RINGERS- sodium chloride, potassium chloride, and calcium chloride irrigant

United States - English - NLM (National Library of Medicine)

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Active ingredient:
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698), CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698)
Available from:
B. Braun Medical Inc.
INN (International Name):
SODIUM CHLORIDE
Composition:
SODIUM CHLORIDE 0.86 g in 100 mL
Administration route:
IRRIGATION
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Ringer's Irrigation USP is indicated for all general irrigation, washing and rinsing purposes which permit use of a sterile, nonpyrogenic electrolyte solution. NOT FOR INJECTION BY USUAL PARENTERAL ROUTES. An electrolyte solution should not be used for irrigation during electrosurgical procedures.
Product summary:
Ringer's Irrigation USP is supplied sterile and nonpyrogenic in PIC™ (Plastic Irrigation Containers). The 1000 mL containers are packaged 16 per case and the 2000 mL containers are packaged 8 per case. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product. Do not warm above 150°F (66°C).
Authorization status:
New Drug Application
Authorization number:
0264-2202-00

RINGERS- sodium chloride, potassium chloride, and calcium chloride irrigant

B. Braun Medical Inc.

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Ringer's Irrigation USP

Package Insert

PIC™ (Plastic Irrigation Containers)

FOR ALL GENERAL IRRIGATION, WASHING AND RINSING PURPOSES

Not For Injection By Usual Parenteral Routes

Semi-rigid Irrigation Container

DESCRIPTION

Ringer's Irrigation USP is a sterile, nonpyrogenic, solution of electrolytes in water for injection

intended only for sterile irrigation, washing and rinsing purposes.

Each 100 mL contains:

Sodium Chloride USP 0.86 g; Potassium Chloride USP 0.03 g

Calcium Chloride Dihydrate USP 0.033 g; Water for Injection USP qs

pH: 5.8 (5.0-7.5). The solution is isotonic (310 mOsmol/liter, calc.) and has the following electrolyte

content (mEq/liter): Na 147; K 4 Ca

4.5; Cl

The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as

a single-dose or short procedure irrigation. When smaller volumes are required the unused portion

should be discarded. Ringer's Irrigation USP may be classified as a sterile irrigant, wash, rinse and

pharmaceutical vehicle.

The formulas of the active ingredients are:

Ingredients

Molecular Formula Molecular Weight

Sodium Chloride USP

NaCl

58.44

Potassium Chloride USP

74.55

Calcium Chloride Dihydrate USP

CaCl

2H O

147.01

The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral

drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic

container is also virtually impermeable to vapor transmission and therefore, requires no overwrap to

maintain the proper drug concentration. The safety of the plastic container has been confirmed by

biological evaluation procedures. The material passes Class Vl testing as specified in the U.S.

Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is

nontoxic and biologically inert.

The PIC™ Container is PVC-free and DEHP-free.

CLINICAL PHARMACOLOGY

Ringer's Irrigation USP exerts a mechanical cleansing action for sterile irrigation of body cavities,

tissues or wounds, indwelling urethral catheters and surgical drainage tubes, and for washing, rinsing or

soaking surgical dressings, instruments and laboratory specimens. It also serves as a vehicle for drugs

used for irrigation or other pharmaceutical preparations.

Ringer's Irrigation USP provides an isotonic irrigation with the same ionic constituents as Ringer's

Injection USP, a modification of Ringer's solution (also called Ringer's mixture) originally used only as

a topical physiologic salt solution.

Ringer's Irrigation USP is considered generally compatible with living tissues and organs.Calcium

Chloride in water dissociates to provide calcium (Ca

) and chloride (Cl

) ions. They are normal

constituents of the body fluids and are dependent on various physiologic mechanisms for maintenance of

balance between intake and output. Approximately 80% of body calcium is excreted in the feces as

insoluble salts; urinary excretion accounts for the remaining 20%.

Potassium chloride in water dissociates to provide potassium (K ) and chloride (Cl

) ions. Potassium is

the chief cation of body cells (160 mEq/liter of intracellular water). It is found in low concentration in

plasma and extracellular fluids (3.5 to 5.0 mEq/liter in a healthy adult). Potassium plays an important role

in electrolyte balance.

Normally about 80 to 90% of the potassium intake is excreted in the urine; the remainder in the stools

and to a small extent, in the perspiration. The kidney does not conserve potassium well so that during

fasting or in patients on a potassium free diet, potassium loss from the body continues resulting in

potassium depletion.

Sodium chloride in water dissociates to provide sodium (Na+) and chloride (Cl

) ions. Sodium (Na ) is

the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte

disturbances. Chloride (Cl

) has an integral role in buffering action when oxygen and carbon dioxide

exchange occurs in the red blood cells. The distribution and excretion of sodium (Na ) and chloride

) are largely under the control of the kidney which maintains a balance between intake and output.

Water is an essential constituent of all body tissues and accounts for approximately 70% of total body

weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each

for insensible water loss by perspiration and urine production).

Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on

the concentration of electrolytes in the body compartments and sodium (Na ) plays a major role in

maintaining physiologic equilibrium.

INDICATIONS AND USAGE

Ringer's Irrigation USP is indicated for all general irrigation, washing and rinsing purposes which

permit use of a sterile, nonpyrogenic electrolyte solution.

CONTRAINDICATIONS

NOT FOR INJECTION BY USUAL PARENTERAL ROUTES.

An electrolyte solution should not be used for irrigation during electrosurgical procedures.

WARNINGS

FOR IRRIGATION ONLY. NOT FOR INJECTION.

Irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes;

thus this irrigation must be regarded as a systemic drug. Absorption of large amounts can cause fluid

and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration,

congested states or pulmonary edema.

The risk of dilutional states is inversely proportional to the electrolyte concentrations of administered

parenteral solutions. The risk of solute overload causing congested states with peripheral and

pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.

Do not warm above 150°F (66°C).

After opening container, its contents should be used promptly to minimize the possibility of bacterial

growth or pyrogen formation.

Discard unused portion of irrigating solution since it contains no preservatives.

PRECAUTIONS

General

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.

When used as a "pour" irrigation, no part of the contents should be allowed to contact the surface below

the outer protected thread area of the semi-rigid wide mouth container. 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.

Use only if solution is clear and container and seal are intact. Discard unused portion.

Drug Interactions

Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use

aseptic technique, mix thoroughly and do not store.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies with Ringer's Irrigation USP have not been performed to evaluate carcinogenic potential,

mutagenic potential, or effects on fertility.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with Ringer's Irrigation USP. It is also not known

whether Ringer's Irrigation USP can cause fetal harm when administered to a pregnant woman or can

affect reproduction capacity. Ringer's Irrigation USP should be given to a pregnant woman only if

clearly needed.

Nursing Mothers

Caution should be exercised when Ringer's Irrigation USP is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of Ringer's Irrigation have not been performed to determine whether patients over 65

years respond differently from younger subjects. Other reported clinical experience has not identified

differences in responses between elderly and younger patients. In general, dose selection for an elderly

patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac

function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug

may be greater in patients with impaired renal function. Because elderly patients are more likely to have

decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal

function.

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 distention 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.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to

administration, whenever solution and container permits. See PRECAUTIONS.

HOW SUPPLIED

Ringer's Irrigation USP is supplied sterile and nonpyrogenic in PIC™ (Plastic Irrigation Containers).

The 1000 mL containers are packaged 16 per case and the 2000 mL containers are packaged 8 per case.

NDC

Cat. No.

Size

Ringer's Irrigation USP

0264-2202-00

R5310-01 1000 mL

0264-2202-50

R5315-01 2000 mL

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from

freezing. It is recommended that the product be stored at room temperature (25°C); 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™ Containers

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 dose 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.

3. Connect the administration set through the sterile set port according to set instructions or remove

screw cap and pour.

4. Do not warm above 150°F to assure minimal bottle distortion. Keep bottles upright.

B. Braun Medical Inc.

Irvine, CA 92614-5895 USA

Made in USA

Y36-002-691

PRINCIPAL DISPLAY PANEL - 1000 mL Bottle Label

Ringer's Irrigation USP

Isotonic Solution for Irrigation

REF R5310-01

NDC 0264-2202-00

1000 mL

PIC™ Container

Exp.

Each 100 mL contains:

Sodium Chloride USP 0.86 g

Potassium Chloride USP 0.03 g

Calcium Chloride 2H O USP 0.033 g

Water for Injection USP qs

Contains no bacteriostat.

pH: 5.8 (5.0–7.5)

310 mOsmol/liter (calc.)

Electrolytes (mEq/liter):

Na 147 K 4 Ca

4.5 Cl

Sterile, nonpyrogenic. Single dose

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).

Recommended Storage:

Room temperature (25°C).

Avoid excessive heat. Protect

from freezing. See Package Insert.

Usual dosage: See Package Insert.

Rx only

PVC-free and DEHP-free

B. Braun Medical Inc.

Irvine, CA 92614-5895 USA

Made in USA

PIC is a trademark of

B. Braun Medical Inc.

Y37-002-329

RINGERS

sodium chloride, potassium chloride, and calcium chloride irrigant

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:0 26 4-220 2

Route of Administration

IRRIGATION

Active Ingredient/Active Moiety

Ingredient Name

Basis of

Stre ng th

Stre ng th

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X) (SODIUM CATION - UNII:LYR4M0 NH37, CHLORIDE

ION - UNII:Q32ZN48 6 9 8 )

SODIUM

CHLORIDE

0 .8 6 g

in 10 0 mL

PO TASSIUM CHLO RIDE (UNII: 6 6 0 YQ9 8 I10 ) (POTASSIUM CATION - UNII:29 5O53K152,

CHLORIDE ION - UNII:Q32ZN48 6 9 8 )

POTASSIUM

CHLORIDE

0 .0 3 g

in 10 0 mL

CALCIUM CHLO RIDE (UNII: M4I0 D6 VV5M) (CALCIUM CATION - UNII:2M8 3C4R6 ZB,

CHLORIDE ION - UNII:Q32ZN48 6 9 8 )

CALCIUM

CHLORIDE

0 .0 33 g

in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

B. Braun Medical Inc.

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:0 26 4-220 2-

16 in 1 CASE

0 8 /0 6 /19 79

1

10 0 0 mL in 1 CONTAINER; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 18 156

0 8 /0 6 /19 79

Labeler -

B. Braun Medical Inc. (002397347)

Revised: 11/2019

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