Neuronox ® Powder for Solution for Injection 200 units

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CLOSTRIDIUM BOTULINUM TOXIN TYPE A

Boleh didapati daripada:

SUNWARD PHARMACEUTICAL SDN. BHD.

INN (Nama Antarabangsa):

CLOSTRIDIUM BOTULINUM TOXIN TYPE A

Unit dalam pakej:

1 Vials

Dikeluarkan oleh:

MEDYTOX INC.

Risalah maklumat

NEURONOX® INJECTION
Clostridium botulinum toxin type A (50/100/200 units) 1
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1. What Neuronox

Injection is used for
2. How Neuronox

Injection works
3. Before you use Neuronox

Injection
4. How Neuronox

Injection
5. While you are using it
6. Side effects
7. Storage and disposal of Neuronox

Injection
8. Product description
9. Manufacturer and Product Registration
Holder
10. Date of revision
WHAT NEURONOX
 INJECTION IS USED FOR
NO
INDICATION
REMARKS
1
Blepharo-
spasm
for
the
treatment
uncontrolled contractions
of the eye muscles/eye
lids
and
surrounding
facial are resulting from
dry eyes for people 18
years of age and older.
2
Paediatric
cerebral
palsy
indicated
for
the
treatment in children 2
age and older for lack of
flexibility
of
upward
bending motions of ankle
joint
which
due
to
impairment in the are of
the brain.
3
Glabellar
Wrinkles
for
the
treatment
for
wrinkless
that
appear
between eyebrows which
refer as frown lines in
adult over the age of 18
and below of the age 65
4
Muscle
spasticity
Upper
limb
spasticity
associated with stroke in
people 20 years of age
and older
HOW NEURONOX
 INJECTION WORKS
The active ingredient in this medicine is
Clostridium
botulinum
toxin
type
A.
Botulinum toxin has the neurotransmitter effect
as
blocker
to
prevent
acetylcholine
which
makes the muscle contract due to dystonia.
This generates the treatment for overactive
smooth muscles or abnormal activity of glands.
BEFORE YOU USE NEURONOX
 INJECTION
_- When you must not use it _
Do not use Neuronox

Injection if:-

you
are
hypersensitive to Clostridium
botulinum toxin type A or other ingredients
of this product.

you have systemic neuromuscular junctional
disorder

you have respiratory dysfunction

you
are
or
think
you
may
be
pregnant,
planning to become pregnant or if you are
breastfeeding.
_- Before you start to use it _
You should check with your doctor if :-

you are immune-compromised patients

you have

Ciri produk

NEURONOX
® Powder for Solution for Injection
(_Clostridium botulinum _toxin type A)
_ _
COMPOSITION
Each vial contains
[Neuronox
®
50Units]
Active ingredient
: Clostridium botulinum toxin type A
50 units(U)
Stabilizer
: Human serum albumin
0.25mg
Isotonic agent
: Sodium chloride
0.45mg
[Neuronox
®
]
Active ingredient
: Clostridium botulinum toxin type A
100 units(U)
Stabilizer
: Human serum albumin
0. 5mg
Isotonic agent
: Sodium chloride
0.9mg
[Neuronox
®
200Units]
Active ingredient
: Clostridium botulinum toxin type A
200 units(U)
Stabilizer
: Human serum albumin
1.0mg
Isotonic agent
: Sodium chloride
1.8mg
* One unit(U) of N
®
corresponds to the calculated median intraperitoneal lethal dose
(LD50) in mice.
DESCRIPTION
Lyophilized white powder for injection in a colorless transparent
glass vial.
INDICATIONS AND USAGE
NEURONOX
®
is indicated for:

Treatment of benign essential blepharospasm in adult patients.

Treatment of equinus foot deformity due to spasticity in pediatric
cerebral palsy patients 2 years of age and older.

Treatment of upper limb spasticity associated with stroke in adult
patients.

Temporary improvement of glabellar lines ranging from moderate to
severe associated with corrugators muscle
and/or procerus muscle activities in adult patients below 65 years of
age.
DOSAGE AND ADMINISTRATION
Route of administration: Intramuscular injection
1. Blepharospasm
For blepharospasm, reconstituted NEURONOX
®
(see Dilution Table) is injected using a sterile, 27 - 30 gauge
needle without electromyographic guidance. The initial recommended
dose is 1.25 - 2.5 U (0.05 mL to 0.1 mL
volume at each site) injected into the medial and lateral pre-tarsal
orbicularis oculi of the upper lid and into the
lateral pre-tarsal orbicularis oculi of the lower lid. In general, the
initial effect of the injections is seen within three
days 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
s