GLUCOSE- dextrose anhydrous injection, solution

Glucose by

Drug Labeling and Warnings

Glucose by is a Prescription medication manufactured, distributed, or labeled by Baxter Healthcare Company, Baxter Healthcare Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 /DailyMed/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/).

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:

INGREDIENTS AND APPEARANCE

GLUCOSE 
dextrose anhydrous injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0338-9787
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	55 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYDROCHLORIC ACID (UNII: QTT17582CB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0338-9787-04	4 in 1 CARTON	10/18/2024
1	NDC: 0338-9787-01	3000 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug for use in drug shortage		10/18/2024

GLUCOSE 
dextrose anhydrous injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0338-9785
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	77 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYDROCHLORIC ACID (UNII: QTT17582CB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0338-9785-20	20 in 1 CARTON	10/18/2024
1	NDC: 0338-9785-01	500 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug for use in drug shortage		10/18/2024

Labeler - Baxter Healthcare Company (005083209)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Healthcare Ltd		221478644	ANALYSIS(0338-9787, 0338-9785) , LABEL(0338-9787, 0338-9785) , MANUFACTURE(0338-9787, 0338-9785) , PACK(0338-9787, 0338-9785) , STERILIZE(0338-9787, 0338-9785)