Procefen 100

Procefen 100
Ingredients: Ketoprofen, Ceftiofur hydrochloride 
Application: Injection
Type of formulation: Antibiotic

DESCRIPTION

Oily suspension from yellowish to brown-yellow color, with a slight odor of the components.

COMPOSITION

Each 1 mL contains the active ingredients:
Ceftiofur hydrochloride : 50 mg,
Ketoprofen : 50 mg.

PHARMACOLOGICAL PROPERTIES

ATCvet Code: QJ01 Antibacterials for system use. QJ01DD99 Ceftiofur, combinations.

Ceftiofur is an antibiotic of the cephalosporin type (third generation). It is active against both gram-positive and gram-negative bacteria including beta-lactamase-producing strains and some anaerobic bacteria: Escherichia coli, Pasteurella haemolytica, Pasteurella multocida, Haemophilus somnus, Actinobacillus pleuropneumoniae, Haemophilus parasuis, Salmonella cholerasuis, Streptococcus suis, Streptococcus zooepidemicus, Pasteurella spp, Staphylococcu0073 spp., Actynomyces pyogenes, Salmonella typhimurium, Streptococcus agalactiae, S. dysgalactiae, S. bovis, Klebsiella spp., Citrobacter spp., Enterobacter spp., Bacillus spp., Proteus spp., Fusobacterium necrophorum and Porphiromonas assacharolytica (Bacteroides melaninogenicus). The mode of action of the antibiotic is inhibiting the bacterial cell wall synthesis.

Ketoprofen is a non-steroidal anti-inflammatory drug (NSAID) of the propionic acid class. Ketoprofen exerts three main pharmacological effects which are common to all NSAIDs: anti-inflammatory, analgesic and antipyretic. The primary mechanism of action is inhibition of prostaglandin synthesis through interference with the cyclo-oxygenase pathway of arachidonic acid metabolism. Also, ketoprofen has been shown to inhibit lipooxygenase, to have an anti-bradykinin activity, to stabilize lysosomal membranes, and to cause a significant inhibition of neutrophil activity. Ketoprofen is a double inhibitor of inflammation through blocking the pathways of action of cycloxygenase and lipoxygenase thereby preventing prostaglandins and leukotrienes from being produced.

Ketoprofen is an analgetic which exerts effect on the central nervous system and the peripheral nervous system. Its action is to inhibit directly the action of bradykinin, a vasodilator and pain mediator.

Following parenteral administration, ceftiofur is absorbed quickly from the injection site and penetrates all of the animal tissues. Its maximum plasma concentration is observed in one hour after administration; its plasma concentration is kept at the therapeutic level for up to 24 hours depending of the animal species. Ceftiofur metabolizes readily within the body to form desfuroylceftiofur which possesses activity equivalent to that of ceftiofur with respect to bacteria. This active metabolite binds reversibly to plasma proteins and is accumulated in the nidus of infection; its activity does not fall at the presence of necrotized tissues.

The antibiotic is excreted mostly with the urine and feces.

Ketoprofen is quickly absorbed. More than 98% binds to blood plasma proteins and accumulates in inflamed tissues. In cows, the plasma peak-levels (8.025 ± 1.9 mcg/ml) are achieved in less than one hour after intramuscular administration. Significant concentrations of ketoprofen found in the synovial liquid and its levels is higher than in the plasma, and the half-life period is 2-3 times higher than in the plasma. Ketoprofen is metabolized in the liver to insignificant biologically active metabolites, and 90 % is excreted in the urine as glucuronide compounds.

INDICATIONS

Treatment of swine respiratory diseases, caused by microorganisms (Haemophilus somnus, Actinobacillus pleuropneumoniae, Salmonella cholerasuis and Streptococcus suis) that sensitive to ceftiofur, as well as treatment of for complex treatment of pigs at the MMA syndrome (mastitis-metritis-agalactia) caused by acute and chronic forms of inflammatory processes of the musculoskeletal system.

DOSAGE AND ADMINISTRATION

Apply once a day intramuscularly, at a rate of 1 ml per 16 kg of body weight (3mg of  ceftiofur and 3 mg of ketoprofen per 1 kg of animal’s body weight) for three days. Shake and warm up the medication to 36 °C before use.

CONTRAINDICATIONS

Do not use in animals with hypersensitivity to ceftiofur or other beta-lactam antibiotics.
Do not use in animals with allergic reactions to ketoprofen.
Do not mix with other medications in the same syringe.
Do not use in animals with acute renal failure.
Do not use in animals with duodenal ulcer and hemorrhagic syndrome.
Do not use concurrently with antibiotics such as macrolides, sulfonamides, tetracycline.
Do not use simultaneously with preparations from carboxylic acid groups, propionic acid derivatives medications, diuretics or anticoagulants.
It is not recommended to use at the same time with aminoglycosides or other nephrotoxic drugs.

WITHDRAWAL PERIOD

Animals may only be slaughtered for human consumption after 12 days from the last treatment.

The milk for human consumption can be used without any restrictions.

HOW SUPPLIED

Neutral glass vials of 10-mL, 20-mL, 50-mL; 100-mL; and 200-mL, closed by a rubber stopper and sealed with an aluminum cover. Secondary package: cartons.

STORAGE

In a dark, dry place, at 10ºС – 25ºС.
Keep out of reach of children.
Shelf life: 2 years.
After taking out of the vial for the first time, the drug should be used within 7 days and stored away from direct light at a temperature of between 4ºС and 8ºС.

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