DOSING

Preparation For Administration

  1. Do not shake the content of the vial. A vigorous shaking could denature the protein and affect the biological activity of the product.
  2. Product should be inspected visually for particulates and discoloration prior to administration, and if these are present, do not use the product.
  3. Use a sterile syringe and appropriate aseptic technique. Remove the cap from the vial containing TheraCIM® (Nimotuzumab) and clean the top of the vial with anti-bacterial solution, and insert the needle into the vial to extract the content.
  4. The TheraCIM® (Nimotuzumab) at the selected dosage should be diluted in 250 ml of sodium chloride 0.9%.

 

Administration

  1. The recommended dosage of TheraCIM® (Nimotuzumab) in each indication is administered as continuous intravenous (IV) infusions combination with a standard radiotherapy and/or chemotherapy.
  2. Nimotuzumab is diluted in 250 ml of sodium chloride 0.9% solution and administered intravenously within 60 minutes for adult patients and 30 minutes for pediatric/adolescent patients.
  3. Pretreatment with diphenhydramine is recommended to minimize possible infusion reaction especially for patients having history of hypersensitivity reaction to any monoclonal antibody or any medicinal products.
  4. TheraCIM® (Nimotuzumab) is formulated as a stable concentrated solution. The solution is clear, free from visible particulate matters, both before and after dilution in isotonic saline solution. Intravenous infusion of the diluted solution does not require the use of an in-line filter during infusion.

 

Storage Conditions

  1. TheraCIM® (Nimotuzumab) should be stored in refrigerator at 2-8 °C. The biological activity of the antibody may be lost after freezing and thawing. Do not freeze or shake
  2. The antibody diluted in the saline buffer is physically and chemically stable for up to 72 hours when stored at room temperature (25 ± 3°C). Nimotuzumab diluted in saline buffer may not be active beyond these conditions, the solution should be discarded and fresh solution should be prepared for infusion.

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