FORTAMOX 500

FORTAMOX 500

500 mg/g, powder for preparation of oral solution for chickens, turkeys, ducks and pigs

QUALITATIVE AND QUANTITATIVE COMPOSITION OF ACTIVE SUBSTANCE:

Amoxicillin trihydrate          500 mg/g

INDICATIONS:

Chicken: treatment of pasterellosis and colibacteriosis

Turkeys: treatment of pasterellosis

Ducks: treatment of infections caused by Streptococcus bovis, Pasteurella anatipestifer and Escherichia coli.

Pigs: treatment of salmonellosis and pasterellosis caused by strains sensitive to amoxicilline.

CONTRINDICATIONS:

Do not use in animlals sensitive to penicillins.

Do not use in rabbits, hamsters, gerbils and guinea pigs.

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).

TARGET SPECIES:

Chicken, turkey, duck and pig.

DOSING AND ADMINISTRATION ROUTE:

Fortamox 500 must be administered after dissolving in drinking water.

Chicken:

Administer in drinking water at a dose of 15 mg amoxicillin trihydrate per kg b.w. Product must be used every second day for 3 days (it means 1 and 3 day of treatment) and in severe cases for 5 days (it means 1, 3 and 5 day of treatment).

To ease calculations in table below there is numer of birds in different age, which must be given 100 g of product after dissolving in 300 litres of water. 100 g of product is intended for treatment of 3330 kg birds.

Age in weeks

No.of birds

1

20.000

2

9.000

3

5.000

4

3.330

6

2.000

8

1.330

Ducks:

Administer in drinking water at a dose of 20 mg amoxicillin trihydrate per b.w. Product must be used every second day for 3 days (it means 1 and 3 day of treatment). Concentration of medicine in water cannot be established as during treatment, quantity of water consumed by birds varies depending on the temperature, light and system of feeding.

Turkeys:

Administer in drinking water in a dose 15-20 mg amoxicillin trihydrate per kg b.w. Product may be used for 5 days every second day (it means 1, 3 and 5 day of treatment). Concentration of drug in drinking water shall be calculated depending on the quantity of water consumed and weight of animals.

Pigs:

Administer in drinking water at a dose of 20 mg of amoxicillin trihydrate / kg b.w. / day. Recommended dose shall be divided and administered every 12 hours for 5 days.

RECOMMENDATIONS FOR PROPER USE:

Aqueous solutions of the preparation shall be prepared directly before use. Medicate dwater shall be used within 12 hours from dissolving. After this time medicated water which was not drunk by animals shall be discarded.

Durng product usage, animals cannot have access to other sources of water than medicated water.

WITHDRAWAL PERIOD:

Edible tissues:

Chickens: 1 day

Turkeys: 5 days

Ducks: 9 days

Pigs: 2 days

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

SPECIAL PRECAUTIONS DURING STORAGE AND TRANSPORT:

Keep away from children.

Store in temperaturę below 25ºC.

Do not use after expiry period given on the label.

Product must be used within:

- 10 days after first opening of immediate packaging

- 12 hours after reconstitution in drinking water

SPECIAL WARNINGS AND PRECAUTIONS, IF NEEDED:

The use of this product should be supported by an assessment of microorganisms susceptibility .

Avoid inhaling of powder . Wash hands after use . Penicillins and cephalosporins may cause hypersensitivity after injection , inhalation , ingestion , and upon contact with the skin. Hypersensitivity to penicillins may lead to cross-reaction with cephalosporins and vice versa. Allergic reactions to these substances may occasionally be very dangerous.

Avoid direct contact with the preparation especially if you are allergic to substances contained in it. Pay attention to recommendations described in the package insert . If adverse effect occurred after exposure to the preparation, such as skin redness, you should consult your doctor and show him the package leaflet . However, in case of symptoms such as swelling of the face, lips and eyelids as well as shortness of breath, seek immediately medical attention .

Laboratory studies in rats revealed no teratogenic effects while taking amoxicillin.

The product may be used only after evaluation by veterinarian the benefit / risk profile of the product.

Neomycin, erythromycin, tetracycline, metal ions and alkalizing agents inhibit the uptake of amoxicillin.

In the event of overdose, treatment should be symptomatic. A specific antidote is not known.

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

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

How to dispose of medicines no longer ask your veterinarian. These measures should help protect the environment.

DATE OF TEXT APPROVAL

21.02.2011

OTHER INFORMATION:

To obtain information on this veterinary medicinal product contact maufacturing authorisation holder: „Biofaktor” Sp. z o.o. Czysta 4 st., 96-100 Skierniewice, ph (46) 8324539

Packaging sizes: 50 g, 100 g, 1000 g.

MANUFACTURING AUTHORISATION HOLDER AND MANUFACTURER: Biofaktor Sp. z o.o. , ul. Czysta 4, 96-100 Skierniewice

Attachments

Ask about this product