E-SE ® (SELENIUM, VITAMIN E) Injection

Manufacturer
Schering Corporation
Effective date
2024-11-12
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:43:50

Label at a glance#

ProductE-SE
Active ingredientSODIUM SELENITE, .ALPHA.-TOCOPHEROL ACETATE, D-
Label structure12 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

FOR VETERINARY USE ONLY

Approved by FDA under NADA # 030-315

PRODUCT INFORMATION

SPL UNCLASSIFIED SECTION

CAUTION Federal law restricts this drug to use by or on the order of a licensed veterinarian.

DESCRIPTION SECTION

DESCRIPTION E-SE Injection is an emulsion of selenium-tocopherol for the prevention and treatment of myositis (Selenium-Tocopherol Deficiency) syndrome in horses. Each mL contains: 5.48 mg sodium selenite (equivalent to 2.5 mg selenium), 50 mg (68 USP units or IU) vitamin E (as d-alpha tocopheryl acetate), 250 mg polyoxyethylated vegetable oil, 2% benzyl alcohol (preservative), water for injection q.s. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH.

CLINICAL PHARMACOLOGY SECTION

PHARMACOLOGY It has been demonstrated that selenium and tocopherol exert physiological effects and that these effects are intertwined with sulfur metabolism. Additionally, tocopherol appears to have a significant role in the oxidation process, thus suggesting an interrelationship between selenium and tocopherol in overcoming sulfur-induced depletion and restoring normal metabolism. Although oral ingestion of adequate amounts of selenium and tocopherol would seemingly restore normal metabolism, it is apparent that the presence of sulfur and, perhaps, other factors interfere during the digestive process with proper utilization of selenium and tocopherol. When selenium and tocopherol are injected, they bypass the digestive process and exert their full metabolic effects promptly on cell metabolism. Anti-inflammatory action has been demonstrated by selenium-tocopherol in the Selye Pouch Technique and experimentally induced polyarthritis study in rats.

VETERINARY INDICATIONS SECTION

INDICATIONS E-SE Injection is recommended for the control of the following clinical signs when associated with myositis (Selenium-Tocopherol Deficiency) syndrome: rapid respiration, profuse sweating, muscle spasms and stiffness, elevated SGOT.

SPL UNCLASSIFIED SECTION

CAUTION Intravenous administration, if elected, should be by slow injection.

Emulsions injected intramuscularly into the horse may produce transitory local muscle soreness and can be prevented to some degree by injecting deeply (2 to 21/2 inches), in divided doses, in two or more sites. Do not continue therapy in horses demonstrating such sensitivity.

Selenium is toxic if administered in excess. A fixed dose schedule is therefore important (read package insert for each selenium-tocopherol product carefully before using).

WARNINGS SECTION

WARNINGS Anaphylactoid reactions, some of which have been fatal, have been reported in horses administered E-SE Injection. Signs include excitement, sweating, trembling, ataxia, respiratory distress, and cardiac dysfunction. These reactions have been reported as associated both with intravenous and intramuscular injections. It is presently unknown whether the mode of application affects the frequency of such reactions. However, reactions associated with intramuscular injections have been reported to manifest more slowly and hence may give more time to institute treatment for anaphylaxis, such as epinephrine and/or corticosteroid injection.

Medications which have been reported to cause major adverse reactions in horses should be avoided when E-SE is administered, unless the condition of the animal requires such use.

Not to be used in horses intended for food.

DOSAGE & ADMINISTRATION SECTION

DOSAGE AND ADMINISTRATION Administration: slow intravenous injection (see WARNINGS) or deep intramuscular injections, in divided doses, in two or more sites in the gluteal or cervical muscles. Dosage: 1 mL per 100 pounds of body weight. May be repeated at 5-10 day intervals.

PRECAUTIONS SECTION

PRECAUTIONS Selenium-Tocopherol Deficiency (STD) syndrome produces a variety and complexity of symptoms often interfering with a proper diagnosis. Even in selenium deficient areas there are other disease conditions which produce similar clinical signs. It is imperative that all these conditions be carefully considered prior to treatment of STD syndrome. Serum selenium levels, elevated SGOT, and creatine levels may serve as aids in arriving at a diagnosis of STD, when associated with other indices.

Important Use only the selenium-tocopherol product recommended for each species. Each formulation is designed for the species indicated to produce the maximum efficacy and safety.

HOW SUPPLIED SECTION

HOW SUPPLIED 100 mL sterile, multiple-dose glass vial, NDC 0061-0709-04.

STORAGE AND HANDLING SECTION

STORAGE Store between 2 and 30 C (36 and 86 F). Protect from freezing.

SPL UNCLASSIFIED SECTION

Rev. 10-2022

Copyright © 2022 Merck & Co., Inc., Rahway,
NJ, USA and its affiliates.
All rights reserved.
Made in Germany.

MERCK
Animal Health

399371 R2

PRINCIPAL DISPLAY PANEL - 100 mL Vial Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100 mL Sterile
Multiple Dose Vial
2.5 mg/mL

SELENIUM

NDC 0061-0709-04

E-SE®
(SELENIUM, VITAMIN E)

Injection
Veterinary

Caution: Federal law restricts
this drug to use by or on the
order of a licensed veterinarian.

Approved by FDA under
NADA # 030-315

MERCK
Animal Health

PRINCIPAL DISPLAY PANEL - 100 mL Vial Carton
PRINCIPAL DISPLAY PANEL - 100 mL Vial Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
86fffa7b-d382-4771-a253-25cccb64b590Product name320251124
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0061-0709-04E-SE1 in 1 CARTONINJECTION, SOLUTION15
0061-0709-04E-SE100 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0061-0709E-SE (SODIUM SELENITE AND .ALPHA.-TOCOPHEROL ACETATE, D-) INJECTION, SOLUTION [SCHERING CORPORATION]52 package rows20241114_74620a2d-a633-4af7-9a29-9da71623e450.zip

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0061-07090061-0709-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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