Rexxolide

RSS

tulathromycin

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 17/09/2021

Authorisation details

Product details
Name
Rexxolide
Agency product number
EMEA/V/C/005384
Active substance
tulathromycin
International non-proprietary name (INN) or common name
tulathromycin
Species
  • Cattle
  • Pigs
  • Sheep
Anatomical therapeutic chemical veterinary (ATCvet) codes
QJ01FA94
Publication details
Marketing-authorisation holder
Dechra Regulatory B.V.
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
03/12/2020
Contact address

Handelsweg 25
5531 AE Bladel
The Netherlands

Product information

10/09/2021 Rexxolide - EMEA/V/C/005384 - IB-0004

Contents

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Pharmacotherapeutic group

Antibacterials for systemic use

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.

Assessment history

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