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Date: Saturday, June 15, 2024 1:23

Release 2.125
Enroxil® 100 mg/ml Oral Solution for Chickens and Turkeys
Species: Chickens, Poultry, Turkeys
Therapeutic indication: Pharmaceuticals: Antimicrobials: Oral preparations: Others
Active ingredient: Enrofloxacin
Product:Enroxil® 100 mg/ml Oral Solution for Chickens and Turkeys
Product index: Enroxil 100 mg/ml Oral Solution for Chickens and Turkeys
Poultry - meat: Chickens : 7 days; Turkeys: 13 days
Poultry - eggs: See notes
Withdrawal notes: Not authorised for use in laying birds producing eggs for human consumption. Do not administer to layer replacement birds within 14 days of coming into lay.
Incorporating:
Qualitative and quantitative composition
1 ml of oral solution contains: Active substance:
Enrofloxacin 100 mg
Excipient: Benzyl alcohol 14 mg
Pharmaceutical form
Oral solution. Clear, yellow solution.
Clinical particulars
Target species
Broilers, broiler breeders, replacement chickens, turkeys.
Indications for use
Treatment of infections caused by the following bacteria susceptible to enrofloxacin:
Chickens
Mycoplasma gallisepticum
Mycoplasma synoviae
Avibacterium paragallinarum
Pasteurella multocida
Turkeys
Mycoplasma gallisepticum
Mycoplasma synoviae
Pasteurella multocida
Contraindications
Do not use for prophylaxis.
Do not use when resistance/cross-resistance to (fluoro)quinolones is known to occur in the flock intended for treatment.
Infections caused by Streptococcus spp., because of only marginal susceptibility to enrofloxacin.
Do not use in other animals.
Do not use in case of hypersensitivity to the active substance, or to any of the excipients.
Special warnings for each target species
Treatment of Mycoplasma spp. infections may not eradicate the organism.
Special precautions for use in animals
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.
Since enrofloxacin was first authorised for use in poultry, there has been widespread reduction in susceptibility of E. coli to fluoroquinolones and emergence of resistant organisms. Resistance has also been reported in Mycoplasma synoviae in the EU.
As enrofloxacin will be partly excreted via kidneys, elimination will be delayed in cases with kidney disorders.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Personal protective equipment consisting of impervious gloves should be worn when handling the veterinary medicinal product. Wash any splashes from skin or eyes immediately with water. Wash hands and exposed skin after use. Do not eat, drink or smoke while using the product.
Other precautions
After the end of treatment, the watering system should be cleaned appropriately to prevent the intake of remaining subtherapeutic doses of the drug, which may lead to resistance.
Adverse reactions
Locomotion disturbances, as a result of damage to joint cartilage, cannot be excluded in cases where fluoroquinolones are used during the growing period, particularly at higher temperatures, when consumption of medicated water is drastically increased for longer periods.
Use during pregnancy and lactation
Laying birds: Do not use in replacement birds within 14 days of coming into lay.
Interactions
When combined with tetracyclines and macrolide antibiotics, enrofloxacin may produce an antagonistic effect.
Resorption of enrofloxacin may be reduced, when it is combined with substances containing magnesium or aluminium.
The serum level of theophylline may increase when it is combined with enrofloxacin.
Do not combine enrofloxacin with non steroidal antiphlogistics.
Increased influx of the air (admixing CO2 from the air) into medicated drinking water may result in precipitation of enrofloxacin.
Precipitation of the salt of enrofloxacin and alkalis may occur at higher concentration of calcium and magnesium in the water system during intermediate dilution in the dosage devices.
Amounts to be administered and administration route
Dosage:
Chickens and turkeys
10 mg enrofloxacin/kg body weight per day for 3-5 consecutive days.
Treatment for 3-5 consecutive days; for 5 consecutive days in mixed infections and chronic progressive forms. If no clinical improvement is achieved within 2-3 days, alternative antimicrobial therapy should be considered based on susceptibility testing.
The uptake of medicated water depends on the clinical condition of the animals. In order to obtain the correct dosage the concentration of Enroxil should be adjusted accordingly. Taking into consideration that 10 mg enrofloxacin per kg body weight corresponds to 0.1 ml of Enroxil per kg body weight; the following calculation should be made to provide the required amount of Enroxil per litre of drinking water:
___ ml Enroxil per kg body weight daily
x average body weight (kg) of the animals to be treated
x number of animals
____________________________________________
=
___ ml Enroxil per litre
drinking water
Total water consumption (l) of the flock at the previous day
Care should be taken that the intended dose is completely ingested.
The product may be put directly into the header tank or introduced via a water proportioner pump. For the preparation of the medicated water for small groups of animals the measuring cup included with the packaging should be used. During preparation of medicated water, the product should be admixed into water and not the other way round.
Only sufficient medicated drinking water should be prepared to cover the daily requirements. Medicated water should be prepared every day, immediately prior to provision. Medication of the water supply should be continuous during the treatment period and no other source of water should be available. Medicated drinking water should be replaced every 24 hours.
Overdose
Due to the low toxicity of enrofloxacin the danger of overdosing is limited. In cases of significant overdose, transient reduction of mobility and cramps may occur. Symptomatic treatment is recommended in such cases.
Withdrawal periods
Chickens: Meat and offal: 7 days.
Turkeys: Meat and offal: 13 days
Not authorised for use in laying birds producing eggs for human consumption. Do not administer to layer replacement birds within 14 days of coming into lay.
Pharmacological particulars
Pharmacotherapeutic group: Quinolone and quinoxaline antibacterials, fluoroquinolones
ATCvet code: QJ01MA90
Pharmacodynamic properties
Enrofloxacin is a synthetic, broad spectrum antimicrobial, bactericidal in action and effective against a wide range of gram-positive and gram-negative bacteria as well as mycoplasmas. It inhibits the enzyme DNA-gyrase in the cell nuclei during replication of bacterial DNA. It also acts on bacterial cells during stationary phase by changing the permeability in the phospholipid cellular membranes.
Antibacterial spectrum: Enrofloxacin is active against many gram-negative bacteria, against gram-positive bacteria and Mycoplasma spp. In vitro susceptibility has been shown in strains of (i) gram-negative species such as Pasteurella multocida and Avibacterium (Haemophilus) paragallinarum and (ii) Mycoplasma gallisepticum and Mycoplasma synoviae. (See Special precautions for use in animals)
Types and mechanisms of resistance: Resistance to fluoroquinolones has been reported to arise from five sources, (i) point mutations in the genes encoding for DNA gyrase and/or topoisomerase IV leading to alterations of the respective enzyme, (ii) alterations of drug permeability in gram-negative bacteria, (iii) efflux mechanisms, (iv) plasmid mediated resistance and (v) gyrase protecting proteins. All mechanisms lead to a reduced susceptibility of the bacteria to fluoroquinolones. Cross-resistance within the fluoroquinolone class of antimicrobials is common.
Pharmacokinetic properties
The pharmacokinetics of enrofloxacin are such that both oral and parenteral administration lead to similar serum levels. Enrofloxacin possesses a high distribution volume. Tissue levels 2-3 times higher than that found in the serum have been demonstrated in laboratory animals and target species. Organs in which high levels can be expected are the lungs, liver, kidney, bone and lymphatic system.
Enrofloxacin also distributes into the cerebrospinal fluid, the aqueous humour.
Pharmaceutical particulars
Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 5 years
Shelf life after first opening the immediate packaging: 28 days
Shelf life after dilution: 24 hours
Do not use after the expiry date stated on the label.
Special precautions for storage
Store in the original package in order to protect from light.
Immediate packaging
Cardboard box with 1 glass vial of 100 ml and measuring cup. Polyethylene bottle of 1 litre and measuring cup.
Not all pack sizes may be marketed.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
KRKA d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia.
Marketing Authorisation Number
Vm 01656/4021
Significant changes
Date of the first authorisation or date of renewal
9 September 2005
Date of revision of the text
June 2018
Any other information
For animal treatment only. To be supplied only on veterinary prescription. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
GTIN description:Enroxil 100 mg/ml Oral Solution for Chickens and Turkeys 1000 ml:
GTIN:08714225153381