Enrocare 25mg/ml Concentrate for Oral Solution

Enrocare 25mg/ml Concentrate for Oral Solution

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 digestive 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 digestive 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

The product should not be used for prophylaxis.
Do not use in case of confirmed or suspected resistance to quinolones, since a high
degree or cross resistance between enrofloxacin and other quinolones exists.
Do not use in cases of known hypersensitivity to fluoroquinolones 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

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.

Special precautions to be taken by the person administering the veterinary medicinal
product to animals

This product may cause allergic reactions in those that are sensitive.
People with known hypersensitivity to (fluoro)quinolones should avoid contact with
the product.
The product is an alkaline solution and may cause irritation if it comes into contact
with the skin or eyes.
Wear impermeable gloves when administering the product.
Rinse any splashes from skin or eyes immediately with water.
Wash hands and exposed skin after use.
Do not smoke, eat or drink when handling the product.

4.6 Adverse reactions (frequency and seriousness)

During the period of rapid growth, enrofloxacin may affect articular cartilage.

4.7 Use during pregnancy, lactation or lay

In the absence of data on its use in some of the target species, caution should be
used when prescribing during these periods and a careful risk/benefit assessment
made.

4.8 Interaction with other medicinal products and other forms of interaction

None known.

4.9 Amounts to be administered and administration route

For administration by gavage or in drinking water.

Dosage

Owing to physiological and pharmacokinetic differences between the wide range of
species for which this 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.
Pet rabbits and rodents: 5 mg enrofloxacin per kg bodyweight (0.2 ml per kg
bodyweight) orally diluted in water, twice daily for 7 days.
Reptiles: 5 mg enrofloxacin per kg bodyweight (0.2 ml per kg bodyweight) orally
diluted in water, 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), orally diluted in water, twice daily for 7 days.
Information 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.
If the product is to be given via the drinking water, concentrations of between 50 and
200 ppm should be considered as suitable working dilutions; concentrations in
excess of 250 ppm should be avoided as precipitation may occur.
Medicated fluids should be made up immediately prior to provision on a daily basis.

20 ml bottle: A 3 ml syringe is provided with the 20 ml bottle for withdrawal of the
product and facilitation of dilution prior to administration. This syringe has
graduations of 0.1 ml. It is recommended to draw up a minimum of 0.1 ml of product
prior to dilution since it is not possible to accurately measure volumes that are lower
than this.
100 ml bottle: A 10 ml syringe is provided with the 100 ml bottle for withdrawal of the
product and facilitation of dilution prior to administration. This syringe has
graduations of 0.2 ml. It is recommended to draw up a minimum of 0.2 ml of product
prior to dilution since it is not possible to accurately measure volumes that are lower
than this.
To withdraw product, firmly insert the syringe hub into the centre of the self-sealing
syringe adaptor of the bottle and remove the required amount.
To avoid inhalation of the medication, care should be taken with restraint of the
animal and administration of the product.

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. There is no antidote and treatment should be
symptomatic.

4.11 Withdrawal period(s)

Do not use in animals producing food intended for human consumption.

5. PHARMACOLOGICAL IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: antibacterials for systemic use, fluoroquinolones.
ATCvet code: QJ01MA90

5.1 Pharmacodynamic properties

Mode of action
Two enzymes essential in DNA replication and transcription, DNA gyrase and
topoisomerase IV, have been identified as the molecular targets of fluoroquinolones.
Target inhibition is caused by non-covalent binding of fluoroquinolone molecules to
these enzymes. Replication forks and translational complexes cannot proceed
beyond such enzyme-DNA-fluoroquinolone complexes, and inhibition of DNA and
mRNA synthesis triggers events resulting in a rapid, drug concentration-dependent
killing of pathogenic bacteria. The mode of action of enrofloxacin is bactericidal and
bactericidal activity is concentration dependent.
Antibacterial spectrum
Enrofloxacin is active against many Gram-negative bacteria such as Escherichia coli,
Klebsiella spp., Actinobacillus pleuropneumoniae, Pasteurella spp. (e.g. Pasteurella
multocida), Bordetella spp., Proteus spp., Pseudomonas spp., against Gram-positive
bacteria such as Staphylococcus spp. (e.g. Staphylococcus aureus) and against
Mycoplasma spp. at the recommended therapeutic doses.
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 Gramnegative 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.

5.2 Pharmacokinetic particulars

The pharmacokinetic properties of enrofloxacin are such that both oral and
parenteral administration leads to similar serum levels. Enrofloxacin possesses a
high distribution volume. Tissue levels 2-3 times higher than 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.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Potassium hydroxide
Benzyl alcohol
Hypromellose
Purified water

6.2 Incompatibilities

None known

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 30 months
Shelf life after first opening the immediate packaging: 90 days.
Shelf life after dilution: Any medicated liquid remaining 24 hours after preparation
must be discarded.

6.4 Special precautions for storage

The bottle is to be stored in the carton.

6.5 Nature and composition of immediate packaging

20 and 100ml amber polyvinyl chloride bottles with a polypropylene self-sealing
syringe adaptor and a child resistant polyethylene screw cap.
The 20ml presentation is packaged in a carton containing a 3ml polypropylene
syringe and the 100ml.

Sizes:

20ml

100ml