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Finetox
- Clostridium Botulinum Toxin Type A (100 Units)
Finetox is a high-purity botulinum toxin formulation designed to maximize product stability and procedural efficiency through a vacuum-drying process.
- Certifications
- KFDA (Export Only)
- Storage
- Store under refrigeration (2°C–8°C)
- Shelf Life
- 2 years from the date of manufacture
- Unit Size
- 1 vial / 100 Units, 1 BOX / 10 vials
- Made in
- Republic of Korea
More Information
01What is FINETOX?
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Appearance
White or slightly yellow dried product in a clear colorless vial and transparent solution when dissolved in normal saline.
Indication
Temporary improvement of moderate to severe glabellar wrinkles due to activities of the corrugator and/or procerus muscles in adults between the ages of 19 and 65.
02Identification
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SDC-PAGE patterns of botulinum toxin protein are the same as standard.
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The purity of FINETOX was determined to be 99.6% with SEL-HPLC.
03Pre-Clinical Study
Nonclinical studies of FINETOX were conducted in mice, rats, rabbits, and monkeys.
| Category | Study | Title of Study |
|---|---|---|
| Toxicity Study | Single-Dose Toxicity Study in Rodents | An Intramuscular Single-Dose Toxicity Study In Rats |
| Repeared-Dose Toxicity Srudy in Rodents | A 4-Week Intramuscular Repeated-Dose Toxicity Study in Rats with a 4-Week Recovery Period | |
| Single-Does Toxicity Study in Non-Rodents | An Intramuscular Single-Dose Toxicity Study in Monkeys | |
| Repeated-Dose Toxicity Study in Non-Rodents | Reproductive Toxicity : An Intramuscular Preliminary Embryo-Fetal Developmental Study in Rats | |
| Reproductive Toxicity Study in Rodents | Reproductive Toxicity : An Intramuscular Preliminary Embryo-Fetal Developmental Study in Rabbits | |
| in Non-Rodents | Reproductive Toxicity : An Intramuscular Embryo-Fetal Developmental Study in Rabbits | |
| Safety Pharmacology Study | Central Nervous System Safety Pharmacology Study | A Study of Effects on Body Temperature and Systemic Activity in Mice |
| Cardiovascular System Safety Pharmacology Study | A Study of Effects on Respiratory Rate and Tidal Volume in Rats | |
| Cardiovascular System Safety Pharmacology Study | hERG Assay | |
| Pharmacodynamics Study | Stability and Effcacy Study | A 24-Week Effcacy Study with Comparator Botox in Rats |
04Efficacy Study 1
According to the electromyography in rats, FINETOX has inhibitory effects on neuronal electrical signal transduction comparable to those of the Brand A product.
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Compound muscle action potential (CMAP)
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| Group | Substance administered | Dose | Volume |
|---|---|---|---|
| Control | Saline | 0 U/kg | 20μL |
| A6.0 U | Brand A | 36 U/kg | |
| B6.0 U | FINETOX | 36 U/kg |
To compare FINETOX with Brand A, 6.0 U Botulinum toxin was injected into the lateral gastrocnemius muscle of the right leg of a rat for electromyography at 0-, 4-, 8-, 12-, 16-, 20- and 24-week.
05Efficacy Study 2
In an MRI for muscle volume assessment in rats, FINETOX has shown its activity that promotes muscle volume reduction comparable to that of the Brand A.
(The sizes of the lateral gastrocnemius muscle of the right leg, the whole leg muscle, and the calf are measured with MRI before and 4, 8, 12, and 24 weeks after injection.)
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Change in lateral Gastrocnemius muscle of the right leg
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Change in whole muscle area
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Change in calf area
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