Product Description

Enrobactin 25 mg/ml Concentrate for Oral Solution is indicated for the treatment of specific bacterial infections across its licensed species. Susceptibility testing of the causal organism should be performed where possible before initiating therapy. Fluoroquinolones should be reserved for conditions that have responded poorly, or are expected to respond poorly, to other classes of antimicrobials, in accordance with official and local antimicrobial policies.

For Pet Rabbits:

Treatment of digestive and respiratory tract infections 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

For Rodents:

Treatment of digestive and respiratory tract infections where clinical experience, supported where possible by susceptibility testing, indicates enrofloxacin as the substance of choice

For Ornamental Birds:

Treatment of digestive and respiratory tract infections where clinical experience, supported where possible by susceptibility testing, indicates enrofloxacin as the substance of choice

For Reptiles:

Treatment of digestive and respiratory tract infections where clinical experience, supported where possible by susceptibility testing, indicates enrofloxacin as the substance of choice

Note: Reptiles are ectothermic; metabolism and immune function are critically dependent on body temperature, which must be appropriately maintained during treatment. Significant pharmacokinetic differences exist between reptile species, so dosing recommendations serve as a starting point for individual dose-setting by the responsible veterinarian

Which Animals Can Use Enrobactin 25 mg/ml Concentrate?

Enrobactin 25 mg/ml Concentrate is licensed for use in pet rabbits, rodents, ornamental birds and reptiles only. It must not be used in animals that are epileptic or prone to seizures. It must not be used in animals producing food intended for human consumption. It must not be administered undiluted under any circumstances, as direct oral administration of the undiluted product has been associated with serious tissue injury. Always use only under the direction of your vet, and ensure a valid prescription is in place before ordering.

Available Strengths & Sizes

Please order the specific pack size as directed on your veterinary prescription. Enrobactin Concentrate for Oral Solution is available in a single strength of 25 mg enrofloxacin per ml.

Not all pack sizes may be marketed. Please confirm availability with your supplier.

Directions for Use

This is a prescription medication and must be used exactly as directed by your veterinary surgeon. Dosage depends on the species, the animal's body weight, and the condition being treated. This product must always be diluted with at least 4 parts water prior to administration; it must never be given undiluted. The diluted solution must be used immediately and any unused diluted product discarded. The product is administered by oral gavage; care should be taken with restraint of the animal to avoid inhalation of the medication. Refer to the dispensing label or product datasheet for full dosing instructions. Treatment should be re-evaluated if no clinical improvement is observed within 3 days.

Contraindications

Source: SPC Section 4.3

Do not use in animals with known hypersensitivity to the active substance (enrofloxacin), to other (fluoro)quinolones, or to any of the excipients (including benzyl alcohol)

Do not use in animals that are epileptic or suffer from seizures, as enrofloxacin may cause CNS stimulation

Do not use in animals producing food intended for human consumption

Storage & Handling

Keep the bottle tightly closed at all times. Any remaining diluted solution must be discarded immediately after use. Keep out of the sight and reach of children and animals at all times. Shelf life of the product as packaged for sale: 3 years. Once opened, use within 28 days. Diluted product: use immediately.

Withdrawal period:

This product must not be used in animals producing food intended for human consumption. No withdrawal period has been established.

Important Warnings

Source: SPC Section 4.5

Critical administration warning: The undiluted product is strongly alkaline. Direct oral administration of the undiluted concentrate has been associated with buccal and pharyngeal necrosis. The product must always be diluted with at least 4 parts water before administration and must only be given by oral gavage as directed

Special caution should be exercised when using this product in animals with impaired renal function

Use of the product in a manner deviating from the SPC instructions may increase the prevalence of bacteria resistant to fluoroquinolones and reduce the effectiveness of treatment with other quinolones due to potential cross-resistance

During periods of rapid growth, enrofloxacin may affect articular cartilage; use with caution in growing animals

Do not use concurrently with antimicrobials acting antagonistically to quinolones (e.g. macrolides, tetracyclines or phenicols)

Do not use concurrently with theophylline, as the elimination of theophylline may be delayed

Substances containing aluminium, calcium or magnesium may impair the absorption of enrofloxacin; avoid simultaneous administration

The safety of this product has not been established during pregnancy or lactation in rabbits and rodents; use only on the basis of a veterinary benefit/risk assessment

The safety of this product has not been established during lay in ornamental birds and reptiles; detrimental effects on developing eggs of avian scavengers have been reported following fluoroquinolone use. Use only on the basis of a veterinary benefit/risk assessment

Human safety — fluoroquinolone hypersensitivity: People with known hypersensitivity to (fluoro)quinolones or to any of the excipients should avoid any contact with this product

Human safety — skin and eye contact: The undiluted product is strongly alkaline and may cause irritation on contact with skin or eyes. Wear impermeable gloves when handling. Avoid skin and eye contact; wash any splashes from skin or eyes immediately with large amounts of water. If irritation persists, seek medical advice

Human safety — general precautions: Do not eat, drink or smoke whilst handling this product. Wash hands thoroughly after use

POM-V Prescription Notice

This product is a Prescription Only Medicine — Veterinary (POM-V). It may only be supplied by a veterinary surgeon or, when prescribed by a veterinary surgeon, by a pharmacist or SQP. A valid veterinary prescription is required before this product can be dispensed.

MA Number: Vm 41821/4026 (UK GB) | Source: VMD Product Information Database (vmd.defra.gov.uk)