Cattle.

Treatment of bovine respiratory disease (BRD) associated with pyrexia due to Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis susceptible to tulathromycin.

Do not use in cases of hypersensitivity to the active substances or to any of the excipients.

Do not use simultaneously with other macrolides or lincosamides (see section "Special warnings").

Do not administer to animals suffering from gastrointestinal lesions, haemorrhagic diathesis, blood dyscrasia or hepatic, renal or cardiac conditions.

Cross resistance occurs with other macrolides. Do not administer simultaneously with antimicrobials with a similar mode of action such as other macrolides or lincosamides.

This veterinary medicinal product does not contain any antimicrobial preservative.

Use of the veterinary medicinal 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 bacteria at farm level, or at local/regional level.

Use of the veterinary medicinal 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 (MLSB resistance).

Since many NSAIDs possess the potential to induce gastrointestinal ulceration, especially in aged cattle and young calves, concomitant use of the veterinary medicinal product with other anti-inflammatory drugs (NSAIDs) or steroidal anti-inflammatory drugs (e.g., corticosteroids) should be avoided within the first 24 hours of treatment. Afterwards concurrent treatment with NSAIDs and steroidal anti-inflammatory drugs should be closely monitored. The use of the veterinary medicinal product (that contains ketoprofen) in aged animals or animals less than 6 weeks should be based on a benefit/risk assessment of the responsible veterinarian.

Avoid use in dehydrated, hypovolaemic or hypotensive animals which require parenteral rehydration, as there may be a potential risk of renal toxicity.

Intra-arterial and intra-venous injection should be avoided.

∙ This veterinary medicinal product may cause hypersensitivity (allergy). People with known hypersensitivity to tulathromycin, ketoprofen, or to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product. In case of accidental spillage onto skin, wash the skin immediately with soap and water.

∙ This veterinary medicinal product may cause adverse effects after dermal exposure and self-injection. Take care to avoid skin contact and accidental self-injection. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

∙ NSAIDs, such as ketoprofen, may affect fertility and be harmful for the unborn child. Pregnant women, women intending to conceive and men planning to have children should use extreme caution while handling this veterinary medicinal product.

∙ This veterinary medicinal product is irritating to eyes. Avoid contact with the eyes. In case of accidental eye exposure, flush the eyes immediately with clean water. If irritation persists, seek medical advice and show the package leaflet to the physician.

∙ Wash hands after use.

Special precautions for the protection of the environment:

Not applicable.

Cattle:

Very common (>1 animal / 10 animals treated):	injection site pain1 injection site swelling1,2 injection site reaction2 injection site oedema2 injection site fibrosis2 injection site haemorrhage2
Very rare (<1 animal / 10,000 animals treated, including isolated reports):	digestive tract disorder renal disorder hypersensitivity reactions (e.g. anaphylaxis, dyspnoea, collapse)3

1 May persist for up to 32 days after injection.

2 Pathomorphological injection site reactions are present for approximately 32 days after injection.

3 In case of such an allergic or anaphylactic reaction, appropriate symptomatic treatment should be administered immediately.

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 section 16 of the package leaflet for respective contact details.

Pregnancy and lactation:

Laboratory studies with tulathromycin in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. Studies with ketoprofen in laboratory species (rats, mice and rabbits) have not produced any evidence of teratogenic effects, but effects on fertility, maternal toxicity and embryotoxicity has been observed. There are known adverse class-effects of NSAIDS and other prostaglandin inhibitors on pregnancy and/or embryofoetal development. The safety of tulathromycin and ketoprofen combination in the target species has not been established during pregnancy and lactation. Use only according to the benefit/risk assessment by the responsible veterinarian.

Do not use concurrently with other diuretics, nephrotoxic veterinary medicinal products or anticoagulants.

Subcutaneous use.

A single subcutaneous injection of 2.5 mg tulathromycin/kg bodyweight and 3 mg ketoprofen/kg bodyweight (equivalent to 1 ml/40 kg bodyweight). For treatment of cattle over 400 kg bodyweight, divide the dose so that no more than 10 ml are injected at one site.

To ensure correct dosage bodyweight should be determined as accurately as possible to avoid underdosing.

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.

If there is persistent elevated body temperature 24 hours after treatment initiation, the responsible veterinarian must evaluate the necessity of further anti-pyretic treatment.

The stopper 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 or an automatic syringe to avoid excessive broaching of the stopper. The draw-off needle should be removed after treatment.

At dosages of 3 and 5 times the recommended dose transient signs of injection site pain and/or swelling which in some instances lasted until day 32. Additionally, transient signs attributed to injection site discomfort (pain) were observed and included restlessness, head-shaking, pawing the ground, and brief decrease in feed intake. Microscopic mucosal erosions of the pylorus of the abomasum were observed at 3 and 5 times the recommended dose. Repeated administration can result in gastric toxicity. Mild myocardial degeneration has been observed in cattle receiving 5 to 6 times the recommended dose.

Not applicable.

Meat and offal: 50 days.

Not authorised for use in cattle 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.