BAKTIOFUR 10% (suspension for injection)

BAKTIOFUR 10% (suspension for injection)
Ingredients: Ceftiofur
Application: Injection
Type of formulation: Antibiotic

Description

An oily suspension ranging from white to light brown in color that may separate during storage.

Composition

1 ml of the product contains:
Active substance:
- ceftiofur free acid - 100 mg.
Excipients: cottonseed oil, medium-chain triglycerides.

Pharmacological properties

ATCvet classification code QJ01 - antibacterial veterinary medicinal products for systemic use. QJ01DD90 - Ceftiofur.

Ceftiofur is a semi-synthetic third-generation cephalosporin antibiotic. 

It has a broad spectrum of activity against Gram-positive bacteria (Arcanobacterium pyogenes, Streptococcus suis) and Gram-negative bacteria (Mannheimia haemolytica, Escherichia coli, Pasteurella multocida, Histophilus somni, Haemophilus parasuis, Fusobacterium necrophorum, Bacteroides melaninogenicus / Porphyromonas asaccharolytica and Actinobacillus pleuropneumoniae). Ceftiofur inhibits the synthesis of bacterial cell wall, thereby exhibiting bactericidal properties.

After intramuscular administration in pigs, ceftiofur is rapidly metabolized to the active metabolite desfuroylceftiofur.

Due to its binding to plasma proteins, desfuroylceftiofur is distributed to sites of inflammation.

The binding of ceftiofur and its main metabolite to plasma proteins is approximately 70%.

The maximum concentration of ceftiofur in the blood plasma of pigs (4.2 ± 0.9 µg/ml) is reached 22 hours after intramuscular administration.

Following administration of the recommended therapeutic dose, ceftiofur plasma concentrations remain above MIC90 values (0.2 µg/ml) for the main target pathogens for up to 158 hours.

Ceftiofur and its metabolites are eliminated within 10 days after intramuscular administration and are excreted mainly in the urine and, to a lesser extent, in the faeces.

Indications for use

Treatment of pigs suffering from septicemia, polyarthritis, polyserositis, as well as respiratory diseases caused by microorganisms: Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis and Streptococcus suis, susceptible to ceftiofur.

Dosage and administration

Intramuscularly at a dose of 1 ml of the product per 20 kg of body weight (5 mg of ceftiofur per 1 kg of body weight) once in the neck area.
Before use, the vial with the product should be thoroughly shaken until a homogeneous suspension is obtained and the sediment is resuspended.
To determine the required dose and prevent administration of an insufficient amount of the product, it is necessary to accurately determine the animal's weight. The maximum volume of the product for administration at one site should not exceed 4 ml.

Contraindications

Do not use in animals with hypersensitivity to β-lactam antibiotics.
Do not administer intravenously.
Do not use simultaneously with other veterinary medicinal products.

Warnings

Adverse reactions
When using the product in accordance with the package leaflet, adverse reactions and complications, as a rule, are not observed.
In some cases, swelling and alopecia may occur at the injection site, which disappear within 56 days after administration of the product.

Special warnings for use
The use of this veterinary medicinal product should be based on the results of susceptibility testing of the pathogens and should take into account official and local antimicrobial policies.
Systemic use of broad-spectrum cephalosporins of the 3rd and 4th generation, such as ceftiofur, should be reserved for the treatment of clinical conditions that respond poorly to treatment with other antimicrobial agents.

Use during pregnancy, lactation, egg-laying
During pregnancy, the benefit of using the product should outweigh the risk of its use. The decision on the use of the product is made by a veterinary practitioner.

Interaction with other medicinal products and other forms of interaction
Do not use the product simultaneously with other veterinary medicinal products, as interaction studies have not been conducted.

Withdrawal period
Pigs: Meat and offal: 71 days.
Slaughter of animals for meat is permitted 71 days after the last administration of the product. Meat obtained before the specified period is disposed of or fed to non-productive animals, depending on the conclusion of a veterinary practitioner.

Special precautions for persons and service personnel
Accidental administration of the product to humans should be avoided. In case of accidental injection to a person, it is necessary to immediately consult a doctor, showing the package leaflet or label of the product. People with known hypersensitivity to penicillins or cephalosporins (β-lactam antibiotics) should avoid contact with the veterinary medicinal product.
If the product gets on the skin, rinse thoroughly with soap and water. If it gets into the eyes, rinse immediately with clean water.

Pharmaceutical form

Vials made of neutral glass (grades NS-1, NS-2, UPS-1), closed with rubber stoppers under aluminum crimp caps of 10, 20, 50, 100 and 200 ml. Secondary packaging - carton box.

Storage

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

Shelf life 

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after first opening the vial: 28 days.
After first opening, store at a temperature between 0 °C and 8 °C.
For veterinary use only!

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