Bocouture® (botulinum toxin type A (150 kD), free from complexing proteins) 50/100 unit vials. Prescribing information: Please refer to the Summary of Product Characteristics (SmPC) before prescribing. Presentation: 50/100 units of Clostridium Botulinum Neurotoxin type A, free from complexing proteins as a powder for solution for injection. Indications: Temporary improvement in the appearance of moderate to severe upper facial lines (glabellar frown lines, crow’s feet lines, horizontal forehead lines) in adults ≥18 and <65 years when the severity of these lines has an important psychological impact for the patient. Dosage and administration: For intramuscular use only. Unit doses recommended for Bocouture are not interchangeable with those for other preparations of botulinum toxin. BOCOUTURE 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 intervals between treatments should not be shorter than 3 months. Reconstitute with 0.9% sodium chloride. Glabellar Frown Lines: Total recommended standard dose is 20 units. 4 units into 5 injection sites (2 injections in each corrugator muscle and 1 injection in the procerus muscle). May be increased to up to 30 units. Injections near the levator palpebrae superioris and into the cranial portion of the orbicularis oculi should be avoided. Crow’s Feet lines: Total recommended standard dosing is 12 units per side (overall total dose: 24 units); 4 units injected bilaterally into each of the 3 injection sites. Injections too close to the Zygomaticus major muscle should be avoided to prevent lip ptosis. Horizontal Forehead Lines: The recommended total dose range is 10 to 20 units; a total injection volume of 10 units to 20 units is injected into the frontalis muscle in five horizontally aligned injection sites at least 2 cm above the orbital rim. An injection volume of 2 units, 3 units or 4 units is applied per injection point, respectively. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Generalised disorders of muscle activity (e.g. myasthenia gravis, Lambert-Eaton syndrome). Infection or inflammation at the proposed injection site. Special warnings and precautions: It should be taken into consideration that horizontal forehead lines may not only be dynamic, but may also result from the loss of dermal elasticity (e.g. associated with ageing or photo damage). In this case, patients may not respond to botulinum toxin products. Should not be injected into a blood vessel. Not recommended for patients with a history of dysphagia and aspiration. Caution in patients with botulinum toxin hypersensitivity, amyotrophic lateral sclerosis, peripheral neuromuscular dysfunction, or in targeted muscles displaying pronounced weakness or atrophy. Bocouture should be used with caution in patients receiving therapy that could have an anticoagulant effect, or if bleeding disorders of any type occur. Too frequent or too high dosing of botulinum toxin type A may increase the risk of antibodies forming. Should not be used during pregnancy unless clearly necessary. Should not be used during breastfeeding. Interactions: Concomitant use with aminoglycosides or spectinomycin requires special care. Peripheral muscle relaxants should be used with caution. 4-aminoquinolines may reduce the effect. Undesirable effects: Usually, undesirable effects are observed within the first week after treatment and are temporary in nature. Undesirable effects independent of indication include; application related undesirable effects (localised pain, inflammation, swelling), class related undesirable effects (localised muscle weakness, blepharoptosis), and toxin spread (very rare - exaggerated muscle weakness, dysphagia, aspiration pneumonia). Hypersensitivity reactions have been reported with botulinum toxin products. Glabellar Frown Lines: Common: headache, muscle disorders (elevation of eyebrow). Crow’s Feet Lines: Common: eyelid oedema, dry eye, injection site haematoma. Upper Facial Lines: Very common: headache. Common: hypoaesthesia, injection site haematoma, application site pain, application site erythema, discomfort (heavy feeling of frontal area), eyelid ptosis, dry eye, facial asymmetry, nausea. For a full list of adverse reactions, please consult the SmPC. Overdose: May result in pronounced neuromuscular paralysis distant from the injection site. Symptoms are not immediately apparent post-injection. Legal Category: POM. List Price: 50 U/vial £90.00, 50 U twin pack £180.00, 100 U/vial £180.00, 100 U twin pack £360.00. Product Licence Number: PL 29978/0002, PL 29978/0005 Marketing Authorisation Holder: Merz Pharmaceuticals GmbH, Eckenheimer Landstraße 100,60318 Frankfurt/Main, Germany. Date of Preparation: October 2023. M-BOC-UK-0432. Further information available from:. Ground Floor Suite B, Breakspear Park, Breakspear Way, Hemel Hempstead, Hertfordshire, HP2 4TZ Tel: +44 (0) 333 200 4143