AZZALURE 10 Speywood units / Millilitre Pdr for Soln for Injection

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

CLOSTRIDIUM BOTULINUM TOXIN TYPE A HAEMAGGLUTININ COMPLEX

Dostopno od:

Ipsen Biopharm Limited

Koda artikla:

M03AX01

INN (mednarodno ime):

CLOSTRIDIUM BOTULINUM TOXIN TYPE A HAEMAGGLUTININ COMPLEX

Odmerek:

10 Speywood units / Millilitre

Farmacevtska oblika:

Pdr for Soln for Injection

Tip zastaranja:

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

Terapevtsko območje:

Other muscle relaxants, peripherally acting agents

Status dovoljenje:

Authorised

Datum dovoljenje:

2010-03-26

Navodilo za uporabo

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
AZZALURE, 10 SPEYWOOD UNITS/0.05 ML, 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)

You find that you often have problems with food or drink getting into
your air

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Azzalure, 10 Speywood units/0.05ml, powder for solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Botulinum toxin type A* 10 Speywood units **/0.05 ml of reconstituted
solution
Vial of 125 units
*_Clostridium botulinum_ toxin A haemagglutinin complex
**One Speywood unit (U) is defined as the median lethal peritoneal
dose in mice (LD50).
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