Label: LACTATED RINGER AND DEXTROSE- sodium chloride, sodium lactate, potassium chloride, calcium chloride and dextrose monohydrate injection, solution
- NDC Code(s): 46066-514-06
- Packager: ASPEN VETERINARY
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Updated December 15, 2017
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- WARNINGS AND PRECAUTIONS
Lactated Ringer and 5% Dextrose Injection is a sterile, non-pyrogenic solution intended for fluid and electrolyte replenishment and caloric supply in single dose containers. May be administered intravenously using aseptic technique. It contains no antimicrobial agents. Discard any unused portion. Composition, osmolarity, pH and ionic concentration and caloric content are shown in Table 1.
*Sodium Lactate USP – (S)-enantiomer
Osmolarity (mOsmol/L) (calc): 525mOsmol per liter
Caloric Content (kcal/L): 180
pH: 5.0 (limit 4.0 – 6.5)
The container is free of PVC and phthalates. The container meets the requirements of USP and is registered with FDA.
Lactated Ringer and 5% Dextrose Injection is intended to restore the electrolyte balance, caloric content and water for hydration. It is capable of inducing diuresis depending on the clinical condition of the patient. Lactated Ringer and 5% Dextrose Injection produces a metabolic alkalinizing effect. Lactate ions are metabolized ultimately to carbon dioxide and water, which requires the consumption of hydrogen cations.
Lactated Ringer and 5% Dextrose 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.
Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.
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.
Lactated Ringer and 5% Dextrose 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 retention; patients with hyperkalemia, severe renal failure, and in conditions in which potassium retention is present; 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 and 5% Dextrose Injection should not be administered simultaneously with blood through the same administration set because of likelihood of coagulation.
The intravenous administration of Lactated Ringer and 5% Dextrose 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 injections.
In patients with diminished renal function, administration of Lactated Ringer and 5% Dextrose Injection may result in sodium or potassium retention.
Do not administer to animals with inadequate renal function. Not for use in lactic acidosis.
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 and evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.
This is a single dose unit. It contains no preservatives. Use entire contents when first opened.
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.
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.
Lactated Ringer and 5% Dextrose Injection should be used with caution. Excess administration may result in metabolic alkalosis.
Caution must be exercised in the administration of Lactated Ringer and 5% Dextrose Injection to patients receiving corticosteroids or corticotropin.
Lactated Ringer and 5% Dextrose Injection should be used with caution in patients with overt or subclinical diabetes mellitus.
Dosage and Administration
To be used as directed by a licensed veterinarian. The dosage of the Lactated Ringer and 5% Dextrose 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. Mix thoroughly when additives have been introduced. Do not store solutions containing additives.
Directions for use of plastic container
Tear overwrap 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.
- GENERAL PRECAUTIONS
- INFORMATION FOR OWNERS/CAREGIVERS
- Lactated Ringer and 5% Dextrose Injection 1000mL
INGREDIENTS AND APPEARANCE
LACTATED RINGER AND DEXTROSE
sodium chloride, sodium lactate, potassium chloride, calcium chloride and dextrose monohydrate injection, solution
Product Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:46066-514 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE 5 g in 100 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 600 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 SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID - UNII:33X04XA5AT) SODIUM LACTATE 310 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:46066-514-06 12 in 1 CASE 1 1000 mL in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/27/2016 Labeler - ASPEN VETERINARY (627265361) Registrant - SYPHARMA PTY LTD (753786292) Establishment Name Address ID/FEI Business Operations SYPHARMA PTY LTD 753786292 manufacture, pack, sterilize