Vetivex ® Hartmann's Solution for Injection

Manufacturer
Dechra Veterinary Products | Dechra Ltd
Effective date
2020-09-09
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:40:49

Label at a glance#

ProductVetivex Hartmanns
Active ingredientSodium chloride, Sodium Lactate, Potassium Chloride, Calcium Chloride
Label structure14 sections

Indications and uses

Hartmann's Solution for Injection is indicated as a source of water and electrolytes or as an alkalinizing agent.

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 equ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

For Animal Use Only

Description:

DESCRIPTION SECTION

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)
pHIonic Concentration (mEq/L)
Sodium Chloride, USP
(NaCl)
Sodium Lactate, USP
(C3H5NaO3)
Potassium Chloride, USP
(KCl)
Calcium Chloride Dihydrate, USP
(CaCl2∙ 2H2O)
SodiumPotassiumCalciumChlorideLactate
300060031740272786.5 (5.0 to 7.0)1315411129
5000

Clinical Pharmacology:

CLINICAL PHARMACOLOGY SECTION

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:

VETERINARY INDICATIONS SECTION

Hartmann's Solution for Injection is indicated as a source of water and electrolytes or as an alkalinizing agent.

Warnings:

WARNINGS SECTION

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.

Adverse Reactions:

ADVERSE REACTIONS SECTION

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:

PRECAUTIONS SECTION

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.

Dosage and Administration:

DOSAGE & ADMINISTRATION SECTION

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.

Overdosage:

OVERDOSAGE SECTION

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

See Warnings, Adverse Reactions and Precautions.

How Supplied:

HOW SUPPLIED SECTION

Hartmann's Solution for Injection is supplied in plastic bags as follows:

NDC CodeVolume
17033-482-03   3000mL*
17033-482-05   5000mL*

* 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.

STORAGE AND HANDLING SECTION

STORAGE: Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored in the moisture barrier overwrap 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

INSTRUCTIONS FOR USE SECTION

To Open

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

  1. 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

SPL UNCLASSIFIED SECTION

WARNING: Additives may be incompatible.

SPL UNCLASSIFIED SECTION

To add medication before solution administration

  1. 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.
SPL UNCLASSIFIED SECTION

To add medication during solution administration

  1. Close clamp on the administration set to stop the flow to the patient.
  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.

SPL UNCLASSIFIED SECTION

CAUTION: Federal law (U.S.A.) restricts this drug to use by or on the order of a licensed veterinarian.

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTIONSPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Vetivex®

Hartmann's Solution for Injection

STERILE - NONPYROGENIC SOLUTION
FOR ANIMAL USE ONLY
KEEP OUT OF REACH OF CHILDREN
CAUTION: FEDERAL LAW (U.S.A.) RESTRICTS THIS DRUG TO USE BY
OR ON THE ORDER OF A LICENSED VETERINARIAN.
NDC: 17033-482-03

3000 mL
Dechra

PRINCIPAL DISPLAY PANEL - 3000 mL Container Label
PRINCIPAL DISPLAY PANEL - 3000 mL Container Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
SODIUM CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17033-482-03Vetivex Hartmanns3000 mL in 1 CONTAINERINJECTION, SOLUTION30003
17033-482-05Vetivex Hartmanns5000 mL in 1 CONTAINERINJECTION, SOLUTION50003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17033-482VETIVEX HARTMANNS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE) INJECTION, SOLUTION [DECHRA VETERINARY PRODUCTS]32 package rows20201022_c4cfde4d-672b-4d5f-aced-e2b7fc1ef593.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17033-48217033-482-03, 17033-482-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 9 · 176 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nacl 0.9% Normal Saline SolutionSODIUM CHLORIDECHI FUNG TECHNOLOGY COMPANY5a53c4c8-c9de-700c-e063-6394a90a3ab52026-08-31WarningsName fallback
generic name: SODIUM CHLORIDE
Sodium ChlorideSODIUM CHLORIDEYYBA CORP597f3347-647c-3545-e063-6294a90abab22026-08-20WarningsName fallback
generic name: SODIUM CHLORIDE
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLC2e5fe9f4-78e5-4af4-8bf9-9680e5dc5e882026-08-20Warnings, Adverse reactionsName fallback
generic name: SODIUM CHLORIDE
Hypertonic SalineSODIUM CHLORIDENAVEH PHARMA (1996) LTD167c7a9c-1228-4fb2-a89c-d3e1483863232026-07-30WarningsName fallback
generic name: SODIUM CHLORIDE
Hypertonic Saline Solution Sodium ChlorideSODIUM CHLORIDENAVEH PHARMA (1996) LTD750ea4b1-de2b-4299-aaa2-331daf383d0d2026-07-30WarningsName fallback
generic name: SODIUM CHLORIDE
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.9a1220fb-6853-45ae-838c-10d8596e1af72026-07-27Warnings, Adverse reactionsName fallback
generic name: SODIUM CHLORIDE
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCaf5cdf1a-19f4-11e2-892e-0800200c9a662026-07-27Warnings, Adverse reactionsName fallback
generic name: SODIUM CHLORIDE
Sodium ChlorideSODIUM CHLORIDELABORATORIOS GRIFOLS SAeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf2026-07-15Warnings, Adverse reactionsName fallback
generic name: SODIUM CHLORIDE
WHWSWB 0.9% SalineSODIUM CHLORIDEYiwu Huanshu E-commerce Co., Ltd4e9c21e5-f2f9-90e4-e063-6394a90acfe22026-07-11WarningsName fallback
generic name: SODIUM CHLORIDE
WHWSWB 0.9% SALINESODIUM CHLORIDEYiwu Huanshu E-commerce Co., Ltd5082b773-79b2-2501-e063-6394a90a170f2026-07-11WarningsName fallback
generic name: SODIUM CHLORIDE
SALINE NASALSODIUM CHLORIDEALAINA HEALTHCARE PRIVATE LIMITEDed30a7f9-7132-42da-9bed-63a9b1c80ab22026-07-07WarningsName fallback
generic name: SODIUM CHLORIDE
OHTrust Artifical EyedropSODIUM CHLORIDENanoplus Technology Co., Limited2ea26d96-704b-17bb-e063-6394a90a7e272026-07-01WarningsName fallback
generic name: SODIUM CHLORIDE
0.9% Sodium Chloride Saline SolutionSODIUM CHLORIDEYunqi Cosmetics (Shenzhen) Co., Ltd546af257-dbd1-11fc-e063-6394a90a8e0a2026-06-16WarningsName fallback
generic name: SODIUM CHLORIDE
Sodium ChlorideSODIUM CHLORIDECardinal Health 107, LLC107af8bc-b6af-4b85-8c8a-ea757dcef1da2026-06-12Adverse reactionsName fallback
generic name: SODIUM CHLORIDE
SALINE CLEANINGSODIUM CHLORIDEGuangzhou Huanmei Cosmetics Co., Ltd.524f07cc-ddb9-dda5-e063-6394a90ac0a52026-05-21WarningsName fallback
generic name: SODIUM CHLORIDE
Sodium ChlorideSODIUM CHLORIDEHospira, Inc.a2a964f7-c3ec-4dfb-e3a0-6d8136a803972026-05-19Warnings, Adverse reactionsName fallback
generic name: SODIUM CHLORIDE
Sodium ChlorideSODIUM CHLORIDESportpharm LLCa2c111f6-74d5-4a5d-82ac-d0f237488cb82026-04-24Warnings, Adverse reactionsName fallback
generic name: SODIUM CHLORIDE
Sodium ChlorideSODIUM CHLORIDEMethod Pharmaceuticals, LLC4b08859e-65bd-8255-e063-6394a90af6142026-04-23WarningsName fallback
generic name: SODIUM CHLORIDE
SODIUM CHLORIDE 1 GRAMSODIUM CHLORIDEGendose Pharmaceuticals, LLCce988ae5-61c6-4324-90e1-a94c8a54d0d02026-04-13WarningsName fallback
generic name: SODIUM CHLORIDE
Walgreens Sodium Chloride Ophthalmic 5 Percent Hypertonicity EyeSODIUM CHLORIDEWalgreen Companybda3b9db-5fc4-408c-a5ae-d1eeb3ee308d2026-04-06WarningsName fallback
generic name: SODIUM CHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.