Target species
Pigs (piglets 24 to 96 hours after birth)
Indications for use, specifying the target species
For the concomitant prevention of iron deficiency anaemia and prevention of clinical signs of coccidiosis (diarrhoea) as well as reduction in oocyst excretion, in piglets in farms with a confirmed history of cystoisospirosis caused by Cystoisospora suis.
Contraindications
Do not use in piglets suspected to be suffering from a deficiency of vitamin E and/or selenium.
Special warnings for each target species
As with any antiparasiticide, 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 cystoisosporosis 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 cystoisosporosis. It is therefore recommended to concomitantly improve the hygiene conditions in the farm concerned, particularly by increasing dryness and cleanliness.
The product is recommended in piglets weighing between 0.9 and 3 kg.
Special precautions for use
Special precautions for use in animals
The recommended dose should not be exceeded, given the relatively low margin of safety for the veterinary medicinal product. The product must not be administered more than once.
It is not recommended to use the veterinary medicinal product in piglets weighing less than 0.9 kg.
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.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to iron (as gleptoferron complex) or toltrazuril or any of the excipients should avoid contact with the veterinary medicinal product.
Exposure to the veterinary medicinal product may cause eye irritation or adverse effects to the skin. Avoid skin and eye contact with the product. In case of accidental exposure to the skin or eyes, wash the affected area with water.
Accidental self-injection may cause local reactions such as irritation, granulomas, or severe anaphylactic reactions in sensitive people. Care should be taken to avoid accidental self-injection. In case of accidental self-injection, 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.
Special precautions for the protection of the environment:
Not applicable
Adverse reactions (frequency and seriousness)
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Hypersensitivity reaction Death1 |
1 Following the administration of parenteral iron injections, associated with genetic factors or deficiencies of vitamin E and/or selenium or attributed to 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 the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy or lactation
Not applicable.
Interaction with other medicinal products and other forms of interaction
None known.
Amounts to be administered and administration route
Intramuscular use. Shake well before for a minimum of 20 seconds.
The recommended dose is 45 mg of toltrazuril and 200 mg of iron per piglet, that is, 1.5 ml of Forceris suspension per piglet, to be administered once, in a single intramuscular injection behind the ear, between 24 and 96 hours after birth.
For the 100 ml vials, the rubber stopper may be punctured up to 30 times. For the 250 ml and 500 ml vials, the rubber stopper may be punctured up to 20 times. If more injections than that are needed, the use of a multiple-dose syringe is recommended.
Overdose (symptoms, emergency procedures, antidotes), if necessary
In safety studies, after any overdosage, an increased susceptibility for (systemic) bacterial disease, arthritis, and abscess formation was observed and a dose-dependent increase in mortality could not be excluded.
During overdosage studies, a transient reduced erythrocyte count, haematocrit and hemoglobin concentration without clinical signs was observed after day 14 following single administration in the target animal safety studies at three times the highest recommended dose (mean 261 mg/piglet toltrazuril and 1156 mg/piglet iron). At 3 times the recommended dose (135 mg/piglet toltrazuril and 600 mg/piglet iron) only a slight transient reduced erythrocyte count was observed after 21 days.
Doses higher than 150 mg/kg/day and 667 mg/kg/day for toltrazuril and iron respectively, i.e. 3 times the highest recommended dose, have not been evaluated in the target animal safety studies. The tolerance of the product after repeated administrations has not been assessed.
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
Withdrawal period(s)
Meat and offal: 70 days.