IRON HYDROGENATED DEXTRAN INJECTION

Manufacturer
Sparhawk Laboratories, Inc.
Effective date
2024-05-30
Label type
OTC ANIMAL DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 02:43:07

Label at a glance#

ProductIRON HYDROGENATED DEXTRAN
Active ingredientIRON
Label structure8 sections

Storage and handling

Store at controlled room temperature between 15 o and 30 o C (59 o - 86 o F). Protect from freezing. TAKE TIME OBSERVE LABEL DIRECTIONS Use within 90 days/3months after first puncture and puncture a maximum of 70 times.

Label contents#

Full prescribing information#

DESCRIPTION SECTION

HEMATINIC

For Prevention and Treatment of Iron Deficiency Anemia in Baby Pigs

NOT FOR HUMAN USE

KEEP OUT OF REACH OF CHILDREN

Approved by FDA under NADA # 138-255

DESCRIPTION

IRON HYDROGENATED DEXTRAN INJECTION is a sterile solution containing 100 mg of elemental iron per mL, stabilized with a low molecular weight hydrogenated dextran and 0.5% phenol as a preservative.

INDICATIONS

INDICATIONS & USAGE SECTION

For the prevention and treatment of anemia due to iron deficiency in baby pigs.

Iron deficiency anemia occurs commonly in the suckling pig, often within the first few days following birth. As body size and blood volume increase rapidly from the first few days following birth, hemoglobin levels in the blood fall due to diminishing iron reserves which cannot be replaced adequately from iron in the sow's milk. Thus, the need  for a readily available outside source of iron is apparent. Without this additional iron many newborn pigs may develop anemia within the first few days of life. Anemia retards growth and lowers the body defenses against disease; scours, pneumonia, and other conditions may develop. Death from anemia or infections may occur, sometimes destroying entire litters.

DOSAGE

ROUTE, METHOD AND FREQUENCY OF ADMINISTRATION

For intramuscular injection only.

For Prevention of iron deficiency anemia, administer 1 mL (100 mg iron) at 2 to 4 days of age.

For Treatment of iron deficiency anemia, administer 1 mL (100 mg iron). Treatment may be repeated in 10 days.

DIRECTIONS FOR USE

Disinfect rubber stopper of vial and injection site with a cotton ball moistened with rubbing alcohol or other suitable disinfectant. Use a small needle (20 gauge, 5/8 inch) and syringe that have been sterilized by boiling in water for 20 minutes. Injection should be made intramuscularly into the back of the ham (see diagram below). Apply tension to the skin at the injection site by pulling skin and fat downward with pressure from the thumb or fingers. Inject into the muscle to a depth of approximately 1/2 inch. Use a clean, sterile needle and syringe for each pig to avoid spreading infection.

Injection SiteInjection Site

PRECAUTIONS

GENERAL PRECAUTIONS SECTION

If disease or abnormal condition is suspected, consult veterinarian before administration.

SIDE EFFECTS

ADVERSE REACTIONS SECTION

Occasionally pigs may exhibit a reaction to iron injection, clinically characterized by prostration and muscular weakness. In extreme cases, death may result.

NOTICE: The intramuscular injection of organic iron preparations into pigs beyond 4 weeks of age may cause staining of muscle tissue.

HOW SUPPLIED

HOW SUPPLIED SECTION

100 mL multiple dose vials.

STORAGE AND HANDLING SECTION

Store at controlled room temperature between 15o and 30oC (59o - 86oF).

Protect from freezing.

TAKE TIME OBSERVE LABEL DIRECTIONS

Use within 90 days/3months after first
puncture and puncture a maximum of
70 times.

CONTACT INFORMATION

SPL UNCLASSIFIED SECTION

To report suspected adverse events for technical
assistance or to obtain a copy of the
Safety Data Sheet (SDS), contact
Sparhawk Laboratories Inc. at
1-800-255-6388 or 1-913-888-7500. For
additional information about adverse
drug experience reporting for animal
drugs, contact FDA at 1-888-FDA-VETS
or www.fda.gov/reportanimalae

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SLI IHD Unit labelSLI IHD Unit labelSLI IHD InsertSLI IHD Insert

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311143iron-dextran complex 100 MG/ML Injectable SolutionSCD10
311143iron dextran 100 MG per 1 ML Injectable SolutionSY10
311143iron-dextran complex (iron 100 MG/ML) Injectable solutionSY10

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
910c1bd7-67d1-44c7-ad4f-9445f827edccProduct name120230808

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58005-040-04IRON HYDROGENATED DEXTRAN100 mL in 1 VIALINJECTION10010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58005-040IRON HYDROGENATED DEXTRAN (IRON) INJECTION [SPARHAWK LABORATORIES, INC.]101 package rows20240601_2dcbe68c-7297-4a78-948b-5e7c6b72cafc.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
IRONACTIVE INGREDIENTE1UOL152H76
IRONACTIVE MOIETYE1UOL152H76

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58005-04058005-040-04

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
IRONE1UOL152H7ACTIB

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 1 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REAL SUMMERIRONKAYONE63021d49-8720-4e4e-a08f-a5d2f6acfaa52024-12-09WarningsName fallback
generic name: IRON
Ferrum Metallicum 6XIRONTrue Botanica, LLC2392929c-996b-01e0-e063-6394a90aa2b92024-10-03WarningsName fallback
generic name: IRON
Ferrum metallicumIRONBoiron85914cb4-f903-80c6-e053-2a91aa0ae14a2023-11-13Name fallback
generic name: IRON
Ferrum metallicumIRONBoiron85912948-19cc-76be-e053-2991aa0a3e5a2023-11-13Name fallback
generic name: IRON
Ferrum metallicumIRONBoiron8591b12c-51c8-9839-e053-2a91aa0aa9372023-11-13Name fallback
generic name: IRON
Ferrum metallicumIRONBoiron85917340-1f94-08db-e053-2a91aa0a77c92023-11-13Name fallback
generic name: IRON
Ferrum metallicumIRONBoiron87372ec7-eacf-90b1-e053-2a91aa0afadf2023-11-13Name fallback
generic name: IRON
Ferrum metallicumIRONBoiron859195ed-0b6c-f4fe-e053-2991aa0ad85b2023-03-03Name fallback
generic name: IRON
Ferrum metallicumIRONBoiron85919b82-39cf-254d-e053-2a91aa0a61502023-02-20Name fallback
generic name: IRON

Reported adverse events (FAERS/openFDA)#

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