VISTABEL, 4 Allergan Units/0.1ml, Powder for solution for injection

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Botulinum toxin type a

제공처:

Allergan Pharmaceuticals Ireland

ATC 코드:

M03AX; M03AX01

INN (International Name):

Botulinum toxin type a

복용량:

4 Allergan Units

약제 형태:

Powder for solution for injection

처방전 유형:

Product subject to prescription which may not be renewed (A)

치료 영역:

Other muscle relaxants, peripherally acting agents; botulinum toxin

승인 상태:

Marketed

승인 날짜:

2008-04-25

환자 정보 전단

VISTABEL, 4 Allergan Units/0.1 ml, Powder for solution for injection
FR/H/0230/001/II/089
Allergan confidential
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

제품 특성 요약

Health Products Regulatory Authority
22 June 2021
CRN00CDJW
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
VISTABEL, 4 Allergan Units/0.1ml, Powder for solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Botulinum toxin type A
1
…………………4 Allergan Units per 0.1ml of reconstituted
solution.
1
of _Clostridium botulinum_
Allergan Units are not interchangeable with other preparations of
botulinum toxin.
Vial of 50 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.
_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).
_Me