Manufacturer : Merz Pharma
Active Substance(s) : BOTULINUM TOXIN TYPE A
Strength : 100u
Pack Size : 1 x 100 Units Vial
Accessories : Package insert
XEOMIN® 100U powder for solution for injection contains 100 units of incobotulinumtoxin A. Native Botulinum toxin type A is a high molecular weight complex, which, in addition to the toxin (150 kD), contains other bacterial non-toxic proteins, like haemagglutinins and non-haemagglutinins. In contrast to conventional preparations containing the botulinum toxin A complex, Xeomin contains pure (150 kD) toxin since it is free from complexing proteins and thus has a low foreign protein content. The foreign protein content administered is considered as one of the factors for secondary therapy failure. IncobotulinumtoxinA is produced from the fermentation of Clostridium botulinum and is subsequently purified to remove complexing proteins. It consists of the purified neurotoxin which has been separated from complexing proteins (haemagglutinins and a non-toxic non-haemagglutinating protein) during production. A prescription medicine product used to improve the look of moderate to severe frown lines between the eyebrows. Also to treat abnormal head position, neck pain caused by cervical dystonia. Also improves eyelids that have had prior treatment with anabotulinum toxin type A.
INFORMATION
XEOMIN® 100u Product Information
XEOMIN® 100u is a purified botulinum toxin type A used for therapeutic and cosmetic purposes. It is indicated for the treatment of upper limb spasticity, cervical dystonia, blepharospasm, and the temporary improvement of moderate to severe glabellar lines. XEOMIN works by inhibiting acetylcholine release, temporarily reducing muscle activity in the target areas.
Key Features and Benefits of XEOMIN® 100u
XEOMIN® offers various advantages for patients requiring muscle relaxation or wrinkle reduction:
- Purity: Does not contain complexing proteins, reducing the risk of antibody development.
- Precision: Provides localized action with a proven safety profile.
- Versatility: Effective for both medical and cosmetic indications.
- Long-Lasting Effects: Clinical effects last 3–4 months, depending on the indication.
Reconstitution Chart for XEOMIN® 100u
Proper reconstitution ensures accurate dosing and effectiveness. Use preservative-free 0.9% Sodium Chloride Injection, USP as the diluent.
- Dilution Guide:
- 0.5 mL: 20 units per 0.1 mL.
- 1 mL: 10 units per 0.1 mL.
- 2 mL: 5 units per 0.1 mL.
- 4 mL: 2.5 units per 0.1 mL.
Instructions:
- Inject the saline into the vial slowly to avoid foaming.
- Gently swirl to mix the solution (do not shake).
- Use the reconstituted solution within 24 hours and store at 2–8°C.
Storage Information for XEOMIN® 100u
- Unopened Vials:
- Can be stored at room temperature (20–25°C), refrigerated (2–8°C), or frozen (-20 to -10°C).
- Do not use after the expiration date.
- Reconstituted Solution:
- Must be refrigerated at 2–8°C.
- Discard unused portions after 24 hours.
Treatment Areas for XEOMIN® 100u
XEOMIN® is indicated for specific therapeutic and cosmetic treatments:
Therapeutic Indications:
- Upper Limb Spasticity:
- Targets muscles like the biceps, brachialis, and flexor digitorum.
- Cervical Dystonia:
- Injections focus on muscles such as the sternocleidomastoid and splenius capitis.
- Blepharospasm:
- Relieves eyelid spasms by targeting the orbicularis oculi muscle.
Cosmetic Indications:
- Glabellar Lines:
- Reduces vertical frown lines between the eyebrows.
- Five injection sites: two in each corrugator muscle and one in the procerus muscle.
Dosing for Different Indications of XEOMIN® 100u
Therapeutic Applications:
- Upper Limb Spasticity:
- Maximum dose: 400 units per session, with dosing tailored to the specific muscle groups.
- Cervical Dystonia:
- Initial dose: 120 units, adjustable based on the patient’s history and muscle mass.
- Retreatment interval: No sooner than every 12 weeks.
- Blepharospasm:
- Initial dose: 10–50 units per eye.
- Maximum dose: 70 units total.
Cosmetic Applications:
- Glabellar Lines:
- Total dose: 20 units, divided into five 4-unit injections.
- Retreatment interval: Every 3–4 months as needed.
Side Effects and Precautions for XEOMIN® 100u
Common Side Effects:
- Therapeutic Use:
- Upper limb spasticity: Seizures, dry mouth, nasopharyngitis.
- Cervical dystonia: Dysphagia, neck pain, muscle weakness.
- Blepharospasm: Eyelid ptosis, dry eye, headache.
- Cosmetic Use:
- Glabellar lines: Headache, injection site bruising, facial asymmetry.
Precautions:
- Contraindications:
- Hypersensitivity to botulinum toxin or any ingredient in XEOMIN.
- Infection at the injection site.
- Warnings:
- Risk of toxin spread causing swallowing or breathing difficulties.
- Avoid injecting near sensitive areas to prevent ptosis or other complications.
Aftercare Following XEOMIN® 100u Treatment
Proper aftercare is crucial for patient safety and optimal outcomes:
- Do Not Manipulate Treated Areas: Avoid touching, rubbing, or applying pressure to the treated sites for 4 hours.
- Upright Position: Remain upright for at least 4 hours post-injection.
- Avoid Strenuous Activity: Refrain from physical exertion for 24 hours.
- Protect From Sun Exposure: Use sunscreen to prevent irritation or discoloration.
- Monitor for Side Effects: Report any unusual symptoms like difficulty swallowing or drooping eyelids.
Drug Interactions with XEOMIN® 100u
- Aminoglycosides: May enhance neuromuscular blocking effects.
- Anticholinergic Drugs: Can increase systemic side effects such as dry mouth or blurred vision.
- Other Botulinum Toxins: Avoid using concurrently to prevent compounded neuromuscular weakness.
XEOMIN® 100u Product Information
XEOMIN® 100u is a purified botulinum toxin type A used for therapeutic and cosmetic purposes. It is indicated for the treatment of upper limb spasticity, cervical dystonia, blepharospasm, and the temporary improvement of moderate to severe glabellar lines. XEOMIN works by inhibiting acetylcholine release, temporarily reducing muscle activity in the target areas.
Key Features and Benefits of XEOMIN® 100u
XEOMIN® offers various advantages for patients requiring muscle relaxation or wrinkle reduction:
- Purity: Does not contain complexing proteins, reducing the risk of antibody development.
- Precision: Provides localized action with a proven safety profile.
- Versatility: Effective for both medical and cosmetic indications.
- Long-Lasting Effects: Clinical effects last 3–4 months, depending on the indication.
Reconstitution Chart for XEOMIN® 100u
Proper reconstitution ensures accurate dosing and effectiveness. Use preservative-free 0.9% Sodium Chloride Injection, USP as the diluent.
- Dilution Guide:
- 0.5 mL: 20 units per 0.1 mL.
- 1 mL: 10 units per 0.1 mL.
- 2 mL: 5 units per 0.1 mL.
- 4 mL: 2.5 units per 0.1 mL.
Instructions:
- Inject the saline into the vial slowly to avoid foaming.
- Gently swirl to mix the solution (do not shake).
- Use the reconstituted solution within 24 hours and store at 2–8°C.
Storage Information for XEOMIN® 100u
- Unopened Vials:
- Can be stored at room temperature (20–25°C), refrigerated (2–8°C), or frozen (-20 to -10°C).
- Do not use after the expiration date.
- Reconstituted Solution:
- Must be refrigerated at 2–8°C.
- Discard unused portions after 24 hours.
Treatment Areas for XEOMIN® 100u
XEOMIN® is indicated for specific therapeutic and cosmetic treatments:
Therapeutic Indications:
- Upper Limb Spasticity:
- Targets muscles like the biceps, brachialis, and flexor digitorum.
- Cervical Dystonia:
- Injections focus on muscles such as the sternocleidomastoid and splenius capitis.
- Blepharospasm:
- Relieves eyelid spasms by targeting the orbicularis oculi muscle.
Cosmetic Indications:
- Glabellar Lines:
- Reduces vertical frown lines between the eyebrows.
- Five injection sites: two in each corrugator muscle and one in the procerus muscle.
Dosing for Different Indications of XEOMIN® 100u
Therapeutic Applications:
- Upper Limb Spasticity:
- Maximum dose: 400 units per session, with dosing tailored to the specific muscle groups.
- Cervical Dystonia:
- Initial dose: 120 units, adjustable based on the patient’s history and muscle mass.
- Retreatment interval: No sooner than every 12 weeks.
- Blepharospasm:
- Initial dose: 10–50 units per eye.
- Maximum dose: 70 units total.
Cosmetic Applications:
- Glabellar Lines:
- Total dose: 20 units, divided into five 4-unit injections.
- Retreatment interval: Every 3–4 months as needed.
Side Effects and Precautions for XEOMIN® 100u
Common Side Effects:
- Therapeutic Use:
- Upper limb spasticity: Seizures, dry mouth, nasopharyngitis.
- Cervical dystonia: Dysphagia, neck pain, muscle weakness.
- Blepharospasm: Eyelid ptosis, dry eye, headache.
- Cosmetic Use:
- Glabellar lines: Headache, injection site bruising, facial asymmetry.
Precautions:
- Contraindications:
- Hypersensitivity to botulinum toxin or any ingredient in XEOMIN.
- Infection at the injection site.
- Warnings:
- Risk of toxin spread causing swallowing or breathing difficulties.
- Avoid injecting near sensitive areas to prevent ptosis or other complications.
Aftercare Following XEOMIN® 100u Treatment
Proper aftercare is crucial for patient safety and optimal outcomes:
- Do Not Manipulate Treated Areas: Avoid touching, rubbing, or applying pressure to the treated sites for 4 hours.
- Upright Position: Remain upright for at least 4 hours post-injection.
- Avoid Strenuous Activity: Refrain from physical exertion for 24 hours.
- Protect From Sun Exposure: Use sunscreen to prevent irritation or discoloration.
- Monitor for Side Effects: Report any unusual symptoms like difficulty swallowing or drooping eyelids.
Drug Interactions with XEOMIN® 100u
- Aminoglycosides: May enhance neuromuscular blocking effects.
- Anticholinergic Drugs: Can increase systemic side effects such as dry mouth or blurred vision.
- Other Botulinum Toxins: Avoid using concurrently to prevent compounded neuromuscular weakness.
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