facial rhytides, including forehead, crow’s feet and glabellar lines._ _ _ _ 4.2 DOSE AND METHOD OF ADMINISTRATION ROUTE OF ADMINISTRATION Intramuscular injection. BOTOX ® Botulinum Toxin Type A Data Prečítajte si celý dokument