Draxxin
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
24-09-2021
Charakterystyka produktu
(SPC)
24-09-2021
Sprawozdanie z oceny publicznego
(PAR)
28-11-2016
Składnik aktywny:
tulathromycin
Dostępny od:
Zoetis Belgium SA
Kod ATC:
QJ01FA94
INN (International Nazwa):
tulathromycin
Grupa terapeutyczna:
Pigs; Cattle; Sheep
Dziedzina terapeutyczna:
Antibacterials for systemic use
Wskazania:
Cattle: Treatment and metaphylaxis of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis sensitive to tulathromycin. The presence of the disease in the herd should be established before metaphylactic treatment.Treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis sensitive to tulathromycin.Pigs: Treatment and metaphylaxis of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis and Bordetella bronchiseptica sensitive to tulathromycin. The presence of the disease in the herd should be established before metaphylactic treatment. Draxxin should only be used if pigs are expected to develop the disease within 2–3 days.Sheep: Treatment of the early stages of infectious pododermatitis (foot rot) associated with virulent Dichelobacter nodosus requiring systemic treatment.
Podsumowanie produktu:
Revision: 25
Status autoryzacji:
Authorised
Data autoryzacji:
2003-11-11
Ulotka dla pacjenta
33
B. PACKAGE LEAFLET
34
PACKAGE LEAFLET:
DRAXXIN 100 MG/ML SOLUTION FOR INJECTION FOR CATTLE, PIGS AND SHEEP
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
BELGIUM
Manufacturer responsible for batch release:
FAREVA AMBOISE
Zone Industrielle,
29 route des Industries
37530 Pocé-sur-Cisse
FRANCE
or
Zoetis Manufacturing & Research Spain, S.L.
Ctra. de Camprodón, s/n°
Finca La Riba
Vall de Bianya
Gerona 17813
SPAIN
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Draxxin 100 mg/ml solution for injection for cattle, pigs and sheep
Tulathromycin
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Tulathromycin
100 mg/ml
Monothioglycerol
5 mg/ml
Clear colourless to slightly yellow solution for injection.
4.
INDICATIONS
CATTLE
Treatment and metaphylaxis of bovine respiratory disease associated
with
_Mannheimia haemolytica_
,
_Pasteurella multocida,_
_Histophilus somni _
and
_ Mycoplasma bovis_
susceptible to tulathromycin. The
presence of the disease in the group must be established before the
product is used.
Treatment of infectious bovine keratoconjunctivitis (IBK) associated
with
_Moraxella bovis_
susceptible
to tulathromycin
_. _
PIGS
Treatment and metaphylaxis of swine respiratory disease associated
with
_Actinobacillus _
_pleuropneumoniae_
,
_Pasteurella multocida,_
_Mycoplasma hyopneumoniae, Haemophilus parasuis_
and
35
_Bordetella bronchiseptica_
susceptible to tulathromycin. The presence of the disease in the group
must
be established before the product is used. The veterinary medicinal
product should only be used if pigs
are expected to develop the disease within 2–3 days.
SHEEP
Treatment of the early stages of infectious pododermatitis (foot rot)
associated with virulent
_Dichelobacter nodosus_
requiring systemic treatment.
5.
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to macrolide antibiotics o
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Draxxin 100 mg/ml solution for injection for cattle, pigs and sheep
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Tulathromycin
100 mg/ml
EXCIPIENT:
Monothioglycerol
5 mg/ml
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear colourless to slightly yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle, pigs and sheep
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cattle
Treatment and metaphylaxis of bovine respiratory disease (BRD)
associated with
_Mannheimia _
_haemolytica_
,
_Pasteurella multocida,_
_Histophilus somni _
and
_ Mycoplasma bovis_
susceptible to
tulathromycin. The presence of the disease in the group must be
established before the product is used.
Treatment of infectious bovine keratoconjunctivitis (IBK) associated
with
_Moraxella bovis_
susceptible
to tulathromycin.
Pigs
Treatment and metaphylaxis of swine respiratory disease (SRD)
associated with
_Actinobacillus _
_pleuropneumoniae_
,
_Pasteurella multocida,_
_Mycoplasma hyopneumoniae, Haemophilus parasuis_
and
_Bordetella bronchiseptica_
susceptible to tulathromycin. The presence of the disease in the group
must
be established before the product is used. The veterinary medicinal
product should only be used if pigs
are expected to develop the disease within 2–3 days.
Sheep
Treatment of the early stages of infectious pododermatitis (foot rot)
associated with virulent
_Dichelobacter nodosus_
requiring systemic treatment.
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to macrolide antibiotics or to
any of the excipients.
3
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Cross resistance occurs with other macrolides. Do not administer
simultaneously with antimicrobials
with a similar mode of action such as other macrolides or
lincosamides.
Sheep:
The efficacy of antimicrobial treatment of foot rot might be reduced
by other factors, such as wet
environmental con
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