Lactated Ringers (Page 2 of 2)

PRECAUTIONS

Do not use for irrigation that may result in absorption into the blood.

Caution should be observed when the solution is used for continuous irrigation or allowed to “dwell” inside body cavities because of possible absorption into the blood stream and the production of circulatory overload.

Aseptic technique is essential with the use of sterile solutions for irrigation of body cavities, wounds and urethral catheters or for wetting dressings that come in contact with body tissues.

The flexible container is designed for use with nonvented irrigation sets. When used for irrigation via irrigation equipment, the administration set should be attached promptly. Unused portions should be discarded and a fresh container of appropriate size used for the start-up of each cycle or repeat procedure. For repeated irrigations of urethral catheters, a separate container should be used for each patient.

Do not administer unless solution is clear and container is undamaged. Discard unused portion.

Pregnancy Category C.

Animal reproduction studies have not been conducted with Lactated Ringer’s Irrigation. It is also not known whether it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. It should be given to a pregnant woman only if clearly needed.

Pediatric Use:

The safety and effectiveness of Lactated Ringer’s Irrigation have not been established. Its limited use in pediatric patients has been inadequate to fully define proper dosage and limitations for use.

ADVERSE REACTIONS

Possible adverse effects arising from the irrigation of body cavities, tissues, or indwelling catheters and tubes are usually avoidable when proper procedures are followed. Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. Excessive volume or pressure during irrigation of closed cavities may cause undue distension or disruption of tissues. Accidental contamination from careless technique may transmit infection.

Should any adverse reaction occur, discontinue the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

OVERDOSAGE

In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. (See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS.)

DOSAGE AND ADMINISTRATION

The dose is dependent upon the capacity or surface area of the structure to be irrigated and the nature of the procedure. When used as a vehicle for other drugs, the manufacturer’s recommendations should be followed.

Tear at notch and along dotted line and remove container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.

Drug Interactions

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 container permits. (See PRECAUTIONS.)

HOW SUPPLIED

Lactated Ringer’s Irrigation is supplied in single-dose 3000 mL flexible irrigation containers (NDC No. 0409–7828–08).

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.

Revised: May, 2009

Printed in USA

EN-2136

Hospira, Inc., Lake Forest, IL 60045 USA

IM-0198

bag ndc 0409-7828-08
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — Pouch Label

TO OPEN TEAR AT NOTCH

2 HDPE

DO NOT REMOVE FROM OVERWRAP UNTIL READY FOR USE. AFTER REMOVING
THE OVERWRAP, CHECK FOR MINUTE LEAKS BY SQUEEZING CONTAINER FIRMLY.
IF LEAKS ARE FOUND, DISCARD SOLUTION AS STERILITY MAY BE IMPAIRED.
RECOMMENDED STORAGE: ROOM TEMPERATURE (25°C). AVOID EXCESSIVE
HEAT. PROTECT FROM FREEZING. SEE INSERT.
98-4321-R14-3/98

PRINCIPAL DISPLAY PANEL -- Pouch Label
(click image for full-size original)
LACTATED RINGERS
sodium chloride, sodium lactate, potassium chloride, and calcium chloride irrigant
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-7828
Route of Administration IRRIGATION DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 600 mg in 100 mL
SODIUM LACTATE (SODIUM CATION and LACTIC ACID, UNSPECIFIED FORM) SODIUM LACTATE 310 mg in 100 mL
POTASSIUM CHLORIDE (POTASSIUM CATION and CHLORIDE ION) POTASSIUM CHLORIDE 30 mg in 100 mL
CALCIUM CHLORIDE (CALCIUM CATION and CHLORIDE ION) CALCIUM CHLORIDE 20 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-7828-08 4 POUCH in 1 CASE contains a POUCH
1 1 BAG in 1 POUCH This package is contained within the CASE (0409-7828-08) and contains a BAG
1 3000 mL in 1 BAG This package is contained within a POUCH and a CASE (0409-7828-08)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019416 05/16/2005 08/01/2021
Labeler — Hospira, Inc. (141588017)

Revised: 05/2020 Hospira, Inc.

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