ANTIBIOTIC

Enrodem 10%

enrofloxacin 100 mg/ml, oral solution for pigs and poultry.

Formula

Enrodem 10% is a homogeneous, slightly yellowish solution containing 1 ml per:

  • Enrofloxacin 100 mg
  • Excipients (potassium hydroxide, hydroxypropylmethylcellulose, benzyl alcohol, purified water) qs ad. 100 ml

Target species

Pigs, poultry (broilers, breeding birds, replacement youth).

Indications

In pigs: for the treatment of gastrointestinal, respiratory and urogenitaly infections produced by microorganisms susceptible to enrofloxacin: Gram Negative bacteria (Pseudomonas aeruginosa, Pasteurella spp, Sal- monella spp, E.coli, Actinobacillus spp, Shigella, Klebsiella, Brachispira, Campylobacter etc) Gram positive bacteria (Erysipelothrix rhusiopatiae, some strains of Streptococcus and Staphylococcus spp. etc), Mycoplas- ma, Brucella, Chlamydia.

In poultry: for the treatment of gastrointestinal and respiratory infec- tions produced by microorganisms susceptible to enrofloxacin: Gram Negative bacteria (Pseudomonas aeruginosa., Pasteurella spp, Salmonella spp, E.coli, Actinobacillus spp, Campylobacter etc) Gram positive bac- teria (some strains of Streptococcus and Staphylococcus spp.), Myco- plasma, Chlamydia.

Administrare

In pigs: the product is administered via drinking water in dosage of 5 mg enrofloxacin/kg body weight/day, corresponding to 0.05 ml Enrodem 10% / kg body weight/day, for 5 consecutive days.

In poultry: the product is administered via drinking water in dosage of 10 mg enrofloxacin/kg b.w. corresponding to 0.1 ml Enrodem 10%/day for 5 consecutive days. In infections with Pseudomonas aeruginosa the dosage is 12 mg enrofloxacin/kg body weight /day (0.12 ml Enrodem 10%/kg body weight) for 5 consecutive days.

Water intake is dependent on the clinical condition of the animals. Therefore, in order to obtain the correct dosage, the concentration in drinking water will have to be adjusted.

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 fluoroquinolones. Do no use in pregnant females. The product should not be used as pre- ventive treatment.

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

Poultry and Pigs: 7 days after cessation of oral medication. Edible tissues of poultry and pigs: 10 days after cessation of oral medication. Not per- mitted for use in laying bird 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.

Fluoroquinolones should be reserved for the treatment of clinical condi- tions 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 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.