BOTOX (BOTULINUM TOXIN TYPE A) IM INJECTION

Riik: Malaisia

keel: inglise

Allikas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Toimeaine:

CLOSTRIDIUM BOTULINUM TOXIN TYPE A

Saadav alates:

Allergan Malaysia Sdn Bhd

INN (Rahvusvaheline Nimetus):

CLOSTRIDIUM BOTULINUM TOXIN TYPE A

Ühikuid pakis:

1Pieces Pieces; 1 Pieces Pieces

Valmistatud:

ALLERGAN PHARMACEUTICALS IRELAND

Infovoldik

Not Applicable

Toote omadused

BOTOX ® (Botulinum Toxin Type A)
Purified Neurotoxin Complex
P RESENTATION
A sterile white vacuum dried powder in a clear glass vial, for use in a single patient. One unit corresponds
to the median lethal dose (LD
50) when reconstituted BOTOX ® is injected intraperitoneally into mice under
defined conditions).
Each vial of BOTOX® 50 Units contains 50 Units of Clostridium botulinum type A neurotoxin complex
900kD, 0.25 mg of human albumin and 0.45 mg of sodium chloride in a sterile, vacuum -dried form without
a preservative.
Each vial of BOTOX® 100 Units contains 100 Units of Clostridium botulinum type A neurotoxin
complex 900kD, 0. 5 mg of human albumin and 0.9 mg of sodium chloride in a sterile, vacuum -dried form
without a preservative.
Each vial of BOTOX® 200 Units contains 200 Units of Clostridium botulinum type A neurotoxin
complex 900kD, 1.0 mg of human albumin and 1.8 mg of sodium chloride in a sterile, vacuum-dried form
without a preservative.
USES
BOTOX ® (botulinum toxin type A) purified neurotoxin complex is indicated for the following
therapeutic
indications :
• BOTOX ® is indicated for the treatment of blepharospasm associated with dystonia, including benign
essential blepharospasm, hemifacial spasm and 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 spasmodic torticollis (cervical dystonia) in adults.
• BOTOX ® is indicated for the treatment of dynamic equinus foot deformity due to spasticity in
paediatric cerebral palsy patients, two years of age and older.
• BOTOX ® is indicated in the manageme nt of focal spasticity:
o including wrist and hand disability due to upper limb spasticity associated with stroke in
adults.
o Including ankle and foot disability due to lower limb spasticity associated with stroke in adult s.
Distant Spread of Toxin Effect
Postmarketing safety data from BOTOX � and other approved botulinum toxins suggest that bo