Lactated Ringers (Page 2 of 3)

Pregnancy

Teratogenic Effects

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.

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 sterile and nonpyrogenic in PIC™ (Plastic Irrigation Container). The 1000 mL containers are packaged 16 per case, the 2000 mL containers are packaged 8 per case, and the 4000 mL containers are packaged 4 per case.

NDC Cat. No. Size
Lactated Ringer’s Irrigation(Canada DIN 01974076)
0264-2203-00 R5410-01 1000 mL
0264-2203-50 R5415-01 2000 mL
0264-2203-70 R5417 4000 mL

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20°–25°C (68°–77°F) [see USP Controlled Room Temperature]; however, brief exposure up to 40°C does not adversely affect the product.

Do not warm above 150°F (66°C).

Rx only

Revised: March 2009
PIC is a trademark of B. Braun Medical Inc.

Directions for Use of PIC™ (Plastic Irrigation Container)

Not for injection.

Aseptic technique is required.

  1. Caution – Before use, perform the following checks:

    • (a) Read the label. Ensure solution is the one ordered and is within the expiration date.
    • (b) Invert container and inspect the solution in good light for cloudiness, haze, or particulate matter; check the container for leakage or damage. Any container which is suspect should not be used.
    • Use only if solution is clear and container and seal are intact.
    • Single unit container. Discard unused portion.
  2. Outer Closure Removal – Grasp the container with one hand and turn the breakaway ring counterclockwise with the other hand until slight resistance is felt. Then, twisting the container in the opposite direction, turn the breakaway ring sharply until the entire outer cap is loose and can be lifted off. (Figure 1)
    Figure 1
  3. Connect the administration set through the sterile set port according to set instructions (Figure 2) or remove screw cap and pour.
    Figure 2
  4. Do not warm above 150°F (66°C) to assure minimal bottle distortion. Keep bottles upright.
Figure 1Figure 2

B. Braun Medical Inc.
Irvine, CA 92614-5895 USA
Made in USA

In Canada, distributed by:
B. Braun Medical Inc. Scarborough, Ontario M1H 2W4

Y36-002-692

PRINCIPAL DISPLAY PANEL — 1000 mL Label

Lactated Ringer’s Irrigation

Isotonic Solution for Irrigation

REF R5410-01 DIN 01974076
NDC 0264-2203-00 HK 22614

1000 mL
PIC™ Container

Lot

Exp.

Each 100 mL contains:
Sodium Chloride USP 0.6 g
Sodium Lactate 0.31 g
Potassium Chloride USP 0.03 g
Calcium Chloride•2H2 O USP 0.02 g
Water for Injection USP qs
pH adjusted with HCl NF

pH: 6.75 (6.0 – 7.5)
Calc. Osmolarity: 275 mOsmol/liter

Electrolytes (mEq/liter): Na+ 130
K+ 4 Ca++ 3 Cl 110 Lactate 28

Sterile, nonpyrogenic. Single unit
container. Discard unused portion.

Not for Injection. Use only if solution is
clear and container and seal are intact.

Warning: Do not warm above 150°F
(66°C).

Store at 20°–25°C (68°–77°F) [see
USP Controlled Room Temperature].
Avoid excessive heat. Protect from
freezing. See Package Insert.

Rx only

PVC-free and DEHP-free

PIC is a trademark of B. Braun Medical Inc.

B|BRAUN

B. Braun Medical Inc.
Irvine, CA 92614-5895 USA
Made in USA

In Canada, distributed by:
B. Braun Medical Inc. Scarborough, Ontario M1H 2W4

Y37-002-320

Principal Display Panel -- 1000 mL Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 2000 mL Label

Lactated Ringer’s Irrigation

Isotonic Solution for Irrigation

REF R5415-01 DIN 01974076
NDC 0264-2203-50 HK 22614

2000 mL
PIC™ Container

Lot

Exp.

Each 100 mL contains:
Sodium Chloride USP 0.6 g
Sodium Lactate 0.31 g
Potassium Chloride USP 0.03 g
Calcium Chloride•2H2 O USP 0.02 g
Water for Injection USP qs
pH adjusted with HCl NF

pH: 6.75 (6.0 – 7.5)
Calc. Osmolarity: 275 mOsmol/liter

Electrolytes (mEq/liter): Na+ 130
K+ 4 Ca++ 3 Cl 110 Lactate 28

Sterile, nonpyrogenic. Single unit
container. Discard unused portion.

Not for Injection. Use only if solution is
clear and container and seal are intact.

Warning: Do not warm above 150°F
(66°C).

Store at 20°–25°C (68°–77°F) [see
USP Controlled Room Temperature].
Avoid excessive heat. Protect from
freezing. See Package Insert.

Rx only

PVC-free and DEHP-free

PIC is a trademark of B. Braun Medical Inc.

B. Braun Medical Inc.
Irvine, CA 92614-5895 USA
Made in USA

In Canada, distributed by:
B. Braun Medical Inc. Scarborough, Ontario M1H 2W4

Y37-002-331

Principal Display Panel -- 2000 mL Label
(click image for full-size original)

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