HEALTH CARE PROVIDER LETTER SECTION.

Healthcare Professional Letter Please refer to the FDA-approved prescribing information for the drug product listed below:o Plasma-Lyte Injection pH 7.4 (click here)o Complete and submit the report Online: http://www.fda.gov/medwatch/report.htm Regular mail or Fax: Download form http://www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 (1-800-332-0178). To report product quality issues associated with this imported product, please contact Baxter Product Surveillance through Baxter Product Feedback Portal (https://productfeedback.baxter.com/). DHCP Letter 1.jpg. DHCP Letter 2. DHCP Letter 3.jpg. DHCP Letter 4.jpg. DHCP Letter 5.jpg. DHCP Letter 6.jpg.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label BaxterViafloGCCE03241000 mL100200300400500600700800900Plasma-Lyte 148(pH 7.4)Solution for InfusionpH 6.5 8.0 IsotonicOsmolarity 295 m0sm/l (approx)Formula per 1000mlSodium Chloride5.26 gPotassium Chloride 0.37 gMagnesium Chloride hexahydrate 0.30 Sodium Acetate trihydrate3.68 gSodium Gluconate5.02 gWater for InjectionsSodium Hydroxidemmol per 100 mL (approx)Sodium140Chloride 98Potassium 5Acetate 27Magnesium1.5Gluconate23IV administrationRead package leaflet before useKeep out of the sight and reach of children Do not remove from overwrap until ready for use Do not use unless solution is clear without visible particlesand container undamagedDo not reconnect partially used bags Store below 30oCPOM070UN-35-03-5601Marketing Authorization Holder:Baxter Healthcare Ltd.Caxton WayThetford Norfolk IP 24 3SEUnited KingdomManufacturer:Bieffe Medital S.A.Ctra de Biescas-Senegue22666 Sabinanigo (Huesca)SpainLOTEXP. PlasmaLyte 1000ml Representative Container Label.jpg.