Země: Singapur
Jazyk: angličtina
Zdroj: HSA (Health Sciences Authority)
Botulinum toxin type A
ABBVIE PTE. LTD.
M03AX01
200 Units
INJECTION, POWDER, FOR SOLUTION
Botulinum toxin type A 200 Units
SUBCUTANEOUS, INTRAMUSCULAR, INTRADERMAL
Prescription Only
Allergan Pharmaceuticals Ireland
ACTIVE
2012-07-27
BOTOX ® (BOTULINUM TOXIN TYPE A) Purified Neurotoxin Complex Distant Spread of Toxin Effect Postmarketing safety data from BOTOX ® and other approved botulinum toxins suggest that botulinum toxin effects may, in some cases, be observed beyond the site of local injection. The symptoms that are consistent with the mechanism of action of botulinum toxin have been reported hours to weeks after injection, and may include muscular weakness, ptosis, diplopia, blurred vision, facial weakness, swallowing and speech disorders, constipation, aspiration pneumonia, difficulty breathing and respiratory depression. The risk of symptoms is probably greatest in children treated for spasticity, but symptoms can also occur in patients who have underlying conditions and comorbidities that would predispose them to these symptoms including adults treated for spasticity and other conditions, and are treated with high doses. Swallowing and breathing difficulties can be life threatening and death has been reported, although a definitive causal association to BOTOX ® has not been established. 1. PRESENTATION BOTOX ® is available in 50, 100 and 200 unit (U) sterile vials of _Clostridium botulinum_ toxin type A in a vacuum-dried form without a preservative. One Allergan unit (U) corresponds to the calculated median lethal dose (LD 50 ) in mice using reconstituted BOTOX ® and injected intraperitoneally. The quantities of the ingredients in each vial are listed below: INGREDIENTS 50 ALLERGAN U VIAL 100 ALLERGAN U VIAL 200 ALLERGAN U VIAL _Clostridium botulinum_ toxin type A neurotoxin complex (900kD) 50 U 100 U 200 U Human Serum Albumin 0.25 mg 0.5 mg 1.0 mg Sodium Chloride 0.45 mg 0.9 mg 1.8 mg 2. USES BOTOX ® is indicated for Přečtěte si celý dokument
BOTOX ® (BOTULINUM TOXIN TYPE A) Purified Neurotoxin Complex Distant Spread of Toxin Effect. Postmarketing safety data from BOTOX ® and other approved botulinum toxins suggest that botulinum toxin effects may, in some cases, be observed beyond the site of local injection. The symptoms that are consistent with the mechanism of action of botulinum toxin have been reported hours to weeks after injection, and may include muscular weakness, ptosis, diplopia, blurred vision, facial weakness, swallowing and speech disorders, constipation, aspiration pneumonia, difficulty breathing and respiratory depression. The risk of symptoms is probably greatest in children treated for spasticity, but symptoms can also occur in patients who have underlying conditions and comorbidities that would predispose them to these symptoms including adults treated for spasticity and other conditions, and are treated with high doses. Swallowing and breathing difficulties can be life threatening and death has been reported, although a definitive causal association to BOTOX ® has not been established. 1. PRESENTATION BOTOX ® is available in 50, 100 and 200 unit (U) sterile vials of _Clostridium botulinum_ toxin type A in a vacuum-dried form without a preservative. One Allergan unit (U) corresponds to the calculated median lethal dose (LD 50 ) in mice using reconstituted BOTOX ® and injected intraperitoneally. The quantities of the ingredients in each vial are listed below: INGREDIENTS 50 ALLERGAN U VIAL 100 ALLERGAN U VIAL 200 ALLERGAN U VIAL _Clostridium botulinum_ toxin type A neurotoxin complex (900kD) 50 U 100 U 200 U Human Serum Albumin 0.25 mg 0.5 mg 1.0 mg Sodium Chloride 0.45 mg 0.9 mg 1.8 mg 2. USES BOTOX ® is indicated for the treatment of blepharospasm associated with dystonia, including benign essential blepharospasm, hemifacial spasm or VIIth nerve disorders in patients 12 years or older. BOTOX ® is indicated for the correction of strabismus in patients 12 years of age or older. BOTOX ® is indicated for the treatment of spasm Přečtěte si celý dokument