CNJ-016 Solution for injection Ref.[9912] Active ingredients: Vaccinia immunoglobulin

For intravenous use only.

2.1 Dosage for Treatment of Severe Complications of Vaccinia Vaccination

Administer VIGIV at a dose of 6000 Units per kg, as soon as symptoms appear and are judged to be due to severe vaccinia-related complication. Consider repeat dosing, depending on the severity of the symptoms and response to treatment; however, clinical data on repeat doses are lacking. Consider higher doses (e.g. 9000 Units per kg) if the patient does not respond to the initial 6000 Units per kg dose. Doses up to 24,000 Units per kg administered to healthy volunteers were well tolerated in clinical trials [see 14 CLINICAL STUDIES].

2.2 Preparation

• Bring VIGIV vials to room temperature prior to dosing.
  • If frozen, thaw vial by placing in a refrigerator at 36 to 46°F (2 to 8°C) until the contents are thawed for approximately 14 hours. Product can be thawed rapidly by placing at room temperature for one hour followed by a water bath at 98.6°F (37°C) until thawed.
  • Do not thaw this product in a microwave oven.
  • Do not refreeze the vial.
• DO NOT SHAKE VIAL. SHAKING VIAL MAY CAUSE FOAMING.
• Remove the entire contents of the vial to obtain the labeled dosage of VIGIV. If partial vials are required for the dosage calculation, withdraw the entire contents of the vial to ensure accurate calculation of the dosage requirement.
• VIGIV is compatible with 0.9% Sodium Chloride USP. No other drug interactions or compatibilities have been evaluated. If a pre-existing catheter must be used, flush the line with 0.9% Sodium Chloride USP before use. VIGIV may be administered either undiluted or diluted no more than 1:2 (v/v).
• VIGIV vial is for single use only. Do not reuse or save VIGIV for future use.
• VIGIV contains no preservatives. Discard partially used vials.

Administration

• Inspect the product prior to use and do not use if solution is cloudy, discolored or contains particulates.
• Administer VIGIV intravenously through a dedicated intravenous line with the rate of infusion of no greater than 2 mL/min.
• For patients weighing less than 50 kg, infuse the product at a rate no greater than 0.04 mL/kg/minute (133.3 Units per kg/minute).
• Adverse drug reactions may be related to the rate of infusion. Slower infusion rate may be needed for patients who develop a minor adverse reaction (e.g. flushing) or for patients with risk factors for thrombosis/thromboembolism.
• Closely monitor and carefully observe patients and their vital signs for any symptoms throughout the infusion period and immediately following an infusion.
• For patients with pre-existing renal insufficiency, or at increased risk of acute kidney injury, thrombosis, or volume overload, do not exceed the recommended infusion rate and follow the infusion schedule closely.
• For patients with risk factors for thrombosis, the maximum daily dose of VIGIV should not exceed 12,000 Units per kg [see 5.4 Thrombosis]

Product may be stored frozen at or below 5°F (≤ -15°C) or refrigerated at 36 to 46°F (2 to 8°C); refer to label for appropriate storage conditions. Do not use after expiration date.

If product is received frozen, use within 60 days of thawing at 2 to 8°C. Begin intravenous infusion within 4 hours after entering the vial.

Do not reuse or save VIGIV for future use. This product contains no preservative; therefore, discard partially used vials.