ANTIBIOTIC

Enrodem 50

enrofloxacin hydrochloride 500 mg/g, powder for swine, poultry and fish

Formula

Enrodem 50 is a white powder containing 1 g per:
Enrofloxacin 500 mg
Excipients (lactose) qs ad. 1g

Target species

Pigs, poultry and fish.

Indications

For pigs: for the treatment and control of gastrointestinal, respi- ratory and urogenitaly infections produced by microorganisms susceptible to enrofloxacin: Gram Negative bacteria (Pseudomonas aeruginosa, Pasteurella spp, Salmonella spp, E.coli, Actinobacillus spp, Shigella, Klebsiella, Campylobacter etc) Gram positive bacteria (Erysipelothrix rhusiopatiae, some strains of Streptococcus and Staphylococcus spp. etc), Mycoplasma, Brucella.
For poultry: for the treatment and control of gastrointestinal and respiratory infections produced by microorganisms susceptible to enrofloxacin: Gram Negative bacteria (Pseudomonas aeruginosa., Pasteurella spp, Salmonella spp, E.coli, Actinobacillus spp, Campylobacter etc) Gram positive bacteria (some strains of Streptococcus and Staphylococcus spp.), Mycoplasma, Chlamydia. For fish: furunculosis, vibriosis, cold water vibriosis, bacterial kidney disease, yersiniosis and other bacterial diseases caused by enrofloxacin -susceptible bacteria.

Administration

In pigs: by oral route, the therapeutically dose is 5 – 10 mg enroflox- acin/Kg bw/day (corresponding to 11 – 22 mg Enrodem 50/kg body weight/day) for 5 consecutive days.
In poultry: the therapeutically dosage is 5-10 mg enrofloxacin/Kg body weight/day (corresponding to11 – 22 mg Enrodem 50/kg body weight/day) for 5 consecutive days. In infections with Pseudomonas spp. the dosage is 12mg enrofloxacin/kg body weight /day (26,4 mg Enrodem 50/kg body weight) for 5 consecutive days.

In fish: 5- 23 mg enrofloxacin/ kg bw fish / day, for 10 consecutive days administered in feed (corresponding to11 – 55,6 mg Enrodem 50/kg bw fish/day).

For any information about this veterinary medicinal product, please contact the local representative of the marketing authorization holder.

Contraindications

Do not use in animals with known hypersensitivity to fluoroquino- lones. Do no use in pregnant females.

Side effects

Locomotion disorders may occur as a result of damage of joint cartilage in case that fluoroquinolones are used during the growing period, particularly at higher temperatures, when consumption of medicated water is drastically increased for longer period.

Special precautions for storage

In original packaging, at temperature below 25°C, protected from moisture and direct sunlight. Keep out of the reach of children!

Advice on correct administration

During treatment, the animals should drink only medicated water and eat only medicated feed.

Withdrawal period

For pig meat: 7 days from the last treatment. For poultry meat: 10 days from the last treatment. For fish meat: 12 days for temperatures over 12°C, 30 days for temperatures up to 120C. Not permitted for use in laying birds producing eggs for human consumption.

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, the veterinary medicinal product 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.

Other information

Presentation: bags of 10 g, 25 g, 50g, 100 g, 500 g, 1000 g, 5 kg, 10 kg, sacks of 25 kg, 50 kg. Not all pack size may be marketed.