Tulissin

Kraj: Unia Europejska

Język: angielski

Źródło: EMA (European Medicines Agency)

Składnik aktywny:

tulathromycin

Dostępny od:

Virbac S.A.

Kod ATC:

QJ01FA94

INN (International Nazwa):

tulathromycin

Grupa terapeutyczna:

Cattle; Pigs; 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 susceptible 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 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 herd should be established before metaphylactic treatment. The 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.

Podsumowanie produktu:

Revision: 3

Status autoryzacji:

Authorised

Data autoryzacji:

2020-04-24

Ulotka dla pacjenta

34
B.
PACKAGE LEAFLET
35
PACKAGE LEAFLET:
TULISSIN 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:
VIRBAC
1
ère
avenue 2065m LID
06516 Carros
France
Manufacturers responsible for batch release:
VIRBAC
1
ère
avenue 2065m LID
06516 Carros
France
FAREVA
Zone Industrielle,
29 route des Industries
37530 Pocé-sur-Cisse
France
The printed package leaflet of the medicinal product must state the
name and address of the
manufacturer responsible for the release of the concerned batch.
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Tulissin 100 mg/ml solution for injection for cattle, pigs and sheep.
tulathromycin
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each ml contains:
ACTIVE SUBSTANCE:
Tulathromycin
100 mg
EXCIPIENTS:
Monothioglycerol
5 mg
Clear colourless to slightly coloured solution.
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
_._
36
Pigs
Treatment and metaphylaxis of swine respiratory disease 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 treat

Charakterystyka produktu

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Tulissin 100 mg/ml solution for injection for cattle, pigs and sheep
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Tulathromycin
100 mg
EXCIPIENTS:
Monothioglycerol
5 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear colourless to slightly coloured 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.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Cross resistance occurs with other macrolides. Do not administer
simultaneously with antimicrobials
3
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