Biseptyl , Spectinomycin Lincomycin , 100 ml

BISEPTYL 100ML

Qualitative and quantitative composition
1 ml of product contains:

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

Pharmaceutical form
Injectable solution. Yellow, transparent solution, free of 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 peak blood concentrations within 20 minutes, maintaining detectable concentrations for 12 hours.
Lincomycin is an antibiotic from the lincosamide group. It has 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 has mainly 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 at 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 tissues, a concentration several times higher than in serum is reached, after crossing the cell wall.
Lincomycin + Spectinomycin: the association of lincomycin and spectinomycin in a ratio of 1:2, produces a synergistic effect that is manifested by a greater efficiency against various pathological processes (swine 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 tract infections, digestive, urogenital, osteoarticular (arthritis), skin, 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 Serpulina, colibacillosis, enzootic pneumonia, salmonellosis.
Dogs: treatment of tonsillitis and otitis, pneumonia, complications of scurvy
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. Do not administer to lactating females whose milk is intended for human consumption.

Amounts to be administered 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. In order to administer the correct dose, the body weight should be determined as accurately as possible to prevent underdosing.

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

Side effects
After intramuscular administration, pain or local 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 should be based on the result of susceptibility/antibiotic resistance testing on the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information on the antimicrobial resistance of the target bacteria.

Withdrawal period
Meat: 14 days before slaughter for human consumption.
Swine and cattle: meat and offal: 14 days.
Cattle: milk from treated animals cannot be used for human consumption.

Shelf life
The shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging: 28 days.

Storage
Keep cool (below 25ºC)