NEURONOX LYOPHILIZED POWDER FOR INJECTION 100 UNITSVIAL

País: Singapur

Idioma: anglès

Font: HSA (Health Sciences Authority)

ingredients actius:

Clostridium Botulinum Type A Toxin-Haemagglutinin Complex

Disponible des:

FONDACO PTE LTD

Codi ATC:

M03AX01

formulario farmacéutico:

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Composición:

Clostridium Botulinum Type A Toxin-Haemagglutinin Complex 100 Units/vial

Vía de administración:

INTRAMUSCULAR

tipo de receta:

Prescription Only

Fabricat per:

MEDYTOX INC.

Estat d'Autorització:

ACTIVE

Data d'autorització:

2019-05-24

Fitxa tècnica

NEURONOX® Injection 100units
(Clostridium botulinum toxin type A)
COMPOSITION
Each vial contains
Active ingredient : Clostridium Botulinum Type A
Toxin-Haemagglutinin Complex
Stabilizer
: Human serum albumin
Isotonic agent
: Sodium chloride
* One unit(U) of Neuronox® corresponds to the calculated median
intraperitoneal lethal dose (LD50) in mice.
DESCRIPTION
It appears as a lyophilized white powder for injection in a colorless
transparent glass vial. Neuronox is intended for
intramuscular injection.
INDICATION AND USAGE
1. Neuronox® is indicated for the treatment of essential
blepharospasm in patients 18 years of age and older.
2. Neuronox® is indicated for the treatment of equinus foot deformity
due to spasticity in pediatric cerebral palsy
patients 2 years of age and older.
3.
Temporary
improvement
of
serious
glabellar
lines
ranging
from
moderate
to
severe
associated
with
corrugators muscle and/or procerus muscle activities in adults over
the age of 20 and below the age of 65.
4. Muscle spasticity : Neuronox® is indicated for the treatment of
upper limb spasticity assciated with stroke in
patient 20 years of age and older.
DOSAGE AND ADMINISTRATION
1. Blepharospasm
For blepharospasm, reconstituted Neuronox® (see Dilution Table) is
injected using a sterile, 27 - 30 gauge needle
at each site) injected into the medial and lateral pre-tarsal
orbicularis oculi of the upper lid and into the lateral
and reaches a peak at one to two weeks post-treatment. Each treatment
lasts approximately three months, following
which the procedure can be repeated. At repeat treatment sessions, the
dose may be increased up to two-fold if the
site. Some tolerance may be found when the drug is used in treating
blepharospasm if treatments are given any more
treatment should not exceed 100U every 12weeks.
2. Pediatric cerebral palsy
For pediatric cerebral palsy, reconstituted Neuronox® (see Dilution
Table) is injected using a sterile, 26-30 gauge
needle. It is recommended to inject to each of the medial and lateral
heads of the gast