Table of contents
Rexxolide 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.
Rexxolide 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.
Rexxolide contains the active substance tulathromycin.
Rexxolide is a ‘generic medicine’. This means that Rexxolide 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.
Rexxolide : EPAR - Medicine overview (PDF/147.63 KB)
First published: 12/03/2021
|Agency product number||
|International non-proprietary name (INN) or common name||
|Anatomical therapeutic chemical veterinary (ATCvet) codes||
Dechra Regulatory B.V.
|Date of issue of marketing authorisation valid throughout the European Union||
10/09/2021 Rexxolide - EMEA/V/C/005384 - IB-0004
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.
Antibacterials for systemic use
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.