Bio

INVOSSA®-K inj
· Description A vial of Solution No. 1 (HC Vial): A white to off-white frozen solution contained in a colorless transparent vial. When thawed, a white to off-white injectable cell suspension.
A vial containing Solution No. 2 (TC Vial): A white to off-white frozen solution contained in a colorless transparent vial. When thawed, a white to off-white injectable cell suspension.
· Storage Store in an airtight container and the vapor phase of liquid nitrogen (at or below - 135℃)
· Shelf Life (Expiration Date) 24 months from the manufacturing date
· Package Unit In one kit, a vial of Solution No. 1 (2ml) and a vial of Solution No. 2 (1ml)
· Drug Substances and Contents
In one Kit, a vial of Solution
No. 1 (2 mL) and a vial of Solution No. 2 (1 mL) contain the following:
  • -A vial of Solution No. 1 (2 mL)
    • Active Ingredient: Human Chondrocyte (in-house spec.) 1.35x107
    • Freeze media: CryoStor 10 (in-house spec.) 2mL
  • -A vial of Solution No. 2 (1 mL)
    • Active Ingredient: Transduced Human Chondrocyte
      (in-house spec.)
      4.5x106
    • Freeze media: CryoStor 10 (in-house spec.) 1mL
Basic Information
Indications and Usage
Treatment of moderate knee osteoarthritis (Kellgren & Lawrence grade 3) with symptoms (e.g. pain) that persist despite three or more months of conservative treatment (medication, physical therapy, etc.)
Dosage and Administration (for Intra-articular Knee Injections)

Administer one kit (1.8x107 cells/3mL) by combining Solutions No. 1 and No. 2 into the intra-articular space of the knee of an adult. As this product is injected into the intra-articular space of the knee, care should be taken to prevent infections in preparation and administration through thorough disinfection. Refer to the following method of administration:

  1. 1) Thaw each vial containing Solution No. 1 and Solution No. 2 at 35 to 37℃ (may use a water bath, heating block, incubator, etc.) for three to five minutes.
  2. 2) Remove the cap from the vial and disinfect the rubber stopper with betadine or a similar disinfectant.
  3. 3) Prepare a 5 mL syringe and two new needles (18 to 21 G) additionally.
  4. 4) Fill the 5 mL syringe with the full amount of Solution No. 1.
  5. 5) Remove the existing needle from the syringe and attach a new needle (18 to 21 G) to the syringe filled with Solution No. 1.
  6. 6) Fill the 5 mL syringe containing Solution No. 1 with the full amount of Solution No. 2.
  7. 7) Tap the syringe carefully with a finger to ensure that cells are evenly suspended; care should be taken to prevent bubble formation.
  8. 8) Remove the existing needle from the syringe and attach a new needle (18 to 21 G).
  9. 9) Remove the solution from the syringe, leaving only 3 mL.
  10. 10) Slowly inject the prepared 3 mL of INVOSSA®-K inj. into the intra-articular space of the knee.
  11. 11) It is recommended that the patient stay overnight in a hospital for observation. However, if hospitalization is not feasible, they should rest for at least two hours and be observed closely.
Storage and Handling Precautions
  1. 1) This product can be stored at or below - 135℃ until the separately specified shelf life date.
  2. 2) This product must be transported to a hospital at or below - 70℃ within 72 hours of manufacture.
  3. 3) This product was manufactured in a sterile environment, and was not additionally sterilized. Therefore, this product must be kept sterile until it is prepared. Do not use the product if its container is damaged.
  4. 4) Since this product contains live allogeneic cartilage-derived chondrocytes, it must be promptly thawed in a water bath, heating block, or incubator. It is recommended that a mixed solution that has been thawed and prepared for administration should be used within 15 minutes at room temperature (15 to 25℃); however, the solution will remain stable for one hour at room temperature.
  5. 5) Do not refreeze the thawed product.
  6. ※ Follow your doctor’s or pharmacist’s instructions when using this product.
    ※ Damage caused by this product is subject to compensation in accordance with the Consumer Dispute Resolution Standard enforced by the Korea Fair Trade Commission. (If the shelf life or expiration date has already passed when you purchase the product and/or if the product is spoiled, deteriorated, or damaged, you may ask for an exchange or refund at the place of purchase.)
    ※ Please do not use the product after the shelf life has expired.
Contact us
  1. Phone : 02-3677-4020
  2. E-mail : invossa_k@kolon.com