GAMMAKED®

FDA INDICATION: Primary immunodeficiency disease (PIDD), idiopathic thrombocytopenic purpura (ITP), chronic inflammatory demyelinating polyneuropathy (CIDP) Package Insert

FORM: Liquid

DISTRIBUTOR: Kedrion Biopharma

ROUTE OF ADMINISTRATION: Intravenous (IV) or Subcutaneous (SC)

PH (AFTER RECONSTITUTION): 4–4.5

CONCENTRATION: 10%

IGA CONTENT: 46 μg/mL

% IGG: ≥98%

NA CONTENT: 1.3 mmol/L

DILUENT: N/A

OSMOLALITY (MOSM/L): 258

INITIAL INFUSION RATE (IV ONLY): PIDD: 1 mg/kg/min
ITP: 1 mg/kg/min
CIDP: 2 mg/kg/min

INITIAL INFUSION RATE (SC ONLY): PIDD: 20 mL/hr/site

SUGAR CONTENT: No added sugars

SHELF LIFE: 36 months in the refrigerator. At room temperature for up to 6 months anytime during the 36-month shelf life, after which the product must be immediately used or discarded.

STORAGE REQUIREMENTS: Store in the refrigerator or at room temperature per shelf life. Do not freeze.
Refrigeration: 2–8°C (36–46°F)
Room temperature: up to 25°C (77°F)

FLUSHING COMPATIBILITY: Dextrose (incompatible with saline)

OTHER WEBSITES: gammaked.com