Target species
Cattle, pigs and sheep.
Indications for use for each target species
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 group must be established before the veterinary medicinal product is used.
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 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.
Contraindications
Do not use in cases of hypersensitivity to macrolide antibiotics or to any of the excipients.
Special warnings
Cross resistance occurs with other macrolides. 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 safe use in the target species
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.
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.
Adverse events
Cattle:
Very common (>1 animal / 10 animals treated): | Injection site paina, injection site swellinga Injection site reactions (e.g. injection site congestion, injection site oedema, injection site fibrosis, injection site haemorrhage)b |
aTransient, can persist for up to 30 days.
bPathomorphological reversible changes, for approximately 30 days after injection.
Pigs:
Very common (>1 animal / 10 animals treated): | Injection site reactions (e.g. injection site congestion, injection site oedema, injection site fibrosis, injection site haemorrhage)a |
aPathomorphological reversible changes, for approximately 30 days after injection.
Sheep:
Very common (>1 animal / 10 animals treated): | Discomforta Head shakea, backing awaya Injection site scratchinga |
aThese 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 respective contact details.
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Pregnancy and lactation:
Use only according to the benefit-risk assessment by the responsible veterinarian.
Laboratory studies in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects.
Interaction with other medicinal products and other forms of interaction
None known.
Amounts to be administered and administration route
Cattle: Subcutaneous use.
A single subcutaneous injection of 2.5 mg tulathromycin/kg body weight (equivalent to 1 ml/40 kg body weight). For treatment of cattle over 300 kg body weight, 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 body weight (equivalent to 1 ml/40 kg body weight) in the neck.
For treatment of pigs over 80 kg body weight, 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 a correct dosage, body weight 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 may be safely punctured up to 25 times.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
In cattle at dosages of three, five or ten times the recommended dose, transient signs attributed to injection site discomfort were observed and included restlessness, head-shaking, pawing the ground, and brief decrease in feed intake. Mild myocardial degeneration has been observed in cattle receiving five to six times the recommended dose.
In young pigs weighing approximately 10 kg given three or five times the therapeutic dose transient signs attributed to injection site discomfort were observed and included excessive vocalisation and restlessness. Lameness was also observed when the hind leg was used as the injection site.
In lambs (approx. 6 weeks old), at dosages of three or five times the recommended dose, transient signs attributed to injection site discomfort were observed, and included walking backwards, head shaking, rubbing the injection site, lying down and getting up, bleating.
Withdrawal periods
Cattle (meat and offal): 22 days
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.