2 DOSAGE AND ADMINISTRATION
For intravenous use only.
Administer ATGAM intravenously and use with concomitant immunosuppressants.
2.1 Dosing Information
2.2 Preparation and Administration InstructionsPreparation of Solution
- •
- Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. However, because ATGAM is a gamma globulin product, it can be transparent to slightly opalescent, colorless to faintly pink or faintly brown, and may develop a slight granular or flaky deposit. Do not shake ATGAM (diluted or undiluted) because excessive foaming and/or denaturation of the protein may occur.
- •
- Dilute ATGAM for intravenous infusion in an inverted bottle/bag of sterile vehicle so the undiluted ATGAM does not contact the air inside. Add the total daily dose of ATGAM to the sterile vehicle (see Compatibility and Stability). Do not exceed a concentration of 4 mg of ATGAM per mL. Gently rotate or swirl the diluted solution to effect thorough mixing.
Administration
Diluted ATGAM should be at room temperature before infusion. ATGAM is appropriately administered into a vascular shunt, arterial venous fistula, or a high-flow central vein using an in-line filter (not supplied) with a pore size of 0.2 to 1.0 micron. Use the in-line filter (not supplied) with all infusions of ATGAM to prevent the administration of any insoluble material that may develop in the product. Use high-flow veins to minimize the occurrence of phlebitis and thrombosis. Infuse ATGAM over a period of at least 4 hours. Monitor patients for signs and symptoms of anaphylaxis during infusion and for at least 24 hours after infusion [see Warnings and Precautions (5.1) and Adverse Reactions (6)].
- •
- Once diluted, ATGAM has been shown to be physically and chemically stable for up to 24 hours at concentrations of up to 4 mg per mL in the following diluents: 0.9% Sodium Chloride Injection, 5% Dextrose and 0.225% Sodium Chloride Injection, and 5% Dextrose and 0.45% Sodium Chloride Injection.
- •
- Do not dilute ATGAM in Dextrose Injection, USP, as low salt concentrations may cause precipitation. Do not use highly acidic infusion solutions since these solutions may contribute to physical instability over time.
- •
- Store diluted ATGAM at room temperature. The diluted solution must be infused within 24 hours (including infusion time).
Preparation of Solution
- •
- Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. However, because ATGAM is a gamma globulin product, it can be transparent to slightly opalescent, colorless to faintly pink or faintly brown, and may develop a slight granular or flaky deposit. Do not shake ATGAM (diluted or undiluted) because excessive foaming and/or denaturation of the protein may occur.
- •
- Dilute ATGAM for intravenous infusion in an inverted bottle/bag of sterile vehicle so the undiluted ATGAM does not contact the air inside. Add the total daily dose of ATGAM to the sterile vehicle (see Compatibility and Stability). Do not exceed a concentration of 4 mg of ATGAM per mL. Gently rotate or swirl the diluted solution to effect thorough mixing.
Administration
Diluted ATGAM should be at room temperature before infusion. ATGAM is appropriately administered into a vascular shunt, arterial venous fistula, or a high-flow central vein using an in-line filter (not supplied) with a pore size of 0.2 to 1.0 micron. Use the in-line filter (not supplied) with all infusions of ATGAM to prevent the administration of any insoluble material that may develop in the product. Use high-flow veins to minimize the occurrence of phlebitis and thrombosis. Infuse ATGAM over a period of at least 4 hours. Monitor patients for signs and symptoms of anaphylaxis during infusion and for at least 24 hours after infusion [see Warnings and Precautions (5.1) and Adverse Reactions (6)].
- •
- Once diluted, ATGAM has been shown to be physically and chemically stable for up to 24 hours at concentrations of up to 4 mg per mL in the following diluents: 0.9% Sodium Chloride Injection, 5% Dextrose and 0.225% Sodium Chloride Injection, and 5% Dextrose and 0.45% Sodium Chloride Injection.
- •
- Do not dilute ATGAM in Dextrose Injection, USP, as low salt concentrations may cause precipitation. Do not use highly acidic infusion solutions since these solutions may contribute to physical instability over time.
- •
- Store diluted ATGAM at room temperature. The diluted solution must be infused within 24 hours (including infusion time).