BROMEX

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ANTIBIOTIC

Enrofloxacin 200 mg/ml + bromhexine HCl 15 mg/ml

Formula

Each ml of product contains:
Enrofloxacin 200 mg
Bromhexine HCl 15 mg

Indications

Treatment of infections caused by the following bacteria susceptible to enrofloxacin:

Mycoplasma gallisepticum,
Mycoplasma synoviae,
Avibacterium paragallinarum,
Pasteurella multocida.

Administration

10 mg enrofloxacin/kg bodyweight per day (corresponding with 0.05 ml Bromex/kg bw) administered for 3-5 consecutive days.

Administer treatment 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 is dependant on the clinical condition of animals. In order to obtain the correct dosage, the concentration in drinking water may have to be adjusted.

To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing.

For any information about this veterinary medicinal product, please contact the local representative of the Marketing Authorization Holder.

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.

Side effects

Not known.

Advice on correct administration

During treatment, the animals should drink only medicated water. Fresh medicated water should be prepared every 24 hours.

Special precautions for storage

Keep away from reach and sight of children!

The product should be stored in original packaging at temperatures bellow 25^oC, protected from direct sunlight and freeze.

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after dilution in drinking water, according to directions: 24 hours.

Shelf-life after first opening of package: 28 days.

Do not use after expiry date which is stated on the label.

Withdrawal period

Meat and offal: 7 days.

Not authorised for use in birds producing eggs for human consumption.

Do not administer to layer replacement birds within 14 days of coming into lay.

Special warnings

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.

The product Bromex 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 be used based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.

Use of the product deviating from the instructions given by 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.

People with known hypersensitivity to any of the product ingredients should avoid contact with the veterinary medicinal product. To prevent any unpleasant effects, personal protective equipment consisting in rubber gloves, goggles and protective masks should be worn when administering the product. Wash hands and exposed skin after use. In case of accidental ingestion or the occurrence of symptoms characterized by skin rash, seek medical advice. Serious symptoms such as face swelling, lips or eye lids, accompanied by breath difficulties, need immediate medical attention.

The studies performed on laboratory animals have not produced any evidence of teratogenic, fetotoxic or maternotoxic effects. Antacid substances may interfere with gastrointestinal absorption of enrofloxacin. In renal disorders treatment, nitrofurans administered concomitant with fluoroquinolones decreased therapeutically efficiency of fluoroquinolones. Fluoroquinolones inhibits teophyline biotransformation leading to a high blood level and potentially toxic of teophyline. “In vitro” enrofloxacin has synergic action to β-lactams, clindamycin and metronidazole.

Special precautions for the disposal of unused product or waste materials

For the environmental protection, medicines should not be disposed of via wastewater or household waste. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.