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|Ingredients:||Clostridium Botulinum neurotoxin type A (150kD), free from complexing proteins.|
|Size:||One vial. It contains 100 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 Xeomin 100 LD50?
Xeomin is a Clostridium botulinum neurotoxin type A powder, which is used as a muscle relaxant. It is a white powder with 100 LD50 units of incobotulinumtoxinA, and 1.0mg human serum albumin and 4.7mg sucrose are excipients. Reconstituting the powder with 9mg/mL (0.9%) sodium chloride solution results in a transparent solution. The 100U powder is supplied in a vial sealed using a rubber stopper. Keep unopened vial at a temperature below 25℃, while reconstituted solution ready for injection should be used immediately. Otherwise, the ready-to-use solution can be stored between 2℃ to 8℃ for only 24 hours. This is a product of Merz Pharma.
What is it used for?
Xeomin 100 LD50 helps to relax muscles especially for adult patients suffering from eyelid spasm (blepharospasm), twisted neck (spasmodic torticollis), as well as stiff muscles.
How does this botulinum neurotoxin work?
There are three types of muscles in the human body—cardiac, smooth, and skeletal muscles. Both cardiac and smooth muscles are involuntary muscles, whereby they function without direct conscious control. As the name suggests, cardiac muscles are found in the heart, while smooth muscles usually line blood vessels and internal organs. On the other hand, skeletal muscles function as a result of conscious effort of the brain and nervous system. The brain initiates muscle contractions by sending electrochemical signals. Once the signals reach the intended destination, chemical molecules called neurotransmitters (e.g. acetylcholine) are released into the muscle fibres, resulting in contraction.
Clostridium botulinum is a type of bacteria commonly found in environmental settings, such as soil and lakes. This bacteria is capable of producing neurotoxins, which may prove fatal in severe cases like food-borne and infant botulism. However, modern medicine technology has isolated the toxin in minute concentration to provide various health benefits, especially for patients suffering from debilitating muscle contractions. The toxin actually works by preventing neurotransmitters from being released into the muscle fibres—allowing the muscles to relax.
How to inject it
Xeomin 100 LD50 is a prescription-only medicine and should only be handled by a qualified doctor with vast experience and skills in preparing and administering Clostridium botulinum neurotoxin type A injections. It is extremely important for you to discuss your patients’ medical history (e.g. existing disorders, allergies, medications) to prevent any untoward effects. Once your patients are cleared for receiving Xeomin injections, explain the expected outcome and any possible side effects.
Start the treatment by first preparing the injection solution. The reconstituting steps are as follows:
- Check if the toxin powder is still within the shelf life. Dispose any expired product.
- Draw an appropriate amount of solvent (9mg/mL (0.9%) sodium chloride solution) into the syringe.
- Insert the needle vertically into the rubber stopper of the vial and inject the solvent slowly to avoid foam formation.
- Remove the needle, carefully swirl and invert the vial to ensure proper mixing of powder with solvent.
The resulting solution is transparent, colourless, and free from particles. Discard any reconstituted solution if it is cloudy or contaminated with particulate. The method of administration is as follows:
Eyelid spasm (Blepharospasm)
- Use suitably-sized sterile needles (e.g. 27G to 30G) for injections.
- Inject Xeomin into the medial and lateral orbicularis oculi muscle of the upper lid and the lateral orbicularis oculi muscle of the lower lid.
Twisted neck (Spasmodic torticollis)
- Use sterilized 25G to 30G needles for superficial muscle injections while 22G needles is best for deeper injections.
- Inject Xeomin into levator scapulae, splenius capitis, sternocleidomastoid, scalenus, and/or the trapezius muscle(s). If any of the muscles are affected, then they require treatment. You can isolate the injection sites via ultrasound or electromyographic tests.
Spasticity of Upper Limbs
- Use sterilized 26G needles for superficial muscle injections while deeper injections may require longer 22G needles.
- Once again, isolating affected muscles for treatment might require ultrasound or electromyographic tests.
Observe the initial results of injections and adjust the dosage until best therapeutic effects are seen. Discard any unused solution and used needles safely. Refer to product manual for more information on dosage, instructions, and precautions.
How long does it last?
The effects of Xeomin 100 LD50 treatments vary according to the injection site. Improvements last for about 3 to 4 months in eyelid spasm (blepharospasm) and twisted neck (spasmodic torticollis) cases. Patients with upper limbs spasticity experience relief for about 12 weeks. The duration may even be longer or shorter across different patients.
Is this product safe?
Xeomin 100 LD50 is manufactured via the biofermentation process of Clostridium botulinum serotype A. The toxin is purified and processed to contain high biologic activity with low protein content. When prepared safely and injected aseptically, this is a very safe product. That being said, patients who are allergic to any of the contents (e.g. botulinum neurotoxin type A, human albumin, sucrose) or suffer from generalized muscle disorders (e.g. myasthenia gravis and Lambert-Eaton syndrome) are contraindicated from using this medicine. In addition, injecting the solution into inflamed and/or infected skin is not recommended. Pediatric patients and pregnant and breastfeeding patients must not use this medicine. Refer to product manual for complete list of contraindications.
Xeomin 100 LD50 side effects
Side effects are possible after receiving Xeomin 100 LD50 injections though it may not be apparent in some clients. The injection process itself can induce localized inflammatory reactions such as pain, redness, swelling, itching, bruising, and/or blood clots. These reactions are temporary and will subside within a week. The usual reactions are excessive muscle weakness or swallowing difficulties caused by muscle relaxation. This may actually cause choking or accidental inhalation of foreign items into the lungs. In extreme cases, clients might suffer from lung inflammation and even death. Though rare, allergic attacks (e.g. hives, swollen oral cavity, difficulty breathing, difficulty swallowing, dizziness, headaches, swollen limbs) can also occur. Inform your clients to get immediate medical help if they notice any allergic symptoms. Refer to product manual for complete list of reactions.
What is it made of?
Xeomin 100 LD50 is Clostridium botulinum neurotoxin type A powder derived from fermentation of Clostridium botulinum serotype A. The toxin is further purified to remove extra accessory proteins. The resulting powder is white in colour and has a molecular weight of 900 kDa, while 150 kDa of it is the active neurotoxin."