GAMMAPLEX® 5%

FDA INDICATION: Primary immunodeficiency disease (PIDD) and idiopathic thrombocytopenic purpura (ITP) Package Insert

FORM: Liquid

DISTRIBUTOR: Bio Products Laboratory

ROUTE OF ADMINISTRATION: Intravenous

PH (AFTER RECONSTITUTION): 4.8–5.1

CONCENTRATION: 5%

IGA CONTENT: <10 μg/mL

% IGG: ≥95%

NA CONTENT: 0.3 g NaCl

DILUENT: N/A

OSMOLALITY (MOSM/L): ≥240 (typically 420–500)

INITIAL INFUSION RATE: 0.5 mg/kg/min (0.01 mL/kg/min) for 15 minutes, then gradually increase to 4mg/kg/min (0.08 mL/kg/min)

SUGAR CONTENT: 5 g D-sorbitol in 100 mL of buffer solution

SHELF LIFE: 36 months

STORAGE REQUIREMENTS: Store at room temperature at 2–25°C (36–77°F). Do not freeze. Protect from light.

FLUSHING COMPATIBILITY: Saline or dextrose

OTHER WEBSITES: gammaplex.com