Active substance: Botulinum toxin type A (150 kD), purified from Clostridium Botulinum cultures (Hall strain), free from complexing proteins.
Qualitative and quantitative composition: One vial contains: 50 units of Botulinum toxin type A (150 kD), free from complexing proteins, human albumin, sucrose. Due to the differences in the potency assays, unit doses are specific to BOCOUTURE®. Therefore the recommended dose units for BOCOUTURE® are not interchangeable with those for other Botulinum toxin preparations. Therapeutic indications: For temporary improvement in the appearance of upper facial lines in adults below 65 years when the severity of these lines has an important psychological impact for the patient:
- moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar frown lines) and/or
- moderate to severe lateral periorbital lines seen at maximum smile (crow's feet lines) and/or
- moderate to severe horizontal forehead lines seen at maximum contraction.
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. Do not use during pregnancy unless clearly necessary. Do not use during breast-feeding. Undesirable effects: Undesirable effects usually occur within the first week following injection and are temporary in nature. They may be related to the active substance, the injection procedure, or both. Application-related: Localised pain, inflammation, paraesthesia, hypoaesthesia, tenderness, swelling, oedema, erythema, itching, localised infection, haematoma, bleeding and/or bruising. Caused by the injection procedure: Pain and/or anxiety may lead to vasovagal responses such as transient symptomatic hypotension, nausea, tinnitus, and syncope. Undesirable effects of the substance class Botulinum toxin type A: Localised muscle weakness, blepharoptosis (possibly caused by the injection technique) are an expression of the pharmacological effect. Toxin spread: When treating other indications with Botulinum toxins, undesirable effects related to spread of the toxin distant from the site of administration have been reported very rarely (exaggerated muscle weakness, dysphagia, and aspiration pneumonia with a fatal outcome in some cases). These cannot be completely ruled out with the use of BOCOUTURE®. Hypersensitivity reactions: Rare reports of severe and/or immediate hypersensitivity reactions such as anaphylaxis, serum sickness, urticaria, soft tissue oedema, and dyspnoea, sometimes either following the administration of conventional Botulinum toxin type A complex preparations alone or in combination with other active substances known to cause similar reactions. The following undesirable effects were reported from clinical experience with BOCOUTURE®: Vertical lines between the eyebrows seen at maximum frown (glabellar frown lines) Common (≥1/100 to <1/10): headache, muscle disorders (elevation of eyebrow); Uncommon (≥1/1,000 to <1/100): Bronchitis, nasopharyngitis, influenza-like illness, depression, insomnia, facial paresis (brow ptosis), eyelid oedema, eyelid ptosis, blurred vision, pruritus, skin nodule, muscle twitching, muscle spasm, sensation of heaviness, injection site: haematoma, pain, tenderness, fatigue. Lateral periorbital lines seen at maximum smile (crow's feet lines) Common (≥1/100 to <1/10): Eyelid oedema, dry eye, injection site: haematoma. Upper facial lines: Very common (≥1/10):headache; Common (≥1/100 to <1/10):hypoaesthesia , eyelid ptosis, dry eye, facial asymmetry, sensation of heaviness, nausea, injection site: haematoma, pain. Post-marketing experience: Flu-like symptoms and hypersensitivity reactions such as swelling, oedema (also apart from the injection site), erythema, pruritus, rash (local and generalized), and breathlessness have been reported.
Merz Pharmaceuticals GmbH, 60048 Frankfurt/Main, Germany.
Date of revision of the text: March 2016 Further information is provided in the Summary of Product Characteristics and the Package Leaflet.
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