Botulism immune globulin iv

Contraindications

Documented hypersensitivity; selective immunoglobulin A deficiency

Cautions

Aseptic meningitis syndrome reported

Acute renal dysfunction may occur

Assess renal function prior to and following administration

Hyperproteinemia, increased serum viscosity and hyponatremia may occur in patients receiving IGIV therapy

Hemolytic anemia can develop subsequent to IGIV therapy due to enhanced RBC sequestration

The product is made from human plasma and may contain infectious agents, e.g. viruses and, theoretically, the Creutzfeldt-Jakob disease agent

Patients should not be volume depleted (hypovolemic) prior to therapy

For IV infusion only; do not exceed recommended rate of administration

IV Incompatibilities

Additive

IV Compatibilities

Solution

Sodium Chloride Injection USP, or one of the following dextrose solutions (with or without NaCl added): 2.5% dextrose in water, 5% dextrose in water, 10% dextrose in water, or 20% dextrose in water

IV Preparation

IV infusion

100 mg ± 20 mg lyophilized immunoglobulin per single-dose vial

Reconstitute the lyophilized powder with 2 mL of Sterile Water for Injection USP, to obtain a 50 mg/mL BabyBIG solution. A double-ended transfer needle or large syringe is suitable for adding the water for reconstitution. When using a double-ended transfer needle, insert one end first into the vial of water. The lyophilized powder is supplied in an evacuated vial; therefore, the water should transfer by suction (the jet of water should be aimed to the side of the vial). After the water is transferred into the evacuated vial, the residual vacuum should be released to hasten the dissolution.

Rotate the container gently to wet all the powder. An approximately 30-minute interval should be allowed for dissolving the powder. DO NOT SHAKE THE VIAL, AS THIS WILL CAUSE FOAMING.

Inspect BabyBIG visually for particulate matter and discoloration prior to administration. Infuse the solution only if it is colorless, free of particulate matter, and not turbid.

To prevent the transmission of hepatitis viruses or other infectious agents from one person to another, use sterile disposable syringes and needles. Never reuse syringes and needles.

IV Administration

Do not pre-dilute BabyBIG before infusion.

Begin infusion within 2 hours after reconstitution is complete and conclude within 4 hours of reconstitution, unless infusion is temporarily interrupted for adverse reaction. Monitor vital signs continuously during infusion.

Administer intravenously using low volume tubing and a constant infusion pump (i.e., an IVAC pump or equivalent) through a separate intravenous line.

If a pre-existing line must be used, do not dilute BabyBIG more than 1:2 with any of the solutions.

Storage

Store the vial containing the lyophilized product between 2o and 8oC (35.6o to 46.4oF). Do not store BabyBIG in the reconstituted state.

Use reconstituted BabyBIG within 2 hours.

Do not use beyond expiration date, and dispose unused product in accordance with local requirements.