DYSPORT 500 Units/ml Pdr for Soln for Injection

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

CLOSTRIDIUM BOTULINUM TOXIN TYPE A HAEMAGGLUTININ COMPLEX

Tilgjengelig fra:

Ipsen Biopharm Limited

ATC-kode:

J06AA04

INN (International Name):

CLOSTRIDIUM BOTULINUM TOXIN TYPE A HAEMAGGLUTININ COMPLEX

Dosering :

500 Units/ml

Legemiddelform:

Pdr for Soln for Injection

Resept typen:

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

Terapeutisk område:

Immune sera

Autorisasjon status:

Authorised

Autorisasjon dato:

2014-01-31

Informasjon til brukeren

Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
DYSPORT
®
500 UNITS
POWDER FOR SOLUTION FOR INJECTION
_Clostridium botulinum_ type A toxin-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 further questions, ask your doctor, pharmacist or nurse.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
WHAT DYSPORT IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DYSPORT
3.
HOW DYSPORT IS GIVEN
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE DYSPORT
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT DYSPORT IS AND WHAT IT IS USED FOR
Dysport contains the active substance_ Clostridium botulinum _type A
toxin-haemagglutinin complex.
WHAT DYSPORT IS USED FOR:
ADULTS
Dysport is used in adults to treat muscle spasms:

In the arm and shoulders

In the lower leg affecting the ankle joint

In the neck

Around the eyes

In the face.
Dysport is also used in adults to treat:

Hyperhidrosis. This is a condition where the body produces excessive
sweating of the armpits,
which interferes with daily living.
CHILDREN
Dysport is used to treat muscle spasms in the legs of children (aged
two years or older) with cerebral
palsy, to improve their walking.
HOW DYSPORT WORKS
Dysport contains a toxin produced by the bacterium _Clostridium
botulinum. _It works by stopping your
muscles contracting. It does this by stopping the release of a
chemical which acts between the nerves and
Page 2 of 9
muscles that makes the muscles contract. This helps to reduce abnormal
muscle contractions known as
spasms.
Dysport injected into the underarm areas will block the nerve

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dysport
500 units
Powder for solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
_Clostridium botulinum_ type A toxin-haemagglutinin complex 500 units*
*One unit (U) is defined as the median lethal intraperitoneal dose in
mice.
During the development of botulinum type A toxin haemagglutinin
complex, the activity was commonly expressed in
terms of a nominal weight, based upon a standard specific activity of
4x 10
7
units/mg.
Any reference to this product expressed in nanograms, whether in the
literature or elsewhere, may therefore be readily
converted into units using the formula 1 ng = 40U.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection
Uncoloured Type I glass vial containing a sterile white lyophilised
powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dysport is indicated for focal spasticity including the:
-
Symptomatic treatment of focal spasticity affecting the upper limbs in
adults
-
Symptomatic treatment of focal spasticity in adults affecting the
ankle joint due to stroke or traumatic brain
injury (TBI)
-
Treatment of dynamic equinus foot deformity due to spasticity in
ambulant paediatric cerebral palsy patients,
two years of age or older.
Dysport is also indicated for the following treatments:
-
Spasmodic torticollis
-
Blepharospasm
-
Hemifacial spasm
-
Persistent severe primary hyperhidrosis of the axillae, which
interferes with the activities of daily living and
is resistant to topical treatment.
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