Plasma-lyte 148 (ph 7.4)

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/)

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 Chloride5.26 g

Potassium Chloride 0.37 g

Magnesium Chloride hexahydrate 0.30 g

Sodium Acetate trihydrate3.68 g

Sodium Gluconate5.02 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^oC

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

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/)

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 Chloride5.26 g

Potassium Chloride 0.37 g

Magnesium Chloride hexahydrate 0.30 g

Sodium Acetate trihydrate3.68 g

Sodium Gluconate5.02 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^oC

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