Iron Dextran Injection

PHARMACEUTICAL FORM

Solution for injection.

A dark brown, slightly viscous, sterile, colloidal, aqueous solution

      CLINICAL PARTICULARS

1    Target species

Pig (piglet)

2    Indications for use, specifying the target species

For prophylaxis and treatment of iron deficiency anaemia in piglets.

3    Contraindications

Do not administer to piglets suspected to suffer from deficiency of vitamin E and/or selenium. Do not use in case 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.

4    Special warnings for each target species

None

5    Special precautions for use

i)            Special precautions for use in animals:

Not applicable

ii)            Special precautions to be taken by the person administering the veterinary medicinal to animals:

Care should be taken to avoid accidental self-injection as well as mucous membrane contact, especially people with known hypersensitivity to iron dextran.

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

Wash hands after use.

    Adverse reactions (frequency and seriousness)

Occasionally 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.

    Use during pregnancy or lactation

Not applicable

    Interaction with other medicinal products and other forms of interaction

The absorption of concomitantly administered oral iron may be reduced.

See also section 6.2.

    Amounts to be administered and administration route

For strictly intramuscular injection.

Piglets:

200 mg Fe³⁺ per animal which is equivalent to

1 ml of the product per animal.

Inject once between the 1st and the 3rd day of life.