Orniflox 25 mg/ml concentrate for oral solution 50ml

   Product Ref: VBORN02 Category: Veterinary Prescription Medication

Temporarily Out of Stock



4.1 Target species Pet rabbits, rodents, ornamental birds and reptiles. 4.2 Indications for use, specifying the target species Pet rabbits Treatment of infections of the alimentary and respiratory tracts caused by enrofloxacin susceptible strains of: Escherichia coli, Pasteurella multocida and Staphylococcus spp.. Treatment of skin and wound infections caused by enrofloxacin susceptible strains of Staphylococcus aureus. Rodents, reptiles and ornamental birds Treatment of infections of the alimentary and respiratory tracts where clinical experience, if possible, supported by susceptibility testing of the causal organism, indicates enrofloxacin as the substance of choice. 4.3 Contraindications Do not use in cases of known hypersensitivity to the active substance, to other (fluoro)quinolones or to any of the excipients. Do not use in animals that are epileptic or suffer from seizures since enrofloxacin may cause CNS stimulation. 4.4 Special warnings for each target species None. 4.5 Special precautions for use Special precautions for use in animals Do not administer undiluted product. Ensure thorough mixing. Direct oral administration has been associated with buccal and pharyngeal necrosis. This veterinary medicinal product should be administered only as indicated in section 4.9 (Amounts to be administered and administration route). 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 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 for cross resistance. Special caution should be taken when using enrofloxacin in animals with impaired renal function. Special precautions to be taken by the person administering the veterinary medicinal product to animals People with known hypersensitivity to fluoroquinolones or to any of the excipients should avoid any contact with the veterinary medicinal product. The undiluted veterinary medicinal product is strongly alkaline and may cause irritation if it comes into contact with the skin or eyes. Personal protective equipment consisting of impermeable gloves should be worn when handling the veterinary medicinal product. Avoid skin and eye contact. Wash any splashes from skin or eyes immediately with large amounts of water. If irritation persists, seek medical advice. Wash hands after use. Do not eat, drink or smoke whilst handling the veterinary medicinal product. 4.6 Adverse reactions (frequency and seriousness) Digestive tract disorders (e.g. diarrhoea) may occur in very rare cases. These signs are generally mild and transient. During the period of rapid growth, enrofloxacin may affect articular cartilage. 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 Pet rabbits and rodents Laboratory studies in rats and rabbits have not produced any evidence of teratogenic effects but have shown evidence of foetotoxic effects at maternotoxic doses. 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. Ornamental birds and reptiles The safety of the veterinary medicinal product has not been established during lay, although detrimental effects on developing eggs of avian scavengers have been reported when these birds ingest livestock meat from animals previously administered fluoroquinolones. Use only according to the benefit-risk assessment by the responsible veterinarian. 4.8 Interaction with other medicinal products and other forms of interaction Do not use enrofloxacin concomitantly with antimicrobial substances acting antagonistically to quinolones (e.g. macrolides, tetracyclines or phenicols). Do not use concurrently with theophylline as the elimination of theophylline may be delayed. The simultaneous application of substances containing aluminium, calcium or magnesium can impair the absorption of enrofloxacin.
Vat Rate: 20%

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Category POM-V
Temperature Ambient
MA/VM/EU No: 43564/4001
Species
  • ornamental bird
  • rabbit
  • reptile
  • rodent
VMD Link Product Information Database (defra.gov.uk)
NOAH Link
Dosage 4.9 Amounts to be administered and administration route Advice on correct administration The undiluted veterinary medicinal product is strongly alkaline and, therefore to avoid caustic effects, it is essential to dilute the product with at least 4 parts water prior to administration. In the case of smaller animals (weighing less than 500 g), it may be appropriate to dilute 0.1 ml of the neat product with >4 parts water and administer a proportion of the total volume. 10 ml bottle: A 1 ml syringe is provided with the 10 ml bottle for withdrawal of small volumes of the product and to facilitate dilution prior to administration. This syringe has dosage graduations of 0.01 and 0.1 ml. The lowest volume that has been demonstrated to be accurate is 0.1 ml. Therefore, for accuracy of dosing, it is recommended to draw up a minimum of 0.1 ml of product. 50 ml bottle: A 5 ml syringe is provided with the 50 ml bottles for withdrawal of product. The diluted solution should be mixed thoroughly prior to administration. Medicated drinking water should be freshly prepared and supplied immediately, preferably in a glass container, and replaced every 12 hours. Any medicated drinking water solution not consumed after 12 hours should be disposed of. The dilution prepared for direct administration should be made on a twice-daily basis immediately prior to provision , preferably in a glass container. This dilution should be administered immediately. Any unused solution should be disposed of immediately after use. After extracting and expressing the amount of veterinary medicinal product required the syringes should be washed with lukewarm water to remove any remaining product. The syringe can subsequently be used to prepare another solution or be opened, emptied and left to dry. Pet rabbits, rodents and reptiles For administration by oral gavage. Ornamental birds For administration via medicated drinking water or by oral gavage (crop needle). The uptake of medicated water depends on the clinical condition of the animals, the environment, the age and the kind of feed provided. In order to obtain the correct dosage, the concentration of enrofloxacin should be adjusted accordingly. In order to ensure consumption of the medicated water, animals should not have access to other water supplies whilst being treated. Dosage Never administer undiluted product. Ensure thorough mixing. Owing to physiological and pharmacokinetic differences between the wide range of species for which this veterinary medicinal product is indicated, the dose rates below are for guidance only. Depending upon the species of animal and the infection to be treated, alternative doses may be appropriate using an evidence-based approach. However, any change in dosing regimen should be based on a benefit-risk assessment by the responsible veterinarian, as tolerance at higher doses has not been investigated. To avoid inhalation of the medication, care should be taken with restraint of the animal and administration of the veterinary medicinal product. Rodents and pet rabbits 5 mg enrofloxacin per kg bodyweight (0.2 ml per kg bodyweight), twice daily for 7 days. Reptiles 5 mg enrofloxacin per kg bodyweight (0.2 ml per kg bodyweight), at 24-48 hour intervals for 6 days. Reptiles are ectothermic, relying on external heat sources to maintain their body temperature at the optimum level for correct function of all body systems. Metabolism of substances and activity of the immune system are, thus, critically dependant on the body temperature. Therefore, the veterinarian must be aware of correct temperature requirements of the respective reptile species and the hydration status of the individual patient. Furthermore, it has to be considered that large differences exist in the pharmacokinetic behaviour of enrofloxacin among different species, which additionally will influence the decision about the correct dosage of the veterinary medicinal product. Therefore, the recommendations made here can only be used as a starting point for individual dose setting. Ornamental birds 10 mg enrofloxacin per kg bodyweight (0.4 ml per kg bodyweight), twice daily for 7 days. Treatment should be re-evaluated if no improvement is seen. It is commonly advised to re-evaluate the treatment if no clinical improvement is observed within 3 days. 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary In cases of accidental overdose digestive tract disorders (e.g. vomiting, diarrhoea) and neurological disorders may occur.
Withdrawals 4.11 Withdrawal period(s) Do not use in animals producing food intended for human consumption.