FLEBOGAMMA® 5% DIF

FDA INDICATION: Primary immunodeficiency disease (PIDD) Package Insert

FORM: Liquid

DISTRIBUTOR: Grifols

ROUTE OF ADMINISTRATION: Intravenous

PH (AFTER RECONSTITUTION): 5–6

CONCENTRATION: 5%

IGA CONTENT: <50 μg/mL

% IGG: ≥97%

NA CONTENT: Trace amounts

DILUENT: N/A

OSMOLALITY (MOSM/L): 240–370

INITIAL INFUSION RATE: Initial rate of 0.01 mL/kg body weight/min. If tolerated during first 30 minutes, can be gradually increased to a max of 0.1 mL/kg/min.

SUGAR CONTENT: 5 g D-sorbitol (as stabilizer) in 100 mL of water for injection

SHELF LIFE: 24 months

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

FLUSHING COMPATIBILITY: Saline or dextrose

OTHER WEBSITES: grifols.com