Toxta 100U | Clinical-Grade Botulinum Toxin Type A
Access restricted to licensed healthcare professionals (HCPs). ClinicalTrials.gov ID: NCT0382XXXX.
Pharmacological Profile
Active Substance: Clostridium Botulinum Toxin Type A (Strain: Hall Hyper)
Purity: 99.8% (HPLC-verified)
Molecular Weight: 900 kDa
Protein Load: ≤1.5ng/(Minimized immunogenicity)
Excipients: 0.5mg Human Serum Albumin (HSA), 0.9mg Sodium Chloride
Endotoxin Level: ≤0.05 EU/
Clinical Efficacy & Data
Phase III Trials: N=320 randomized, double-blind, active-controlled.
Efficacy Rate: 82% of subjects demonstrated ≥2-grade improvement on the Facial Wrinkle Scale (FWS) at Day 30.
Onset: 5-14 days post-injection.
Duration: 4-6 months.
Technology: JETEMA Vacuum-Drying (Maintains 98% biological activity post-reconstitution).
Standard Reconstitution & Administration Protocol
Diluent: 2.5mL of 0.9% Preservative-Free Sodium Chloride.
Target Concentration: 4U / 0.1mL.
Specification: 30G to 31G micro-.
Intramuscular Administration: 4U (0.1mL) per injection site. Maximum cumulative dose: 50U per session.
Storage: Store unopened at 2-8°C. Administer within 24 hours post-reconstitution (store at 2-8°C). Shelf life: 36 months.
Regulatory Compliance & Contraindications
Class III Medical Device (). Contraindicated in patients with known hypersensitivity to botulinum toxin type A or any formulation excipients, pregnant or lactating women, and individuals with diagnosed neuromuscular junction disorders (e.g., Myasthenia Gravis). Refer to full prescribing information prior to administration. JETEMA Patent No. KR 10-2018-0034567.

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