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Enrofloxacin HCl 500 mg/g.
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ANTIBIOTIC
Enrodem 50
Formula
Each gram of product contains:
Enrofloxacin HCl (active substance): 500 mg
Target species
Pigs, poultry and fish.
Indications
In pigs and chickens: for the treatment and control of gastrointestinal, respiratory and urogenitaly infections produced by microorganisms susceptible to enrofloxacin: Gram Negative bacteria (Pseudomonas spp., Pasteurella spp., Salmonella spp., E.coli, Actinobacillus spp., Shigella spp., Klebsiella spp., Brachispira spp., Campylobacter spp.) Gram positive bacteria (Erysipelothrix rhusiopatiae, some strains of Streptococcus and Staphylococcus etc), Mycoplasma, Brucella spp., Chlamydia spp.
In fish: treatment of vibriosis, streptococcosis, yersiniosis and other bacterial diseases caused by enrofloxacin-susceptible bacteria.
Administration
In pigs: the product is administered in feed, in dose of 5-10 mg enrofloxacin/kg bw Enrodem 50/kg body weight/day (corresponding to 11-22 mg Enrodem 50/kg body weight/day) for 5 consecutive days.
In chickens: the product is administered in feed, in dose of 5-10 mg enrofloxacin/kg bw (corresponding with 22 mg Enrodem 50/kg body weight/day) for 5 consecutive days. In infections with Pseudomonas spp. the dosage is 12 mg enrofloxacin/kg body weight /day (26.4 mg Enrodem 50/kg body weight) for 5 consecutive days.
In fish: the product is administered in feed in dose of 5-23 mg enrofloxacin/kg fish/day, (corresponding to 11 – 50.6 mg Enrodem 50/ kg fish / day) for 10 consecutive days.
In infections caused by Streptococcus spp., the dose is increased to 50-100 mg enrofloxacin/kg fish/day (110-220 mg Enrodem 50/kg fish/day) for 10 consecutive days
The uptake of medicated 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.
For any information about this veterinary medicinal product, please contact the local representative of the marketing authorization holder.
- Contraindications
- Side effects
- Storage
- Correct administration
- Withdrawal period
- Warnings
- Disposal
- Other information
Contraindications
Do not use in animals with known hypersensitivity to fluoroquinolones.
Do no use as prevention.
Side effects
Locomotion disorders may occur as a result of damage of joint cartilage in case that fluoroquinolones are used during the growing period.
Special precautions for storage
Keep away from reach and sight of children.
Keep in original packaging, at temperature below 25oC, protected from direct sunlight and moisture.
Shelf-life after first opening of primary package: 28 days.
Shelf life after incorporation into meal or pelleted feed: 7 days
Do not use after expiry date which is stated on the label.
Advice on correct administration
During treatment, the animals should eat only medicated feed. To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing. The product should be well mixed with the feed to be homogenous.
Withdrawal period
Meat and offal:
Pigs, chickens: 28 days.
Fish: 360oC-days.
Not permitted for use in laying birds producing eggs for human consumption.
Special warnings
Enrodem 50 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. Official and local policies regarding antimicrobials must be taken into account when using the product. Use of the product deviating from the instructions given by the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance.
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.
Do not administer to pregnant sows.
Animals with severe kidney disease should receive lower doses.
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.
Other information
Bags 10g, 25g, 50g, 100g, 500g, 1000g, 5kg, 10kg and 25kg.
Not all pack sizes may be marketed.
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