ENRODEM 50

Medicated premix


Enrofloxacin hydrochloride /g, powder for swine, poultry and fish.

MANUFACTURING AUTHORISATION HOLDER: SC DELOS IMPEX ’96 SRL, Str. Horia, Cloşca şi Crişan, nr. 81, Otopeni, jud. Ilfov
Tel: 0372.714.433, Fax: 0372.714.460.

NAME OF THE VETERINARY MEDICINAL PRODUCT: ENRODEM 50, 500 mg enrofloxacin hydrochloride/g, powder for swine, poultry and fish.

STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS: 1 gram ENRODEM 50 contains: Enrofloxacin hydrochloride 500 mg (equivalent to 453,95 mg enrofloxacin as base), Excipient (lactose monohydrate) qs ad1 g

INDICATIONS
For pigs: for the treatment and control of gastrointestinal, respiratory 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.

CONTRAINDICATIONS : Do not use in animals with known hypersensitivity to fluoroquinolones. Do no use in pregnant females.

ADVERSE REACTIONS: 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.

TARGET SPECIES: Pigs, poultry and fish.

DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
In pigs: by oral route, the therapeutically dose is 5 mg enrofloxacin/Kg bw/day (corresponding to 11 mg Enrodem 50/kg body weight/day) for 5 consecutive days.
In poultry: the therapeutically dosage is 10 mg enrofloxacin/Kg body weight/day (corresponding to 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 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 to 11 – 50,6 mg Enrodem 50 /kg bw fish/day). Based on the recommended doses and the number and weight of the animals to be treated, the exact daily amount of Enrodem 50 should be calculated according to the following formula:
The uptake of medicated water or feed is dependant on the clinical condition of animals. In order to obtain the correct dosage, the concentration in feed may have to be adjusted. In some fish species the feed intake is dependant on water temperature. In order to obtain the correct dosage, the concentration in feed may have to be adjusted.

ADVICE ON CORRECT ADMINISTRATION: During treatment, the animals should drink only medicated water and eat only medicated feed.

WITHDRAWAL PERIOD
For pig &poultry meat: 28 days from the last treatment. For fish meat: 12 days at temeperatures above 12 ºC, 30 days bellow 12 °C.
Not permitted for use in laying birds producing eggs for human consumption.

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!

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 gloves, eye-glasses and protective masks, should be worn when handling the product. 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.
In lactating sows, the product should be administered with caution, after assessment of risk-benefit ratio, because it could lead to arthropathy in suckling piglets following consumption of milk with enrofloxacin. 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 is possible, fluoroquinolones should only be used based on susceptibility testing. If that isn’t possible, the treatment should be done according to official and local antimicrobial policies regarding susceptibility of target bacteria isolated from animals.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY: 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. For any information about this veterinary medicinal product, please contact the local representative of the marketing authorization holder.