PANZYGA Solution for injection Ref.[10905] Active ingredients: Human normal immunoglobulin G Immunoglobulins, normal human, IV

For intravenous use only.

2.1 Dose

^* Significant differences in the half-life of IgG among patients with PI may necessitate the dose and frequency of immunoglobulin therapy to vary from patient to patient. Determine the proper dose and frequency by monitoring the clinical response. Adjust dose over time to achieve the desired trough levels of IgG and clinical responses.

The initial infusion rate should be maintained for 30 min. Following the initial infusion, and if tolerated, the infusion rate may be gradually increased every 15-30 minutes, as tolerated to the maximum infusion rate shown in the table above for each indication.

Measles Exposure

If a patient with primary humoral immunodeficiency has been exposed to measles, it may be prudent to administer an extra dose of IGIV as soon as possible and within 6 days of exposure. A dose of 400 mg/kg should provide a serum level >240 mIU/mL of measles antibodies for at least two weeks.

If a patient with primary humoral immunodeficiency is at risk of future measles exposure and receives a dose of less than 530 mg/kg every 3-4 weeks, the dose should be increased to at least 530 mg/kg. This should provide a serum level of 240 mIU/mL of measles antibodies for at least 22 days after infusion.

2.2 Administration

• Inspect parenteral products visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use PANZYGA if it is turbid and/or if discoloration is observed. Using a needle, no larger than a 16-gauge needle, insert the needle only once within the stopper area (delineated by the raised ring for penetration). Penetrate the stopper perpendicularly to its plane and within the ring.
• PANZYGA bottles may be pooled under aseptic conditions into sterile infusion bags. Infuse within 8 hours after pooling.
• Administer at room or body temperature only by the intravenous route
• PANZYGA is not supplied with an infusion set. If a filtered infusion set is used (not mandatory), choose a filter size of 0.2-200 microns.
• Do not administer PANZYGA simultaneously with another intravenous preparation in the same infusion set, including immune globulin products from another manufacturer.
• After administration, the infusion line may be flushed with either normal saline or 5% dextrose in water.
• Monitor the patient carefully throughout the infusion. Certain adverse drug reactions are related to the rate of infusion, and will disappear promptly after slowing or stopping the infusion. In such cases, after symptoms subside, resume the infusion at a lower rate. Ensure that patients with pre-existing renal insufficiency are not volume depleted. For patients at risk of renal dysfunction or thromboembolic events, administer PANZYGA at the minimum infusion rate practicable [see Warnings and Precautions (5.2, 5.4)]. Do not exceed 3.3 mg/kg/min (0.033 mL/kg/min). Discontinue if renal function deteriorates.

With intravenous administration, overdose may lead to fluid overload and hyperviscosity. Patients at risk of complications of fluid overload and hyperviscosity include elderly patients and those with cardiac or renal impairment.

Store PANZYGA for 36 months at +2°C to +8°C (36°F to 46°F) from the date of manufacture. Within its shelf-life, the product may be stored at ≤ +25°C (77°F) for up to 12 months. After storage at ≤ +25°C (77°F), either use immediately or discard the product.

Do not use after expiration date.

Do not freeze. Do not use frozen product.

PANZYGA contains no preservatives. The PANZYGA bottle is for single use only. Use promptly any bottle that has been entered or opened, and discard partially used bottles.

Dispose of any unused product or waste material in accordance with local requirements.