SPELIMIX® FORTE

powder for oral administration

Description

Yellow-grey powder.

Composition

1 g of the drug contains:

active ingredients: florfenicol – 40 mg; lincomycin (lincomycin hydrochloride) – 44 mg; spectinomycin (spectinomycin sulfate) – 44 mg;

Excipient: wheat groats.

Pharmacological properties

ATC vet QJ01 - antibacterials for systemic use.

Spelimix® Forte is a complex drug with a broad spectrum of antibacterial action. The combination of florfenicol, lincomycin and spectinomycin provides potentiated synergistic action on bacteria.

Florfenicol is a synthetic broad-spectrum antibiotic, a thiamphenicol derivative. It is effective against Pasteurella spp., Actinobacillus pleuropneumoniae, Bordetella bronchiseptica, Salmonella spp., Escherichia coli, Proteus spp., Haemophilus spp., Staphylococcus spp., Streptococcus spp., Shigella spp., Klebsiella spp., Enterobacter spp., Aeromonas salmonicida, Campylobacter spp., Edwardsiella ictaluri, Edwardsiella tarda, Flexibacter spp., Vibrio spp., as well as mycoplasma (Mycoplasma spp.). The mechanism of action consists in inhibition of microbial cell peptidyl transferase enzyme activity, particularly – in the area of 70S ribosomes.

Lincomycin is a lincosamide antibiotic. It provides bacteriostatic or bactericidal action depending on concentration. It affects mostly gram-positive Staphylococcus spp., Streptococcus spp., Bacillus anthracis, Corynebacterium spp., gram-negative bacteria (Actinobacillus spp., Bordetella spp.) and certain types of Nocardiа and Actinomyces. It is particularly effective against Serpulina hyodysenteriae and Mycoplasma spp. Lincomycin inhibits protein synthesis in microorganisms, binding ribosomal 50S subunits of bacterial cells.

Spectinomycin is a of tricyclic structure antibiotic of aminoglycosides. It is mostly effective against gram-negative microorganisms, particularly, E. coli, Pasteurella multocida, Salmonella spp., Clostridium spp., Erysipelothrix rhusiopathiae, Haemophilus spp., Vibrio spp., as well as gram-positive microorganisms and Mycoplasma spp. Its efficacy consists in inhibition of protein synthesis in microbial cell. By binding of ribosomal 30S subunit of microorganisms, it prevents elongation of polypeptide chain at translocation stage.

After oral administration, florfenicol is well absorbed (up to 90 %) from digestive tract and distributed in organs and tissues, reaching concentrations of 4-8 μg/g in lungs, heart, pancreatic gland, skeletal muscles and spleen. Relatively high concentrations are present in bile, kidneys, small intestine and urine. Metabolites, excreted in urine, contain florfenicolamine, florfenicol oxamic acid, monochloroflorfenicol. Florphenicolamine is the most long-term metabolite present in liver. About 64 % of florfenicol is biotransformed into florfenicol amine. Half-life of florfenicol makes 2.6-3.2 hours on average. Florfenicol is primarily excreted in urine unchanged - up to 50 %. Florfenicol and its metabolites are also excreted in feces.

After oral administration, lincomycin is well absorbed from digestive tract (almost 60%) and distributed in organs and tissues, including the bone tissue. Lincomycin binds with proteins up to 50%. Lincomycin concentration in serum reaches its maximum in 2 after administration. Its half-life makes 2.5-3 hours. Most of lincomycin and its metabolites are primarily excreted in urine and bile. Small amounts are excreted in feces.

Spectinomycin is poorly absorbed in digestive tract. In 24 hours following oral administration minor concentrations of the antibiotic are observed in kidneys, liver, lungs, muscles and fat tissue. Spectinomycin binding to proteins does not exceed 10%. Its concentration in serum reaches maximum in 4 hours. Spectinomycin is scarcely biotransformed in the body and is excreted unchanged in feces.

Administration

Treatment of enzootic pneumonia, salmonellosis, dysentery, actinobacillary pleuropneumonia, eperythrozoonosis, MMA (mastitis-metritis-agalactia) syndrome, necrotic enteritis, colibacillosis, mycoplasmosis and other diseases of digestive tract and breathing organs caused by drug-sensitive microorganisms in swine.

Dosage

Administer orally with feed individually or by group method in a dose of 0.5-1 kg of the drug per 1 t of feed for 5-7 days.

If administered with feed, mix the drug with the feed thoroughly. It is recommended to mix it with 3-10 % of the total feed first, then mix the resulting mixture with the remaining feed.

Contraindications

Do not administer to animals with hypersensitivity to florfenicol, lincomycin and spectinomycin.

Do not administer to rabbits, horses, cattle and laying hens.

Do not administer to pregnant and lactating animals.

Do not administer to animals with impaired renal and hepatic function.

Do not use in combination with erythromycin, antibiotics of the penicillin group, cephalosporins and fluoroquinolones as well as thiamfenicol and chloramfenicol.

Precautions

The drug is not prescribed in sub-therapeutic doses.

Animal slaughter for meat is possible in 14 days following the last drug administration. Meat, obtained before the mentioned term shall be utilized or fed to non-productive animals depending on the statement of a veterinary physician.

Packaging

Polymer or glass jars, bags made of film or foil materials of 100 and 1000 g.

Paper bags of 25 kg.

Storage

Store in a dry, dark place out of the reach of children at 0-30 °С.

Shelf life

1 year.

Shelf life after mixing with feed is 3 months.

For veterinary use only!