Veterinary Lactated Ringers and Dextrose description, usages, side effects, indications, overdosage, supplying and lots more!

Veterinary Lactated Ringers and Dextrose

Abbott Laboratories


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

For Animal Use Only

Description

Veterinary Lactated Ringer’s and 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in a single dose container for intravenous administration. It contains no antimicrobial agents.
Discard unused portion. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1.

DescriptionDescription

Lactated Ringer’s and 5% Dextrose Injection, USP administered intravenously has value as a source of water, electrolytes, and calories. Normal physiologic range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions may cause vein damage.

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 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

Lactated Ringer’s and 5% Dextrose Injection, USP has value as a source of water, electrolytes, and calories. It is capable of inducing diuresis depending on the clinical condition of the patient.
Lactated Ringer’s and 5% Dextrose Injection, USP produces a metabolic alkalinizing effect. Lactate ions are metabolized ultimately to carbon dioxide and water, which requires the consumption of hydrogen cations.

Indications and Usage

Lactated Ringer’s and 5% Dextrose Injection, USP is indicated as a source of water, electrolytes and calories or as an alkalinizing agent.

Contraindications

Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.

Warnings

Lactated Ringer’s and 5% Dextrose 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 and 5% Dextrose 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 and 5% Dextrose 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 and 5% Dextrose 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 and 5% Dextrose 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 Lactated Ringer’s and 5% Dextrose Injection, USP may result in sodium or potassium retention.

Lactated Ringer’s and 5% Dextrose Injection, USP is not for use in the treatment of lactic acidosis.

Side Effects

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.

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 and 5% Dextrose Injection, USP should be used with caution. Excess administration may result in metabolic alkalosis.

Caution must be exercised in the administration of Lactated Ringer’s and 5% Dextrose Injection, USP to patients receiving corticosteroids or corticotropin.

Lactated Ringer’s and 5% Dextrose Injection, USP should be used with caution in patients with overt or subclinical diabetes mellitus.
Do not administer unless solution is clear and the seal is intact.

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 injections in 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 veterinarian, if available. If, in the informed judgement 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.

OverDosage

In an event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See Warnings , Precautions  and Adverse Events .

How Supplied

Lactated Ringer’s and 5% Dextrose Injection, USP in plastic containers is available as follows:

List Number     Size (mL)     Code             NDC

04937-04-10     1000             2B8254         0044-4937-10

Exposure of pharmaceutical products to heat should be minimized.
Avoid excessive heat. It is recommended the product be stored at room temperature (25°C/77°F); brief exposure up to 40°C/104°F does not adversely affect the product.

Directions for use of 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
1. Suspend container from eyelet support.
2. Remove plastic 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 administration
1. Prepare medication site.
2. Using syringe with 19 to 22 gauge needle, puncture 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 administration
1. 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 restricts this drug to use by or on the order of a licensed veterinarian.

Manufactured for:
Abbott Laboratories
North Chicago, IL 60064

For customer service call (888) 299-7416

Printed in USA

07-19-69-400

Rev. August 2012

Directions for use of plastic container

Principal Display Panel

04937-04-10
Principal Display Panel Veterinary Lactated Ringer's and 5% Dextrose Injection USP    
1000 ml

Principal Display Panel

Veterinary Lactated Ringers and Dextrose

sodium chloride, sodium lactate, potassium chloride, calcium chloride and dextrose monohydrate INJECTION, SOLUTION

Product Information

Product Type Prescription animal drug label Item Code (Source) NDC:0044-4937
Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Dextrose monohydrate ANHYDROUS DEXTROSE 5 g
SODIUM CHLORIDE 600 mg
sodium lactate 310 mg
potassium chloride 30 mg
calcium chloride 20 mg

Inactive Ingredients

Ingredient Name Strength
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0044-4937-10 1000 in 1 CONTAINER

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-03-23


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