Target species Cattle, pigs 4.2 Indications for use, specifying the target species For the treatment of specific infectious conditions (stated below) caused by microorganisms susceptible to tylosin. Cattle (adult): -Respiratory infections, metritis caused by Gram-positive microorganisms, mastitis caused by Streptococcus spp, Staphylococcus spp and interdigital necrobacillosis, i.e. panaritium or foot root. Calves: -Respiratory infections and necrobacillosis. Pigs (more than 25 kg): -Enzootic pneumonia, haemorrhagic enteritis, erysipelas and metritis. -Arthritis caused by Mycoplasma spp. and Staphylococcus spp. For information regarding swine dysentery see section 4.5. 4.3 Contraindications Do not use in horses. Intramuscular injection can be fatal in chickens and turkeys. Do not use in known cases of hypersensitivity to tylosin, other macrolides or to any of the excipients. 4.4 Special warnings for each target species None 4.5 Special precautions for use Special precautions for use in animals Use of the product should be based on identification and susceptibility testing of the target pathogens. If it 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 product should be in accordance with official, national and regional antimicrobial policies. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to tylosin and may decrease the effectiveness of treatment with other macrolide antibiotics due to the potential for cross resistance. A high rate of in vitro resistance has been demonstrated in European strains of Brachyspira hyodysenteriae implying that the product will not be sufficiently efficacious against swine dysentery. The efficacy data do not support the use of tylosin for the treatment of bovine mastitis caused by Mycoplama spp. Use of tylosin in this case presents a serious concern to animal and human health, potentially delaying a correct diagnosis, enabling the spread of the pathogen to other cows, impeding efficient/prudent control measures and increasing the risk for the development of antimicrobial resistance. Where repeat injections are to be administered, use different sites for each injection. Special precautions to be taken by the person administering the veterinary medicinal product to animals Care should be taken to avoid accidental self-injection. In case of accidental self- injection, seek medical advice immediately and show the package leaflet or the label to the physician. In the event of accidental skin contact, wash thoroughly with soap and water. In case of accidental eye contact, flush the eyes with plenty of clean, running water. Wash hands after use. Tylosin may induce irritation. Macrolides, such as tylosin, may also cause hypersensitivity (allergy) following injection, inhalation, ingestion or contact with skin or eye. Hypersensitivity to tylosin may lead to cross reactions to other macrolides and vice versa. Allergic reactions to these substances may occasionally be serious and therefore direct contact should be avoided. Do not handle the product if you are allergic to ingredients in the product.If you develop symptoms following exposure, such as skin rash, you should seek medical advice and show the physician this warning. Swelling of the face, lips and eyes or difficulty in breathing are more serious symptoms and require urgent medical attention. 4.6 Adverse reactions (frequency and seriousness) Hypersensivity reactions may occur (uncommon). Blemishes may occur at the site of injection and can persist for up to 21 days following administration. In very rare cases the following have been observed: - Swelling/inflammation at the site of injection -Vulval swelling in cattle, -Oedema of the rectal mucosa, partial anal protrusion (rosebudding), erythema and pruritus in pigs. -Anaphylactic shock and death. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports). 4.7 Use during pregnancy, lactation or lay Studies in laboratory animals have neither produced any evidence of a teratogenic or foetotoxic effects nor consequences on animals’ fertility. The safety of the veterinary medicinal product has not been established during pregnancy and lactation in the target species. Use only according to the benefit/risk assessment by the responsible veterinarian. 4.8 Interaction with other medicinal products and other forms of interaction None known.
Vat Rate: 20%