MIFLOR (solution for injection)

Oily liquid from colourless to light yellow. Opalescence is acceptable.

1 ml of the product contains the following active substances:

- florfenicol — 300 mg;

- flunixin meglumine — 27,4 mg.

Excipients: dimethyl sulfoxide, propylene glycol, citric acid, polyethylene glycol.

ATC vet classification code QJ01 — antibacterial veterinary medicinal products for systemic use. QJ01BA99 — Amphenicols, combinations.

The active substances of the product are florfenicol and flunixin.

Florfenicol is a derivative of thiamphenicol in which the hydroxyl group is replaced by a fluorine atom, which accounts for its antibacterial activity against acetyltransferase-producing bacteria. It is active against Gram-negative (Enterobacter spp., E. coli, Pasteurella haemolytica, P. piscicida, Vibrio spp., Haemophilus somnus, Fusobacterium necrophorum, Bacteroides melaninogenicus, Bordetella bronchiseptica, Salmonella spp., Klebsiella spp., Proteus spp., Shigella spp.) and Gram-positive (Staphylococcus spp., Streptococcus spp., and others) microorganisms. It is also active against most mycoplasmas (Mycoplasma hyopneumoniae, M. hyorhinis, and others).

The mechanism of action of florfenicol involves binding to the 70S ribosomal subunits and blocking protein synthesis in the bacterial cell. Resistance to florfenicol develops slowly and progresses slowly.

Flunixin is a non-steroidal anti-inflammatory drug with anti-inflammatory, analgesic, and antipyretic effects. Flunixin acts as a non-selective inhibitor of cyclooxygenase (COX-1 and COX-2), preventing the conversion of arachidonic acid into prostaglandins, which are involved in the development of the inflammatory process. In this way, the synthesis of inflammatory mediators responsible for fever, pain, and hyperemia is suppressed. Flunixin also inhibits thromboxane release. Flunixin exerts its antipyretic effect by inhibiting the synthesis of prostaglandin E₂ in the hypothalamus.

Following subcutaneous administration to cattle at the recommended dose of florfenicol at 40 mg/kg b.w., effective plasma concentrations (above MIC₉₀ for Mannheimia haemolytica) are maintained for approximately 50 hours. The maximum plasma concentration of the antibiotic (Cmax) of 9,9 µg/ml is reached at 8 hours (Tmax).

Following subcutaneous administration to cattle at the recommended dose of flunixin at 2,2 mg/kg b.w., its maximum plasma concentration (2,8 µg/ml) is reached within 1 hour. The degree of plasma protein binding is approximately 20% for florfenicol and over 99% for flunixin. 68% of florfenicol metabolites are excreted in urine and approximately 8% in faeces; for flunixin — 34% and 57%, respectively.

Treatment of bovine respiratory disease caused by microorganisms (Mycoplasma bovis, Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni) susceptible to florfenicol.

- cattle: subcutaneous injection in the neck region at a dose of 40 mg florfenicol and 3,65 mg flunixin meglumine per 1 kg body weight, or 2 ml of the product per 15 kg body weight, as a single administration. If necessary and in cases of chronic disease, a repeat injection may be given after 48 hours. The dose must not exceed 10 ml per injection site.

Do not use in animals hypersensitive to florfenicol or flunixin.

Do not use in adult breeding bulls. Do not use in lactating dairy cows whose milk is intended for human consumption. Do not use in pregnant animals.

Do not use concomitantly with thiamphenicol or chloramphenicol, penicillin-group antibiotics, cephalosporins, or fluoroquinolones, due to the risk of toxicosis.

Do not use together with sulphonamides preparations.

Do not use in animals with cardiac, hepatic, or renal disease, or in animals with gastrointestinal ulcers or bleeding.

Do not use together with other non-steroidal anti-inflammatory drugs or corticosteroid preparations.

Do not use when strains resistant to florfenicol have been identified.

Do not use concomitantly with nephrotoxic drugs.

Pain at the injection site is possible. Occasionally (in animals sensitive to phenicols), allergic reactions may occur (skin rash, pruritus, and oedema), which resolve within 28 days. If such reactions occur, administration of the product must be discontinued and desensitising therapy should be instituted.

A transient loss of appetite, reduced water intake, or diarrhoea may occur in animals.

Do not administer more than 10 mL per injection site. Injections must be administered in the neck region only.

The product should be used taking into account the spectrum of pathogens causing respiratory disease prevalent on the given farm and their susceptibility to florfenicol.

Do not use concomitantly with thiamphenicol or chloramphenicol, penicillin-group antibiotics, cephalosporins, or fluoroquinolones, due to the risk of toxicosis.

Do not use together with sulphonamides preparations.

When used concomitantly with preparations containing Mg²⁺, Al³⁺, or Ca²⁺ cations, the latter may bind to florfenicol and impair its absorption.

Do not use together with other non-steroidal anti-inflammatory drugs or corticosteroid preparations.

Do not use concomitantly with nephrotoxic drugs.

Slaughter of animals for meat is permitted 46 days (cattle) after the last administration of the product. Meat obtained before the end of this period must be disposed of or may be fed to non-productive animals in accordance with the decision of a veterinarian.

Neutral glass vials of type NS-1, NS-2, USP-1, sealed with rubber stoppers under aluminium crimp caps, in volumes of 10, 20, 50, 100, and 200 ml. Secondary packaging - cardboard box.

Store in a dry, dark place, out of reach of children, at a temperature between 5 °C and 25 °C.

2 years. 

After first opening the vial, the product must be used within 28 days.