Oral Solution

NAME AND ADRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER, IF DIFFERENT

MANUFACTURING AUTHORIZATION HOLDER

S.C. Delos Impex ’96 S.R.L. 81, Horia, Closca si Crisan Street, Otopeni, Ilfov District, Romania Tel. +0040-372 714 433 Fax: +0040-0372 871 445

NAME OF THE VETERINARY MEDICINAL PRODUCT

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

STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS

1 ml solution contains: Enrofloxacin 200 mg, Bromhexine HCl 15 mg, Excipients qs ad. 1 ml.

INDICATIONS: In poultry, the product Bromex, due to its combination 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 treatment of intestinal infections produced by Salmonella sp., E.coli and other enrofloxacin-susceptible bacteria.

CONTRAINDICATIONS: Do not use in animals with known hypersensitivity to fluoroquinolones.

ADVERSE REACTIONS: Not known.

TARGET SPECIES: Poultry.

DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Poultry (chicken broilers, breeders, replacement chickens).

The product is administered via drinking water in dose of 0.05 ml Bromex/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. Based on the recommended doses and the number and weight of the animals to be treated, the exact daily amount of Bromex should be calculated according to the following formula:

ml Bromex / kg body weight/day x mean body weight of animals to be treated (kg)

=

ml Bromex / liter of drinking water

Mean daily water consumption (liters) / animal

 

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.

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
Edible tissues of poultry: 10 days after cessation of oral medication. Not permitted for use in laying bird producing eggs for human consumption.

SPECIAL PRECAUTIONS FOR STORAGE

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

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.

DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

March 2013

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.