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Product: BOCOUTURE® 50U
Manufacturer: Merz Pharmaceuticals
Active Substance(s) : Botulinum toxin type A
Strength: 50U
Pack Size: 1 vial
Accessories: Package insert
 
 
 
 

What is BOCOUTURE 50U?

Bocouture 50U is a prescription-only medication made of botulinum toxin type A, which has gained approval for treating glabellar lines or frown lines. Only the purified form of Clostridium botulinum toxin, particularly the Hall strain, is included in this formulation. It is free from neurotoxin-associated proteins, which may trigger therapy failure due to the development of neutralizing antibodies.

What Bocouture 50U is formulated to do

Bocouture 50U contains botulinum type A, a neurotoxin produced by Clostridium botulinum bacteria. This botulinum toxin complex undergoes extensive purification to remove traces of complexing proteins, rendering its formulation more effective than other preparations. Various research studies have showed that while complexing proteins protect this neurotoxin in the gastrointestinal tract, they may also induce the formation of antibodies, resulting in the reduction or total loss of this treatment’s effects.

Bocouture 50U has been found to contain the least amount of complexing proteins when compared to other preparations on the market. This means that there is minimal risk of antibody formation, even with repeated applications of the medication. With this, patients may experience the reduction of glabellar lines for longer periods of time.

Manufacturer

This product is manufactured by Merz Pharmaceuticals GmbH.

Origin

Bocouture is produced in Frankfurt, Germany.

What else you need to know

Common side effects associated with the treatment

Most side effects from Botouture 50U are caused by misplaced injections of the neurotoxin, which can trigger the temporary paralysis of nearby muscles. To avoid this, only trained, licensed medical practitioners may inject this substance.

Certain undesired effects may occur, although are only temporary in nature. These may include:

  • Localized pain;
  • Inflammation;
  • Redness or discoloration;
  • Hematoma;
  • Skin nodules;
  • And headache.

Patients who are allergic to any ingredient in this formulation should not use it. Additionally, pregnant and breastfeeding patients should not receive these injections.

Which skin type is it good for?

This treatment works for all skin types, particularly those with the noticeable appearance of lines or wrinkles. It is indicated for moderate to severe horizontal forehead lines that are visible at maximum contraction, vertical lines between the eyebrows visible at maximum frown, and lateral periorbital lines visible at maximum smile.

Is the formulation modified to remove certain substances?

Bocouture 50U is specially formulated to be free from complexing proteins, which are also known as neurotoxin-associated proteins. It also does not contain albumin or sucrose.

Precautions and contraindications

This treatment is contraindicated in patients with neuromuscular conditions and dysphagia. The safety of Bocouture 50U in children, pregnant or breastfeeding women, and patients over the age of 65 has not been established. It is therefore not advisable to treat these people with botulinum toxin medications.

Awards and certifications

Bocouture has been approved by European regulatory authorities for the treatment of glabellar lines and lateral periorbital lines.

Packaging information

Bocouture 50U is a neuromodulator or muscle relaxant that contains 50 units of Botulinum toxin type A (150 kD) in white powder form. It is contained in a glass vial with a bromobutyl rubber stopper and tamper-proof seal. Check the integrity of the packaging before use. Do not use if the aluminum seal is broken or if the packaging is damaged.

Suggested Usage

  • Prior to injection, reconstitute 50 units of Bocouture 50U in 1.25ml of unpreserved sodium chloride solution.
  • Perform dilution and reconstitution in accordance with proper aseptic technique.
  • Follow the recommended injection sites and product volumes for each area. Refer to the package insert for the complete usage instructions.
  • A follow-up injection can be performed at least 3 months after the initial treatment.

Composition

1 vial of Bocouture 50U contains 50 units of purified Botulinum toxin Type A (150 kD) from Hall strain cultures of Clostridium botulinum. The active ingredient is in supplied in a white powder form, requiring dilution in 1.25 ml sodium hydrochloride prior to injection.

What is in the box

Each box of Bocouture 50U contains 1 vial with 50 units of Botulinum toxin type A powder.

Duration of effect

The beneficial effects and safety of Bocouture 50U has been demonstrated by various clinical trial data for treating upper facial lines. The effects for both combined and separate treatments are maintained for up to 4 months. At this time, follow-up treatments may be performed.

Storage conditions

Bocouture 50U must be kept out of the sight and reach of children. Store at a temperature not exceeding 25℃, and do not freeze or heat the packaging.

Expiry (shelf life)

  • Since the ingredients of Bocouture 50U are microbiological in nature, the reconstituted product must be used immediately. Stability has been demonstrated if used within 24 hours.
  • Any unopened vials should be used prior to the expiration date listed on the product packaging.
  • For best results, follow the aforementioned storage instructions. This will prevent premature degradation of the product.

More information

Information about this product that is provided by RaskelMedical.com is only summary and does not cover all of the information about this product.

We offer only genuine products from original manufacturers. All listed brands are the trademarks of their respective owners. We operate independently and without support or affiliation with the manufacturers.

 

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