NOVATOX 100U

Compound Muscle Action Potential (CMAP) Insights

Our product undergoes rigorous testing, with a spotlight on Compound Muscle Action Potential (CMAP). Single muscle administration results in unparalleled contraction suppression and muscle palsy effects. Comparative studies with Botox liquor demonstrate equivalence, emphasizing high muscle contraction inhibition persistence at certain doses (5 units/kg).

Clinical Journey: From Concept to Approval

• Clinical Sample Production: Meticulous creation of clinical samples to ensure consistent quality.
• Clinical CRO Selection: Collaboration with reputable Clinical Research Organizations for robust clinical trials.
• IND Document Submission/Examination/Approval: Rigorous regulatory processes to meet international standards.
• Permission for Export: Securing permissions for global distribution.
• Clinical Trials (Phase I and II): Comprehensive trials to assess safety and efficacy.
• KGMP License: Compliance with Korean Good Manufacturing Practice standards.
• Manufacturing Process: Innovation in the production process, securing domestic patents and PCTs.
• Domestic Patent for Drying Process: Exclusive patent for a cutting-edge drying process.

Composition: Quality in Every Vial

• 100 Units of Clostridium Botulinum Toxin Type A (IHS): The active ingredient for effective muscle contraction inhibition.
• 0.5mg of Human Serum Albumin (EP): Enhancing stability and bioavailability.
• 0.9mg of Sodium Chloride (EP): Maintaining isotonicity.
• Use of Strains Identified with Clostridium Botulinum ATCC 3502: Ensuring consistency and quality.
• Securing Stable Production Process Technology: Simplifying the undiluted solution manufacturing process.
• Production of More than 99% Undiluted Solution: Ensuring potency and effectiveness.

Innovation in Resistance Management

The small amount of stock solution injected per vial contributes to a significantly low incidence of resistance within the same product group. This innovation emphasizes our commitment to efficacy and longevity of results.

Embark on a journey of transformation with our groundbreaking solution, meticulously crafted and rigorously tested for optimal results. Our commitment to excellence ensures a product that stands at the forefront of muscle contraction inhibition.

Uses

The primary indications for Novatox 100U involve its application in treating specific diseases or conditions. It may be utilized in various medical fields, including but not limited to:

• Neurology: For conditions related to muscle spasticity.
• Cosmetic Procedures: Often used for reducing wrinkles and fine lines through muscle relaxation.

The effectiveness of Novatox 100U can vary based on individual patient factors, including age, health status, and concurrent medications.

Dosage

The recommended dosage of Novatox 100U should be determined by a qualified healthcare provider based on the patient’s condition and response to treatment. Typically, dosages are measured in units (e.g., 100 units) and administered via injection. It is critical to adhere to prescribed dosages to minimize risks associated with overdosage or underdosage.

Administration

Novatox 100U is usually administered through intramuscular injections by trained healthcare professionals. Proper technique is essential to ensure effective delivery and minimize discomfort or complications at the injection site.

Side Effects

Like any pharmaceutical product, Novatox 100U may have side effects. Common side effects can include:

• Localized pain at the injection site
• Headaches
• Nausea
• Temporary muscle weakness

Serious adverse reactions are rare but can occur; therefore, patients should be monitored closely after administration.