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Protection
GAMMAGARD LIQUID - IV Administration

Protecting life's moments with sustained protection against infection1,2

In the IV administration of GAMMAGARD LIQUID clinical study:

validated acute serious bacterial infections

Summary of Validated Acute Serious Bacterial Infections for the Per-Protocol Analysis

 

P valueb P < .0001 | 95% confidence interval (0.000, 0.064)

aSerious acute bacterial infections were defined by FDA and met specific diagnostic requirements.

bThe rate of validated infections was compared with a rate of <1 per subject per year, in accordance with recommendations by the FDA Blood Products Advisory Committee.

hospitalizations secondary to validated bacterial infections
 
validated other bacterial infections
 

Summary of Validated Other Bacterial Infections

cThe rate of validated infections was compared with a rate of <1 per subject per year, in accordance with recommendations by the FDA Blood Products Advisory Committee.

dOther bacterial infections that met specific diagnostic requirements.

References: 1. GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% [Prescribing Information]. Westlake Village, CA: Baxalta US Inc. 2. Church JA, Leibl H, Stein MR, et al, and the US-PID-IGIV 10%-Study Group. Efficacy, safety and tolerability of a new 10% liquid intravenous immune globulin [IVIG 10%] in patients with primary immunodeficiency. J Clin Immunol. 2006;26:388-395.


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