DOXIDEM 50

Water Soluble Powders

Water-soluble powder 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

DOXIDEM 50, water-soluble powder, 500 mg/g doxycycline hyclate, for pigs and poultry.

STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS

1 gram DOXIDEM 50 contains: Doxycycline hyclate 500 mg (equivalent to 450.50 mg doxycycline base), Excipient (lactose monohydrate) qs ad. 1 g

INDICATIONS

In pigs, Doxidem 50 is indicated for treatment of respiratory, digestive and urogenitaly infections caused by susceptible strains of bacteria: Bacillus, Corynebacterium, Erysipelothrix, Listeria, Streptococcus, Actinobacillus, Bordetella, Francisella, Haemophillus, Pasteurella, Manhaemia, Campylobacter, Leptospira, Lawsonia intracellularis, Actinomyces, Fusobacterium, Mycoplasma, Chlamydia, Rickettsia.

In poultry Doxidem 50 is indicated for treatment of respiratory and digestive infections caused by susceptible strains of bacteria: Escherichia coli, Corynebacterium, Erysipelothrix, Listeria, Streptococcus, Actinobacillus, Bordetella, Francisella, Haemophillus, Pasteurella, Campylobacter, Borellia, Actinomyces, Fusobacterium, Mycoplasma, Chlamydia, Rickettsia and Anaplasma spp.

CONTRAINDICATIONS

Do not use in animals with known hypersensitivity to tetracyclines.

ADVERSE REACTIONS

In some cases, the animal with severe renal failure could develop adverse reactions characterized by: anorexia, vomit, diarrhea, abdominal colic, painful defecation. The possible toxic phenomena are due to doxycycline high concentrations in blood and tissues, which occur after the administration of multiple high doses and in low intervals or in case of severe renal failure.

Digestive apparatus: anorexia, vomits, diarrhea, abdominal colic and pancreatitis; administered for long periods of time can produce staphylococcal enteritis or candidosis (oral, intestinal, pulmonary). Teeth: dental pigmentation, caries and dental enamel hypoplasia in suckling and young off-springs to who mothers were treated with Doxidem 50 in the latest period of gestation or after birth.

TARGET SPECIES

Pigs and poultry.

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

In poultry: by oral route the therapeutically dose is 20 –40 mg Doxidem 50/kg bw/day, (10 – 20 mg doxycicline /kg body weight / day), for 5 consecutive days.

In pigs:  by oral route the therapeutically dose is 20 –40 mg Doxidem 50/kg bw/day, (10 – 20 mg doxycicline /kg body weight / day), 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 DOXIDEM 50 should be calculated according to the following formula:

In feed:

Doxidem furaj

In drinking water:

Doxidem apa

During treatment, the animals should eat only medicated feed and drink only medicated water. To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing. The use of suitable calibrating weighing equipment is recommended if part packs are used. The daily amount is to be added to the drinking water such all medication will be consumed in 24 hours. Medicated drinking water should be freshly prepared every 24 hours.The uptake of medicated water is dependant on the clinical condition of animals. In order to obtain the correct dosage, the concentration in feed or drinking water may have to be adjusted.
ADVICE ON CORRECT ADMINISTRATION

WITHDRAWAL PERIOD

Pigs: 10 days

Poultry: 7 days

Not permitted for use in laying birds producing eggs for human consumption.

SPECIAL PRECAUTIONS FOR STORAGE

Keep away from reach and sight of children! Store in original packaging, at room temperature (15–25°C), protected from moisture and direct sunlight.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. After opening the package the product should be used entirely. Shelf life after incorporation into meal: 7 days 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 dust 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.

Due to variability (time, geographical) in susceptibility of bacteria for doxycycline, bacteriological sampling and susceptibility testing of microorganisms from diseased birds on farm are highly recommended. A high resistance rate of E.coli, isolated from chickens, against tetracyclines has been documented. Therefore the product should be used for the treatment of infections caused by E.coli only after susceptibility testing has been carried out. As eradication of the target pathogens may not be achieved, medication should therefore be combined with good management practices, e.g. good hygiene, proper ventilation, no overstocking.

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

November 2011

OTHER INFORMATION

Thermo-sealed PET bags with aluminum insertion, containing 10g, 25g, 50g, 100g, 500g, 1000g, 5kg, 10kg and PET sacks with aluminum insert of 25kg, 50kg. Not all pack sizes may be marketed.

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