{"effective_time":"20241218","health_care_provider_letter":["Health Care Professional Letter Baxter has worked proactively to prepare the Training Materials for Baxter Medical Information page ( https://meded.baxter.com/hurricane-helene-clinical-resources/baxter-resources-for-products-authorized-for-temporary-importation ) Please refer to the UK prescribing information as follows for any pharmaceutical calculations of a final product that uses concentrated Glucose injection: • 70% Glucose Injection (click https://mhraproducts4853.blob.core.windows.net/docs/6be6cb79cc56be57f99cfd218cfbd1b34bca8047) ) – Local product name in the UK: Glucose 70% w/v Concentrate for solution for infusion • 50% Glucose Injection (click https://mhraproducts4853.blob.core.windows.net/docs/6d79a27acece3f48020b83e2b3716a2353b6f8b3 ) – Local product name in the UK: Glucose 50% w/v Concentrate for solution for infusion Please refer to the FDA-approved prescribing information for the 70% Dextrose Injection USP: • 70% Dextrose Injection USP (click https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0332f34a-7038-47cc-ba59-d55cad6b73ca ) Reporting Adverse Events or Product (Quality Issues) To report adverse events associated with these imported products, please call Baxter at 1-866-888-2472, or fax: 1-800-759-1801. Adverse events or quality problems experienced with the use of these imported products may also be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax: • Complete and submit the report Online : www.fda.gov/medwatch/report.htm • Regular mail or Fax : Download form 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 these imported products, please contact Baxter Product Surveillance through Baxter Product Feedback Portal ( https://productfeedback.baxter.com/ ). DHCP Letter 1 of 8 DHCP Letter 2 of 8 DHCP Letter 3 of 8 DHCP Letter 4 of 8 DHCP Letter 5 of 8 DHCP Letter 6 of 8 DHCP Letter 7 of 8 DHCP Letter 8 of 8"],"id":"4e25becb-0dcb-4597-a032-56524384130c","openfda":{},"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label Code B0257 3000 ml Baxter Logo Glucose 50% w/v Concentrate for solution for infusion VIAFLEX container Hypertonic Free from bacterial endotoxins Formula per 1000 ml Anhydrous Glucose Water for Injections HCI for pH adjustment Megajoules (approx.) 500 g 8.4 (2000 kcal) 50% Dilute before use – bulk source container Not for direct intravenous infusion For use under medical supervision For intravenous use following dilution under aseptic conditions Check compatibility with other admixture components before use Keep out of the sight and reach of children Do not store above 25°C Do not use unless solution is clear and container is undamaged Single use only Do not store partially used containers Discard any unused portion, waste materials and all associated devices Do not administer simultaneously with blood or, before or after, using the same transfusion equipment Discontinue infusion if adverse reaction occurs Baxter Healthcare Ltd Caxton Way Thetford Norfolk IP24 3SE UK LOT EXP POM PL 00116/0271 TH-35-01-934 Carton Label Baxter Logo Code FKB0257B Glucose 50% w/v Concentrate for solution for infusion Hypertonic Do not store above 25°C Keep out of sight and reach of children Baxter Healthcare Ltd Caxton Way, Thetford, Norfolk, IP24 3SE, UK POM LOT: EXP: 4 x 3000 ml (≈15.5 kg) 50% PL 00116/0271 TH-25-02-116 Baxter Logo Code FKB0257B Glucose 50% w/v Concentrate for solution for infusion Hypertonic POM 4 x 3000 ml (≈15.5 kg) 50% LOT: EXP: Container Label 1 – - 2- - 3- - 4- Code B0273 500 ml Baxter Logo Glucose 70% w/v Concentrate for solution for infusion VIAFLEX container Hypertonic Free from bacterial endotoxins Formula per 1000 ml Anhydrous Glucose Water for Injections HCI for pH adjustment Megajoules (approx.) 700 g 11.8 (2800 kcal) 70% Dilute before use – bulk source container Not for direct intravenous infusion For use under medical supervision For intravenous use following dilution under aseptic conditions Check compatibility with other admixture components before use Keep out of the sight and reach of children Do not store above 25°C Do not use unless solution is clear and container is undamaged Single use only Do not store partially used containers Discard any unused portion, waste materials and all associated devices Do not administer simultaneously with blood or, before or after, using the same transfusion equipment Discontinue infusion if adverse reaction occurs Baxter Healthcare Ltd Caxton Way Thetford Norfolk IP24 3SE UK Lot Expiry POM PL 00116/0272 TH-35-01-931 -1 - -2 - -3 - -4 Carton Label Baxter Logo Code FKB0273B Glucose 70% w/v Concentrate for solution for infusion Hypertonic Do not store above 25°C Keep out of sight and reach of children Baxter Healthcare Ltd Caxton Way, Thetford, Norfolk, IP24 3SE, UK LOT: EXP: 20 x 500 ml (≈15.0 kg) 70% POM PL 00116/0272 TH-25-02-117 Baxter Logo Code FKB0273B Glucose 70% w/v Concentrate for solution for infusion Hypertonic 20 x 500 ml (≈15.0 kg) 70% POM PL 00116/0272 LOT: EXP: Container Label 0338-9787-01 Carton Label 0338-9878-01 Container Label 0338-9785-01 Carton Label 0338-9785-01"],"set_id":"5b44c747-ee6f-484a-9d42-aa04b76a5588","spl_product_data_elements":["Glucose Dextrose anhydrous DEXTROSE MONOHYDRATE ANHYDROUS DEXTROSE WATER HYDROCHLORIC ACID Glucose Dextrose anhydrous DEXTROSE MONOHYDRATE ANHYDROUS DEXTROSE WATER HYDROCHLORIC ACID"],"version":"5"}