GLEPTOFORTE- gleptoferron injection 
Ceva Sante Animale

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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.

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: 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 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 picture

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 picture

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 picture

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

HOW SUPPLIED:

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

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

bottle label

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

bottle label

GLEPTOFORTE 
gleptoferron injection
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:13744-525
Route of AdministrationINTRAMUSCULAR
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLEPTOFERRON (UNII: 898723IQHQ) (GLEPTOFERRON - UNII:898723IQHQ) GLEPTOFERRON200 mg  in 1 mL
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13744-525-01100 mL in 1 VIAL, MULTI-DOSE
2NDC:13744-525-02250 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANADAANADA20058709/13/2016
Labeler - Ceva Sante Animale (261126049)
Registrant - Ceva Sante Animale (261126049)

Revised: 12/2021
Document Id: f0453f44-4afd-489a-a291-014157dd32b7
Set id: 0ad089b5-8efe-4e37-bf41-12c8ffe02436
Version: 6
Effective Time: 20211220
 
Ceva Sante Animale