DYSPORT, POWDER FOR SOLUTION FOR INJECTION.
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
CLOSTRIDIUM BOTULINUM TOXIN TYPE A HAEMAGGLUTININ COMPLEX
Available from:
Ipsen Limited
Dosage:
500 Units/ml
Pharmaceutical form:
Pdr for Soln for Injection
Authorization date:
1994-07-20
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dysport 500 Units Powder for solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
_Clostridium botulinum _type A toxin-haemagglutinin complex 500 units*
* One unit (U) is defined as the median lethal intraperitoneal dose in mice.
During the development of botulinum type A toxin haemagglutinin complex, the activity was commonly expressed in
terms of a nominal weight, based upon a standard specific activity of 4x 10
7
units/mg
Any reference to this product expressed in nanograms, whether in the literature or elsewhere, may therefore be readily
converted into units using the formula 1 ng = 40U.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Powder for Solution for Injection
Uncoloured Type I glass vial containing a sterile white lyophilised powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dysport is indicated for the treatment of:
Spasticity of the arm in patients following a stroke.
Dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients, two years of age
or older
Spasmodic torticollis
Blepharospasm
Hemifacial spasm
Persistent severe primary hyperhidrosis of the axillae, which interferes with the activities of daily living and is
resistant to topical treatment.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Dysport should only be administered by physicians who have experience in the diagnosis and treatment of the
conditions indicated and who have received appropriate training in the administration of Dysport.
The units of Dysport are specific to the preparation and are not interchangeable with other preparations of botulinum
toxin.
AXILLARY HYPERHIDROSIS
Posology
IRISH MEDICINES BOARD
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