Ringer’s Injection, USP in VIAFLEX Plastic Container

Ringer’s Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. The pH may have been adjusted with sodium hydroxide. Composition, osmolarity, pH and ionic concentration are shown in Table 1.

The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.

Ringer’s Injection has value as a source of water and electrolytes. It is capable of inducing diuresis depending on the clinical condition of the patient.

Ringer’s Injection is indicated as a source of water and electrolytes.

Ringer’s Injection is contraindicated in:

• -Patients with known hypersensitivity to the product or any ingredients in the formulation (see WARNINGS).
• -Newborns (≤28 days of age) receiving concomitant treatment with ceftriaxone, even if separate infusion lines are used due to the risk of fatal ceftriaxone-calcium salt precipitation in the neonate’s bloodstream.
• -In patients older than 28 days, including adults, ceftriaxone must not be administered simultaneously with intravenous calcium-containing solutions, including Ringer’s Injection through the same infusion line (e.g., via a Y-connector). If the same infusion line is used for sequential administration, the line must be thoroughly flushed between infusions with a compatible fluid.

Ceftriaxone

For information on interaction with ceftriaxone – See CONTRAINDICATIONS.

Other Products that Cause Hyperkalemia

Administration of Ringer’s Injection in patients treated concurrently or recently with products that are associated with hyperkalemia increases the risk of severe and potentially fatal hyperkalemia, in particular in the presence of other risk factors for hyperkalemia.

Avoid use of Ringer’s Injection in patients receiving such products (e.g, potassium sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, or the immunosuppressants cyclosporine and tacrolimus). If use cannot be avoided, monitor serum potassium concentrations

Digoxin

Administration of calcium may increase the effects of digitalis and lead to serious or fatal cardiac arrhythmia. In patients treated with digoxin, consider reducing the volume, and/or rate of administration.

Other Products that Affect Fluid and/or Electrolyte Balance

Administration of Ringer’s Injection in patients treated concomitantly with medications associated with sodium and fluid retention may increase the risk of hypernatremia and volume overload. Avoid use of Ringer’s Injection in patients receiving such products, such as corticosteroids or corticotropin. If use cannot be avoided, monitor serum electrolytes, fluid balance, and acid-base balance.

Other Drugs that Increase the Risk of Hyponatremia

Administration of Ringer’s Injection in patients treated concomitantly with medications associated with hyponatremia may increase the risk of developing hyponatremia.

Avoid use of Ringer’s Injection in patients receiving products, such as diuretics, and certain antiepileptic and psychotropic medications. Drugs that increase the vasopressin effect reduce renal electrolyte free water excretion and may also increase the risk of hyponatremia following treatment with intravenous fluids. If use cannot be avoided, monitor serum sodium concentrations.

Other Drugs that Increase the Risk of Hypercalcemia

Avoid Ringer’s Injection in patients treated with thiazide diuretics or vitamin D, as these can increase the risk of hypercalcemia.

The following adverse reactions associated with the use of Ringer’s Injection were identified in clinical trials or postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure.

Hypersensitivity reactions: anaphylaxis, shortness of breath, palpitations, erythema, hives, urticaria, chills, and pyrexia

Metabolism and nutritional disorders: electrolyte imbalance, fluid overload, and hyponatremia

Nervous System Disorders: hyponatremic encephalopathy.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.

Excessive administration of Ringer’s Injection can cause:

• hyperkalemia and hypernatremia, especially in patients with severe renal impairment.
• hyperchloremia.
• loss of bicarbonate with an acidifying effect.
• hypercalcemia.
• fluid overload (which can lead to pulmonary and/or peripheral edema). See WARNINGS and ADVERSE REACTIONS.

When assessing an overdose, any additives in the solution must also be considered. The effects of an overdose may require immediate medical attention and treatment. Interventions include discontinuation of Ringer’s Injection administration, dose reduction, and other measures as indicated for the specific clinical constellation (e.g., monitoring of fluid balance, electrolyte concentrations and acid base balance).

Important Administration Instructions

• Ringer’s Injection is intended for intravenous administration using sterile equipment.
• Do not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air contained in the primary container.
• Set the vent to the closed position on a vented intravenous administration set to prevent air embolism.
• Use a dedicated line without any connections to avoid air embolism.
• Do not pressurize intravenous solutions contained in flexible plastic containers to increase flow rates in order to avoid air embolism due to incomplete evacuation of residual air in the container.
• Prior to infusion, visually inspect the solution for particulate matter and discoloration. The solution should be clear and there should be no precipitates. Do not administer unless solution is clear and container is undamaged.
• Do not administer Ringer’s Injection simultaneously with citrate anticoagulated/preserved blood through the same administration set because of the likelihood of coagulation precipitated by the calcium content of Ringer’s Injection.

Dosing Information

The choice of product, dosage, volume, rate, and duration of administration is dependent upon the age, weight and clinical condition of the patient and concomitant therapy, and administration should be determined by a physician experienced in intravenous fluid therapy.

Introduction of Additives

Additives may be incompatible.

Evaluate all additions to the plastic container for compatibility and stability of the resulting preparation. Consult with a pharmacist, if available.

Additives known to be incompatible with Ringer’s Injection due to precipitate formation are: amphotericin B, cortisone, erythromycin lactobionate, etamivan, ethyl alcohol, thiopental sodium, disodium edetate.

If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. After addition, if there is a discoloration and/or the appearance of precipitates, insoluble complexes or crystals, do not use. Do not store solutions containing additives. Discard any unused portion.

Ringer’s Injection, USP in VIAFLEX plastic container is available as follows:

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored between 20ºC to 25°C (68º F to 77°F). [See USP controlled room temperature.]; brief exposure up to 40°C (104° F) does not adversely affect the product.

For information on risk of air embolism – see PRECAUTIONS.

Baxter Healthcare Corporation
Deerfield, IL 60015 USA

Printed in USA

07-19-00-0097

Rev. February 2019

Baxter and Viaflex are trademarks of Baxter International Inc.

LOT EXP

2B2304
NDC 0338-0105-04

Ringer's
Injection USP

1000 mL
EACH 100 mL CONTAINS 860 mg SODIUM CHLORIDE
USP 33 mg CALCIUM CHLORIDE USP 30 mg
POTASSIUM CHLORIDE USP pH 5.5 (5.0 TO 7.5) pH
MAY BE ADJUSTED WITH SODIUM HYDROXIDE mEq/L
SODIUM 147.5 POTASSIUM 4 CALCIUM 4.5 CHLORIDE
156 OSMOLARITY 309 mOsmol/L (CALC) STERILE
NONPYROGENIC SINGLE DOSE CONTAINER ADDITIVES MAY
BE INCOMPATIBLE CONSULT WITH PHARMACIST IF AVAILABLE
WHEN INTRODUCING ADDITIVES USE ASEPTIC TECHNIQUE
MIX THOROUGHLY DO NOT STORE DOSAGE
INTRAVENOUSLY AS DIRECTED BY A PHYSICIAN SEE
DIRECTIONS CAUTIONS SQUEEZE AND INSPECT INNER BAG
WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS
ARE FOUND MUST NOT BE USED IN SERIES CONNECTIONS
DO NOT ADMINISTER SIMULTANEOUSLY WITH BLOOD DO
NOT USE UNLESS SOLUTION IS CLEAR RX ONLY STORE
UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM
TEMPERATURE (25ºC/77ºF) UNTIL READY TO USE AVOID
EXCESSIVE HEAT SEE INSERT

VIAFLEX CONTAINER PL 146 PLASTIC

BAXTER VIAFLEX AND PL 146 ARE TRADEMARKS OF
BAXTER INTERNATIONAL INC

FOR PRODUCT INFORMATION 1-800-933-0303

Baxter Logo
Baxter Healthcare Corporation
Deerfield, IL 60015 USA

Made in USA

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2B2304Q 24-1000 ML
VIAFLEX® CONTAINER

RINGER'S INJECTION, USP

EXP
XXXXX

SECONDARY BAR CODE
(17) YYMM00 (10) XXXXX

LOT
XXXXX

PRIMARY BAR CODE
(01) 50303380105040