Ferroferon 200 mg/ml Solution for Injection for Pigs

Composition

Each ml contains:

Active substances:

Iron(III)-Ions 200.0 mg

as Gleptoferron 532.6 mg

Excipients:

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

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Pharmacological properties

4.1 ATCvet code:

QB03AC91

4.2 Pharmacodynamics

Iron is an essential micronutrient. It takes a major role in the oxygen transport of haemoglobin and myoglobin, as well as it has a key role in enzymes, such as cytochromes, catalases, and peroxidases.

Iron has a high recovery rate from metabolism and food ingested. Thus, deficiency occurs only very rarely in adult animals.

4.3 Pharmacokinetics

After intramuscular injection, the iron complex is absorbed into the lymphatic tissue within 3 days. Here, the complex is split to release Fe3+ which is stored as ferritin in the main storage organs (e.g. liver, spleen and the reticuloendothelial system). In the blood, free Fe3+ binds to transferrin (transport form) and is mainly used for the synthesis of haemoglobin.

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Target species

Pigs (piglets)

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Indications

For prevention and treatment of iron deficiency anaemia in piglets.

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Dosage

For strictly intramuscular use.

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.

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.

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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.

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Adverse reactions

Pigs (piglets):

Uncommon (1 to 10 animals / 1,000 animals treated): Injection site skin discolouration1, injection site swelling1,2

Rare (1 to 10 animals / 10,000 animals treated): Death3

Very rare (< 1 animal / 10,000 animals treated, including isolated reports): Hypersensitivity, Death4

1 Should disappear within a few days.

2 Slight, soft.

3 Associated with genetic factors or deficiency of vitamin E and/or selenium

4 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.

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Warnings

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.

3.11 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.

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Use during pregnancy, lactation or lay

Not applicable

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Interactions

The absorption of concomitantly administered oral iron may be reduced.

See also section 5.1.

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Overdose

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.

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Special warnings

None.

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Withdrawal period

Meat and offal: Zero days.

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Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

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Immediate packaging

100 ml clear glass vial (type II), 100 ml LDPE bottle or 200 ml LDPE bottle with chlorobutyl rubber closure (type I) and aluminium/polypropylene cap

Pack sizes:

Carton box with 1 glass vial with 100 ml

Carton box with 10 glass vials with 100 ml

Carton box with 10 LDPE bottles with 100 ml

1 LDPE bottle with 100 ml wrapped in plastic

Carton box with 10 LDPE bottles with 200 ml

1 LDPE bottle with 200 ml wrapped in plastic

Not all pack sizes may be marketed.

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Storage

Do not freeze.

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Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 2 years. Shelf-life after first opening the immediate packaging: 28 days.

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Disposal of unused product

Medicines should not be disposed of via wastewater.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

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Additional information

Vm 20631/3001

Vm 20631/5001

8 DATE OF FIRST AUTHORISATION

05 October 2012

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

October 2024

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Gavin Hall Approved: 04 March 2025

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Registration holder

Serumwerk Bernburg AG

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