Newlux 100U Botulinum Toxin Type A
150kDa purified Clostridium botulinum toxin from Hall strain. Manufactured via cGMP-compliant Size Exclusion Chromatography (SEC) and Ion Exchange Chromatography (IEC). Engineered for precise localized targeting with a fixed 0.5cm³ diffusion radius.
Phase III Clinical Efficacy (n=324): 82% reduction in severe glabellar lines at 30 days post-administration.
Pharmacodynamics: Initial onset 48-72 hours. Peak therapeutic effect at 14 days. Sustained denervation duration: 12-16 weeks.
Excipients: 0.5mg Human Serum Albumin (HSA), 0.9mg Sodium Chloride.
Active Neurotoxin Purity: 98.7%
Monomeric Form Ratio: 99.3%
Endotoxin Level: < 0.1 ng/vial
Solution pH Balance: 6.8
Molecular Weight: 150 kDa
RECONSTITUTION
Vacuum-dried lyophilized powder. Inject 2.5mL sterile, preservative-free 0.9% Sodium Chloride into the 100U vial. Yields a concentration of 4U per 0.1mL. Rotate gently; do not agitate.
STABILITY PROTOCOL
Unopened shelf life: 36 months when stored at 2-8°C. Post-reconstitution: Administer within 24 hours. Must maintain continuous 2-8°C cold chain during transport and storage.
ADMINISTRATION GUIDELINES
Target corrugator and procerus muscle complex.
Inject exactly 0.1mL (4U) per muscular site.
Distribute evenly across 5 standard injection sites.
Maximum dosage: 20U per aesthetic treatment session.
Maintain strict vertical insertion (90° injection angle).
Avoid superficial dermal tracking to prevent ptosis.
CONTRAINDICATIONS
Strictly for administration by certified medical practitioners. Contraindicated in individuals diagnosed with Amyotrophic Lateral Sclerosis (ALS), Myasthenia Gravis, or Lambert-Eaton syndrome. Absolute maximum cumulative dosage is 300U within a 90-day biological period. Clinical outcomes vary ±15% dependent on regional muscle mass and precise injection depth.

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