DOXYFORT 500

DOXYFORT 500, 500 mg/g powder for administration in drinking water for cattle, pigs and chickens

1.

NAME AND ADDRESS OF MANUFACTURING AUTHORISATION HOLDER AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Manufacturing authorisation holder and manufacturer:

„Biofaktor” Sp. z o.o.

Czysta 4 st.

96-100 Skierniewice

2.

NAME OF THE VETERINARY MEDICINAL PRODUCT

DOXYFORT 500, 500 mg/g powder for administration in drinking water for cattle, pigs and chickens

3.

QUALITATIVE AND QUANTITATIVE COMPOSITION OF ACTIVE SUBSTANCE

Doxycycline hyclate 500 mg/g

4.

INDICATIONS

Doxyfort 500 is used for treatment of the following diseases in cattle, pigs and poultry:

Cattle (calves):

- bronchopneumonia and pleuropneumonia caused by Pasteurella spp., Streptococcus spp., Corynobacterium pyogenes, Haemophilus somnus and Mycoplasma spp.

Pigs:

- infectious arthropic rhinitis caused by Pasteurella haemolitica and Bordetella bronchiseptica;

- bronchopneumonia caused by P. multocida, Streptococcus suis, Mycoplasma hyorhinis

- pleuropneumonia caused by Haemophilus pleuropneumoniae.

Chickens:

- infectons of respiratory tract caused by Mycoplasma spp., Escherichia coli, Haemophilus paragallinarum and Bordetella avium.

- enteritis caused by Clostridium perfringens and Clostridium colium.

5.

CONTRAINDICATIONS

Do not use in case of hypersensitivity to tetracycline and in acute renal and liver failure.

6.

ADVERSE EFFECTS

Not observed.

The occurrence of adverse events after administration of the product or observing any ill effects not listed in this leaflet (including symptoms in humans in contact with the drug), you must notify the competent veterinary surgeon, responsible entity or the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products . The application form should be downloaded from the website http://www.urpl.gov.pl (Faculty of Veterinary Medicinal Products).

7.

TARGET SPECIES

Cattle, pig, chicken.

8.

DOSING AND ADMINISTRATION ROUTE

DOXYFORT 500 is administered after dissolving in drinking water in the following quantities:

Cattle (calves): 1g of preparation per 100 kg of body weight (5 mg of doxycycline hyclate per 1 kg of body weight) twice daily for 3-5 days.

Pigs: 1 g of preparation per 50 kg of body weight (10 mg of doxycyline hyclate per 1 kg of body weight) or 200 g of preparation per 1000 l of drinking water for 3-5 days

Chicken: 250-500 g preparation per 1000 l of drinking water (25 mg of doxycycline hyclate per 1 kg of body weight) for 3-5 days.

REMARK: above dosing includes limited ability in water uptake by sick birds.

REMARK: aqueous solution of the preparation shall be kept at room temperature and used within 24 hours.

9.

RECOMMENDATIONS FOR PROPER USE

Use according to the leaflet.

10.

WITHDRAWAL PERIOD

Edible tissues:

Cattle: 14 days

Pig: 8 days

Chicken: 4 days

Do not use for cows during lactation producing milk for human consumption. Do not use for hens laying eggs for human consumption.

11.

SPECIAL PRECAUTIONS DURING STORAGE AND TRANSPORT

Keep away from children.

Store in original packaging, in temperaturę below 25oC.

Do not use after expiry period stated on the label.

Product must be used within:

- 8 days after first opening of the immediate packaging

- 24 godz. after reconstitution in drinking water

12.

SPECIAL WARNING AND PRECAUTIONS IF NEEDED

Calves shall receive doxycycline inndividually, in strictly defined doses.

In case of changes in uptake of feed and drinking water by chickens, concentration of product must be adjusted so that the recommended dose was taken.

In case of accidental ingestion, seek immediate medical attention, show the package leaflet or packaging of the product .

People preparing the medicinal product should use protective equipment ( gloves , apron , goggles ) to prevent direct contact of the product with skin and mucous membranes .

Due to the accumulation of doxycycline in young bone tissue , do not use the product or limit its use during pregnancy and lactation.

Do not use in laying hens producing eggs for human consumption.

Concomitant use of penicillins, aminoglycosides , cephalosporins and flumechines can reduce the effectiveness of doxycycline . Pentobarbital and phenytoin reduce its plasma half-life . Metal ions ( Ca , Mg , Al) only slightly form chelates with doxycycline .

Doxycycline has a high therapeutic index . Average dose when administered orally is 10-25 mg / kg while the LD50 for the most sensitive species is 1700 mg / kg bw after oral administration. Product must be administered to calves individuall , because its overdose can cause severe inflammation of the heart muscle.

13.

SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM THIS PRODUCT, IF NECESSARY

Medicines should not be disposed of via wastewater or household waste.

About disposal of medicines ask your veterinarian. This will help to protect the environment.

14.

DATE OF APPROVAL OF TEXT

19.01.2011

15.

OTHER INFORMATION

To obtain information on this veterinary medicinal product, contact marketing authorisation holder.

Packaging sizes:

HDPE container with LDPE lid and guarantee lock.

50 g, 100 g, 500 g, 1000 g.

 

   

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