Azzalure, 125 Speywood units, powder for solution for injection

מדינה: מלטה

שפה: אנגלית

מקור: Medicines Authority

זמין מ:

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

קוד ATC:

M03AX01

INN (שם בינלאומי):

BOTULINUM TOXIN TYPE A 125 U

טופס פרצבטיות:

POWDER FOR SOLUTION FOR INJECTION

הרכב:

BOTULINUM TOXIN TYPE A 125 U

סוג מרשם:

POM

איזור תרפויטי:

MUSCLE RELAXANTS

מצב אישור:

Authorised

תאריך אישור:

2023-07-18

עלון מידע

IPSEN
CONFIDENTIAL
1 OF 8
PACKAGE LEAFLET
IPSEN
CONFIDENTIAL
2 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 myasthenia gravis, Eaton Lambert syndrome or amyotrophic
lateral sclerosis.
WARNINGS AND PRECAUTIONS
Talk to your doctor before you have the Azzalure injection if:
•
you have any neuromuscular disorders
•
you often have difficulty swallowing food (dysphagia)
IPSEN
CONFIDENTIAL
3 OF 8
•
y

מאפייני מוצר

IPSEN
CONFIDENTIAL
1 OF 12
SUMMARY OF PRODUCT CHARACTERISTICS
IPSEN
CONFIDENTIAL
2 OF 12
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.
IPSEN
CONFIDENTIAL
3 OF 12
Intramuscular injections should be performed using a sterile suita