DYSPORT FOR INJECTION 500 uvial

国: シンガポール

言語: 英語

ソース: HSA (Health Sciences Authority)

有効成分:

CLOSTRIDIUM BOTULINUM TYPE A TOXIN-HAEMAGGLUTININ COMPLEX

から入手可能:

IPSEN PHARMA SINGAPORE PTE. LTD.

ATCコード:

M03AX01

投薬量:

500 U/Vial

医薬品形態:

INJECTION, POWDER, FOR SOLUTION

構図:

CLOSTRIDIUM BOTULINUM TYPE A TOXIN-HAEMAGGLUTININ COMPLEX 500 U/Vial

投与経路:

SUBCUTANEOUS, INTRAMUSCULAR

処方タイプ:

Prescription Only

製:

IPSEN BIOPHARM LTD

認証ステータス:

ACTIVE

承認日:

1999-05-31

情報リーフレット

PATIENT INFORMATION LEAFLET
INFORMATION FOR THE PATIENT
Please read this leaflet carefully. It provides some information about
this medicine. If there are
any questions, please ask the doctor. The name of this medicine is
Dysport. Its active ingredient
is _Clostridium botulinum _type A toxin-haemagglutinin complex.
Dysport also contains albumin
and lactose, and is presented as a powder. For the injection, Dysport
will be dissolved in Sodium
Chloride for Injection.
PACK SIZE
Each pack contains 1 or 2 vials of Dysport, although not all pack
sizes may be marketed.
WHAT IS DYSPORT?
Dysport is a toxin produced by _Clostridium botulinum _bacteria. The
toxin acts on the junctions
between the nerves and muscles, preventing the release of one of the
chemical messengers called
acetylcholine from the nerve endings which would normally cause the
muscle to contract. If the
messenger is prevented from being released this results in a weakened
muscle and helps to
reduce some of the abnormal muscle contractions. It can also be used
to prevent muscles which
cause frown lines and crow’s feet lines from contracting. This
muscle relaxation is temporary
and gradually wears off.
Each vial of Dysport contains 500 units of the toxin complex. These
units apply to Dysport only
and are not the same for other medicines containing botulinum toxin.
Dysport is also available in
300 units vial.
WHO MAKES DYSPORT?
Dysport is manufactured by:
Ipsen Biopharm Limited,
Ash Road, Wrexham Industrial Estate,
Wrexham LL13 9UF, UK.
The product licence holder is:
A. Menarini Singapore Pte Ltd
30 Pasir Panjang Road, #08-32
Mapletree Business City
Singapore 117440
WHAT IS DYSPORT USED FOR?
Dysport is used to manage the symptoms of upper limbs and lower limbs
spasticity in adults as
well as equinus foot deformity due to spasticity in children (2 years
of age or older) with cerebral
palsy. Dysport is also used for the treatment of spasmodic
torticollis, blepharospasm, hemifacial
spasm and axillary hyperhidrosis in adults. Upper limbs and lower
limbs spastic

製品の特徴

DYSPORT_ _
_Clostridium botulinum _
type A toxin-haemagglutinin complex
INFORMATION FOR THE DOCTOR
1.
NAME OF THE MEDICINAL PRODUCT
Dysport
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Clostridium botulinum _
type A toxin-haemagglutinin complex 500 units*
_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
-
Upper limbs in paediatric cerebral palsy patients, two years of age or
older
Dysport is indicated in adults for symptomatic treatment of:
-
Spasmodic torticollis
-
Blepharospasm
-
Hemifacial spasm
-
Axillary hyperhidrosis
Dysport 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
THE UNITS OF DYSPORT ARE SPECIFIC TO THE PREPARATION AND ARE NOT
INTERCHANGEABLE WITH OTHER
PREPARATIONS OF BOTULINUM TOXIN.
Dysport should only be administered by appropriately trained
physicians.
For the treatment of focal spasticity, Dysport can also be
administered by healthcare professionals having
received appropriate training and qualification in accordance with
national guidelines (e.g., Royal College
of Physicians).
For instructions on reconstitution of the powder for solution for
injection, handling and disposal of vials,
please refer to se