MegaCure®
MegaCure®
Medical Device
| Principle of action |
This product is a gel-type product containing cross-linked hyaluronic acid and water for injection in powdered cross-linked ADM derived from human body. By applying the product to the wound area, it protects the wound area and maintains a moist environment to act as a covering material. It can also be easily applied to the wound without a separate process such as mixing with sterile distilled water or normal saline. |
| Purpose of use |
It can be used on all open wounds that have not healed such as trauma and chronic ulcers. However, it is not used for third-degree burns. |
| Storage method and Shelf life |
1) Room temperature (1~30’C) 2) Avoid direct sunlight and high temperature and high humidity 3 years from the date of manufacture |
| Precautions for use |
A. General Notices 1) The instruction for use and precautions shall be read and unless the user follow the instruction for use and precautions, performance, infection, or side effects may arise. 2) It shall be used only by medical professionals and be used only as intended. 3) If side effects are discovered in the transplanted patient, immediately report it to the Ministry of Food and Drug Safety, and the hospital and doctor who performed the transplant will take necessary medical measures for the patient. 4) It is prohibited transplant this product into the body. B. Notices regarding adverse events after use of medical device and deadly side effects of accidents due to careless handling 1) The user's arbitrary reuse may lead to sterilization destruction and microbial contamination of the product, and if the contaminated product is used, inflammation, fever, edema, allergy, etc. may occur. 2) If the expiration date of the product has passed, the use of the product is prohibited. If an expired product is used, inflammation, fever, edema, etc. may occur. C. Use for pregnant women, lactating women, childbearing women, newborns, infants, children, the elderly 1) There are no clinical data for this product for pregnant or lactating women. Its use is not recommended for safety reasons. 2) Since clinical trials have not been conducted on the safety and efficacy of this product for children, its use is not recommended. D. Notices in application 1) This product is a Gamma sterilized product and must not be re-sterilized, and once opened, the product must not be re-sterilized and reused. 2) Each individually packaged product should only be used on one patient. E. Requirements for prevention of accidents 1) Since this product is manufactured through a GMP process certified by the Ministry of Food and Drug Safety, it is recommended to use this product in an environment (sterile environment) and facilities similar to the manufacturing environment when using this product. 2) The affected area where the transplantation takes place shall be kept non-contaminated. |
