Glucose Dailymed

Health Care Professional Letter

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.

To report product quality issues associated with these imported products, please contact Baxter Product Surveillance through Baxter - Product Feedback Portal (https://productfeedback.baxter.com/).

Please also refer to the local prescribing information of the imported product, translated into English, available for: • 0.9% Sodium Chloride Injection (click https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/723233) • 5% Glucose Injection (click https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/723235)• 10% Glucose Injection (click https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/723237)• 5% Glucose/0.9% Sodium Chloride Injection (click https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/723238)

Please refer to the FDA-approved prescribing information for each drug product uled below: • 0.9% Sodium Chloride Injection USP (click https://www.dailymed.nlm.nih.gov/dailymed/getFile.cfm?setid=f55bd888-5e01-474d-871b-24654c070178&type=pdf&name=f55bd888-5e01-474d-871b-24654c070178) • 5% Dextrose Injection USP (click https://www.dailymed.nlm.nih.gov/dailymed/getFile.cfm?setid=3bb406a9-f5cb-403a-b1bb-5c4facbea3d5&type=pdf&name=3bb406a9-f5cb-403a-b1bb-5c4facbea3d5) • 10% Dextrose Injection USP (click https://www.dailymed.nlm.nih.gov/dailymed/getFile.cfm?setid=3bb406a9-f5cb-403a-b1bb-5c4facbea3d5&type=pdf&name=3bb406a9-f5cb-403a-b1bb-5c4facbea3d5) • 5% Dextrose/0.9% Sodium Chloride Injection USP (click https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016678s007,016683s103,016687s104,016689s107,016697s098lbl.pdf)

Package Insert

Package/label Principal Display Panel

Baxter Logo Trademark

A6C0162US

GLUCOSE INJECTION

50

100

150

200

250ml10% GLUCOSE

[Strength] 250ml: 25g[Description] This product is a colorless or almostcolorless clear liquid[Dosage and Administration] Intravenous drip   See the package insert for details For details of [Indications], [Adverse Reactions],[Contraindications], and [Precautions], please refer to thepackage insert

[Storage] Store in overwrap

The solution should be clear and should be usedup at one timeInspect the inner bag by squeezing it and discard solution if leakage occursLicense Number: H19994063

AA

[Drug Marketing Authorization Holder] [Manufacturer]Name: Baxter Healthcare (Shanghai) Co., Ltd.Address: No. 388, Tingzhu Road, Jinshan District, Shanghai

BarCode (01) 00303389797012

LOTMFGEXP

10% Glucose Injection

250ml X 40

LOT S0000000 EXP YYYY-MM A6C0162US 1C/N LIC H19994063

10% Glucose Injection

250ml X 40

LOT S0000000 EXP YYYY-MM MFG YYYY-MM-DD 1C/N 0000