ANTIBIOTIC

Bromex

200 mg enrofloxacin /ml, 15 mg bromhexine HCl/ml, oral solution for poultry (chicken broilers, breeders, replacement chickens).

Formula

Enrofloxacina – 200 mg

Bromhexin HCl – 15 mg

Target species

Poultry.

Indications

In poultry, the product Bromex, due to its combina- tion between enrofloxacin (as antimicrobial) and a expectorant agent (bromhexine), is indicated to be used for treatment and control of respiratory infections associated with Mycoplasma sp., Pasteurella multocida., Haemophillus paragalinarum, Chronic Respiratory Disease (CRD), in some infections produced by susceptible strains of Staphylococcus, and also for other enrofloxacin-susceptible bacteria. Also, when the situation imposes, the product could be used for treat- ment of intestinal infections produced by Salmonella sp., E.coli and other enrofloxacin-susceptible bacteria.

Administration

Poultry (chicken broilers, breeders, replacement chickens).
The product is administered via drinking water in dose of 0.05 ml Bro- mex/kg bw, continuously for 5 days. From clinical studies these dose may be achieved by the inclusion of 0.3 ml Bromex/litre of drinking water, administered continuously for 5 days.

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

Contraindications

Do not give to animals with known hypersensitivity to polymixines.

Side effects

None.

Special precautions for storage

Keep away from reach and sight of children! The product should be stored in original packaging at temperature bellow 25°C, protected from direct sunlight and moisture. Protect from freezing. 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. Close tight the recipient after every use. Do not use after expiry date which is stated on the label.

Advice on correct administration

During treatment, the animals should drink only medicated water. Fresh medicated water should be prepared every 24 hours. To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing.

Withdrawal period

For pig and poultry meat and organs: 2 day from cessation of treatment. For eggs: zero days from the cessation of treatment.

Special warnings

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 rub- ber gloves, goggles and protective masks should be worn when admin- istering 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 swell-
ing, lips or eye lids, accompanied by breath difficulties, need immediate medical attention. Whenever possible, the treatments should be based on susceptibility testing of the bacteria isolated from the animal. If this isn’t possible, the treatment should be done as per official and local antimi- crobial policies.

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 prod- ucts should be disposed of in accordance with local requirements.

Other information

PE-HD flasks of 100 ml, 500 ml, and 1000 ml.
PE-HD cans of 5 l, 10 l, and 20 l.
Not all pack sizes may be marketed.
For any information regarding this veterinary medicinal product, please contact the local representative of the marketing authorization holder.