ENRODEM 10%

Oral Solution

Oral solution for pigs and poultry.

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: ENRODEM 10%, as enrofloxacin 100 mg/ml, oral solution for pigs and poultry.

STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS

1 ml solution contains: Enrofloxacin 100 mg., Excipients (potassium hydroxide, hypromellose, benzyl alcohol, purified water) ad…1 ml

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, Salmonella spp, E.coli, Actinobacillus spp, Shigella, Klebsiella, Brachispira, Campylobacter etc) Gram positive bacteria (Erysipelothrix rhusiopatiae, some strains of Streptococcus and Staphylococcus spp. etc), Mycoplasma, Brucella, Chlamydia.

In poultry: for the treatment 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.

CONTRAINDICATIONS: Do not use in animals with known hypersensitivity to fluoroquinolones. Do no use in pregnant females. The product should not be used as preventive treatment.

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. After prolonged treatment with Enrodem 10%, rarely were registered vomit and diarrhoea.

TARGET SPECIES: Pigs and poultry.

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

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. Based on the recommended doses and the number and weight of the animals to be treated, the exact daily amount of Enrodem 10% should be calculated according to the following formula:

Enrodem 10

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.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.

WITHDRAWAL PERIOD: Edible tissues of pig: 7 days after cessation of oral medication. 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:

July 2011

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.