Forceris

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

toltrazuril, iron (III) ion

Available from:

CEVA Santé Animale

ATC code:

QP51AJ51

INN (International Name):

toltrazuril, iron (III) ion

Therapeutic group:

Pigs (piglets)

Therapeutic area:

toltrazuril, combinations

Therapeutic indications:

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.

Product summary:

Revision: 1

Authorization status:

Authorised

Authorization date:

2019-04-23

Patient Information leaflet

15
B. PACKAGE LEAFLET
16
PACKAGE LEAFLET
FORCERIS 30 MG/ML + 133 MG/ML SUSPENSION FOR INJECTION FOR PIGLETS
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
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Forceris 30 mg/ml + 133 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
30.0 mg
Iron (III)
133.4 mg
(as gleptoferron)
355.2 mg
EXCIPIENTS:
Phenol
6.4 mg
Dark brown suspension.
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._
5.
CONTRAINDICATIONS
Do not use in piglets suspected to be suffering from a deficiency of
vitamin E and/or selenium.
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.
17
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

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Forceris 30 mg/ml + 133 mg/ml suspension for injection for piglets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCES:
Toltrazuril
30.0 mg
Iron (III)
133.4 mg
(as gleptoferron
355.2 mg)
EXCIPIENTS:
Phenol
6.4 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Dark brown suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs (piglets 24 to 96 hours after birth)
4.2
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 coccidiosis caused by
_Cystoisospora suis. _
4.3
CONTRAINDICATIONS
Do not use in piglets suspected to be suffering from a deficiency of
vitamin E and/or selenium.
4.4
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.
3
4.5
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 me