|Ingredients:||Clostridium Botulinum neurotoxin type A (150kD), free from complexing proteins.|
|Size:||One vial. It contains 50 LD50 units powder for solution for injection.|
|Manufacturer:||Merz Pharmaceutical GmbH.|
|Also Included:||Package leaflet only.|
|Storage:||Keep out of the reach and sight of children. Do not store above 25 ℃.|
What is Bocouture 50U?
Bocouture 50U is a powder designed by Merz Aesthetics as a muscle-relaxing agent. The active ingredient is 50 units of botulinum toxin type A (150 kD) that is free from complexing proteins. Other excipients are human serum albumin and sucrose. The toxin comes in the form of white powder supplied in a glass vial packed with a tamper-proof aluminum seal and rubber stopper. The powder must be reconstituted with 1.25mL of unpreserved sodium chloride 9mg/mL (0.9%) solution for the injection. This yields a transparent, colourless and particulate-free solution with a concentration of 40U/mL. Store any unopened vials in a clean environment with a temperature below 25℃. As for reconstituted solutions, use them immediately after preparing or store it for up to 24 hours at a temperature between 2℃ to 8℃. This is a prescription-only medicine.
What is it used for?
Bocouture 50U has been designed to provide aesthetic benefits to patients under 65 years old who experience severe to moderate glabellar frown lines, crow’s feet, and forehead lines.
How does this botulinum toxin type A work?
The skin’s structure is composed of 3 layers—epidermis, dermis and subcutaneous—along many cells, like collagen, elastin and hyaluronic acid, which ensure that skin is elastic and properly hydrated. Not only that, these cells are also extremely capable of regenerating themselves repeatedly to repair any skin damages. Hence, young skin is usually flawless with minimal issues.
However, as age catches up with skin, the quantity and quality of many important cells diminish. This is known as intrinsic or biological ageing, whereby the body’s system becomes sluggish. Dermal damages are also not being repaired on time. In addition, external ageing factors, like excessive sun exposure and smoking, introduce lots of free radicals that damage the already-weakened skin. So, the skin structure collapses and wrinkles form on areas where repeated facial expressions occur.
Botulinum toxin is notorious for its neurotoxicity. It is produced by Clostridium botulinum bacteria, which exist freely in lakes and soil. Nowadays, the toxin is harvested and purified to deliver various health benefits, from treating muscle spasms to erasing dynamic wrinkles. Bocouture 50U erases moderate to severe wrinkles by blocking signals sent by the brain to help contract muscles. As a result, wrinkles and lines are not obvious even when various facial expressions are made.
How to inject it
Though it is used as an aesthetic treatment, Bocouture 50U is a very potent injectable and its administration is regarded as a medical procedure. Hence, only approved medical practitioners specialising in botulinum toxin injections are permitted to handle this medicine. Besides that, the patient’s medical history must first be assessed to ensure suitability before administering the medicine. As part of a pre-procedure method, the content of the glass vial (50 units of toxin powder) must reconstituted with 1.25mL of unpreserved sodium chloride 9 mg/ml (0.9%) solution for the injection. The resulting transparent, colourless, and particulate-free solution is then ready for injection. Injection techniques and dosage depend on the area affected:
1. Vertical frown lines
- Inject 4 units into 5 sites. See the product manual for detailed use instructions.
- The initial total dosage is 20 units.
2. Crow’s feet
- Inject 4 units bilaterally into 3 sites. See the product manual for detailed use instructions.
- The initial total dosage is 12 units for each eye.
3. Horizontal forehead lines
- Inject a total of 10 to 20 units into 5 sites. See the product manual for detailed use instructions.
- The initial total dosage is 10 to 20 units.
Ensure that strict aseptic techniques are observed for the entirety of treatment session. Discard any leftover solution and used needles responsibly. In addition, expired powder and/or prepared solution that do not follow the stated characteristics must be disposed of. Refer to the package insert for more details on reconstitution methods and usage instructions.
How long does Bocouture 50U last?
The muscle-relaxing effects of Bocouture 50U are dependent on the areas in which the medicine was administered. However, these results vary across patients:
- Glabellar frown lines
Patients may notice improvements just 2 to 3 days after treatment, which can last up to 4 months.
- Crow’s feet
Patients may notice improvements within 6 days following treatment, which can last up to 3 months.
- Forehead lines
Patients may notice improvements within a week after treatment, which can last up to 4 months.
Is this product safe?
Despite its notorious neurotoxicity, the botulinum toxin in Bocouture 50U has been expertly designed to provide only a curative dosage specific for aesthetic purposes. Not only that, this medicine has proven to deliver amazing results without a risk of antibody formation. Bocouture 50U has one of the lowest amounts of accessory bacterial protein, and repeated injections do not cause antibody productions. Though it is proven to be safe, this medicine is still contraindicated in certain cases:
- Clients with hypersensitivity/allergy to botulinum toxin type A;
- Clients with hypersensitivity/allergy to human serum albumin;
- Clients with hypersensitivity/allergy to sucrose;
- Clients with generalised muscle disorder (e.g. Lambert-Eaton myasthenic syndrome);
- Clients with dermal infections/inflammations on proposed site of product administration.
Refer to the package insert for more details on contraindications, precautions and warnings.
What are the side effects?
Patients may experience mild localised inflammatory reactions (e.g. pain, swelling, redness, itching, bruising) on injection sites. Besides that, they may also develop common reactions like headaches, heavy feeling in the upper part of the face and muscle activity disorder (e.g. raised eyebrows). Uncommon reactions like drooping eyelids, swollen eyelids, blurred vision, fainting, nausea, skin nodule formation, itching, tiredness and insomnia can still occur for any of patient. Hence, during the initial consultation session, patients should be educated on all possible side effects. These effects appear within a week following treatment and should subside soon after. Inform patients to seek medical help if the symptoms worsen or new symptoms emerge. Refer to the package insert for more details on adverse reactions.
What is it made of?
Bocouture 50U is made of 50 units (150 kD) of botulinum toxin type A purified from fermentation of Clostridium botulinum (Hall strain). Human serum albumin and sucrose act as the excipients. The white toxin powder must be dissolved with 1.25mL of unpreserved sodium chloride 9mg/mL (0.9%) solution for the injection. This yields a transparent, colourless and particulate-free solution with concentration of 40U/mL, which can then be used to correct moderate to severe wrinkles (e.g. glabellar frown lines, crow’s feet, forehead lines)."