Enrotron Flavour Tablets for dogs 150mg Pack of 5x10

Target species Dogs 4.2 Indications for use, specifying the target species For the treatment of bacterial single or combined infections of the respiratory, alimentary or urinary tract, the skin or wounds, caused by Enrofloxacin-sensitive gram-negative and gram –positive bacteria: E. coli, Pasteurella spp., Haemophilus spp. and staphylococci. 4.3 Contraindications Do not use in young or growing dogs (dogs aged less than 12 months (small breed) or less than 18 months (large breed)) as the product may cause epiphyseal cartilage alterations in growing puppies. Do not use in dogs having seizure disorders, since enrofloxacin may cause CNS stimulation. Do not use in dogs with known hypersensitivity to fluoroquinolones or to any of the excipients of the product. Do not use in case of resistance to quinolones, as there exists almost complete cross resistance to other quinolones and complete cross resistance to other fluoroquinolones. Do not use with tetracyclines, phenicols or macrolides because of potential antagonistic effects. See also section 4.7 4.4 Special warnings for each target species None. 4.5 Special precautions for use Special precautions for use in animals Official and local antimicrobial policies should be taken into account when the product is used. Skin infections are mostly secondary to an underlying disease. It is advisable to determine the underlying cause and to treat the animal accordingly. Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials. Whenever possible, fluoroquinolones should only be used based on susceptibility testing. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential cross resistance. As enrofloxacin is metabolized by the liver and partly eliminated via the kidneys, elimination may be delayed in dogs with liver or renal disturbances. Therefore, in cases of known liver or renal impairment, the product should be used with caution. The chewable tablets are flavoured. In order to avoid any accidental ingestion, store tablets out of reach of the animals. Special precautions to be taken by the person administering the veterinary medicinal product to animals People with known hypersensitivity to fluoroquinolones should avoid contact with the veterinary medicinal product. Wash hands after use. In case of contact with the eyes, wash immediately with plenty of clean water. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. 4.6 Adverse reactions (frequency and seriousness) In rare cases vomiting and diarrhoea are observed. See section 4.3. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports) 4.7 Use during pregnancy, lactation or lay Pregnancy: Do not use during pregnancy. Lactation: Do not use during lactation. 4.8 Interaction with other medicinal products and other forms of interaction Concurrent use of flunixin should be under careful veterinary monitoring, as the interactions between these drugs may lead to adverse events related to delayed elimination. Elimination of theophylline may be delayed. Antagonistic effect may occur if enrofloxacin is combined with phenicols, macrolide antibiotics or tetracyclines. Substances containing magnesium or aluminium, if administered at the same time, may impair the enrofloxacin resorption.