Ringers

Baxter Healthcare Corporation

Ringer’s Injection, USPin VIAFLEX Plastic Container

FULL PRESCRIBING INFORMATION: CONTENTS*

• RINGERS DESCRIPTION
• CLINICAL PHARMACOLOGY
• RINGERS INDICATIONS AND USAGE
• RINGERS CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • Pregnancy
  • Pediatric Use
  • Geriatric Use
• RINGERS ADVERSE REACTIONS
• RINGERS DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• DIRECTIONS FOR USE OF VIAFLEX PLASTIC CONTAINER
  • To Open
  • Preparation for Administration
  • To Add Medication
• PRINCIPAL DISPLAY PANEL - PACKAGING LABELING

FULL PRESCRIBING INFORMATION

RINGERS DESCRIPTION

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.

CLINICAL PHARMACOLOGY

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

RINGERS INDICATIONS AND USAGE

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

RINGERS CONTRAINDICATIONS

None known

WARNINGS

Ringer’s Injection, USP should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there exists edema with sodium retention.

Ringer’s Injection, USP should be used with great care, if at all, in patients with hyperkalemia, severe renal failure, and in conditions in which potassium retention is present.

Ringer’s Injection, USP should not be administered simultaneously with blood through the same administration set because of the likelihood of coagulation.

The intravenous administration of Ringer’s Injection, USP 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 the injection. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injection.

In patients with diminished renal function, administration of Ringer’s Injection, USP may result in sodium or potassium retention.

PRECAUTIONS

Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.

Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates can result in air embolism if the residual air in the container is not fully evacuated prior to administration.

Use of a vented intravenous administration set with the vent in the open position could result in air embolism. Vented intravenous administration sets with the vent in the open position should not be used with flexible plastic containers.

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.

Caution must be exercised in the administration of Ringer’s Injection, USP to patients receiving corticosteroids or corticotropin.

Pregnancy

Teratogenic Effects

Pregnancy Category C

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

Pediatric Use

The use of Ringer’s Injection, USP in pediatric patients is based on clinical practice.

Geriatric Use

Clinical studies of Ringer’s Injection, USP did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Do not administer unless solution is clear and seal is intact.

RINGERS ADVERSE REACTIONS

Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation, and hypervolemia.

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.

RINGERS DOSAGE AND ADMINISTRATION

As directed by a physician. Dosage is dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations.

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

All injections in VIAFLEX plastic containers are intended for intravenous administration using sterile equipment.

Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. 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. Do not store solutions containing additives.

HOW SUPPLIED

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 at room temperature (25°C); brief exposure up to 40°C does not adversely affect the product.

DIRECTIONS FOR USE OF VIAFLEX PLASTIC CONTAINER

To Open

Tear overwrap down side at slit and remove solution 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. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow directions below.

Preparation for Administration

• Suspend container from eyelet support.
• Remove protector from outlet port at bottom of container.
• Attach administration set. Refer to complete directions accompanying set.

To Add Medication

WARNING: Additives may be incompatible

To add medication before solution administration

• Prepare medication site.
• Using syringe with 19 to 22 gauge needle, puncture medication port and inject.
• Mix solution and medication thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly.

To add medication during solution administration

• Close clamp on the set.
• Prepare medication site.
• Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
• Remove container from IV pole and/or turn to an upright position.
• Evacuate both ports by squeezing them while container is in the upright position.
• Mix solution and medication thoroughly.
• Return container to in use position and continue administration.

Baxter Healthcare Corporation
Deerfield, IL 60015 USA

Printed in USA

*BAR CODE POSITION ONLY
071969768

07-19-69-768

Rev. September 2013

BAXTER, VIAFLEX AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INC.

PRINCIPAL DISPLAY PANEL - PACKAGING LABELING

2B2303
NDC 0338-0105-03

Ringer's
Injection USP

500 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 Logo
Baxter Healthcare Corporation
Deerfield, IL 60015 USA

Made in USA

For Product Information
1-800-933-0303

Baxter VIAFLEX and
PL 146 are trademarks of
Baxter International Inc

2B2303Q

24-500 ML
VIAFLEX CONTAINER

RINGER'S INJECTION, USP

EXP
XXXXX

SECONDARY BAR CODE
(17) YYMM00 (10) XXXXX

LOT
XXXXX

PRIMARY BAR CODE
(01) 50303380105033