Vistabel 4 Allergan Units/0.1ml, powder for solution for injection

देश: माल्टा

भाषा: अंग्रेज़ी

स्रोत: Medicines Authority

थमां उपलब्ध:

AbbVie Limited Citywest Business Campus, Dublin 24, Ireland

ए.टी.सी कोड:

M03AX01

INN (इंटरनेशनल नाम):

BOTULINUM TOXIN TYPE A 4 Allergan units/0.1 millilitre

फार्मास्यूटिकल फॉर्म:

POWDER FOR SOLUTION FOR INJECTION

रचना:

BOTULINUM TOXIN TYPE A 4 Allergan units/0.1 millilitre

प्रिस्क्रिप्शन प्रकार:

POM

चिकित्सीय क्षेत्र:

MUSCLE RELAXANTS

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

2005-10-04

सूचना पत्रक

PACKAGE LEAFLET: INFORMATION FOR THE USER
VISTABEL, 4 ALLERGAN UNITS/0.1ML,
POWDER FOR SOLUTION FOR INJECTION
Botulinum toxin type A
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
_ _
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What VISTABEL is and what it is used for
2.
What you need to know before you use VISTABEL
3.
How to use VISTABEL
4.
Possible side effects
5.
How to store VISTABEL
6.
Contents of the pack and other information
1
WHAT VISTABEL IS AND WHAT IT IS USED FOR
VISTABEL
is a peripherally acting muscle relaxant.
VISTABEL acts by blocking the nervous impulses directed towards all
the muscles in which it has
been injected. This prevents muscles from contracting, leading to a
temporary and reversible paralysis.
VISTABEL is used for the temporary improvement in the appearance of:
•
vertical lines between the eyebrows seen at maximum frown and/or,
•
fan-shaped lines from the corner of the eyes seen at maximum smile
and/or,
•
forehead lines seen at maximum raised eyebrows,
when the severity of the facial lines has an important psychological
impact in adult patients.
2
WHAT YOU NEED TO KNOW BEFORE YOU USE VISTABEL
DO NOT USE VISTABEL:
•
If you are allergic (hypersensitive) to botulinum toxin type A or any
of the other ingredients of this
medicine (listed in section 6);
•
If you are diagnosed with myasthenia gravis or Eaton Lambert Syndrome
(chronic diseases
affecting the muscles);
•
If you have infection at the proposed injection sites.
WARNINGS AND PRECAUTIONS:
Adverse reactions possibly related to the spread of toxin di

उत्पाद विशेषताएं

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1. NAME OF THE MEDICINAL PRODUCT
VISTABEL, 4 Allergan Units/0.1 ml, Powder for solution for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Botulinum toxin type A
1
…………………4 Allergan Units per 0.1 ml of reconstituted
solution.
1
of
_Clostridium botulinum _
_ _
Allergan Units are not interchangeable with other preparations of
botulinum toxin.
Vial of 50 Units.
Vial of 100 Units.
_ _
For a full list of excipients,
_ _
see section 6.1.
3. PHARMACEUTICAL FORM
Powder for solution for injection.
White Powder
VISTABEL product appears as a thin white deposit that may be difficult
to see on the base of the vial.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
VISTABEL is indicated for the temporary improvement in the appearance
of:
•
moderate to severe vertical lines between the eyebrows seen at maximum
frown (glabellar lines)
and/or,
•
moderate to severe lateral canthal lines (crow’s feet lines) seen at
maximum smile and/or,
•
moderate to severe forehead lines seen at maximum eyebrow elevation,
when the severity of the facial lines has an important psychological
impact in adult patients.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
Refer to specific recommendations for each indication described below.
Botulinum toxin units are not interchangeable from one product to
another. Doses recommended in
Allergan Units are different from other botulinum toxin preparations.
_Elderly patients _
There is limited phase 3 clinical data with VISTABEL in patients older
than 65 years (see section 5.1).
No specific dose adjustment is required for use in the elderly.
3
_Paediatric population _
The safety and effectiveness of VISTABEL in the treatment of glabellar
lines seen at maximum frown,
crow’s feet lines
seen at maximum smile, or forehead lines seen at maximum eyebrow
elevation
in
individuals under 18 years of age have not been demonstrated.
_ _
The use of VISTABEL is not
recommended in individuals under 18 years (see section 4.4).
_Method of Administrat