50% And 70% Glucose Injection

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/).

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:

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/).

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: