DYSPORT® 500u (Romanian)

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 < 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.

The potency Units of Dysport Cosmetic (ababotulinumtoxinA) for injection are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products, and, therefore, units of biological activity of Dysport cannot be compared to nor converted into units of any other botulinum toxin products assessed with any other specific assay method.

Indication-specific dosage and administration recommendations should be followed.

In treating adult patients for one or more indications with Dysport, the maximum cumulative dose should generally not exceed 400 Units, in a 3-month interval.

The safety and effectiveness of dosing with Dysport more frequently than every 3 months have not been clinically evaluated.

The safe and effective use of Dysport depends upon proper storage of the product, selection of the correct dose, and proper reconstitution and administration techniques. Physicians administering Dysport must understand the relevant neuromuscular and structural anatomy of the area involved and any alterations to the anatomy due to prior surgical procedures and disease.

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.

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.