Description
Bocouture 100 units is a prescription-only botulinum toxin type A medicine supplied as a white powder for solution for injection. Each vial contains 100 units of botulinum toxin type A. The product is indicated in adults under 65 years for the temporary improvement in the appearance of moderate to severe upper facial lines, including glabellar frown lines, lateral periorbital lines (crow’s feet), and horizontal forehead lines, where their severity has an important psychological impact.
Following intramuscular administration, botulinum toxin type A acts at cholinergic nerve terminals and inhibits acetylcholine release at the neuromuscular junction. This produces temporary chemical denervation and reduced muscle activity. Recovery of neuromuscular transmission normally occurs within approximately 3–4 months as nerve terminals regenerate and reconnect with the motor endplate.
Treatment Areas / Indications
According to the current UK SmPC, Bocouture 100 units is indicated for temporary improvement in the appearance of:
- Moderate to severe glabellar frown lines between the eyebrows at maximum frown.
- Moderate to severe lateral periorbital lines (crow’s feet) at maximum smile.
- Moderate to severe horizontal forehead lines at maximum contraction.
- Adults below 65 years, where the severity of the lines has an important psychological impact.
Usage / Administration
IFU/SmPC-only information:
- Route/depth: Reconstituted Bocouture is intended for intramuscular injection. For lateral periorbital lines, the SmPC specifies intramuscular injection into the orbicularis oculi muscle directly under the dermis.
- Needle: A thin sterile needle such as 30–33 gauge, 0.20–0.30 mm diameter and 13 mm length is specified as an example.
- Injection volume: Approximately 0.04–0.1 mL per injection site is recommended.
- Glabellar lines: Standard dose is 20 units across five sites, with 4 units per site; the physician may increase the dose to up to 30 units according to individual needs.
- Crow’s feet: 4 units are administered at each of three injection sites per side, giving a standard total of 24 units.
- Forehead lines: A total of 10–20 units is injected across five horizontally aligned sites, with 2, 3 or 4 units per injection point.
- Treatment frequency: Treatment intervals should not be shorter than 3 months.
- Reconstitution: Bocouture 100 units may be reconstituted using 2 mL of 0.9% sodium chloride solution for injection to produce 5 units/0.1 mL, or 2.5 mL to produce 4 units/0.1 mL.
- Professional use: Bocouture should only be administered by an appropriately qualified healthcare practitioner with relevant expertise and the required equipment, in accordance with national guidelines.
Bocouture 100 Units Dilution
| Target concentration | 100-unit vial | Result |
|---|---|---|
| 5 units / 0.1 mL | 2 mL 0.9% sodium chloride | 5 units/0.1 mL |
| 4 units / 0.1 mL | 2.5 mL 0.9% sodium chloride | 4 units/0.1 mL |
After reconstitution, the product should be used immediately and is intended for one treatment in one patient.
Ingredient List
- Active: Botulinum toxin type A (150 kD) — 100 units per vial.
Presentation & Longevity
Bocouture 100 units is supplied as a white powder for solution for injection in a Type I glass vial, with a bromobutyl rubber stopper and aluminium tamper-proof seal. The UK SmPC lists pack sizes containing 1, 2, 3 or 6 vials, although not all pack sizes may be marketed.
The unopened product has a 3-year shelf life according to the current UK product information. It should not be stored above 25°C.
For the authorised facial indications, the documented duration of effect is up to approximately 4 months for glabellar lines, lateral periorbital lines and horizontal forehead lines. Individual response may vary.
Regulatory Status
Bocouture 100 units is a UK-authorised prescription-only medicine, rather than a CE/UKCA-classified dermal filler or medical device. The current UK marketing authorisation number is PL 29978/0005, with Merz Pharmaceuticals GmbH listed as marketing authorisation holder and Merz Aesthetics UK Ltd as the UK company.
Current MHRA guidance confirms that Bocouture is among the botulinum toxin type A products authorised for aesthetic use in the UK. The MHRA also stresses that botulinum toxin units are not interchangeable between products and warns against unlicensed or counterfeit products.
FAQ
1. How does Bocouture 100 units work?
Bocouture contains purified botulinum toxin type A, which acts at cholinergic nerve terminals at the neuromuscular junction. It inhibits the release of acetylcholine, temporarily reducing muscle activity in the treated area. The pharmacological effect is reversible as new nerve terminals develop and reconnect with motor endplates. The current UK SmPC states that recovery of neuromuscular transmission normally occurs within approximately 3–4 months following intramuscular injection.
2. What is Bocouture 100 units used for?
The UK-authorised aesthetic indications cover the temporary improvement in moderate to severe upper facial lines in adults below 65 years where their severity has an important psychological impact. These include glabellar frown lines, lateral periorbital lines or crow’s feet, and horizontal forehead lines. The specific indication, patient suitability and dosing should be assessed by an appropriately qualified healthcare practitioner using the current product information.
3. What is the official Bocouture 100 units dilution?
The current UK SmPC describes reconstitution with 0.9% sodium chloride solution for injection. For a 100-unit vial, adding 2 mL produces a concentration of 5 units per 0.1 mL, while adding 2.5 mL produces 4 units per 0.1 mL. These are manufacturer-specified reconstitution options. Reconstitution should be performed using appropriate aseptic practice and the product should be used according to the current SmPC.
4. How long does Bocouture 100 units last?
For the authorised facial indications, the UK SmPC states that the effect lasts up to 4 months following injection. The timing of onset differs by treatment area: improvement in glabellar lines generally occurs within 2–3 days, crow’s feet improvement mostly occurs within the first 6 days, and forehead-line improvement usually occurs within 7 days. Maximum effect is described around day 30 for each indication.
5. Is Bocouture equivalent to Botox or Azzalure?
Bocouture, BOTOX and Azzalure are botulinum toxin type A medicines, but their formulations, potency assays and licensed dosing instructions differ. Bocouture contains purified 150 kD neurotoxin without complexing proteins, while Azzalure contains a haemagglutinin complex. BOTOX and Bocouture use different unit systems. UK product information specifically states that botulinum toxin units are not interchangeable, so one product should not be substituted using an assumed unit-for-unit conversion.
