Baycox Iron - patient leaflet, side effects, dosage

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Baycox Iron 36 mg/ml +182 mg/ml suspension for injection for piglets toltrazuril / iron (III) (as gleptoferron)

3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

Each ml contains:

Active substances:

Toltrazuril

Iron (III) (as gleptoferron

Excipients:

Phenol

Slightly viscous dark brown suspension.

For the concurrent prevention of clinical signs of coccidiosis (such as diarrhoea) in neonatal piglets on farms with a confirmed history of coccidiosis caused by Cystoisospora suis, and prevention of iron deficiency anaemia.

5.

CONTRAINDICATIONS

Do not use in piglets suspected to be suffering from a deficiency of vitamin E and/or selenium. Do not use in cases of hypersensitivity to the active substances or to any of the excipients.

6. ADVERSE REACTIONS

Transient discolouration of the tissue and/or slight swelling may be observed commonly at the site of injection. Anaphylactic reactions may occur rarely.

Deaths have been reported rarely in piglets following the administration of parenteral iron injections. These deaths have been associated with genetic factors or deficiencies of vitamin E and/or selenium. Piglet 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 defined using the following convention:

• – very common (more than 1 in 10 animals treated displaying adverse reaction(s))

• – common (more than 1 but less than 10 animals in 100 animals treated )

• – uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

• – rare (more than 1 but less than 10 animals in 10,000 animals treated)

• – very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

7. TARGET SPECIES

Pigs (piglets 48 to 72 hours after birth).

8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Intramuscular use.

Shake well before use until a visually homogenous suspension is obtained and no residual product is adhering to (the bottom of) the glass vial.

The veterinary medicinal product should be administered to piglets between 48 to 72 hours after birth with a single intramuscular injection of 20 mg toltrazuril/kg body weight and 100 mg iron (as gleptoferron complex)/kg body weight, which is a dose volume of 0.55 ml/kg body weight.

To ensure the correct dosage, the piglets' body weight should be determined as accurately as possible.

Each piglet should be injected with a 21 gauge needle. The preferred injection site is the neck area (see illustration below).

9. ADVICE ON CORRECT ADMINISTRATION

2. Pull the skin to the side before inserting the needle.

The rubber stopper of the vial may be safely punctured up to 30 times.

When administering the product to a group of animals, use a draw-off needle that has been placed in the vial stopper to avoid excess broaching of the stopper. The draw-off needle should be removed after administration.

When administering the product to larger groups of animals, a multi-dosing device (with vented drawoff apparatus) is recommended. The doser on the device should be adjusted according to the piglets' weight prior to injection.

10. WITHDRAWAL PERIOD(S)

Meat and offal: 53 days.

11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

This veterinary medicinal product does not require any special storage conditions.

Do not use this veterinary medicinal product after the expiry date which is stated on the carton and label after "EXP'’. The expiry date refers to the last day of that month.

Shelflife after first opening the container: 28 days.

12. SPECIAL WARNING(S)

Special warnings for each target species:

Neonatal piglets may experience clinical signs similar to those due to coccidiosis (such as diarrhoea) for numerous reasons (e.g. other pathogens, stress). Should clinical signs be observed in the two weeks following administration of the product, contact your veterinarian to obtain an appropriate differential diagnosis.

Frequent and repeated use of antiprotozoals from the same class may lead to the development of resistance.

It is recommended to administer the product to all the piglets in a litter.

Once clinical signs of coccidiosis are evident, damage to the small intestine will have already occurred. Therefore, the product should be administered to all animals before the expected onset of clinical signs, that is, in the prepatent period.

Hygienic measures may reduce the risk of porcine coccidiosis. It is therefore recommended to concomitantly improve the hygiene conditions in the farm concerned, particularly by increasing dryness and cleanliness.

The product is not recommended for use in piglets weighing less than 0.9 kg.

Special precautions for use in animals :

The product must not be administered more than once.

Only use this veterinary medicinal product where Cystoisospora suis has been historically confirmed on a farm. The responsible veterinarian should take into account the results of clinical examinations and/or analysis of faecal samples and/or histological findings, which confirmed the presence of C. suis in a previous infection episode on the farm.

It is not recommended to use the veterinary medicinal product in piglets weighing less than 0.9 kg, as the efficacy and safety of the product has not been evaluated in such small piglets.

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

This product contains iron (as gleptoferron complex), which has been associated with anaphylactic reactions after injection. People with known hypersensitivity to iron (as gleptoferron complex) should avoid contact with the veterinary medicinal product.

Accidental self-injection may cause adverse effects. Care should be taken to avoid accidental selfinjection. In case of accidental self-inj ection, seek medical advice immediately and show the package leaflet or the label to the physician.

This product may be harmful for the unborn child. Pregnant women and women intending to conceive should avoid contact with the veterinary medicinal product, especially accidental self-injection.

Wash hands after use and/or spillage.

Pregnancy and lactation:

Not applicable.

Interactions with other medicinal products and other forms of interaction: None known.

Overdose (symptoms, emergency procedures, antidotes) :

The tolerance of the veterinary medicinal product has been assessed after a single intramuscular administration of up to 5 times the recommended dose, as well as after repeated administrations.

A single intramuscular administration of 5 times the recommended dose, or 3 administrations of the recommended dose, did not cause systemic adverse effects or abnormalities in local injection site observations.

After the 2nd or 3rd administration of 3 times the recommended dose, clinical signs were observed such as apathy, dyspnoea, elevated rectal temperatures, reddening of the skin, ataxia, and/or adverse events of the legs or joints (such as polyarthritis). In some cases (n=13 out of n=29 animals treated multiple times with 3 times the recommended dose) this resulted in death of the animals. These observations are presumably due to iron overload.

Transferrin-iron saturation levels may lead to increased susceptibility for (systemic) bacterial infection, pain, inflammatory reactions as well as abscess formation at the injection site.

Persistent discolouration of muscle tissue at the injection site may occur.

After an overdose, iatrogenic poisoning may occur which may cause the following clinical signs: pale mucous membranes, haemorrhagic gastroenteritis, vomiting, tachycardia, hypotension, dyspnoea, oedema of the limbs, lameness, shock, liver damage, and death.

In case of overdose, supportive measures such as chelating agents (e.g. deferoxamine) can be used.

Incompatibilities :

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

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required. These measures should help to protect the environment.

14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency ( ).

15. OTHER INFORMATION

Pack size:

Cardboard box with 1 vial of 100 ml.

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