Label: VETERINARY LACTATED- sodium chloride, sodium lactate, potassium chloride, calcium chloride injection, solution
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NDC Code(s):
86094-898-01,
86094-898-03,
86094-898-05,
86094-898-25, view more86094-898-50
- Packager: Ivali LLC
- Category: PRESCRIPTION ANIMAL DRUG LABEL
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated April 26, 2018
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
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Description
Lactated 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 or preservatives. Discard unused portion. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1:
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Clinical Pharmacology
Lactated 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.
Lactated Ringer's Injection, USP produces a metabolic alkalinizing effect. Lactate ions are metabolized ultimately to carbon dioxide and water, which requires consumption of hydrogen cations
- Indications and Usage
- Contraindications
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Warnings
Do not administer to horses by intraperitoneal injection.
Lactated 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.
Lactated 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.
Lactated Ringer's Injection, USP should be used with great care, in patients with metabolic or respiratory alkalosis. The administration of lactate ions should be done with great care in those conditions in which there is an increased level or an impaired utilization of these ions, such as severe hepatic insufficiency.
Lactated 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 Lactated Ringer's Injection, USP can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, over hydration, congested states, or pulmonary edema. The risk of dilutive states is inversely proportional to the electrolyte concentration of the injections. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injections.
In patients with diminished renal function, administration of lactated Ringer's Injection, USP may result in sodium or potassium retention.
Lactated Ringer's Injection, USP is not used for treatment of lactic acidosis.
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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.
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Precautions
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.
Lactated Ringer's Injection,USP must be used with caution. Excess administration may result in metabolic alkalosis.
Caution must be exercised in the administration of Lactated Ringer's Injection, USP to patients receiving corticosteroids or corticotrophin.
Do not administer unless solution is clear and seal is intact.
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Dosage and Administration
As directed by a veterinarian. 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 solutions for injections in plastic containers are intended for intravenous administration using sterile equipment and aseptic technique.
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 veterinarian, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives. Discard unused portion.
- Over Dosage
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How Supplied
Veterinary Lactated Ringer's Injection, USP in plastic container is available as follows:
HOW SUPPLIED NDC Code Volume 86094-898-25 250 mL* 86094-898-50 500 mL* 86094-898-01 1000 mL* 86094-898-03 3000 mL** 86094-898-05 5000 mL** *PVC Free, DEHP Free and Latex Free Bag. The volumetric scales on the single dose plastic container should only be used as a reference. For precise dosage of volumes it is recommeded the use of IV Infusion pump or IV Burrette.
**The plastic container is fabricated from a specially formulated polyvinyl chloride. 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 withing 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 animals accourding to USP biological tests for plastic containers, as well as tissue culture toxicity studies.
- Storage
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Directions for use of plastic container
To OpenTear 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 Administration1. Suspend container from eyelet support.
2. Remove protector from outlet port at bottom of container.
3. Attach administration set. Refer to complete directions accompanying set.
To Add Medication
WARNING: Additives may be incompatible.To add medication before solution administration1. Prepare medication site.
2. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
3. 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 administration1. Close clamp on the set.
2. Prepare medication site.
3. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
4. Remove container from IV pole and/or turn to an upright position.
5. Evacuate both ports by squeezing them while container is in the upright position.
6. Mix solution and medication thoroughly.
7. Return container to in-use position and continue administration.
CAUTION: Federal law (USA) restricts this drug to use by or on the order of a licensed veterinarian.
Manufactured for:
IVALI LLC18205 Biscayne Blvd., Suite 2202
Aventura FloridaPrinted in Argentina
For a copy of the Safety Data Sheet (SDS) or to report adverse reactions call IVALI LLC. Customer service at 1-305-692-7665
IVALI is a trademark of IVALI LLC., all rights reserved.
© 2018 IVALI LLC.
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Principal Display Panel
NDC 86094-898-25
Veterinary Lactated Ringer's Injection, USP
250 mlNDC 86094-898-50
Veterinary Lactated Ringer's Injection, USP
500 ml86094-898-01
Veterinary Lactated Ringer's Injection, USP
1000 ml86094-898-03
Veterinary Lactated Ringer's Injection, USP
3000 mlNDC 50989-898-05
Veterinary Lactated Ringer's Injection, USP
5000 ml -
INGREDIENTS AND APPEARANCE
VETERINARY LACTATED
sodium chloride, sodium lactate, potassium chloride, calcium chloride injection, solutionProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:86094-898 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 600 mg in 100 mL SODIUM LACTATE (UNII: TU7HW0W0QT) (LACTIC ACID - UNII:33X04XA5AT, SODIUM CATION - UNII:LYR4M0NH37) SODIUM LACTATE 310 mg in 100 mL POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698) POTASSIUM CHLORIDE 30 mg in 100 mL CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE 20 mg in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:86094-898-25 250 mL in 1 CONTAINER 2 NDC:86094-898-50 500 mL in 1 CONTAINER 3 NDC:86094-898-01 1000 mL in 1 CONTAINER 4 NDC:86094-898-03 3000 mL in 1 PACKAGE 5 NDC:86094-898-05 5000 mL in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 04/26/2018 Labeler - Ivali LLC (081136076) Establishment Name Address ID/FEI Business Operations LABORATORIOS JAYOR S.R.L. 979312485 manufacture, api manufacture