Tuloxxin 100 mg/ml Solution for Injection for Cattle, Pigs and Sheep
Active ingredient: Tulathromycin
Form
Injection
Species
Manufacturer
KRKA, d.d., Novo mesto
VMD MA No.
01656/5074
What it's used for
Cattle Treatment and metaphylaxis of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and...
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Prescription required
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Tuloxxin 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, Pasteurella multocida, Histophilus somni and
bovis
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, Pasteurella multocida, Mycoplasma
hyopneumoniae, and . 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: April 2025
AN: 01455/2023Page 2 of 8
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.
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. The cap may be safely punctured up to 20 times.
When treating groups of animals in one run, use a draw-off needle that has been
placed in the vial stopper to avoid excess broaching of the stopper. The draw-off
needle should be removed after treatment.
excipients.
Very common
(>1 animal / 10 animals
treated):
Injection site reactions (congestion, oedema,
fibrosis, haemorrhage, pain)
1
Reversible. May be observed or persist for approximately 30 days after injection.
Pigs:
Very common
(>1 animal / 10 animals
treated):
Injection site reactions (congestion, oedema,
fibrosis, haemorrhage)
1
Reversible, may be observed approximately for 30 days after injection.
Sheep:
Very common
(>1 animal / 10 animals
treated):
Discomfort (head shaking, rubbing injection site,
backing away)
1
The signs resolve within a few minutes.
Reporting adverse events is important. It allows continuous safety monitoring of a
veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to
either the marketing authorisation holder or its local representative or the national
competent authority via the national reporting system. See also the package leaflet
for contact details.
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 pathogens. 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.
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. In case of accidental spillage
onto skin, wash the skin immediately with soap and water.
Revised: April 2025
AN: 01455/2023Page 3 of 8
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.
Revised: April 2025
AN: 01455/2023Page 4 of 8
Once opened, store below 25C.
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.
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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