Summary of Product Characteristics

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

URSOFERRAN 200 mg/mlSolution for injection for pigs

(For Belgium, Luxembourg, Italy, Czech Republic, Slovakia, Poland, France, Austria)

Prolongal200 mg/ml, For United Kingdom, Hungary, Spain:

Ferroferon 200 mg/ml, For Sweden, Denmark: Ursoglepto vet.)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains:

Active substances:

Iron(III)-Ions 200.0 mg

as Gleptoferron 532,6 mg

Excipients:

Phenol 5.0 mg

Water for injections ad 1 ml

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection.

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

4. CLINICAL PARTICULARS

4.1 Target species

Pig (piglet)

4.2 Indications for use, specifying the target species

For prophylaxis and treatment of iron deficiency anaemia in piglets.

4.3 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.

4.4 Special warnings for each target species

None

4.5 Special precautions for use

Not applicable

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.

4.6 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.

4.7 Use during pregnancy or lactation

Not applicable

4.8 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.

4.9 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.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

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.

4.11 Withdrawal period

Meat and offal: Zero days

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group:Iron trivalent, parenteral preparations, gleptoferron

ATCvet Code:QB03AC91

5.1 Pharmacodynamic properties

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.

5.2 Pharmacokinetic particulars

After intramuscular injection, the iron complex is absorbed into the lymphatic tissue within 3 days. Here, the complex is split to releaseFe³⁺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.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Phenol (preservative)

Water for injections

6.2 Incompatibilities

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

6.3 Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 24 months.

Shelf-life after first opening of the container: 28 days.

6.4 Special precautions for storage

Do not freeze.

6.5 Nature and composition of immediate packaging

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

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

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

iron4u APS

Næsseslottet

Dronninggårds Allé 136

DK-2840 Holte

Denmark

8. MARKETING AUTHORISATION NUMBER

Vm:42877/4000

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date:05 October 2012

10 DATE OF REVISION OF THE TEXT

Date: November 2013

Approved:29/11/2013