DYSPORT 300

국가: 이스라엘

언어: 영어

출처: Ministry of Health

유효 성분:

BOTULINUM TOXIN TYPE A

제공처:

MEDISON PHARMA LTD

ATC 코드:

M03AX01

약제 형태:

POWDER FOR SOLUTION FOR INJECTION

구성:

BOTULINUM TOXIN TYPE A 300 U/VIAL

관리 경로:

S.C, I.M

처방전 유형:

Required

Manufactured by:

IPSEN BIOPHARM LTD, UK

치료 영역:

BOTULINUM TOXIN

치료 징후:

Dysport is indicated for symptomatic treatment of focal spasticity of:- Upper limbs in adults due to stroke or traumatic brain injury- 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 pediatric cerebral palsy patients, two years of age or older.Dysport is indicated in adults for symptomatic treatment of:- Spasmodic torticollis- Blepharospasm- Hemifacial spasm.Dysport is indicated for symptomatic treatment of persistent severe primary hyperhidrosis of the axillae, which interferes with the activities of daily living and is resistant to topical treatment.Dysport is indicated for the temporary improvement in the appearance of moderate to severe:- glabellar lines (vertical lines between the eyebrows) seen at 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.

승인 날짜:

2020-01-31

환자 정보 전단

DYSP-PIL-0222-V1 Page 1 of 12
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
DYSPORT 300
DYSPORT 500
POWDER FOR SOLUTION FOR INJECTION
ACTIVE INGREDIENT AND ITS QUANTITY:
Botulinum A toxin _(Clostridium botulinum_ _type A_ _toxin_
haemagglutinin complex)
_ _
Dysport 300
Each vial contains 300 units of Botulinum A toxin
Dysport 500
Each vial contains 500 units of Botulinum A toxin
_ _
For the list of inactive ingredients - see section 6 "ADDITIONAL
INFORMATION".
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains concise information about this medicine. If you have any
further questions,
consult your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if it seems to you that their medical condition is similar
to yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Dysport contains a toxin produced by the bacterium _Clostridium
botulinum_. Dysport is
a muscle relaxant. It works by preventing the release of a chemical
which acts
between the nerves and muscles that makes the muscles contract. This
helps to
reduce abnormal muscle contractions known as spasms.
Dysport is also used to prevent contraction of the muscles causing
lines on the
forehead, appearing upon frowning, and at the outer corner of the eye.
This muscle
relaxation is temporary and gradually wears off. Some people are
distressed when
lines appear on their face.
Dysport is indicated for symptomatic treatment of focal spasticity:
-
of upper limbs in adults due to stroke or traumatic brain injury.
-
of lower limbs in adults affecting the ankle joint due to stroke or
traumatic
brain injury.
-
For treatment of pediatric cerebral palsy patients (two years of age
or older)
who can walk, to treat foot deformity caused by persistent muscle
spasms in
the legs.
-
of upper limbs in pediatric cerebral palsy patients two years of age
or older
Dysport is indicated in AD

제품 특성 요약

DYSP-SPC-1121-V1 Page 1 of 27
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Dysport 300
Dysport 500
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Dysport 300:
_ Clostridium botulinum _
type A toxin-haemagglutinin complex 300 units
Dysport 500:
_Clostridium botulinum _
type A toxin-haemagglutinin complex 500 units
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 due to stroke or traumatic brain injury.
-
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 pediatric cerebral palsy patients, two years of age or
older.
Dysport is indicated in adults for symptomatic treatment of:
-
Spasmodic torticollis
-
Blepharospasm
-
Hemifacial spasm
Dysport is indicated for symptomatic treatment of persistent severe
primary hyperhidrosis of the
axillae, which interferes with the activities of daily living and is
resistant to topical treatment.
Dysport is indicated for the temporary improvement in the appearance
of moderate to severe:
-
Glabellar lines (vertical lines between the eyebrows) seen at 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 an appropriately qualified
healthcare practitioner with
expertise in the treatment of the relevant indication and the use of
the required equipment, in
accordance with national guidelines.
_ _
For instructions on reconstitution of the powder for solution for