Halagon
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
18-10-2021
Valmisteyhteenveto
(SPC)
18-10-2021
Julkisesta arviointikertomuksesta
(PAR)
22-12-2016
Aktiivinen ainesosa:
halofuginone lactate
Saatavilla:
Emdoka BVBA
ATC-koodi:
QP51AX08
INN (Kansainvälinen yleisnimi):
halofuginone
Terapeuttinen ryhmä:
Calves, newborn
Terapeuttinen alue:
halofuginone, Other antiprotozoal agents
Käyttöaiheet:
In newborn calves:Prevention of diarrhoea due to diagnosed Cryptosporidium parvum infection, 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 infection. Administration should start within 24 hours after the onset of diarrhoea. In both cases, the reduction of oocysts excretion has been demonstrated.
Tuoteyhteenveto:
Revision: 4
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2016-12-13
Pakkausseloste
15
B. PACKAGE LEAFLET
_ _
16
_ _
PACKAGE LEAFLET:
HALAGON 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:
EMDOKA bvba
John Lijsenstraat 16
B-2321 Hoogstraten
Belgium
Manufacturer responsible for batch release:
Divasa-Farmavic, S.A.
Ctra. Sant Hipolit, Km. 71
08503 Gurb-Vic, Barcelona
Spain
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
HALAGON 0.5 mg/ml oral solution for calves
halofuginone (as lactate salt)
3.
STATEMENT OF ACTIVE SUBSTANCE (S) AND OTHER INGREDIENTS
Each ml contains:
ACTIVE SUBSTANCE:
Halofuginone (as lactate salt)
0.50 mg
Equivalent to 0.6086 mg of halofuginone lactate
EXCIPIENTS:
Benzoic acid (E210)
1 mg
Tartrazine (E102)
0.03 mg
Clear yellow oral solution.
4.
INDICATION(S)
In new-born calves:
•
Prevention of diarrhoea due to diagnosed
_Cryptosporidium parvum _
infection, 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 _
infection.
Administration should start within 24 hours after the onset of
diarrhoea.
In both cases, the reduction of oocysts excretion has been
demonstrated.
5.
CONTRAINDICATIONS
17
Do not use on an empty stomach.
Do not use in case 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
An increase in the level of diarrhoea has been observed in very 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
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 (l
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
HALAGON 0.5 mg/ml oral solution for calves
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Halofuginone (as lactate salt)
0.50 mg
Equivalent to 0.6086 mg of halofuginone lactate
EXCIPIENTS:
Benzoic acid (E210)
1 mg
Tartrazine (E102)
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 newborn calves:
•
Prevention of diarrhoea due to diagnosed
_Cryptosporidium parvum_
infection, 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_
infection.
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.
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.
3
4.5.
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Administer after colostrum feeding, or after milk or milk replacer
feeding only. An appropriate device
for oral administration is included. For treatment of anorexic calves,
the product should be administered
in half a liter 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 allergi
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