GLEPTOFORTE- gleptoferron injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GLEPTOFERRON (UNII: 898723IQHQ) (GLEPTOFERRON - UNII:898723IQHQ)

Available from:

Ceva Sante Animale

Administration route:

INTRAMUSCULAR

Prescription type:

OTC

Therapeutic indications:

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.

Product summary:

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

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

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)
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_WHERE TO USE:_
GleptoForte is for intramuscular use. The preferred site of