URSOFERRAN- iron dextran solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

IRON DEXTRAN (UNII: 95HR524N2M) (FERRIC CATION - UNII:91O4LML611)

Available from:

Ceva Sante Animale

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION

Therapeutic indications:

Indication(s) For prevention and treatment of iron deficiency anaemia in piglets. Contraindications Do not administer to piglets suspected to suffer from deficiency of vitamin E and / or selenium. Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Do not use in clinically diseased animals, especially not in case of diarrhoea.

Authorization status:

unapproved drug other

Summary of Product characteristics

URSOFERRAN- IRON DEXTRAN SOLUTION
CEVA SANTE ANIMALE
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
----------
URSOFERRAN® 200 MG/ML
Solution for injection for pigs
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE
MANUFACTURING AUTHORISATION
HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder:
Serumwerk Bernburg AG
Hallesche Landstr. 105 b
06406 Bernburg, Germany
Manufacturer responsible for batch release:
Serumwerk Bernburg AG
Hallesche Landstr. 105 b
06406 Bernburg, Germany
NAME OF THE VETERINARY MEDICINAL PRODUCT
URSOFERRAN 200 mg/ml
Solution for injection for pigs
Iron(III)-Ions (as Gleptoferron)
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each ml contains:
Active substances:
Iron(III)-Ions 200.0 mg
(as Gleptoferron 532.6 mg)
Excipients:
Phenol 5.0 mg
A dark brown, slightly viscous, sterile, colloidal,
aqueous solution.
INDICATION(S)
For prevention and treatment of iron deficiency anaemia in piglets.
CONTRAINDICATIONS
Do not administer to piglets suspected to suffer from deficiency of
vitamin E and / or selenium. Do not
use in cases of hypersensitivity to the active substance or to any of
the excipients.
Do not use in clinically diseased animals, especially not in case of
diarrhoea.
ADVERSE REACTIONS
Uncommonly discolouration of the tissue and / or slight, soft swelling
may be observed at the site of
injection. This should disappear within a few days. Also
hypersensitivity reactions can occur.
Rarely deaths have occurred in piglets following the administration of
parenteral iron dextran
preparations. These deaths have been associated with genetic factors
or deficiency of vitamin E and/or
selenium.
Very rarely piglets deaths have been reported which have been
attributed to an increased susceptibility
to infection due to temporary
blocking of the reticuloendothelial system.
The frequency of adverse reactions is