Draxxin 100 mg/ml Solution for Injection for Cattle, Pigs and Sheep

Cross-resistance has been shown between tulathromycin and other macrolides in the
target pathogen(s). Use of the veterinary medicinal product should be carefully
considered when susceptibility testing has shown resistance to tulathromycin
because its effectiveness may be reduced. 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 conditions, as well as inappropriate farm management.
Treatment of foot rot should therefore be undertaken along with other flock
management tools, for example providing dry environment.
Antibiotic treatment of benign foot rot is not considered appropriate. Tulathromycin
showed limited efficacy in sheep with severe clinical signs or chronic foot rot and
should therefore only be given at an early stage of foot rot.

Special precautions for use in animals
Use of the product should be based on identification and susceptibility testing of the
target pathogen(s). If this is not possible, therapy should be based on
epidemiological information and knowledge of susceptibility of the target pathogens
at farm level, or at local/regional level.
Use of the product should be in accordance with official, national and regional
antimicrobial policies .
An antibiotic with a lower risk of antimicrobial resistance selection (lower AMEG
category) should be used for first line treatment where susceptibility testing suggests
the likely efficacy of this approach.

Revised: June 2025
AN: 00432/2025
If a hypersensitivity reaction occurs appropriate treatment should be administered
without delay.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
Tulathromycin is irritating to eyes. In case of accidental eye exposure, flush the eyes
immediately with clean water.
Tulathromycin may cause sensitisation by skin contact resulting in e.g. reddening of
the skin (erythema) and/or dermatitis. In case of accidental spillage onto skin, wash
the skin immediately with soap and water.
Wash hands after use.
In case of accidental self-injection, seek medical advice immediately and show the
package leaflet or the label to the physician.
If there is suspicion of a hypersensitivity reaction following accidental exposure
(recognised by e.g. itching, difficulty in breathing, hives, swelling on the face, nausea,
vomiting) appropriate treatment should be administered. Seek medical advice
immediately and show the package leaflet or the label to the physician.
Special precautions for the protection of the environment
Not applicable.
Other precautions
Not applicable.