Animal NDC 58005-040-04 Iron Hydrogenated Dextran
Iron

Animal Product Information

Field Name Field Value
Animal NDC Code 58005-040-04
Proprietary Name Iron Hydrogenated Dextran What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Iron What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Sparhawk Laboratories, Inc.
Product Type Otc Animal Drug
Usage Information
    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.
Active Ingredient(s)
  • Iron
Marketing Category NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number NADA138255 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Iron Hydrogenated Dextran Images

Iron Hydrogenated Dextran Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Description



HEMATINIC

For Prevention and Treatment of Iron Deficiency Anemia in Baby Pigs

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

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



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



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.


Precautions



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


Side Effects



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



100 mL multiple dose vials.


Storage And Handling



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

Protect from freezing.

TAKE TIME OBSERVE LABEL DIRECTIONS

See accompanying leaflet for additional information.


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.