Patient leaflet - Forceris
B. PACKAGE LEAFLET
PACKAGE LEAFLET
Forceris 30 mg/ml + 133 mg/ml suspension for injection for piglets
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1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder and manufacturer responsible for batch release :
Ceva Santé Animale
10 av. de La Ballastière
33500 Libourne
France
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Forceris 30 mg/ml + 133 mg/ml suspension for injection for piglets
toltrazuril / iron (III) (as gleptoferron)
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3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each ml contains:
Active substances:
Toltrazuril 30.0 mg
Iron (III)
133.4 mg
355.2 mg
6.4 mg
(as gleptoferron)
Excipients:
Phenol
Dark brown suspension.
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4. INDICATION
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 coccidiosis caused by Cystoisospora suis.
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CONTRAINDICATIONS
Do not use in piglets suspected to be suffering from a deficiency of vitamin E and/or selenium.
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6. ADVERSE REACTIONS
Deaths have been reported very 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.
Hypersensitivity reactions can occur.
The frequency of adverse reactions is defined using the following convention:
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– very common (more than 1 in 10 animals treated displaying adverse reaction(s))
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– common (more than 1 but less than 10 animals in 100 animals treated)
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– uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
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– rare (more than 1 but less than 10 animals in 10,000 animals treated)
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– 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.
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7. TARGET SPECIES
Pigs (piglets 24 to 96 hours after birth)
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8. DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
Intramuscular use.
Shake well (for 20 seconds) before use.
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.
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9. ADVICE ON CORRECT ADMINISTRATION
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10. WITHDRAWAL PERIOD(S)
Meat and offal: 70 days.
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11. SPECIAL STORAGE CONDITIONS
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 after „EXP“. The expiry date refers to the last day of that month.
Shelf life after first opening the container: 28 days.
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12. SPECIAL WARNING(S)
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 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 recommended in piglets weighing between 0.9 and 3 kg.
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.
Pregnancy and lactation:
Not applicable.
Interactions with other medicinal products and other forms of interaction: None known.
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.
Incompatibilities:
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
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13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIAL, IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
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14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED