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CNJ-016 Injection Dosage

Generic name: HUMAN VACCINIA VIRUS IMMUNE GLOBULIN 1[iU] in 1mL
Dosage form: injection

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

For intravenous use only.

2.1 Dosage for Treatment of Severe Complications of Vaccinia Vaccination

VIGIV should be administered at a dose of 6,000 Units per kg, as soon as symptoms appear and are judged to be due to severe vaccinia-related complication. Consideration may be given to repeat dosing, depending on the severity of the symptoms and response to treatment; however, clinical data on repeat doses are lacking. The administration of higher doses (e.g. 9,000 Units per kg) may be considered in the event that the patient does not respond to the initial 6,000 Units per kg dose. In clinical trials, doses of up to 24,000 Units per kg administered to healthy volunteers were well tolerated [see 14 CLINICAL STUDIES].

2.2 Preparation

Visually inspect parenteral products for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use CNJ-016 if the solution is turbid.
DO NOT SHAKE VIAL. SHAKING VIAL MAY CAUSE FOAMING.
Remove the entire contents of the vial to obtain the labeled dosage of CNJ-016. If partial vials are required for the dosage calculation, the entire contents of the vial should be withdrawn to ensure accurate calculation of the dosage requirement.
CNJ-016 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, the line should be flushed with 0.9% Sodium Chloride USP before use. Do not dilute more than 1:2 (v/v).
CNJ-016 vial is for single use only. Do not reuse or save CNJ-016 for future use.
CNJ-016 contains no preservatives. Discard partially used vials.

Administration

Parenteral products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. CNJ-016 should not be used if the solution is turbid.
Administer CNJ-016 intravenously through a dedicated intravenous line with the rate of infusion of no greater than 2 mL/min.
The maximum rate of infusion utilized for CNJ-016 is 4 mL/min [see 6.1 Clinical Trials Experience].
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).
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.
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 5.3 Thrombotic Events].

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