Tilmovet 250 mg/ml
Država: Austrija
Jezik: engleski
Izvor: HMA (Heads of Medicines Agencies)
Uputa o lijeku
(PIL)
24-08-2013
Svojstava lijeka
(SPC)
24-08-2013
Aktivni sastojci:
tilmicosin 250 mg/ml
Dostupno od:
Huvepharma N.V.
ATC koda:
QJ01FA91
Farmaceutski oblik:
Concentrate for oral solution
Terapijska grupa:
tilmicosin
Područje terapije:
Cattle Young, Chicken Broilers, Chicken Young, Pigs, Turkeys
Datum autorizacije:
2010-03-26
Uputa o lijeku
TILMOVET 250 MG/ML CONCENTRATE FOR ORAL SOLUTION
Huvepharma NV
Page 1 of 14
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
TILMOVET 250 MG/ML CONCENTRATE FOR ORAL SOLUTION
Huvepharma NV
Page 2 of 14
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
TILMOVET 250 MG/ML CONCENTRATE FOR ORAL SOLUTION _FOR PIGS, CHICKENS, TURKEYS _
_AND CATTLE (CALVES)_ (BE, BG, CZ, EL, HU, IE, NL, PL, RO, UK)
TILMOVET 250 MG/ML CONCENTRADO EN SOLUCIÓN ORAL (ES)
TILMOVET 250 MG/ML CONCENTRADO LIQUIDO PER USO ORALE (IT)
TILMOVET 250 MG/ML SOLUTION BUVABLE (FR)
TILMOVET 250 MG/ML LÖSUNG (AT)
TILMOVET 250 MG/ML SOLUÇÃO ORAL (PT)
TILMOVET VET, ORAL OPLØSNUNG (DK)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance
Tilmicosin: 250 mg per ml.
Excipients
For the full list of excipients: see section 6.1
3.
PHARMACEUTICAL FORM
Concentrate for oral solution
Clear yellow to amber solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens (broilers and pullets), turkeys, pigs and cattle (calves).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Pigs: For the treatment and prevention of respiratory infections associated with
_Mycoplasma hyopneumoniae_, _Pasteurella multocida and Actinobacillus _
_pleuropneumoniae when the disease has been diagnosed at the herd level_.
Chickens:
For the treatment and prevention of respiratory infections in poultry flocks associated
with _Mycoplasma gallisepticum and Mycoplasma synoviae when the disease has _
_been diagnosed at the herd level_.
Turkeys: For the treatment and prevention of respiratory infections in turkey flocks
associated with _Mycoplasma gallisepticum _and _Mycoplasma synoviae when t
Pročitajte cijeli dokument
Svojstava lijeka
TILMOVET 250 MG/ML CONCENTRATE FOR ORAL SOLUTION
Huvepharma NV
Page 1 of 14
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
TILMOVET 250 MG/ML CONCENTRATE FOR ORAL SOLUTION
Huvepharma NV
Page 2 of 14
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
TILMOVET 250 MG/ML CONCENTRATE FOR ORAL SOLUTION _FOR PIGS, CHICKENS, TURKEYS _
_AND CATTLE (CALVES)_ (BE, BG, CZ, EL, HU, IE, NL, PL, RO, UK)
TILMOVET 250 MG/ML CONCENTRADO EN SOLUCIÓN ORAL (ES)
TILMOVET 250 MG/ML CONCENTRADO LIQUIDO PER USO ORALE (IT)
TILMOVET 250 MG/ML SOLUTION BUVABLE (FR)
TILMOVET 250 MG/ML LÖSUNG (AT)
TILMOVET 250 MG/ML SOLUÇÃO ORAL (PT)
TILMOVET VET, ORAL OPLØSNUNG (DK)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance
Tilmicosin: 250 mg per ml.
Excipients
For the full list of excipients: see section 6.1
3.
PHARMACEUTICAL FORM
Concentrate for oral solution
Clear yellow to amber solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens (broilers and pullets), turkeys, pigs and cattle (calves).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Pigs: For the treatment and prevention of respiratory infections associated with
_Mycoplasma hyopneumoniae_, _Pasteurella multocida and Actinobacillus _
_pleuropneumoniae when the disease has been diagnosed at the herd level_.
Chickens:
For the treatment and prevention of respiratory infections in poultry flocks associated
with _Mycoplasma gallisepticum and Mycoplasma synoviae when the disease has _
_been diagnosed at the herd level_.
Turkeys: For the treatment and prevention of respiratory infections in turkey flocks
associated with _Mycoplasma gallisepticum _and _Mycoplasma synoviae when t
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