Botulax powder lyophilized for solution for injection

País: Armênia

Língua: inglês

Origem: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredientes ativos:

clostridium botulinum toxin type A

Disponível em:

Hugel Inc

Código ATC:

M03AX01

DCI (Denominação Comum Internacional):

clostridium botulinum toxin type A

Dosagem:

100U

Forma farmacêutica:

powder lyophilized for solution for injection

Unidades em pacote:

glass vial

Tipo de prescrição:

Prescription

Status de autorização:

Registered

Data de autorização:

2021-11-23

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
BOTULAX
LYOPHILIZED POWDER FOR SOLUTION FOR INJECTION
50, 100 OR 200 UNITS
1. NAME OF THE MEDICINAL PRODUCT
Botulax
50, 100 or 200 Units
Lyophilized powder for solution for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
_Active component _
Botulinum toxin* type A, 50, 100 or 200 Units/vial.
* from Clostridium botulinum CBFC26
_ _
_Excipients:_ sodium chloride and others.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Lyophilized powder for solution for injection.
White powder in a colorless transparent vial.
Botulax should be colorless and transparent liquid after
reconstitution with saline solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Botulax is indicated for:
1. Benign essential blepharospasm in adult patients, 18 years of age
or above
2. Temporary improvement of serious glabellar wrinkles ranging from
moderate to severe
associated with corrugators muscle and/or procerus muscle activities
in adults aged between 18
and 65
3. Muscle spasticity: for adult patients aged 20 or above with post
stroke upper limb spasticity.
4. Treatment for pediatric cerebral palsy patient aged 2 or above with
dynamic equinus foot
deformity by spasticity.
5. Temporary improvement of lateral canthal lines (crow’s feet
lines) ranging from moderate to
severe associated with orbicularis oculi muscles activity in adults
aged between 19 and 65.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_PAEDIATRIC POPULATION_
Safety and effectiveness of this product in children and adolescent
below the age of 18 years for
blepharospasm and glabellar lines, below the age of 19 years for
lateral canthal lines (crow’s feet
lines), and below the age of 20 years for muscle spasticity (post
stroke upper limb spasticity)
have not been established. Safety and effectiveness of dynamic equinus
foot deformity by
spasticity of children with pediatric cerebral palsy in children below
the age of 2 years were not
investigated, therefore special caution is required.
METHOD OF