Azzalure, 125 Speywood units, powder for solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Clostridium botulinum toxin type a haemagglutinin complex

Available from:

Ipsen Pharma

ATC code:

M03AX; M03AX01

INN (International Name):

Clostridium botulinum toxin type a haemagglutinin complex

Dosage:

125 Speywood

Pharmaceutical form:

Powder for solution for injection

Prescription type:

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

Therapeutic area:

Other muscle relaxants, peripherally acting agents; botulinum toxin

Authorization status:

Marketed

Authorization date:

2010-03-26

Patient Information leaflet

____________________________________________________________________________________________________________
Document name: 54_AZZ_IE
Reason for change: National Phase submission following EOP for Type II
Variation addition of ADRs in post marketing experience
- FR/H/0341/001/II/061
Document replaced: 50_AZZ_UKIE
Preparation date:09/06/2022
Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
AZZALURE, 125 SPEYWOOD UNITS, 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.

If you get any side effects, talk to your doctor. This includes any
possible side effects not listed in
this leaflet. See Section 4.
IN THIS LEAFLET:
1.
What Azzalure is and what it is used for
2.
What you need to know before you use Azzalure
3.
How to use Azzalure
4.
Possible side effects
5.
How to store Azzalure
6.
Contents of the pack and other information
1.
WHAT AZZALURE IS AND WHAT IT IS USED FOR
Azzalure contains a substance, botulinum toxin A, which causes muscles
to relax. Azzalure 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.
Some people are distressed when lines appear on their face. Azzalure
can be 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) and lateral canthal lines (crow’s feet lines).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE AZZALURE
DO NOT HAVE AN AZZALURE INJECTION IF:

You are allergic to
_Clostridium 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 myasth

Summary of Product characteristics

Health Products Regulatory Authority
20 July 2022
CRN00CPS6
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Azzalure, 125 Speywood units, powder for solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Botulinum toxin type A* Quantity corresponding to 125 Speywood units
(U)** for one vial.
*_Clostridium botulinum_ toxin A haemagglutinin complex
** The Speywood units of Azzalure are specific to the preparation and
are not interchangeable with other preparations of
botulinum toxin.
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection.
The powder is white.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Azzalure is indicated for the temporary improvement in the appearance
of moderate to severe:
● Glabellar lines (vertical lines between the eyebrows) seen at
maximum frown and/or
● Lateral canthal lines (crow’s feet lines) seen at maximum smile
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 units are different depending on the medicinal
products. The Speywood units of Azzalure are specific to the
preparation and are not interchangeable with other preparations of
botulinum toxin.
Paediatric population
The safety and efficacy of Azzalure in individuals aged up to 18 years
have not been established. The use of Azzalure is not
recommended in subjects under 18 years.
Method of administration:
Azzalure should only be administered by physicians with appropriate
qualifications and expertise in this treatment and having
the required equipment.
Once reconstituted, Azzalure should only be used to treat a single
patient, during a single session.
For instructions on reconstitution of the medicinal product before
administration, see section 6.6.
Remove any make-up and disinfect the skin with a local antiseptic.
Intramuscular injections should be performed using a sterile 29 - 30
gauge need