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The Efficacy Study of our product involves assessing its effects on Compound Muscle Action Potential (CMAP). When administered to a single muscle,the product exhibits contraction suppression and muscle palsy effects, which vary depending on the concentration of administration. Notably, our product demonstrated comparable efficacy to the well-known Botox liquor, and its muscle contraction inhibition was found to persist effectively at certain doses (5 units/kg).
Clinical Sample Production:
We meticulously produce clinical samples of our product to ensure its quality, safety, and efficacy. These samples undergo rigorous testing and analysis before advancing to further stages.
Clinical CRO Selection:
IND Document Submission/Examination/Approval:
We compile and submit the Investigational New Drug (IND) documents to regulatory authorities for examination and approval. These documents provide detailed information on the product's safety, preclinical data, and proposed clinical trial protocols.
Permission for Export:
Clinical Trials (Phase I and II):
To evaluate the safety and efficacy of our product, we conduct comprehensive Phase I and II clinical trials on human participants. These trials are designed to assess the product's tolerability, dosage, and potential side effects.
KGMP License:
Manufacturing Process, Domestic Patents, and PCTs:
Our product's manufacturing process is carefully developed, incorporating domestic patents and Patent Cooperation Treaty (PCT) protection. These measures safeguard our proprietary technology and ensure its exclusivity.
Domestic Patent for Drying Process:
We hold a domestic patent for our innovative drying process, optimizing the quality and stability of the final product.
Composition:
Each vial of our product contains 100 units of Clostridium botulinum Toxin Type A (IHS), 0.5mg of Human Serum Albumin (EP), and 0.9mg of Sodium Chloride (EP). We utilize strains identified with Clostridium botulinum ATCC 3502, guaranteeing consistent and reliable performance.
Securing Stable Production Process Technology:
High Purity Undiluted Solution:
We are proud to produce an undiluted solution with a purity of more than 99%. This high purity enhances the product's efficacy and minimizes the risk of adverse reactions.
Low Incidence of Resistance:
Our product's unique formulation allows for small amounts of stock solution to be injected per vial, leading to a significantly low incidence of resistance within the same product group. This highlights our commitment to providing long-lasting and effective results.
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.
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