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In 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 herd should be established before metaphylactic treatment.
Treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis susceptible to tulathromycin.
In 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 herd should be established before metaphylactic treatment. The product should only be used if pigs are expected to develop the disease within 2–3 days.
In sheep
Treatment of the early stages of infectious pododermatitis (foot rot) associated with virulent Dichelobacter nodosus requiring systemic treatment.
Active substance:
Tulathromycin 100 mg/ml
Excipients:
Monothioglycerol 5 mg/ml
Do not use in cases of hypersensitivity to macrolide antibiotics or to any of the excipients.
Do not use simultaneously with other macrolides or lincosamides.
Do not use in lactating 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.
Subcutaneous administration of TROMICIN 100 mg/ml to cattle causes very 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.
Cattle
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. For multiple vial entry, an aspirating needle or multi-dose syringe is recommended to avoid excessive broaching of the stopper.
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.
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.
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.
This veterinary medicinal product does not require any special storage conditions.
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf-life after first opening the immediate packaging: 28 days.
Special warnings for each target species
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
Special precautions for use in animals
Use of the product should be based on susceptibility testing of bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional or farm-level) epidemiological information regarding the susceptibility of the target bacteria. Official, national and regional antimicrobial policies should be taken into account when using the product. 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.
Special precautions to be taken by the person administering the medicinal products to animals
People with known hypersensitivity to tulathromycin should avoid contact with the veterinary medicinal product. It is recommended to wear protective equipment consisting of a robe, goggles and rubber gloves when handling the veterinary medicinal product. Tulathromycin is irritating to eyes. In case of accidental eye exposure, flush the eyes immediately with clean water. Tulathromycin may cause sensitization by skin contact. 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 (recognized by e.g. itching, difficulty in breathing, hives, swelling on the face, nausea, vomitus) appropriate treatment should be administered. Seek medical advice immediately and show the package leaflet or the label to the physician.
Use during pregnancy, lactation or lay
Use during pregnancy: laboratory studies in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. Bovine product safety has been demonstrated during gestation. Use during lactation: product safety has been demonstrated in piglets and calves when the product has been used in sows and lactating cows.
Interaction with other medicinal products and other forms of interaction
None known.
Overdose (symptoms, emergency procedures, antidotes), if necessary
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 5 to 6 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.
Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Vials of 50 ml, 100 ml, 250 ml and 500 ml.
The 500 ml vials must not be used for pigs and sheep.
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