MYOBLOC SOLUTION

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

RIMABOTULINUMTOXINB

Inapatikana kutoka:

SOLSTICE NEUROSCIENCES, LLC, A SUBSIDIARY OF MDD US OPERATIONS, LLC

ATC kanuni:

M03AX01

INN (Jina la Kimataifa):

BOTULINUM TOXIN

Kipimo:

5000UNIT

Dawa fomu:

SOLUTION

Tungo:

RIMABOTULINUMTOXINB 5000UNIT

Njia ya uendeshaji:

INTRAMUSCULAR

Vitengo katika mfuko:

100

Dawa ya aina:

Schedule D

Eneo la matibabu:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Bidhaa muhtasari:

Active ingredient group (AIG) number: 0150061001; AHFS:

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2004-08-19

Tabia za bidhaa

PRODUCT MONOGRAPH
MYOBLOC
®
(BOTULINUM TOXIN TYPE B)
5000 UNITS/ML
STERILE SOLUTION FOR INTRAMUSCULAR INJECTION
NEUROMUSCULAR BLOCKING AGENT
Solstice NeuroSciences, LLC
3830 Valley Centre Drive, Suite 705-5
San Diego, CA
92130
Date of Preparation:
Control #: 093208
August 09, 2004
Solstice NeuroSciences, LLC
This Product Monograph is the exclusive property of Solstice
NeuroSciences, LLC
It may not be copied in whole or in part without the expressed
permission of Solstice
NeuroSciences, LLC
PRODUCT MONOGRAPH
N
AME OF
D
RUG
MYOBLOC
®
(Botulinum Toxin Type B)
5000 Units/mL; Sterile Solution for Intramuscular Injection
T
HERAPEUTIC
C
LASSIFICATION
Neuromuscular Blocking Agent
A
CTION AND
C
LINICAL
P
HARMACOLOGY
The mechanism of action of Botulinum Toxin Type B in blocking the
release of
acetylcholine (ACh) at the neuromuscular junction is believed to occur
by a three step
process: 1) extracellular binding of the toxin to specific acceptors
on the motor nerve
terminals; 2) internalization and release of the toxin into the
cytosol of the nerve
terminals; and 3) inhibition of ACh release from nerve terminals at
the neuromuscular
junction.
There are eight antigenically distinct Botulinum serotypes: A, B, C
1
, C
2
, D, E, F, and G.
All are neurotoxins except serotype C
2
. These neurotoxins are zinc-dependent
endopeptidases that target and cleave different intracellular proteins
(1). These
targeted cellular proteins are part of the intracellular docking
proteins responsible for the
release of ACh from synaptic vesicles into the neuromuscular junction.
Botulinum Toxin
Solstice NeuroSciences, LLC
3
Product Monograph
July 6, 2004
Type A cleaves (SNAP-25) whereas Type B cleaves Vesicle-Associated
Membrane
Protein (VAMP, also known as synaptobrevin), (1,2,3) resulting in an
inhibition of ACh
release and localized muscle weakness (paresis/paralysis) that
gradually reverses over
time. The precise mechanism by which Botulinum Toxin-induced muscle
weakness is
reversed is unknown.
There are no known antibodies that cross-react w