Alluzience, 200 Speywood units/ml, solution for injection

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Ipsen Pharma 65 Quai Georges Gorse, 92100 Boulogne-Billancourt,, France

ATC code:

M03AX01

INN (International Name):

BOTULINUM TOXIN TYPE A 125 U/ml

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

BOTULINUM TOXIN TYPE A 125 U/ml

Prescription type:

POM

Therapeutic area:

MUSCLE RELAXANTS

Authorization status:

Authorised

Authorization date:

2023-09-14

Patient Information leaflet

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 Syndrome or amyotrophic
lateral sclerosis.
WARNINGS AND PRECAUTIONS
Talk to your doctor before you have the Alluzience injection if:
•
you have any neuromuscular disorders
•
you often have difficulty swallowing food (dysphagia)
•
you find that you often have problems with food or drink ge

Summary of Product characteristics

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 INDICATION
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 median time to onset as reported subjectively by patients was 3
da