Kriptazen

Pays: Union européenne

Langue: anglais

Source: EMA (European Medicines Agency)

Ingrédients actifs:

halofuginone

Disponible depuis:

Virbac S.A.

Code ATC:

QP51AX08

DCI (Dénomination commune internationale):

halofuginone

Groupe thérapeutique:

Calves, newborn

Domaine thérapeutique:

Antiprotozoals

indications thérapeutiques:

In new born calves:- Prevention of diarrhoea due to diagnosed Cryptosporidium parvum, in farms with history of cryptosporidiosis,Administration should start in the first 24 to 48 hours of age- Reduction of diarrhoea due to diagnosed Cryptosporidium parvum.Administration should start within 24 hours after the onset of diarrhoea.In both cases, the reduction of oocysts excretion has been demonstrated.

Descriptif du produit:

Revision: 2

Statut de autorisation:

Authorised

Date de l'autorisation:

2019-02-08

Notice patient

17
B. PACKAGE LEAFLET
18
PACKAGE LEAFLET:
KRIPTAZEN 0.5 MG/ML ORAL SOLUTION FOR CALVES
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:
VIRBAC
1
ère
avenue – 2065 m – LID
06516 Carros
France
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Kriptazen 0.5 mg/ml oral solution for calves
halofuginone
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each ml contains:
ACTIVE SUBSTANCE:
Halofuginone
0.50 mg
(as lactate salt)
EXCIPIENTS:
Benzoic acid (E 210)
1.00 mg
Tartrazine (E 102)
0.03 mg
Clear yellow solution.
4.
INDICATION(S)
Cattle (new born calves):
‐
Prevention of diarrhoea due to diagnosed
_Cryptosporidium parvum_
, in farms with history of
cryptosporidiosis.
Administration should start in the first 24 to 48 hours of age.
‐
Reduction of diarrhoea due to diagnosed
_Cryptosporidium parvum_
.
Administration should start within 24 hours after the onset of
diarrhoea.
In both cases, the reduction of oocysts excretion has been
demonstrated.
5.
CONTRAINDICATIONS
Do not use on an empty stomach.
Do not use in cases of diarrhoea established for more than 24 hours
and in weak animals.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
6.
ADVERSE REACTIONS
19
An increase in the level of diarrhoea has been observed in rare cases
in treated animals.
The frequency of adverse reactions is defined using the following
convention:
- Very common (more than 1 in 10 animals treated displaying adverse
reactions)
- 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

Résumé des caractéristiques du produit

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Kriptazen 0.5 mg/ml oral solution for calves.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Halofuginone
0.50 mg
(as lactate salt)
EXCIPIENTS:
Benzoic acid (E 210)
1.00 mg
Tartrazine (E 102)
0.03 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution.
Clear yellow solution.
4.
CLINICAL PARTICULARS
4.1.
TARGET SPECIES
Cattle (newborn calves).
4.2.
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In new born calves:
-
Prevention of diarrhoea due to diagnosed
_Cryptosporidium parvum_
, in farms with history of
cryptosporidiosis.
Administration should start in the first 24 to 48 hours of age.
-
Reduction of diarrhoea due to diagnosed
_Cryptosporidium parvum_
.
Administration should start within 24 hours after the onset of
diarrhoea.
In both cases, the reduction of oocysts excretion has been
demonstrated.
4.3.
CONTRAINDICATIONS
Do not use on an empty stomach.
Do not use in cases of diarrhoea established for more than 24 hours
and in weak animals.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
4.4.
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5.
SPECIAL PRECAUTIONS FOR USE
3
Special precautions for use in animals
Administer after colostrum feeding, or after milk or milk replacer
feeding only, using an appropriate
device for oral administration. Do not use on an empty stomach. For
treatment of anorexic calves, the
product should be administered in half a litre of an electrolyte
solution. The animals should receive
enough colostrum according to good breeding practice.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
-
People with known hypersensitivity to the active substance or any of
the excipients should
administer the veterinary medicinal product with caution.
-
Repetitive contact with the product may lead to skin allergies.
-
Avoid skin, eye or mucosal c