0.9% SODIUM CHLORIDE (Page 2 of 2)

DOSAGE & ADMINISTRATION

The dose is dependent upon the age, weight and clinical condition of the patient.

Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit (see PRECAUTIONS).

INSTRUCTIONS FOR USE

Check flexible container solution composition, lot number, and expiry date.

Do not remove solution container from its overwrap until immediately before use.

Use sterile equipment and aseptic technique.

To Open

Turn solution container over so that the text is face down. Using the pre-cut corner tabs, peel open the overwrap and remove solution container.
Check the solution container for leaks by squeezing firmly. If leaks are found, or if the seal is not intact, discard the solution.
Do not use if the solution is cloudy or a precipitate is present.

To Add Medication

Identify WHITE Additive Port with arrow pointing toward container.
Immediately before injecting additives, break off WHITE Additive Port Cap with the arrow pointing toward container.
Hold base of WHITE Additive Port horizontally.
Insert needle horizontally through the center of WHITE Additive Port’s septum and inject additives.
Mix container contents thoroughly.

Preparation for Administration

Immediately before inserting the infusion set, break off BLUE Infusion Port Cap with the arrow pointing away from container.
Use a non-vented infusion set or close the air-inlet on a vented set.
Close the roller clamp of the infusion set.
Hold the base of BLUE Infusion Port.
Insert spike through BLUE Infusion Port by rotating wrist slightly until the spike is inserted.
NOTE: See full directions accompanying administration set.

WARNING: Do not use flexible container in series connections.

HOW SUPPLIED

0.9% Sodium Chloride Injection, USP is supplied in single-dose flexible plastic containers as follows:

HS
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Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.

Manufactured for:

LOGO
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Lake Zurich, IL 60047 www.fresenius-kabi.com/us

Revised: January 2021

PRINCIPAL DISPLAY PANEL — 51662-1577-1 — BAG LABELING AND SERIALIZATION LABELING

51662-1577-1

BAG LABELING

BAG
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SERIALIZED LABELING

Serialized Label
(click image for full-size original)
0.9% SODIUM CHLORIDE
sodium chloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51662-1577(NDC:63323-623)
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 9 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51662-1577-1 500 mL in 1 BAG None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207310 07/17/2021
Labeler — HF Acquisition Co LLC, DBA HealthFirst (045657305)
Registrant — HF Acquisition Co LLC, DBA HealthFirst (045657305)
Establishment
Name Address ID/FEI Operations
HF Acquisition Co LLC, DBA HealthFirst 045657305 relabel (51662-1577)

Revised: 07/2021 HF Acquisition Co LLC, DBA HealthFirst

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