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Animal NDC 13744-525-01 Gleptoforte

Gleptoferron

Animal Product Information

Field Name Field Value
Animal NDC Code 13744-525-01
Proprietary Name Gleptoforte 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 Gleptoferron 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 Ceva Sante Animale
Product Type Otc Animal Drug
Usage Information
    INDICATIONS: GleptoForte® is recommended for both the routine prevention and treatment of baby pig anemia due to iron deciency.NOTICE: Organic iron preparations injected intramuscularly into pigs beyond 4 weeks of age may cause staining of the muscle tissue.
Active Ingredient(s)
  • Gleptoferron
Marketing Category ANADA - ABBREVIATED 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 ANADA200587 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.

Gleptoforte Images

Gleptoforte 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



GleptoForte®

(gleptoferron)

200 mg/mL of iron

Solution for intramuscular injection

NOT FOR USE IN HUMANS

KEEP OUT OF REACH OF CHILDREN

Approved by FDA under ANADA # 200-587

DESCRIPTION: GleptoForte® is a sterile aqueous colloidal solution of gleptoferron, a macromolecular complex of ferric hydroxide and dextran glucoheptonic acid. Each milliliter contains 200 mg of elemental iron. The solution contains 0.5% phenol as preservative.


Mechanism Of Action



ACTIONS: GleptoForte® contains gleptoferron which provides a rapidly absorbed and readily utilizable form of iron for the prevention and treatment of baby pig anemia.


Indications & Usage



INDICATIONS: GleptoForte® is recommended for both the routine prevention and treatment of baby pig anemia due to iron deciency.

NOTICE: Organic iron preparations injected intramuscularly into pigs beyond 4 weeks of age may cause staining of the muscle tissue.


Dosage & Administration



DOSAGE AND ADMINISTRATION: GleptoForte® is for intramuscular use only. Prevention: 1 mL (200 mg iron) per pig on or before 3 days of age. Treatment: 1 mL (200 mg iron) per pig as soon as signs of deficiency appear.

WITHDRAWAL PERIODS: No withdrawal period is required when used according to labeling.

ANIMAL SAFETY WARNINGS AND PRECAUTIONS: Occasionally pigs may show a reaction to injectable iron, clinically characterized by prostration with muscular weakness. In extreme cases, death may occur.

For a copy of the Safety Data Sheet (SDS) or to report suspected adverse drug events, contact CEVA at 1-800-999-0297.

For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/AnimalVeterinary/SafetyHealth.

HOW TO INJECT:

What to use

1. GleptoForte® (gleptoferron) injection

2. Ordinary 10 mL syringe with 18-guage needle or smaller, or dosage delivery device with 4-guage draw off spike or smaller

3. Disinfectant (rubbing alcohol or tincture of iodine)

Where to use:

GleptoForte® is for intramuscular use. The preferred site of injection is the ham muscle. Push the needle directly into the ham to approximately a one-half (1/2) inch depth. Avoid injection into a blood vessel. This is best avoided by pulling back slightly on the plunger after the needle is seated in the ham. If properly located, resistance will be offered to this effort. If the plunger is pulled back easily, remove and relocate the needle.

Step 1 The pig is held under-arm, between knees, or by an assistant. Disinfect the injection site. Pull down skin and fat with thumb as shown. Approximately halfway along a line between the anus and the thumb is the best injection site.

Step 2 Before injecting GleptoForte®, point the needle upward and gently press the plunger to expel all air from syringe. The needle is inserted at right-angle to the skin into the ham approximately a one-half (1/2) inch depth and the injection made.

Step 3 Use a new needle between each stopper puncture. Protect the needle from contamination and disinfect between animal injections.


How Supplied



HOW SUPPLIED:

GleptoForte® (gleptoferron) injection is available in 100 mL and 250 mL multi-dose vials.


Storage And Handling



STORAGE: Store at 20°C - 25°C (68°F - 77°F). Do not freeze.

100 mL Vial: Use within 28 days of first puncture and puncture a maximum of seventy-five (75) times with an 18-guage needle or five (5) times with a dosage delivery device. If using a needle larger than 18-guage or a draw-off spike larger than 4-guage, discard any remaining product immediately ater use.

250 mL Vial: Use within 28 days of first puncture and puncture a maximum of one hundred (100) times with an 18-guage needle or five (5) times with a dosage delivery device. If using a needle larger than 18-guage or a draw-off spike larger than 4-guage, discard any remaining product immediately ater use. 

Manufactured for:
Ceva Animal Health, LLC, Lenexa, KS 66215
1-800-999-0297

GleptoForte® is a registered trademark of Ceva Santé Animale


Principal Display Panel - 100 Ml Bottle Label



GleptoForte®

(gleptoferron) 200 mg/mL of iron

Solution for intramuscular injection

For the prevention and treatment of Baby Pig Anemia due to iron deficiency

NOT FOR USE IN HUMANS

KEEP OUT OF REACH OF CHILDREN

Approved by FDA under ANADA # 200-587

Net Contents: 100mL


Principal Display Panel - 250 Ml Bottle Label



GleptoForte®

(gleptoferron) 200 mg/mL of iron

Solution for intramuscular injection

For the prevention and treatment of Baby Pig Anemia due to iron deficiency

NOT FOR USE IN HUMANS

KEEP OUT OF REACH OF CHILDREN

Approved by FDA under ANADA # 200-587

Net Contents: 250mL


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