DYSPORT® 500u (Czech)

DYSPORT is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for:

• The temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adults under 65 years of age.
• The treatment of cervical dystonia in adults.
• The treatment of spasticity in patients 2 years of age and older.

DYSPORT is a prescription medicine that is injected into muscles and used:

• to treat cervical dystonia (CD) in adults.
• to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults younger than 65 years of age for a short period of time (temporary).
• to treat increased muscle stiffness in people 2 years of age and older with spasticity.

• Botulinum toxin type A, the active ingredient in DYSPORT, is a purified neurotoxin type A complex produced by fermentation of the bacterium Clostridium botulinum type A, Hall Strain. It is purified from the culture supernatant by a series of precipitation, dialysis, and chromatography steps. The neurotoxin complex is composed of the neurotoxin, hemagglutinin proteins, and non-toxin nonhemagglutinin protein.
• DYSPORT® (abobotulinumtoxinA) for injection is a sterile, lyophilized powder supplied in a single-dose vial for reconstitution intended for intramuscular injection. Each vial contains 300 Units or 500 Units of lyophilized abobotulinumtoxinA, human serum albumin (125 mcg), and lactose (2.5 mg). DYSPORT may contain trace amounts of cow’s milk proteins.

1. Contraindications

   DYSPORT is contraindicated in patients with known hypersensitivity to any botulinum toxin products, cow’s milk protein, or to any of the components in the formulation, or infection at the proposed injection site(s).

   Serious hypersensitivity reactions including anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea have been reported. If such a serious reaction occurs, discontinue DYSPORT and institute appropriate medical therapy immediately.

2. After-care

   DYSPORT may cause loss of strength or general muscle weakness, blurred vision, or drooping eyelids within hours to weeks of taking DYSPORT. If this happens, do not drive a car, operate machinery, or do other dangerous activities.