Label: VETONE- lactated ringers sodium chloride,sodium lactate,potassium chloride,calcium chloride injection, solution
- NDC Code(s): 13985-933-01, 13985-933-05, 13985-933-25, 13985-933-50
- Packager: MWI
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Updated September 4, 2018
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STERILE NONPYROGENIC SOLUTIONFor Animal Use Only
VetOne Lactated Ringer’s Injection is a sterile, non-pyrogenic solution intended for fluid and electrolyte
replenishment in single dose containers. May be administered intravenously, subcutaneously or
intraperitoneally (except in horses) using aseptic technique. It contains no antimicrobial agents.
Discard any unused portion. Composition, osmolarity, pH and ionic concentration are shown In Table 1
*Sodium Lactate USP — (S)-enantiomer
Osmolarity (mOsmol/L) (calc): 273mOsmol per liter
pH: 6.5 (limit 6.0 - 7.5)
The container is free of PVC and phthalates. The container meets the requirements of USP and is
registered with US FDA.
A multiple electrolyte intravenous solution is intended to restore the electrolyte balance and water for
hydration. A combination of multiple electrolytes and sodium lactate, an alkalinizing agent, will
provide electrolyte balance and normalize the pH of the acid-base of the physiological system.
VetOne Lactated Ringer′s Injection is indicated as a source of water and electrolytes for all species. It is also
used as an alkalinizing agent.
VetOne Lactated Ringer′s Injection is contraindicated in patients with a known hypersensitivity to sodium
lactate; congestive heart failure or severe impairment of renal function; clinical states in which the
administration of sodium and chloride is detrimental.
The introduction of additives to any solution, regardless of type of container, requires special attention
to ensure that no incompatibilities result. While some incompatibilities are readily absorbed, one must
be aware that subtle physical, chemical and pharmacological incompatibilities can occur. The medical
literature, the package insert and other available sources of information should be reviewed for
thorough understanding of possible incompatibilities.
VetOne Lactated Ringer′s Injection 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 and sodium
VetOne Lactated Ringer′s Injection 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.
VetOne Lactated Ringer′s Injection should be used with great care in patients Wth 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.
VetOne Lactated Ringer′s Injection should not be administered simultaneously with blood through the same
administration set because of likelihood of coagulation.
The intravenous administration of VetOne Lactated Ringer′s Injection can cause fluid and/or solute overloading
resulting in dilution of serum electrolyte concentrations, over-hydration, congested states, or
pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte
concentrations of the injections. The risk of solute overloading causing congested states with
peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the
In patients with diminished renal function, administration of VetOne Lactated Ringer′s Injection may result in
sodium or potassium retention.
Do not administer to horses by intraperitoneal injection. Do not administer to animals with inadequate
renal function. Not for use in lactic acidosis.
Adverse reactions may occur due to the solution or the technique of administration including fever
response, infection at the site of injection or allergic reactions. Prolonged intravenous infusion of this
type of product may cause venous thrombosis or phlebitis extending from the site of injection,
extravasation, and hypervolemia.
If an adverse reaction does occur discontinue the infusion and evaluate the patient, institute
appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if
This is a single dose unit. It contains no preservatives. Use entire contents when first opened.
Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid
balance, electrolyte concentrations, and acid base balance during prolonged therapy or whenever the
condition of the patient warrants such evaluation.
VetOne Lactated Ringer′s Injection should be used with caution. Excess administration may result in metabolic
Do not administer unless solution is clear and both seal and container are intact.
Solution must be warmed to body temperature prior to administration and administered at a slow rate.
Use solution promptly following initial entry.
Reactions which may occur because of the solution or the technique of administration, include febrile
response, infection at the site of injection, extravasation, and hypervolemia.
If an adverse reaction occur, discontinue the infusion and evaluate the patient, institute appropriate therapeutic
countermeasures, and save remainder of the fluid for examination if deemed necessary.
DOSAGE AND ADMINISTRATION
To be used as directed by a licensed veterinarian. The dosage of the VetOne Lactated Ringer′s Injection is
dependent upon the age, weight and clinical conditions of the patient as well as laboratory
determinations. Parenteral drug products should be inspected visually for particulate matter and
discoloration prior to administration.
For use in one patient on one occasion only. Discard any unused portion. Care should be taken with
administration technique to avoid administration site reactions and infection.
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 judgement of the doctor‚
it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced.
Do not store solutions containing additives.
In an event of over-hydration or solute overload, re-evaluate the patient and institute appropriate
corrective measures. See Warnings, Precautions and Adverse Events.
VetOne Lactated Ringer′s Injection in 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 (86°F/30°C). Protect from freezing.
DIRECTIONS FOR USE OF PLASTIC CONTAINER
Tear owerwrap 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
solution container 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 inlet/outlet port at bottom of container.
3. Attach administration set.
TO Add Medication
WARNING: Additives may be incompatible.
TO add medication before solution administration
1. Prepare medication site.
2. Using syringe with 0.63mm to 0.80mm 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 the clamp on the administration set.
2. Prepare medication site.
3. Using syringe with 0.63mm to 0.80mm needle, puncture 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.
INGREDIENTS AND APPEARANCE
lactated ringers sodium chloride,sodium lactate,potassium chloride,calcium chloride injection, solution
Product Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:13985-933 Route of Administration INTRAVENOUS, SUBCUTANEOUS, INTRAPERITONEAL 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) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID - UNII:33X04XA5AT) 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:13985-933-25 24 in 1 CARTON 1 250 mL in 1 BAG 2 NDC:13985-933-50 24 in 1 CARTON 2 500 mL in 1 BAG 3 NDC:13985-933-01 12 in 1 CARTON 3 1000 mL in 1 BAG 4 NDC:13985-933-05 2 in 1 CARTON 4 5000 mL in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 08/03/2018 Labeler - MWI (019926120) Registrant - Sypharma Pty Ltd (753786292) Establishment Name Address ID/FEI Business Operations Sypharma Pty Ltd 753786292 manufacture, pack, sterilize Establishment Name Address ID/FEI Business Operations New Zealand Salt Company Limited 594169799 api manufacture