DOXYFLOR ® (solution for injection)

Oily liquid of yellowish-brown to dark brown colour with a characteristic odour of the components.

1 ml of the product contains active substances:

- florfenicol – 200 mg

- doxycycline hyclate – 100 mg

Excipients: propylene glycol, dimethyl sulfoxide, polyethylene glycol 400.

ATC vet classification code: QJ01 – antibacterial veterinary medicinal products for systemic use; QJ01RA92 – amphenicols, combinations with other antimicrobials.

DOXYFLOR is a combination veterinary medicinal product containing florfenicol and doxycycline.

Florfenicol is a derivative of thiamphenicol in which the hydroxyl group is substituted by a fluorine atom, which determines its antibacterial activity against acetyltransferase-producing bacteria.

It is active against Gram-negative (Enterobacter spp., E. coli, Pasteurella haemolytica, P. multocida, Vibrio spp., Haemophilus somnus, H. parasuis, Fusobacterium necrophorum, Actinobacillus pleuropneumoniae, Bordetella bronchiseptica, Salmonella spp., Klebsiella spp., Proteus spp., Shigella spp., Campylobacter spp.) and Gram-positive (Staphylococcus spp., Streptococcus spp. and others) microorganisms.

Florfenicol is active against most mycoplasmas (Mycoplasma hyopneumoniae, M. hyorhinis and others).

The mechanism of action of florfenicol involves binding to the 70S ribosomal subunit, resulting in inhibition of protein synthesis in the bacterial cell.

Doxycycline is a bacteriostatic antibiotic belonging to the tetracycline group.

It exerts a bacteriostatic effect by inhibiting microbial protein synthesis through blocking the binding of aminoacyl-tRNA to the “mRNA–ribosome” complex. Doxycycline has a broad spectrum of antimicrobial activity against Gram-positive (Staphylococcus spp., Diplococcus pneumoniae, Streptococcus spp., Bacillus anthracis, Clostridium tetani, Clostridium perfringens, Listeria monocytogenes) and Gram-negative (Haemophilus influenza, E. coli, Enterobacter spp., Klebsiella spp., Salmonella spp., Shigella spp., Yersinia spp., Pasteurella spp., Bordetella bronchiseptica) bacteria, as well as mycoplasmas (Mycoplasma spp.), rickettsiae (Rickettsia spp.) and chlamydiae (Chlamydia spp.).

After intramuscular administration of florfenicol to cattle, its therapeutic concentration in blood plasma is maintained for 48 hours.

The mean half-life in cattle is 18,3 hours.

In pigs, the mean half-life is 2,2 hours.

High concentrations of florfenicol are reached in lungs, kidneys and bile, as well as in muscles, intestine, heart, liver, spleen and blood serum.

Florfenicol is excreted mainly unchanged via the kidneys by glomerular filtration and with bile, where it is inactivated by chelate complex formation.

Doxycycline is widely distributed in the tissues and body fluids.

Protein binding in plasma is 80–95%.

Half of the administered dose of doxycycline is absorbed within 50 minutes.

The maximum concentration of doxycycline in blood is observed after 2–4 hours, and the therapeutic concentration is maintained for 18–24 hours.

Doxycycline is excreted mainly with bile.

Treatment of respiratory diseases (bronchopneumonia, pneumonia and other respiratory diseases) and diseases of the digestive tract (colibacillosis, salmonellosis) in calves, as well as keratoconjunctivitis, foot rot, staphylococcosis, chlamydiosis, wound infections, arthritis and other diseases caused by microorganisms sensitive to florfenicol and doxycycline.

Treatment of respiratory diseases (bronchopneumonia, pneumonia, enzootic pneumonia of pigs, atrophic rhinitis and other respiratory diseases) and diseases of the digestive tract (colibacillosis, salmonellosis) in pigs, as well as staphylococcosis, erysipelas, chlamydiosis, wound infections, arthritis and other diseases caused by microorganisms sensitive to florfenicol and doxycycline.

Intramuscular use:

Calves: 1 ml of the product per 10 kg body weight (corresponding to 20 mg florfenicol and 10 mg doxycycline hyclate per 1 kg body weight) once daily.

Pigs: 0,75 ml of the product per 10 kg body weight (corresponding to 15 mg florfenicol and 7,5 mg doxycycline hyclate per 1 kg body weight) once daily.

The course of treatment is 3–5 days.

Due to possible local oedema and pain reaction when the volume of injection exceeds 2,5 ml for piglets and 5 ml for adult pigs and calves, it is recommended to administer the product in several injection sites.

Hypersensitivity to the active substances or to any of the excipients.

Do not use concomitantly with thiamphenicol or chloramphenicol, penicillins, cephalosporins or fluoroquinolones due to the possible risk of toxicosis.

Do not use together with sulfonamides.

Do not use in animals with severe hepatic or renal disorders.

Do not use concomitantly with calcium-containing products, which may reduce the effect of the product.

Do not use in animals during pregnancy and lactation, as well as in bulls and boars intended for breeding.

Do not use in case of detection of resistant strains of pathogens.

In some cases, swelling, pain and erythema at the injection site may occur; these usually disappear within 2–3 days without any intervention.

Therefore, due to possible local oedema and pain reaction when the injection volume exceeds 2,5 ml for piglets and 5 ml for adult pigs and calves, it is recommended to administer the product in several injection sites.

High doses or prolonged use of the product may cause neurotoxic effects (for example, ataxia).

In accordance with clinical practice, treatment should be based on susceptibility testing of the isolated pathogen to doxycycline and florfenicol.

Initially, the product should be tested on a small group of 7–8 animals.

In the absence of complications within 2–3 days, the product may be administered to the whole herd.

Do not use in animals during pregnancy and lactation, as well as in bulls and boars intended for breeding.

Interaction with other medicinal products and other forms of interaction

Do not use concomitantly with thiamphenicol or chloramphenicol, penicillins, cephalosporins or fluoroquinolones due to the possible risk of toxicosis.

Do not use concomitantly with calcium-containing products, which may reduce the effect of the product.

Doxycycline enhances the effect of anticoagulants.

Meat and offal from treated pigs may be used for human consumption only after 34 days following the last administration of the product.

Meat and offal from treated calves may be used for human consumption only after 40 days following the last administration of the product.

Meat obtained before the end of these periods should be disposed of or used for feeding non-productive animals in accordance with the advice of a veterinarian.

Vials of neutral glass of type NS-1, NS-2, USP-1, closed with rubber stoppers and sealed with aluminium caps, of 10, 20, 50, 100 and 200 ml.

Secondary packaging – cardboard box.

Store in a dry, dark place out of the reach of children at a temperature from 5 °C to 25 °C.

Shelf life is 2 years from the date of manufacture.

Shelf life after first opening of the vial is 14 days, provided that the product is withdrawn under aseptic conditions and the vial is further stored at a temperature from 10 °C to 15 °C.