Botox® Powder for Solution for Injection 200 UnitsVial

Country: Singapúr

Tungumál: enska

Heimild: HSA (Health Sciences Authority)

Virkt innihaldsefni:

Botulinum toxin type A

Fáanlegur frá:

ABBVIE PTE. LTD.

ATC númer:

M03AX01

Skammtar:

200 Units

Lyfjaform:

INJECTION, POWDER, FOR SOLUTION

Samsetning:

Botulinum toxin type A 200 Units

Stjórnsýsluleið:

SUBCUTANEOUS, INTRAMUSCULAR, INTRADERMAL

Gerð lyfseðils:

Prescription Only

Framleitt af:

Allergan Pharmaceuticals Ireland

Leyfisstaða:

ACTIVE

Leyfisdagur:

2012-07-27

Upplýsingar fylgiseðill

 
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�

Vara einkenni

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