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XEOMIN is indicated for the symptomatic treatment in adults of
• blepharospasm and hemifacial spasm,
• cervical dystonia of a predominantly rotational form (spasmodic torticollis),
• spasticity of the upper limb,
• chronic sialorrhea due to neurological disorders.
XEOMIN is indicated for the symptomatic treatment in children and adolescents aged 2 to 17 years and weighing ≥ 12 kg of
• chronic sialorrhea due to neurological / neurodevelopmental disorders.
4.2 Posology and method of administration
Due to unit differences in the potency assay, unit doses for XEOMIN are not interchangeable with those for other preparations of Botulinum toxin type A.
For detailed information regarding clinical studies with XEOMIN in comparison to conventional Botulinum toxin type A complex (900 kD), see section 5.1.
XEOMIN should only be administered by an appropriately qualified healthcare practitioner with expertise in the treatment of the relevant indication and the use of the required equipment, in accordance with national guidelines.
The optimum dose, frequency and number of injection sites should be determined by an appropriately qualified healthcare practitioner. Optimum dose levels should be determined by titration but the recommended maximum dose should not be exceeded.
The recommended single doses of XEOMIN should not be exceeded.