LYDAXX 100 mg/ml Solution for Injection for Cattle, Pigs and Sheep
Active ingredient: Tulathromycin
Form
Injection
Species
Manufacturer
Vetoquinol SA
VMD MA No.
06462/5003
What it's used for
Cattle Treatment and metaphylaxis of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, bovis established before the product is used....
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LYDAXX 100 mg/ml Solution for Injection for Cattle, Pigs and Sheep — SPC Details
Source: VMD Summary of Product Characteristics (SPC). Last updated 26 Mar 2026.
Treatment and metaphylaxis of bovine respiratory disease (BRD) associated with
Mannheimia haemolytica,
bovis
established before the product is used.
Treatment of infectious bovine keratoconjunctivitis (IBK) associated with
bovis
Pigs
Treatment and metaphylaxis of swine respiratory disease (SRD) associated with
Actinobacillus pleuropneumoniae,
hyopneumoniae, Haemophilus parasuis
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.
Revised: February 2023
AN: 03065/2022
Sheep
Treatment of the early stages of infectious pododermatitis (foot rot) associated with
virulent Dichelobacter nodosus requiring systemic treatment.
Subcutaneous use.
A single subcutaneous injection of 2.5 mg tulathromycin/kg bodyweight (equivalent to
1 ml/40 kg bodyweight). For treatment of cattle over 300 kg bodyweight, divide the
dose so that no more than 7.5 ml are injected at one site.
Pigs
Intramuscular use.
Revised: February 2023
AN: 03065/2022
A single intramuscular injection of 2.5 mg tulathromycin/kg bodyweight (equivalent to
1 ml/40 kg bodyweight) in the neck.
For treatment of pigs over 80 kg bodyweight, divide the dose so that no more than 2
ml are injected at one site.
For any respiratory disease, it is recommended to treat animals in the early stages of
the disease and to evaluate the response to treatment within 48 hours after injection.
If clinical signs of respiratory disease persist or increase, or if relapse occurs, treatment
should be changed, using another antibiotic, and continued until clinical signs have
resolved.
Sheep
Intramuscular use.
A single intramuscular injection of 2.5 mg tulathromycin/kg body weight (equivalent to
1 ml/40 kg body weight) in the neck.
To ensure correct dosage, bodyweight should be determined as accurately as possible
to avoid underdosing. For multiple vial entry, an aspirating needle or multi-dose syringe
is recommended to avoid excessive broaching of the stopper. The cap may be safely
punctured up to 30 times.
excipients.
commonly transient pain reactions and local swellings at the injection site that can
persist for up to 30 days. No such reactions have been observed in pigs and sheep
after intramuscular administration.
Pathomorphological injection site reactions (including reversible changes of
congestion, oedema, fibrosis and haemorrhage) are very common for approximately
30 days after injection in cattle and pig.
In sheep transient signs of discomfort (head shaking, rubbing injection site, backing
away) are very common after intramuscular injection. These signs resolve within a few
minutes.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
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 veterinary medicinal product should be based on susceptibility testing of the
bacteria isolated from the animal. If this is not possible, therapy should be based on
local (regional, farm level) epidemiological information about susceptibility of the target
bacteria.
Official, national and regional antimicrobial policies should be taken into account when
the product is used. Use of the product deviating from the instructions given in the SPC
may increase the prevalence of bacteria resistant to tulathromycin and may decrease
the effectiveness of treatment with other macrolides, lincosamides and group B
streptogramins, due to the potential for cross resistance.
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.
Revised: February 2023
AN: 03065/2022
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.
Pigs (meat and offal): 13 days.
Sheep (meat and offal): 16 days.
Not authorised for use in animals producing milk for human consumption.
Do not use in pregnant animals, which are intended to produce milk for human
consumption, within 2 months of expected parturition.
Revised: February 2023
AN: 03065/2022
5.
This information is sourced from the official Summary of Product Characteristics (SPC) published by the Veterinary Medicines Directorate (VMD). It is provided for informational purposes only and does not replace professional veterinary advice. Always consult your vet before administering any medication.
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Related Conditions
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