BOTOX INJECTION

देश: दक्षिण अफ़्रीका

भाषा: अंग्रेज़ी

स्रोत: South African Health Products Regulatory Authority (SAHPRA)

थमां उपलब्ध:

Abbvie (Pty) Ltd

डोज़:

See ingredients

फार्मास्यूटिकल फॉर्म:

INJECTION

रचना:

0,1 ML CLOSTRIDIUM BOTULINUM TOXIN TYPE 0,025 MCG (100 U)

प्राधिकरण का दर्जा:

Registered

प्राधिकरण की तारीख:

1993-05-02

सूचना पत्रक

Page 1 of 16
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
BOTOX
®
vacuum-dried injection
Botulinum toxin type A
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN BOTOX
®

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor, pharmacist,
nurse or other health care
provider.
BOTOX
®
is not for self medication and must be administered only by a medical
practitioner
and who is qualified for its use.
WHAT IS IN THIS LEAFLET
1.
What BOTOX
®
is and what it is used for
2.
What you need to know before you are given BOTOX
®
3.
How to receive BOTOX
®
4.
Possible side effects
5.
How to store BOTOX
®
6.
Contents of the pack and other information
1. WHAT BOTOX
®
IS AND WHAT IT IS USED FOR
BOTOX
®
is a muscle relaxant used to treat a number of conditions within the
body. It contains
the active substance Botulinum toxin type A and is injected into
either the muscles, the bladder
wall or deep into the skin. It works by partially blocking the nerve
impulses to any muscles that
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Page 2 of 16
have been injected and reduces excessive contractions of these
muscles.

BOTOX
®
can be injected directly into the muscles, and can be used to control
the following
conditions:

In children aged two years or older with cerebral palsy, who can walk,
BOTOX
®
is used
to control foot deformity caused by persistant muscle spasms in the
legs.

In adults:

Persistent muscle spasms in the wrist and hand of patients who have
suffered a
stroke;

Persistent muscle spasms in the eyelid and face;

Persistent muscle spasms in the neck and shoulders.

BOTOX
®
is used to reduce the symptoms of chronic migraine in adults who have
had
headaches on 15 or more days each month of which at least 8 days are
with migraine and
who have not responded well to other preventative migraine
medications.
Chronic migraine is a disease affecting the nervous system. Patients
usually suffer from
head pain which is often accompanied by excessive sensitivity to
light, loud sounds or

उत्पाद विशेषताएं

Page 1 of 56
PACKAGE INSERT
SCHEDULING STATUS
1. NAME OF THE MEDICINE
BOTOX
®
vacuum-dried injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
BOTOX
®
(Botulinum toxin type A) is a sterile, vacuum-dried form of purified
Botulinum toxin
type A, produced from a culture of _ Clostridium botulinum._ The
crystalline complex is re-
dissolved in a solution containing saline and albumin and sterile
filtered (0,2 microns) prior to
vacuum-drying.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Vacuum-dried injection
Clear glass vial containing a small white vacuum-dried powder cake.
Reconstituted BOTOX
®
is a clear, colourless to slightly yellow solution free of particulate
matter.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
BOTOX
®
is indicated for the treatment and/or management of:
_NEUROLOGIC DISORDERS _

Focal spasticity associated with dynamic equinus foot deformity due to
spasticity in
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Page 2 of 56
paediatric cerebral palsy patients, two years of age or older by
specialists trained in the
procedure.

Focal spasticity of the wrist and hand in adult post-stroke patients.

Selected cases of strabismus and blepharospasm associated with
dystonia, including
benign essential blepharospasm or VII nerve disorders (hemifacial
spasm), in patients 12
years of age and older.
The efficacy of BOTOX
®
in deviations over 50 prism diopters, in restrictive strabismus, in
Duane's syndrome with lateral rectus weakness and in secondary
strabismus caused by
prior surgical over-recession of the antagonist is doubtful. BOTOX

is ineffective in chronic
paralytic strabismus.

The reduction of the signs and symptoms of cervical dystonia
(spasmodic torticollis) in
adults.

Symptom relief in adults fulfilling criteria for chronic migraine
(headaches on ≥ 15 days per
month of which at least 8 days with migraine) in patients who have
responded inadequately
or are intolerant of prophylactic migraine medications.
_BLADDER DISORDERS_

Idiopathic overactive bladder with symptoms of urin