Plasma-lyte 148 (ph 7.4) Injection, Solution
FDA Label NDC 0338-9593

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Baxter Healthcare Corporation for the product Plasma-lyte 148 (ph 7.4) (NDC 0338-9593). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding healthcare professional letter, package/label principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Healthcare Professional Letter

Dhcp Letter 1.jpg (Image 01)

Dhcp Letter 1.jpg (Image 01)

Dhcp Letter 2 (Image 02)

Dhcp Letter 2 (Image 02)

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/)

Dhcp Letter 3.jpg (Image 03)

Dhcp Letter 3.jpg (Image 03)

Dhcp Letter 4.jpg (Image 04)

Dhcp Letter 4.jpg (Image 04)

Dhcp Letter 5.jpg (Image 05)

Dhcp Letter 5.jpg (Image 05)

Dhcp Letter 6.jpg (Image 06)

Dhcp Letter 6.jpg (Image 06)

Package/Label Principal Display Panel

Plasmalyte 1000ml Representative Container Label.jpg (Image 07)

Plasmalyte 1000ml Representative Container Label.jpg (Image 07)

Container Label

Baxter

Viaflo

GCCE0324

1000 mL

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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 30oC

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

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