Tulinovet
tulathromycin
Table of contents
Overview
Tulinovet is an antibiotic medicine that is used to treat the following diseases if they are caused by bacteria that are susceptible to it:
- bovine respiratory disease (BRD) in cattle caused by Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis;
- infectious bovine keratoconjunctivitis (IBK) in cattle, an eye disease caused by Moraxella bovis;
- swine respiratory disease (SRD) in pigs caused by Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis and Bordetella bronchiseptica;
- early stages of foot rot in sheep caused by Dichelobacter nodosus, which requires treatment with a medicine given by mouth or by injection.
Tulinovet can also be used for metaphylaxis of BRD and SRD. This involves treating at the same time both diseased animals and healthy animals in close contact with them, to prevent further spread of the disease. The medicine should only be used for metaphylaxis in cattle and pigs once presence of the disease in the herd has been established.
Tulinovet contains the active substance tulathromycin.
Tulinovet is a ‘generic medicine’. This means that Tulinovet contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the European Union (EU) called Draxxin.
For more information, see the package leaflet.
Authorisation details
Product details | |
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Name |
Tulinovet
|
Agency product number |
EMEA/V/C/005076
|
Active substance |
tulathromycin
|
International non-proprietary name (INN) or common name |
tulathromycin
|
Species |
|
Anatomical therapeutic chemical veterinary (ATCvet) codes |
QJ01FA94
|
Generic |
This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines. |
Publication details | |
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Marketing-authorisation holder |
VMD N.V.
|
Revision |
2
|
Date of issue of marketing authorisation valid throughout the European Union |
16/09/2020
|
Contact address |
Hoge Mauw 900 |
Product information
30/09/2021 Tulinovet - EMEA/V/C/005076 - IB/0002
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
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Antibacterials for systemic use
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Macrolides
Therapeutic indication
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.