Pigs.

Treatment and metaphylaxis of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis and Bordetella bronchiseptica. 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.

Do not use in cases of hypersensitivity to macrolide antibiotics or to any of the excipients.

Cross-resistance has been shown between tulathromycin and other macrolides in the target pathogen(s). Use of the veterinary medicinal product should be carefully considered when susceptibility testing has shown resistance to tulathromycin because its effectiveness may be reduced. Do not administer simultaneously with antimicrobials with a similar mode of action such as other macrolides or lincosamides.

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.

An antibiotic with a lower risk of antimicrobial resistance selection (lower AMEG category) should be used for first line treatment where susceptibility testing suggests the likely efficacy of this approach.”

If a hypersensitivity reaction occurs appropriate treatment should be administered without delay.

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.

Not applicable.

1 Can persist for approximately 30 days after injection.

2 Reversible changes of congestion.

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.

The safety of the veterinary medicinal product has not been established during 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.

None known.

Intramuscular use.

A single intramuscular injection of 2.5 mg tulathromycin/kg body weight (equivalent to 1 ml of the veterinary medicinal product/10 kg body weight) in the neck.

For treatment of pigs over 40 kg body weight, divide the dose so that no more than 4 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.

To ensure 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.

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.

Not applicable.

Meat and offal: 13 days.