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Baytril Max Solution for injection 100ml |
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Baytril Max Solution for injection for the treatment of bovine respiratory disease associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma species, where clinical experience, supported where possible, by sensitivity testing of the causal organism, indicates enrofloxacin as the drug of choice.
Indicated for the treatment of local signs (inflammation, milk quality and yield) associated with peracute/acute mastitis in lactating dairy cattle caused by E. coli, where herd history and previous sensitivity testing indicate enrofloxacin as the drug of choice.
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Presentation
A ready to use clear yellow sterile aqueous injectable solution containing as active ingredient 100 mg/ml enrofloxacin, with 20 mg/ml benzyl alcohol and 30 mg/ml butyl alcohol as preservatives.
Uses
Cattle
The product is indicated for the treatment of bovine respiratory disease associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma species, where clinical experience, supported where possible, by sensitivity testing of the causal organism, indicates enrofloxacin as the drug of choice.
Indicated for the treatment of local signs (inflammation, milk quality and yield) associated with peracute/acute mastitis in lactating dairy cattle caused by E. coli, where herd history and previous sensitivity testing indicate enrofloxacin as the drug of choice.
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Dosage and administration
Dosage and duration of treatment
For respiratory infections in cattle: administer by subcutaneous injection.
· A single dose of 7.5 mg/kg bodyweight (7.5 ml per 100 kg bodyweight)
Not more than 15 ml should be administered at one subcutaneous injection site.
For E. coli mastitis in cattle: administer by slow intravenous injection.
· 5.0 ml per 100 kg bodyweight (5 mg enrofloxacin per kg bodyweight) daily for 2 days.
To ensure correct dosage, body weight should be determined as accurately as possible to avoid underdosing.
Use during pregnancy and lactation
Not restricted
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Contra-indications, warnings, etc
Baytril Max 10% Solution for Injection should not be used for prophylaxis.
The safety of the product has not been established in calves when administered by the intravenous route and use of this route of administration in calves is therefore not recommended.
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.
Transient local reactions may occur at injection site. Normal sterile precautions should be taken.
Do not exceed the recommended dose. A dose of 25 mg/kg bodyweight administered by the subcutaneous route for 15 consecutive days is tolerated without any clinical symptoms. Clinical signs seen in gross overdosage include lethargy, lameness, ataxia, slight salivation and muscle tremors. In accidental overdose there is no antidote and treatment should be symptomatic.
User safety
Baytril Max is an alkaline solution.
Wash any splashes from skin or eyes immediately with water.
Do not eat, drink or smoke whilst using the product.
Care should be taken to avoid self-injection. If accidental self-injection occurs, seek medical advice immediately.
Withdrawal Periods
Subcutaneous Use: Animals must not be slaughtered for human consumption during treatment. Cattle may be slaughtered for human consumption only after 14 days from the injection. Milk for human consumption must not be taken during treatment. Milk for human consumption may only be taken from cattle after 84 hours (i.e. 7 milkings) from the last treatment.
Intravenous Use: Animals must not be slaughtered for human consumption during treatment. Cattle may be slaughtered for human consumption only after 4 days from the injection. Milk for human consumption must not be taken during treatment. Milk for human consumption may only be taken from cattle after 72 hours (i.e. 6 milkings) from the last treatment.
Pharmaceutical precautions
Store below 25°C. Do not freeze.
Following withdrawal of the first dose, use product within 28 days. Discard if visibly contaminated.
Any unused product and containers should be disposed of in accordance with national requirements.
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Legal category
POM-V
Packaging Quantities
Individually packed multi-dose bottles of 100 ml amber type I glass with siliconised grey rubber butyl stopper.
Further information
Enrofloxacin is a synthetic, broad spectrum antimicrobial substance belonging to the fluoroquinolone group of antibiotics.
It is bactericidal in action with activity against many Gram positive and Gram negative bacteria and mycoplasmas. The mechanism of action of the quinolones is unique among antimicrobials - they act primarily to inhibit bacterial DNA gyrase, an enzyme responsible for controlling the supercoiling of bacterial DNA during replication. Resealing of the double stranded helix is inhibited resulting in irreversible degradation of the chromosomal DNA. The fluoroquinolones also possess activity against bacteria in the stationary phase by an alteration of the permeability of the outer membrane phospholipid cell wall but are inactive against strict anaerobes.
Molecular resistance to fluoroquinolones has been observed to arise from two principal sources, (i) alteration to DNA gyrase or topoisomerase IV and (ii) alterations in drug permeability of the bacterial cell. Both mechanisms lead to a reduced susceptibility of the bacteria to fluoroquinolones. Clinical resistance is dependent on several mutations accumulating in a step-wise manner.
The pharmacokinetics of enrofloxacin are such that oral and parenteral administration leads to similar serum levels. Enrofloxacin is lipid soluble and amphoteric and possesses a high distribution volume. Tissue levels 2-3 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, skin, bone and lymphatic system. Enrofloxacin also distributes into the cerebrospinal fluid, the aqueous humour and the foetus in pregnant animals.
After subcutaneous administration of 7.5 mg/kg the mean peak plasma concentration is 0.8 µg/ml achieved within 6 hours. Enrofloxacin is partly metabolised in the liver. Approximately 45 per cent of the dose is excreted in the urine and 55 per cent in the faeces as active and metabolites.
After an intravenous dose of 5 mg enrofloxacin per kg body weight (bw) to lactating dairy cattle, the total systemic exposure over the dosing interval of 24 h was at 7.1 mg*h/L. In cattle serum, approximately 30% of drug exposure (2.31 mg*h/L) consisted of ciprofloxacin, the active metabolite of enrofloxacin. The drug was well distributed into the body compartments (Venro = 1.5 L/kg, Vcipro = 8.51 L/kg). Total body clearance was 0.71 L/h/kg. In milk, most of drug activity consisted of ciprofloxacin. Overall drug concentrations peaked at 4.1 mg/kg two hours after treatment. Overall drug exposure over 24 h was 22.1 mg*h/L. The actives were eliminated from milk with a mean exposure half-life of 2.8 h.
Marketing authorisation number
Vm 00010/4103
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