Ferroferon 200 mg/ml Solution for Injection for Pigs

A dark brown, slightly viscous, sterile, colloidal, aqueous solution
3. CLINICAL INFORMATION
3.1 Target species
Pigs (piglets)
3.2 Indications for use for each target species
For prevention and treatment of iron deficiency anaemia in piglets.
3.3 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.
AN: 03545/2023 and 03546/2023
3.4 Special warnings
None.
3.5 Special precautions for use
Special precautions for safe use in the target species:
Not applicable.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
People with known hypersensitivity to iron dextran, or those with haemochromatosis
should avoid contact with the veterinary medicinal product.
Care should be taken to avoid accidental self-injection, as well as contact with the
eyes and mouth.
In case of accidental injection, seek medical advice immediately and show the
package leaflet or label to the physician.
Wash hands after use.
Special precautions for the protection of the environment:
Not applicable.
3.6 Adverse events
Pigs (piglets):
Uncommon (1 to 10 animals / 1,000
animals treated):
Injection site skin discolouration
,
injection site swelling
1,2
Rare (1 to 10 animals / 10,000 animals
treated):
Death
Very rare (< 1 animal / 10,000 animals
treated, including isolated reports):
Hypersensitivity
Death
1
Should disappear within a few days.
Slight, soft.
Associated with genetic factors or deficiency of vitamin E and/or selenium
Attributed to an increased susceptibility to infection due to temporary blocking of the
reticuloendothelial system.
Reporting adverse events is important. It allows continuous safety monitoring of a
veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to
either the marketing authorisation holder or its local representative or the national
competent authority via the national reporting system. See the package leaflet for
respective contact details.
3.7 Use during pregnancy, lactation or lay
Not applicable
AN: 03545/2023 and 03546/2023
3.8 Interaction with other medicinal products and other forms of interaction
The absorption of concomitantly administered oral iron may be reduced.
See also section 5.1.
3.9 Administration routes and dosage
For strictly intramuscular use.
Piglets:
200 mg Fe
3+
per animal which is equivalent to 1 ml of the product per animal.
Inject once between the 1st and the 3rd day of life.
The use of a multidose syringe is recommended. To refill the syringe use a draw-off
needle to avoid excessive broaching of the stopper. The stopper must not be
broached more than 10 times. When treating groups of animals in one run, use a
draw-off needle that has been placed in the vial stopper to avoid excess broaching of
the stopper. The draw-off needle has to be removed after treatment.
3.10 Symptoms of overdose (and where applicable, emergency procedures and
antidotes)
Transferrin-iron saturation levels leading to increased susceptibility for (systemic)
bacterial disease, pain, inflammation reactions as well as abscess formation at the
injection site may occur.
Persistent discolouration of muscle tissue at the injection site may occur.
Iatrogenic poisoning with following symptoms: pale mucous membranes,
hemorrhagic gastroenteritis, vomiting, tachycardia, hypotension, dyspnoea, edema of
the limbs, lameness, shock, death, liver damage. Supportive measures such as
chelating agents can be used.
3.11 Special restrictions for use and special conditions for use, including
restrictions on the use of antimicrobial and antiparasitic veterinary
medicinal products in order to limit the risk of development of resistance
Not applicable.
3.12 Withdrawal periods
Meat and offal: Zero days.
4.