Halocur
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
18-09-2019
Charakterystyka produktu
(SPC)
18-09-2019
Sprawozdanie z oceny publicznego
(PAR)
23-02-2021
Składnik aktywny:
halofuginone
Dostępny od:
Intervet International BV
Kod ATC:
QP51AX08
INN (International Nazwa):
halofuginone
Grupa terapeutyczna:
Calves, newborn
Dziedzina terapeutyczna:
Antiprotozoals
Wskazania:
In newborn calvesPrevention 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 oocyst excretion has been demonstrated.
Podsumowanie produktu:
Revision: 9
Status autoryzacji:
Authorised
Data autoryzacji:
1999-10-29
Ulotka dla pacjenta
12
B. PACKAGE LEAFLET
13
PACKAGE LEAFLET:
HALOCUR 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:
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands
Manufacturer responsible for batch release:
Intervet Productions S.A.
Rue de Lyons
27460 Igoville
France
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
HALOCUR 0.5 mg/ml oral solution for calves
3.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
The veterinary medicinal product is a canary yellow oral solution.
HALOCUR contains 0.5 mg/ml halofuginone base (as lactate salt).
4.
INDICATION(S)
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 case of diarrhoea established for more than 24 hours and
in weak animals.
6.
ADVERSE REACTIONS
An increase in the level of diarrhoea has been observed in treated
animals in very rare cases.
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
)
14
- 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 you think that the
medicine has not worked, please inform your veterinary surgeon.
7.
TARGET
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
HALOCUR 0.5 mg/ml oral solution for calves
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Halofuginone base
0.50 mg/ml
(as lactate salt)
EXCIPIENTS:
Benzoic acid (E 210) 1.00 mg/ml
Tartrazine (E 102) 0.03 mg/ml
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Oral solution
Canary yellow homogenous clear solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
New born calves.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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 case of diarrhoea established for more than 24 hours and
in weak animals.
4.4
SPECIAL WARNINGS
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
3
Administer after colostrum feeding, or after milk or milk replacer
feeding only, using either a syringe
or any 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
Repetitive contact with the product may lead to skin allergies. Avoid
skin, eye or mucosal contact
with the product. Wear protective gloves while handling the product.
In case of skin and eye contact wash the exposed area thoroughly with
clean water. If eye irritation
persists, seek medical advice.
Wash hands after use.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
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