Label: VETIVEX HARTMANNS- sodium chloride, sodium lactate, potassium chloride, and calcium chloride injection, solution
- NDC Code(s): 17033-482-03, 17033-482-05
- Packager: Dechra Veterinary Products
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated September 9, 2020
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- Official Label (Printer Friendly)
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Description:
Hartmann's Solution for Injection is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for parenteral administration. It contains no antimicrobial agents. Discard unused portions.
Table 1 Hartmann's Solution for Injection Size (mL) Composition (mg/100mL) Osmolarity (mOsmol/L)
(Calculated)pH Ionic Concentration (mEq/L) Sodium Chloride, USP
(NaCl)Sodium Lactate, USP
(C3H5NaO3)Potassium Chloride, USP
(KCl)Calcium Chloride Dihydrate, USP
(CaCl2∙ 2H2O)Sodium Potassium Calcium Chloride Lactate 3000 600 317 40 27 278 6.5 (5.0 to 7.0) 131 5 4 111 29 5000 -
Clinical Pharmacology:
Hartmann's Solution for Injection has value as a source of water and electrolytes. lt is capable of inducing diuresis depending on the clinical condition of the patient.
Hartmann's Solution for Injection 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:
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Warnings:
Do not administer to horses by intraperitoneal injection.
Hartmann's Solution for 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 with sodium retention.
Hartmann's Solution for 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.
Hartmann's Solution for Injection 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.
Hartmann's Solution for Injection should not be administered simultaneously with blood through the same administration set because of the likelihood of coagulation.
The parenteral administration of Hartmann's Solution for Injection 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 injections. 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 Hartmann's Solution for Injection may result in sodium or potassium retention.
Hartmann's Solution for Injection is not for use in the 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.
Hartmann's Solution for Injection must be used with caution. Excess administration may result in metabolic alkalosis.
Do not administer unless solution is clear and seal is intact.
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.
lf 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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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 injection contained in plastic containers are intended for 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.
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Overdosage:
In an event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures.
See Warnings, Adverse Reactions and Precautions.
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How Supplied:
Hartmann's Solution for Injection is supplied in plastic bags as follows:
NDC Code Volume - *
- Latex Free Bag. 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 animals according to USP biological tests for plastic containers, as well as tissue culture toxicity studies.
17033-482-03 3000mL* 17033-482-05 5000mL* -
Directions for use of plastic container
To Open
Tear overwrap down side at slit and remove solution bag. 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 resealable 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 administration set to stop the flow to the patient.
- 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.
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DISTRIBUTED BY:
Dechra Veterinary Products
7015 College Boulevard, Suite 525 Overland Park, KS 66211
Made in El Salvador.
For a copy of the Safety Data Sheet (SDS) or to report adverse reactions call
Dechra Veterinary Products at (866) 933-2472.
© 2017 Dechra Ltd.
VETIVEX® is a trademark of Dechra Ltd; all rights reserved.Rev. 10/17
- PRINCIPAL DISPLAY PANEL - 3000 mL Container Label
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INGREDIENTS AND APPEARANCE
VETIVEX HARTMANNS
sodium chloride, sodium lactate, potassium chloride, and calcium chloride injection, solutionProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:17033-482 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium chloride (UNII: 451W47IQ8X) (Chloride ion - UNII:Q32ZN48698, Sodium cation - UNII:LYR4M0NH37) Sodium chloride 600 mg in 100 mL Sodium Lactate (UNII: TU7HW0W0QT) (Lactic acid, unspecified form - UNII:33X04XA5AT, sodium cation - UNII:LYR4M0NH37) Sodium Lactate 317 mg in 100 mL Potassium Chloride (UNII: 660YQ98I10) (Potassium cation - UNII:295O53K152, chloride ion - UNII:Q32ZN48698) Potassium Chloride 40 mg in 100 mL Calcium Chloride (UNII: M4I0D6VV5M) (Calcium cation - UNII:2M83C4R6ZB, chloride ion - UNII:Q32ZN48698) Calcium Chloride 27 mg in 100 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Sodium (UNII: 9NEZ333N27) Potassium (UNII: RWP5GA015D) Calcium (UNII: SY7Q814VUP) Chloride ion (UNII: Q32ZN48698) Lactic acid, unspecified form (UNII: 33X04XA5AT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17033-482-03 3000 mL in 1 CONTAINER 2 NDC:17033-482-05 5000 mL in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 12/01/2017 Labeler - Dechra Veterinary Products (362142734) Registrant - Dechra Ltd (641097493)
