Tulieve 100 mg/ml Solution for Injection for Cattle, Pigs and Sheep
Active ingredient: Tulathromycin
Form
Injection
Species
Manufacturer
Norbrook Laboratories Limited
VMD MA No.
02000/4441
What it's used for
before the veterinary medicinal product is used. AN: 01377/2024 & 01378/2024 Treatment of infectious bovine keratoconjunctivitis (IBK) associated with susc...
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Tulieve 100 mg/ml Solution for Injection for Cattle, Pigs and Sheep — SPC Details
Source: VMD Summary of Product Characteristics (SPC). Last updated 27 Mar 2026.
AN: 01377/2024 & 01378/2024
Treatment of infectious bovine keratoconjunctivitis (IBK) associated with
susceptible to tulathromycin.
Pigs
Treatment and metaphylaxis of swine respiratory disease (SRD) associated with
Actinobacillus pleuropneumoniae,
Haemophilus parasuis and susceptible to Tulathromycin. The
presence of the disease in the group must be established before the veterinary medicinal
product is used. The veterinary medicinal 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.
bodyweight, divide the dose so that no more than 7.5 ml are injected at one site.
AN: 01377/2024 & 01378/2024
Pigs
A single intramuscular injection of 2.5 mg tulathromycin/kg bodyweight (equivalent to 1 ml
of the veterinary medicinal product/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
A single intramuscular injection of 2.5 mg tulathromycin/kg body weight (equivalent to 1 ml
of the veterinary medicinal product /40 kg body weight) in the neck.
To ensure a correct dosage bodyweight should be determined as accurately as possible.
For multiple vial entry, an aspirating needle or multi-dose syringe is recommended to avoid
excessive broaching of the stopper. The stopper of 50ml and 100ml vials may be safely
punctured up to 52 times. The stopper of 250ml, 500ml, and 1000ml vials may be safely
punctured up to 80 times.
antibiotics or to any of the excipients.
Very common
(>1 animal / 10 animals treated):
Injection site swelling
Injection site fibrosis
Injection
site haemorrhge
Injection site odema
Injection site reaction
Injection site pain
1
Can persist for approximately 30 days after injection.
Reversible changes of congestion.
Transient.
AN: 01377/2024 & 01378/2024
Pigs:
Very common
(>1 animal / 10 animals treated):
Injection site reaction
Injection site fibrosis
Injection
site haemorrhage
Injection site oedema
.
Can persist for approximately 30 days after injection.
Reversible changes of congestion.
Sheep
Very common
(>1 animal / 10 animals treated):
Discomfort
1
Transient, resolving within a few minutes: head shaking, rubbing injection site, backing
away.
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 the package leaflet for respective 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 others 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 safe use in the target species:
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.
AN: 01377/2024 & 01378/2024
Official, national and regional antimicrobial policies should be taken into account when the
veterinary medicinal product is used.
Use of the veterinary medicinal 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.
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.
conditions.
HDPE vials: Do not store above 30°C.
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.
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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