Baycox Iron

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

Iron(iii) ion, toltrazuril

Διαθέσιμο από:

Bayer Animal Health GmbH

Φαρμακολογική κατηγορία (ATC):

QP51AJ51

INN (Διεθνής Όνομα):

toltrazuril, iron (III) ion

Θεραπευτική ομάδα:

Pigs (piglets)

Θεραπευτική περιοχή:

toltrazuril, combinations

Θεραπευτικές ενδείξεις:

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.

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2019-05-20

Φύλλο οδηγιών χρήσης

16
B. PACKAGE LEAFLET
17
PACKAGE LEAFLET:
BAYCOX IRON 36 MG/ML + 182 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:
Bayer Animal Health GmbH
51368 Leverkusen
Germany
Manufacturer responsible for batch release:
Produlab Pharma BV
Raamsdonksveer
4941 SJ
Netherlands
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
36.4 mg
Iron (III)
182 mg
(as gleptoferron
484.7 mg)
EXCIPIENTS:
Phenol
5 mg
Slightly viscous dark brown suspension.
4.
INDICATION(S)
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.
18
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 anim

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Baycox Iron 36 mg/ml + 182 mg/ml suspension for injection for piglets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCES:
Toltrazuril
36.4 mg
Iron (III)
182 mg
(as gleptoferron
484.7 mg)
EXCIPIENTS:
Phenol
5 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Slightly viscous dark brown suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs (piglets 48 to 72 hours after birth).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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.
4.3
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.
4.4
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, the responsible
veterinarian should be informed.
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.
3
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