Description
Solution for injection for treating systemic and organ-specific diseases in cattle and pigs
Active substance and excipient content
Active substance:
Enrofloxacin – 100 mg/ml
Excipient:
Benzyl alcohol (E-1519) – 15.7 mg/ml
Therapeutic indications
Cattle
Treatment of respiratory tract infections caused by strains of Pasteurella multocida, Mannheimia haemolytica and Mycoplasma spp. susceptible to enrofloxacin.
Treatment of gastrointestinal tract infections caused by strains of Escherichia coli susceptible to enrofloxacin.
Treatment of septicaemia caused by strains of Escherichia coli susceptible to enrofloxacin.
Treatment of acute mycoplasma arthritis caused by strains of Mycoplasma bovis susceptible to enrofloxacin in cattle aged less than 2 years.
Pigs
Treatment of respiratory tract infections caused by strains of Pasteurella multocida, Mycoplasma spp. and Actinobacillus pleuropneumoniae susceptible to enrofloxacin.
Treatment of urinary tract infections caused by strains of Escherichia coli susceptible to enrofloxacin.
Treatment of Postpartum Dysgalactia Syndrome – PDS (Metritis Mastitis Agalactia MMA) caused by strains of Escherichia coli and Klebsiella spp. susceptible to enrofloxacin.
Treatment of gastrointestinal tract infections caused by strains of Escherichia coli susceptible to enrofloxacin.
Treatment of septicaemia caused by strains of Escherichia coli susceptible to enrofloxacin.
Contraindications
Do not use the product as a preventive measure.
Do not use in case of known bacterial resistance/cross-resistance to fluoroquinolones or quinolones.
Do not use in case of hypersensitivity to the active substance or any excipient.
Do not use in growing horses due to risk of joint cartilage damage.
Adverse reactions
Reported very rarely. Long-term use of high product doses in growing animals may lead to developmental changes in cartilage and transitory alimentary tract and nervous system disorders.
Any adverse reactions emerged after administration of the product or any observed symptoms not listed in the leaflet (including symptoms reported in humans following exposure to the product) should be reported to the competent veterinarian, Marketing Authorization Holder or the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. The report form should be downloaded from https://www.urpl.gov.pl (Department of Veterinary Medicinal Products).
Amount to be administered per species, method and route of administration
Product for subcutaneous or intramuscular use.
Subsequent product doses to be administered at different injection sites.
Cattle
5 mg of enrofloxacin per kg of body weight, which corresponds to 1 ml per 20 kg of body weight, injected subcutaneously once a day for 3–5 days.
Acute mycoplasma arthritis caused by Mycoplasma bovis susceptible to enrofloxacin in calves aged less than 2 years: 5 mg of enrofloxacin per kg of body weight, which corresponds to 1 ml per 20 kg of body weight, injected subcutaneously once a day for 5 days. In case of subcutaneous administration, do not inject more than 5 ml of the product per site.
Pigs
2.5 mg of enrofloxacin per kg of body weight, which corresponds to 0.5 ml per 20 kg of body weight, injected intramuscularly once a day for 3 days.
Gastrointestinal tract infection or septicaemia caused by Escherichia coli: 5 mg of enrofloxacin per kg of body weight, which corresponds to 1 ml per 20 kg of body weight, injected intramuscularly once a day for 3 days.
Inject the product in the neck, near the base of the ear.
Do not exceed 3 ml per site.
Instructions for use
In order to ensure proper amounts to be administered, determine body weight as precisely as possible, to avoid dose underestimation.
Withdrawal period
Cattle:
Edible tissues: 12 days.
Milk: 4 days.
Pigs: Edible tissues: 13 days.
Special precautions for storage
Keep out of the sight and reach of children.
Store below 250C. Protect from light. Do not freeze.
Do not use this veterinary medicinal product after the use-by date given on the label.
Expiry date refers to the last day of a given month.
Special warnings
Special precautions for use in animals:
Degenerative changes in joint cartilage were observed in calves treated with 30 mg of enrofloxacin per kg of body weight, administered per os for 14 days.
Principles of prudent use:
If possible, fluoroquinolone use should be based on results of antibiotic resistance test.
During product use, comply with the applicable national and local guidelines for using antimicrobial drugs.
Fluoroquinolones should be used in treating only those diseases in which observed response to administration of other classes of antimicrobial drugs is not satisfactory or the response to treatment is expected to be insufficient.
Using the product contrary to provisions of the Summary of Product Characteristics may lead to increased frequency of microbial resistance to flouroquinolones and decreased efficacy of treatment using fluoroquionolones due to emergence of a potential cross-resistance.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
In case of accidental self-injection, immediately seek doctor’s assistance and present the doctor with the information leaflet or package. In case of contact with skin, mucous membranes – immediately flush affected sites with water.
People with known hypersensitivity to enrofloxacin should avoid contact with the veterinary medicinal product.
Pregnancy:
Do not use the product during pregnancy.
Lactation:
Do not use the product during breastfeeding.
Interaction with other medicinal products and other forms of interaction:
Do not use together with macrolide, tetracycline antibiotics and theophylline.
Overdose (symptoms, emergency procedures, antidotes):
Enrofloxacin displays low toxicity after single-dose administration, and low acute toxicity. LD50 is about 4000-5000 mg/kg of body weight after per os administration in rats and mice, whereas in rabbits which are more susceptible – 500-800 mg/kg of body weight.
After a single-dose administration of a particularly high amount, toxic effects may be manifested by lethargy, convulsions, tonic seizures, ataxia and dyspnoea.
Use of enrofloxacin doses exceeding 5 mg/kg of body weight may cause changes in vision, retinal degeneration and blindness.
Pharmaceutical incompatibilities:
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with any other veterinary medicinal products.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Medicines should not be disposed of via wastewater or household waste. Ask your veterinary surgeon how to dispose of medicines no longer required. These
measures should help to protect the environment.
Pack size
100 ml
Shelf life
2 years
Other information
For more information about this veterinary medicinal product, contact the Marketing Authorization Holder.
For animal treatment only.
Subject to medical prescription – prescription drug.
To be administered only by a veterinary surgeon.
2015-04-22 SPC
CPLW 2015-04-22
25.07.2017 r.
