IRON 200- iron injection

IRON by

Drug Labeling and Warnings

IRON by is a Animal medication manufactured, distributed, or labeled by Durvet, Inc., Sparhawk Laboratories, Inc., Chemdex Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

Iron-200

For prevention or treatment of nursing
piglet anemia due to iron deficiency.
Approved by FDA under NADA # 138-255
NOT FOR HUMAN USE
KEEP OUT OF REACH OF CHILDREN
For use in animals only

Indications: For prevention or treatment of nursing piglet anemia due to iron deficiency.
Dosage and Administration:
For Intramuscular Injection only.
Prevention: 1 mL (200 mg iron) at 1-3 days of
age. Treatment: 1 mL (200 mg iron) at the first
signs of Iron deficiency.
Notice: Iron hydrogenated dextran injection
injected intramuscularly into nursing piglets may
cause muscle staining that generally resolves
within 14 days after administration.
Refer to onsert and read carefully before use.

Iron-200 Injection is a sterile solution
containing a complex of ferric hydroxide with a low molecular weight dextran fraction equivalent to
200 mg elemental iron per mL with 0.5% phenol as a preservative.
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and
86°F).
Use within 24 months of first puncture.

DESCRIPTION

Approved by FDA under NADA # 138-255

IRON-200 INJECTION
(iron hydrogenated dextran injection)

200mg/mL
Description: Iron Dextrans are sterile solutions containing a complex of ferric hydroxide with a low molecular weight dextran fraction. Iron-200 Injection is equivalent to 200 mg elemental iron per mL with 0.5% phenol as a preservative.

Actions. Injectable Iron-200 Injection is easy and economical to use. Injection into the ham is rapid, safe, effective, quickly absorbed by the blood and goes to work immediately. With injectable Iron-200 Injection, the right dosage can be given to every animal with assurance that it will be utilized. Iron deficiency anemia occurs commonly in the nursing piglet, 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. This natural deficiency lowers the resistance of the nursing piglet and scours, pneumonia or other infections may develop and lead to death of the animal. Nursing piglets not hampered by iron deficiency anemia are more likely to experience normal growth and to maintain their normal level of resistance to disease. Adequate iron is necessary for normal, healthy, vigorous growth.

INDICATIONS & USAGE

Indications: Iron-200 Injection is intended for the prevention or treatment of anemia in nursing piglets due to iron deficiency.
Notice: Iron hydrogenated dextran injected intramuscularly into nursing piglets may cause muscle staining that generally resolves within 14 days after administration.
Dosage and Administration: For the prevention of anemia due to iron deficiency, administer an intramuscular injection of 200 milligrams of elemental iron (1 mL) at 1 to 3 days of age. For the treatment of anemia due to iron deficiency, administer an intramuscular injection of 200 milligrams of elemental iron (1 mL) at first signs of anemia.

WARNINGS AND PRECAUTIONS

Warnings

Withdrawal Periods: No withdrawal period is required when used according to labeling.

User Safety Warnings: Not for use in humans. Keep out of reach of children. To obtain a Safety Data Sheet(s), contact Sparhawk Laboratories Inc at 1-800-255-6388 or at sparhawklabs.com
Animal Safety Warnings: Clinical signs associated with iron toxicity in piglets include convulsion, respiratory distress (tachypnea, dyspnea) injection site reactions (inflammation, infection or necrosis), muscle tremors or weakness, prostration, and death. There is increased risk for iron toxicity in piglets born to sows with vitamin E/ selenium deficiencies.

DOSAGE & ADMINISTRATION

Directions For Use: Use a clean, sterile syringe and needle (20 gauge, ½” needle); and ensure the injection site is clean and dry. Administer intramuscularly into the back of the ham muscle to a depth of approximately ½ inch (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.

Iron-200 Injection cannot be considered a substitute for sound animal husbandry. If disease is present in the litter CONSULT A VETERINARIAN.

Side Effects: Occasionally, nursing piglets may show a reaction to injectable iron, clinically characterized by prostration with muscular weakness. In extreme cases, death may result.

SPL UNCLASSIFIED SECTION

Questions/Comments: Contact Sparhawk Laboratories Inc at 1-800-255-6388 or sparhawklabs.com. To report side effects, contact Sparhawk Laboratories Inc at 1-800-255-6388. For additional information about reporting side effects for animal drugs, contact FDA at 1-888-FDA-VETS or
http://www.fda.gov/reportanimalae

HOW SUPPLIED

How Supplied: Iron-200 Injection is available in 100 mL multidose vials.

STORAGE AND HANDLING

Storage, Handling, and Disposal: Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F).

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

IRON  200
iron injection

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 30798-345
Route of Administration	INTRAMUSCULAR

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7)	IRON	200 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PHENOL (UNII: 339NCG44TV)	.5 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30798-345-10	100 mL in 1 VIAL, MULTI-DOSE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA138255	08/11/1995

Labeler - Durvet, Inc. (056387798)

Registrant - Sparhawk Laboratories, Inc. (147979082)

Establishment
Name	Address	ID/FEI	Business Operations
Sparhawk Laboratories, Inc.		147979082	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Chemdex Inc.		360684898	api manufacture