{"effective_time":"20241108","health_care_provider_letter":["Healthcare Professional Letter Please refer to the FDA-approved prescribing information for the drug product listed below: • Plasma-Lyte A Injection pH 7.4 (click here ) • 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 a 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"],"id":"0fe5a11d-9640-4645-8d45-488a04ea6550","openfda":{"brand_name":["Plasma-Lyte 148 (pH 7.4)"],"generic_name":["SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Baxter Healthcare Corporation"],"package_ndc":["0338-9593-01","0338-9593-10"],"product_ndc":["0338-9593"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRAVENOUS"],"rxcui":["801109","801357"],"spl_id":["0fe5a11d-9640-4645-8d45-488a04ea6550"],"spl_set_id":["fe935c8d-f42d-42e4-8665-0dc66829f231"],"substance_name":["SODIUM CHLORIDE","SODIUM GLUCONATE","SODIUM ACETATE","POTASSIUM CHLORIDE","MAGNESIUM CHLORIDE"],"unii":["451W47IQ8X","R6Q3791S76","4550K0SC9B","660YQ98I10","02F3473H9O"]},"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label Baxter Viaflo GCCE0324 1000 mL 100 200 300 400 500 600 700 800 900 Plasma-Lyte 148 (pH 7.4) Solution for Infusion pH 6.5 – 8.0 Isotonic Osmolarity 295 m0sm/l (approx) Formula per 1000ml Sodium Chloride 5.26 g Potassium Chloride 0.37 g Magnesium Chloride hexahydrate 0.30 g Sodium Acetate trihydrate 3.68 g Sodium Gluconate 5.02 g Water for Injections Sodium Hydroxide mmol per 100 mL (approx) Sodium 140 Chloride 98 Potassium 5 Acetate 27 Magnesium 1.5 Gluconate 23 IV administration Read package leaflet before use Keep 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 particles and container undamaged Do not reconnect partially used bags Store below 30 o C POM 07 0 UN-35-03-560 1 Marketing Authorization Holder: Baxter Healthcare Ltd. Caxton Way Thetford Norfolk IP 24 3SE United Kingdom Manufacturer: Bieffe Medital S.A. Ctra de Biescas-Senegüé 22666 Sabiñánigo (Huesca) Spain LOT EXP PlasmaLyte 1000ml Representative Container Label.jpg"],"set_id":"fe935c8d-f42d-42e4-8665-0dc66829f231","spl_product_data_elements":["Plasma-Lyte 148 (pH 7.4) Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, Magnesium Chloride SODIUM CHLORIDE SODIUM CATION CHLORIDE ION SODIUM GLUCONATE GLUCONIC ACID SODIUM CATION SODIUM ACETATE ACETATE ION SODIUM CATION POTASSIUM CHLORIDE POTASSIUM CATION CHLORIDE ION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION WATER SODIUM HYDROXIDE"],"version":"2"}