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Description
Details
Composition
Each vial contains
- Active ingredient: Clostridium botulinum toxin type A 200 units(U) (Korean Minimum Requirement for Biopharmaceutical Product)
- Stabilizer: Human serum albumin 0.5mg (Korean Minimum Requirement for Biopharmaceutical Product)
- Isotonic agent: Sodium chloride (EP) 0.9mg
* One unit(U) of Meditoxin corresponds to the calculated median intraperitoneal lethal dose (LD50) in mice.
Description
It appears as a lyophilized white powder for injection in a colorless transparent vial.
Proven Efficacy & Safety
The efficacy and the safety of Meditoxin are proved to be comparable to Botox(Allergan Inc.)’s in various clinical studies.
Comparative clinical study for essential blepharospasm with Meditoxin vs. Botox
Methodology: Multi-center, double-blinded, randomized, active-controlled, parallel designed, phase Ⅲ clinical study.
Subjects: 60 patients diagnosed as essential blepharospasm (Meditoxin n=31 / Botox n=29).
Results: The efficacy of Meditoxin was not inferior to Botox in this clinical study. No difference was noted in the frequency of the adverse events.
Meditoxin can be safely used as an alternative to Botox treatment at 1:1 equivalence.
Comparative clinical study for equinus deformity in cerebral palsy with Meditoxin vs. Botox
Methodology: Multi-center, double-blinded, randomized, active-controlled, parallel designed, phase Ⅲ clinical study
Subjects: 119 pediatric patients diagnosed as spastic cerebral palsy with equinus foot deformity (Meditoxin n=60 / Botox n=59)
Results: Meditoxin was not inferior to Botox in this clinical study. No differences were noted in the frequency of the adverse events.
Meditoxin can be safely used as an alternative to Botox treatment.
Indication
1. Meditoxin is indicated for the treatment of benign essential blepharospasm in patients 18 years of age and above.
2. Meditoxin is indicated for the treatment of equinus foot deformity due to spasticity in pediatric cerebral palsy patients 2 years of age and above.
Storage
The unopened lyophilized vial should be stored in a freezer(blow -5℃) or refrigerator (2~8℃).
How supplied
Meditoxin is supplied in a single-use vial.
Expiration
The shelf-life of Meditoxin is 36 months from the manufacturing date.
Specification
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