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GAMMAPLEX® 5%
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