Dysport 300unit powder for solution for injection vials

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

유효 성분:

Botulinum toxin type A

제공처:

Ipsen Ltd

ATC 코드:

M03AX01

INN (International Name):

Botulinum toxin type A

복용량:

300unit

약제 형태:

Powder for solution for injection

관리 경로:

Intramuscular; Subcutaneous

수업:

No Controlled Drug Status

처방전 유형:

Valid as a prescribable product

제품 요약:

BNF: 04090300; GTIN: 5036611000257

환자 정보 전단

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
DYSPORT
®
300 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 ARE GIVEN 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:

Around the eyes

In the face

In the neck

In the arm and shoulders

In the leg
Dysport is also used in adults to treat:

Hyperhidrosis. This is a condition where there is excess sweating of
the armpits, which interferes
with daily living.
CHILDREN:
Dysport is used in children (aged two years or older) with cerebral
palsy to treat muscle spasms in the
legs, 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 8
muscles that makes the muscles contract. This helps to reduce abnormal
muscle contractions known as
spasms.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DYSPORT
DO NOT USE DYSPORT:
If you are allergic

제품 특성 요약

OBJECT 1
DYSPORT 300 UNITS
Summary of Product Characteristics Updated 24-Jul-2017 | Ipsen Ltd
1. Name of the medicinal product
Dysport
300 units
Powder for solution for injection
2. Qualitative and quantitative composition
_Clostridium botulinum _type A toxin-haemagglutinin complex 300 units*
*One unit (U) is defined as the median lethal intraperitoneal dose in
mice.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for solution for injection
4. Clinical particulars
4.1 Therapeutic indications
Dysport is indicated for symptomatic treatment of focal spasticity of:
- Upper limbs in adults
- Lower limbs in adults affecting the ankle joint due to stroke or
traumatic brain injury (TBI)
- Dynamic equinus foot deformity in ambulant paediatric cerebral palsy
patients, two years of age or
older.
Dysport is indicated in adults for symptomatic treatment of:
- Spasmodic torticollis
- Blepharospasm
- Hemifacial spasm
- Severe primary hyperhidrosis of the axillae, which does not respond
to topical treatment with
antiperspirants or antihidrotics.
4.2 Posology and method of administration
THE UNITS OF DYSPORT ARE SPECIFIC TO THE PREPARATION AND ARE NOT
INTERCHANGEABLE WITH OTHER
PREPARATIONS OF BOTULINUM TOXIN.
Training: Dysport should only be administered by appropriately trained
physicians.
Ipsen can facilitate training in administration of Dysport injections.
For instructions on reconstitution of the powder for solution for
injection, handling and disposal of vials
please refer to section 6.6.
FOCAL SPASTICITY IN ADULTS
_UPPER LIMB: _
Posology
Dosing in initial and sequential treatment sessions should be tailored
to the individual based on the size,
number and location of muscles involved, severity of spasticity, the
presence of local muscle weakness,
the patient's response to previous treatment, and/or adverse event
history with Dysport. In clinical trials,
doses of 500 units and 1000 units were divided among selected muscles
at a given treatment session as
shown below.
No more than 1 ml should ge