Dysport powder lyophilized for solution for injection

Country: Арменија

Језик: Енглески

Извор: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активни састојак:

clostridium botulinum type A toxin-haemagglutinin complex

Доступно од:

Ipsen Biopharm Limited

АТЦ код:

M03AX01

INN (Међународно име):

clostridium botulinum type A toxin-haemagglutinin complex

Дозирање:

300U

Фармацеутски облик:

powder lyophilized for solution for injection

Јединице у пакету:

glass vial 3ml

Тип рецептора:

Prescription

Статус ауторизације:

Registered

Датум одобрења:

2019-03-13

Карактеристике производа

Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Dysport 300 units
Dysport 500 units
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
_Clostridium botulinum_ type A toxin-haemagglutinin complex 300 units*
or
_Clostridium botulinum_ type A toxin-haemagglutinin complex 500 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
-
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
-
Axillary hyperhidrosis
-
The temporary improvement in the appearance of moderate to severe
glabellar lines (vertical
lines between the eyebrows) seen at frown, 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.
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.
Page 2 of 17
FOCAL SPASTICITY AFFECTING THE UPPER LIMBS
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
select