FDA Label for Plasma-lyte 148 (ph 7.4)
View Indications, Usage & Precautions
Plasma-lyte 148 (ph 7.4) Product Label
The following document was submitted to the FDA by the labeler of this product Baxter Healthcare Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Healthcare Professional Letter
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/)
Package/Label Principal Display Panel
Container Label
Baxter
Viaflo
GCCE0324
1000 mL
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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 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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