Alluzience, 200 Speywood units/mL, solution for injection

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Botulinum Toxin A - Haemagglutinin Complex

Dostupné z:

Ipsen Pharma

ATC kód:

M03AX01

INN (Medzinárodný Name):

Botulinum Toxin A - Haemagglutinin Complex

Dávkovanie:

200 unit(s)/millilitre

Forma lieku:

Solution for injection

Terapeutické oblasti:

botulinum toxin

Stav Autorizácia:

Marketed

Dátum Autorizácia:

2021-09-10

Príbalový leták

Document name: 47_ALL_IE
Reason for change: National Phase submission for Grouped Type II
variation to add the post-marketing paragraph with
“Hypoaesthesia” and “Muscle atrophy” ADRs -
SE/H/2019/01/II/007/G
Document replaced: 43_ALL_IE
Preparation date:18/01/2023
Page 1 of 6
PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
ALLUZIENCE
®
, 200 SPEYWOOD UNITS/ML, SOLUTION FOR INJECTION
_Clostridium botulinum_
toxin type A haemagglutinin complex
_ _
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.
•
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See Section 4.
WHAT IS IN THIS LEAFLET
1.
What Alluzience is and what it is used for
2.
What you need to know before you use Alluzience
3.
How to use Alluzience
4.
Possible side effects
5.
How to store Alluzience
6.
Contents of the pack and other information
1.
WHAT ALLUZIENCE IS AND WHAT IT IS USED FOR
Alluzience contains the active substance botulinum toxin A, which
causes muscles to relax. Alluzience
acts at the junction between the nerves and muscle to prevent the
release of a chemical messenger
called acetylcholine from the nerve endings. This prevents muscles
from contracting. The muscle
relaxation is temporary and gradually wears off.
The well-being of some people can be impacted when lines appear on
their face. Alluzience is used in
adults under 65 years to temporarily improve the appearance of any
moderate to severe glabellar lines
(the vertical frown lines between the eyebrows).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ALLUZIENCE
DO NOT HAVE AN ALLUZIENCE INJECTION IF:
•
you are allergic to botulinum
_ _
toxin A or any of the other ingredients of this medicine (listed in
Section 6).
•
you have an infection at the proposed site of injection.
•
you have myasthenia gravis, Eaton Lambert Syndrom

Súhrn charakteristických

Health Products Regulatory Authority
05 April 2023
CRN00D111
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Alluzience, 200 Speywood units/mL, solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
_Clostridium botulinum_ toxin type A haemagglutinin complex 200
Speywood units/ml
Botulinum toxin units are not interchangeable from one product to
another. Doses recommended in Speywood units are
different from other botulinum toxin preparations.
Each vial contains 125 Speywood units in 0.625 ml of solution.
For the full list of excipients see Section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Alluzience is indicated for the temporary improvement in the
appearance of moderate to severe glabellar lines (vertical lines
between the eyebrows) seen at maximum frown in adult patients under 65
years, when the severity of these lines has an
important psychological impact on the patient.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
Botulinum toxin product units differ depending on the medicinal
products. Botulinum toxin units are not interchangeable from
one product to another. Doses recommended in Speywood units are
different from other botulinum toxin preparations.
_Paediatric Population_
The safety and efficacy of Alluzience in children aged up to 18 years
have not been established. The use of Alluzience is not
recommended in patients under 18 years.
Method of administration:
Alluzience should only be administered by a physician with appropriate
qualifications and expertise in this treatment and
having the required equipment.
A vial of Alluzience should only be used to treat a single patient,
during a single session. Remove any make-up and disinfect
the skin with a local antiseptic before administration.
The intramuscular injections should be performed using a sterile
needle with a suitable gauge.
Dosing and treatment intervals depend on assessment of the individual
patient's response.
The