BISEPTYL 100ML- SPECTINOMICINA 100MG/ LINCOMICINA 50MG

PRODUCT NAME
BISEPTYL 100ML

Qualitative and quantitative composition
1 ml of product contains:

Active substance:
Spectinomycin (in sulfate form) 100 mg;
Lincomycin (as hydrochloride) 50 mg.
Excipient(s):
Citric acid monohydrate, sodium citrate dihydrate, benzyl alcohol, water for injection.

Pharmaceutical form
Injectable solution. Yellow, transparent solution, without particles.

Target species:
Cattle, pigs, dogs.

Therapeutic action
Spectinomycin is a bacteriostatic antibiotic. It acts by inhibiting bacterial protein synthesis, by binding to the 30 S ribosomal subunit. It is active against: Salmonella spp., Pasteurella multocida, Escherichia coli and Mycoplasma. After intramuscular administration, it is rapidly absorbed and reaches the maximum concentration in the blood in 20 minutes, maintaining detectable concentrations for 12 hours.
Lincomycin is an antibiotic from the lincosamide group. It presents a mechanism of action and a bacterial spectrum similar to macrolides. It acts by inhibiting bacterial protein synthesis by binding to the 50 S ribosomal subunit, preventing the coupling of transfer RNA molecules. It mainly has a bacteriostatic action, but in high concentrations it can become bactericidal. It is active against Staphylococcus aureus, Streptococcus spp., (β-hemolytic strains) Str. viridans, Clostridium tetani, Cl. perfringens, Erisypelothrix rhusiopathiae, Leptospira spp. and Mycoplasma. After intramuscular administration, it is well absorbed. It shows a plasma maximum 2-4 hours after administration, and therapeutic concentrations persist for approximately 6-8 hours. It is widely distributed throughout the body, crosses the placental barrier. In the tissues, a concentration several times higher than in the serum is reached, after crossing the cell wall.
Lincomycin + Spectinomycin: the combination of lincomycin and spectinomycin in a ratio of 1:2 produces a synergistic effect that results in greater efficiency against various pathological processes (porcine dysentery), compared to the situation when these antibiotics are used separately.

Therapeutic indications:
BISEPTYL is effective in pigs, cattle and dogs for the treatment of infections caused by sensitive germs:
Cattle: treatment of respiratory, digestive, uro-genital, osteoarticular (arthritis), skin infections, treatment of umbilical infections, treatment of infected wounds and abscesses, treatment of meningitis, peritonitis and septicemia, treatment of pneumonia, colibacillosis, mastitis, metritis and panaritium.
Pigs: treatment of dysentery with Serpulin, colibacillosis, enzootic pneumonia, salmonellosis.
Dog: treatment of tonsillitis and otitis, pneumonia, complications of the jaw,
prevention of post-operative infectious complications in all target species.

Contraindications
Do not administer to horses because lincomycin produces hemorrhagic colitis and diarrhea with serious results. Do not administer to animals with a history of hypersensitivity to lincomycin or spectinomycin or to those that have suffered infections with Monilia spp. Do not administer to pregnant or lactating females. It is not administered to lactating females, whose milk is intended for human consumption.

Amounts to administer and route of administration
In all target species: 10-20 mg spectinomycin + 5-10 mg lincomycin/kg body weight (equivalent to 1 ml BISEPTYL for every 5-10 kg body weight) intramuscularly every 12 hours, for 4-7 days. To administer the correct dose, live weight must be determined as accurately as possible to prevent underdosing.

Overdose
By administering a dose 3 times higher than the therapeutic dose, usually only a local irritation is caused.

Side effects
After intramuscular administration, local pain or irritation may occur.
Interactions with other medicinal products or other forms of interaction.
Do not administer together with macrolides or aminoglycosides. There is physical incompatibility with penicillin sodium, ampicillin sodium, kanamycin sulfate, colistin methanesulfonate and riboflavin 5-phosphate and therefore it should not be mixed with these substances.

Special precautions for use in animals
The use of the product must be based on the result of the susceptibility/antibioresistance test on the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm-level) epidemiological information about the antibiotic resistance of the target bacteria.

Waiting time
Meat: 14 days before slaughter for human consumption.
Pigs and cattle: meat and organs: 14 days.
Cattle: milk from treated animals cannot be intended for human consumption.

Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Validity period after the first opening of the primary packaging: 28 days.

Storage
Store in a cool place (below 25ºC), away from light.

Presentation
Glass bottles with a capacity of 100 ML