Enrotron Solution for injection 50mg 100ml

   Product Ref: FOENR04 Category: E

42.10


Vat Rate: 20%

Prescription Required



4.2 Indications for use, specifying the target species Calves Treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of Pasteurella multocida, Mannheimia haemolytica and Mycoplasma spp. Treatment of infections of the alimentary tract caused by enrofloxacin susceptible strains of Escherichia coli. Treatment of septicaemia caused by enrofloxacin susceptible strains of Escherichia coli. Treatment of acute mycoplasma-associated arthritis due to enrofloxacin susceptible strains of Mycoplasma bovis. Pigs Treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of Pasteurella multocida, Mycoplasma spp. and Actinobacillus pleuropneumoniae. Treatment of infections of the alimentary tract caused by enrofloxacin susceptible strains of Escherichia coli. Treatment of septicaemia caused by enrofloxacin susceptible strains of Escherichia coli. Dogs Treatment of infections of the alimentary, respiratory and urogenital tracts (including prostatitis, adjunctive antibiotic therapy for pyometra), skin and wound infections, otitis (externa/media) caused by enrofloxacin susceptible strains of Staphylococcus spp., Escherichia coli, Pasteurella spp., Klebsiella spp., Bordetella spp., Pseudomonas spp. and Proteus spp. Cats Treatment of infections of the alimentary, respiratory and urogenital tracts (as adjunctive antibiotic therapy for pyometra), skin and wound infections, caused by enrofloxacin susceptible strains of, e.g.: Staphylococcus spp., Escherichia coli, Pasteurella spp., Klebsiella spp., Bordetella spp., Pseudomonas spp. and Proteusspp. 4.3 Contraindications Do not treat dogs under 1 year of age with the product as damage to the articular cartilage may occur during the period of rapid growth, specifically in large breeds of dogs. As a precaution do not treat very large breeds of dog with the product until they are 18 months of age because of their longer growth period. Do not use in cats less than 8 weeks of age. Do not use for prophylaxis. Do not use in animals that are epileptic or suffer from seizures since enrofloxacin may cause CNS stimulation.Do not use in cases of known hypersensitivity to fluoroquinolones or to any of the excipients. Do not use when resistance / cross resistance to (fluoro)quinolones is known to occur. Refer to section 4.5. Do not use in growing horses because of possible deleterious damage on articular cartilage. 4.4 Special warnings for each target species None. 4.5 Special precautions for use Special precautions for use in animals Enrofloxacin should be used with caution in epileptic animals or animals affected by renal dysfunction. Official and local antimicrobial policies should be taken into account when the product is used. 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 the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance. Degenerative changes of articular cartilage were observed in calves treated orally with 30 mg enrofloxacin/kg bw during 14 days. The use of enrofloxacin in growing lambs at the recommended dose for 15 days caused histological changes in the articular cartilage, not associated with clinical signs. Special precautions to be taken by the person administering the veterinary medicinal product to animals The product is an alkaline solution. Direct contact with skin should be avoided due to sensitisation, contact dermatitis and possible hypersensitivity reactions to (fluoro) quinolones. Wear gloves. In case of eye or skin contact, rinse immediately with water. Do not eat, drink or smoke whilst handling the product. Care should be taken to avoid accidental self-injection. If accidental self injection occurs seek medical advice immediately and show the package leaflet or the label to the physician. 4.6 Adverse reactions (frequency and seriousness) During the period of rapid growth, enrofloxacin may affect articular cartilage. Occasionally skin reactions have been seen after administration to kennelled greyhounds. Local tissue reactions may occur at the injection site. Normal sterile precautions should be taken. 4.7 Use during pregnancy or lactation Can be used during pregnancy and lactation. 4.8 Interaction with other medicinal products and other forms of interaction Antagonistic effects due to concurrent administration of macrolides, and tetracyclines may occur. Enrofloxacin may interfere with the metabolism of theophylline, decreasing theophylline clearance resulting in increased plasma levels of theophylline. Care should be taken during the concomitant use of flunixin and enrofloxacin in dogs to avoid adverse drug reactions. The decrease in drug clearances as a result of co-administration of flunixin and enrofloxacin indicates that these substances interact during the elimination phase. Thus, in dogs, the co-administration of enrofloxacin and flunixin increased the AUC and the elimination half-life of flunixin and increased the elimination half-life and reduced the Cmax of enrofloxacin.
Vat Rate: 20%

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Category POM-V
Temperature Ambient
MA/VM/EU No: 24745/4030
Species
  • cat
  • cattle
  • dog
  • pig
VMD Link Product Information Database (defra.gov.uk)
NOAH Link
Dosage 4.9 Amounts to be administered and administration route Intravenous, subcutaneous or intramuscular use. Repeated injections should be made at different injection sites. To ensure a correct dosage, body weight (bw) should be determined as accurately as possible to avoid underdosing. Calves 5 mg of enrofloxacin/kg bw, corresponding to 1 ml/10 kg bw, once daily for 3-5 days. Acute mycoplasma-associated arthritis due to enrofloxacin susceptible strains of Mycoplasma bovis: 5 mg of enrofloxacin/kg bw, corresponding to 1 ml/10 kg bw, once daily for 5 days. The product can be administered by slow intravenous or subcutaneous administration. Not more than 10 ml should be administered at one subcutaneous injection site. Pigs 2.5 mg of enrofloxacin/kg bw, corresponding to 0.5 ml/10 kg bw, once daily by intramuscular injection for 3 days. Alimentary tract infection or septicaemia caused by Escherichia coli: 5 mg of enrofloxacin/kg bw, corresponding to 1 ml/10 kg bw, once daily by intramuscular injection for 3 days. In pigs, the injection should be made in the neck at the ear base. Not more than 3 ml should be administered at one intramuscular injection site. Dogs and cats 5 mg of enrofloxacin/kg bw, corresponding to 1 ml/10 kg bw, daily by subcutaneous injection for up to 5 days. Treatment may be initiated with injectable product and maintained with enrofloxacin tablets. Duration of treatment should be based on the duration of treatment approved for the appropriate indication in the SPC of the tablet product. 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary Do not exceed the recommended dosage. In accidental overdose there is no antidote and treatment should be symptomatic. In target animal studies, cats have been shown to suffer ocular damage after receiving doses of more than 15 mg/kg once daily for 21 consecutive days. Doses of 30 mg/kg given once daily for 21 consecutive days have been shown to cause irreversible ocular damage. At 50 mg/kg given once daily for 21 consecutive days, blindness can occur. In dogs and cats, lack of appetite and nausea may occur following overdose. Overdose may result in CNS and renal dysfunction. In dogs, 10-fold over dosage results in neurological symptoms such as ataxia, tremor, nystagmus or convulsions. These symptoms are reversible on cessation of treatment. No signs of over dosage were observed in pigs following administration of the product at five times the recommended therapeutic dose.
Withdrawals Calves: Following intravenous injection: Meat and offal: 5 days. Following subcutaneous injection: Meat and offal: 12 days. Not authorised for use in animals producing milk for human consumption Pigs: Meat and offal: 13 days.