COMBIKEL 40 L.A.

Description

Suspension for Injection

COMPOSITION:
1 ml of the product contains:
• Procaine benzylpenicillin — 120,000 IU (120 mg)
• Benzathine benzylpenicillin — 80,000 IU (61.21 mg)
• Dihydrostreptomycin sulfate — 200,000 IU (200 mg)

Excipients: procaine hydrochloride, sodium methyl parahydroxybenzoate, sodium formaldehyde sulfoxylate, povidone, sorbitol 70% non-crystallizing, disodium edetate, sodium carmellose, sodium citrate, sodium metabisulfite, disodium hydrogen phosphite pentahydrate, sodium dithionite, water for injection.

INDICATIONS FOR USE:
Treatment of horses, cattle, swine, sheep, goats, dogs, and cats for diseases caused by microorganisms sensitive to benzylpenicillin and dihydrostreptomycin, including:

o Otitis, peritonitis, mastitis, meningitis
o Leptospirosis, actinomycosis, erysipelas
o Actinobacillosis, polyarthritis, septicemia
o Respiratory diseases (bronchopneumonia, rhinitis, laryngitis, pasteurellosis)
o Genitourinary diseases (pyelonephritis, nephritis, endometritis)
o Skin and soft tissue infections
o Postoperative treatment to prevent infections during the recovery period

PHARMACOLOGICAL PROPERTIES:
• Benzylpenicillin is a β-lactam antibiotic with a broad bactericidal spectrum against Gram-positive and Gram-negative microorganisms, including Streptococcus spp., Staphylococcus spp., Pasteurella spp., Corynebacterium spp., and others.
• Dihydrostreptomycin is an aminoglycoside antibiotic active against E. coli, Salmonella spp., Leptospira spp., Staphylococcus aureus, and other bacteria.
• Synergistic action: the combination of benzylpenicillin and dihydrostreptomycin provides broad-spectrum bactericidal activity.

DOSAGE:

1. 1. Cattle:
      o 5–10 ml per 100 kg body weight (for respiratory diseases — 5 ml per 100 kg) once daily.
   2. Horses, swine, sheep, goats:
      o 5 ml per 50 kg body weight once daily.
   3. Dogs and cats:
      o 0.5 ml per 5 kg body weight once daily.

Treatment course: 3 days.

WITHDRAWAL PERIOD:
• Meat: animals may be slaughtered 30 days after the last administration.
• Milk: may be used for human consumption 5 days after the last administration.

CONTRAINDICATIONS:
• Hypersensitivity to benzylpenicillin or dihydrostreptomycin.
• Do not use in animals with impaired renal function.
• Do not administer intravenously.
• Do not use in rabbits, guinea pigs, hamsters, or gerbils.
• Do not use simultaneously with tetracyclines or other aminoglycosides.

ADVERSE REACTIONS:
• Possible allergic reactions, including anaphylactic shock, urticaria, and edema.
• Rapid administration may cause cardiovascular disturbances.
• Symptoms of procaine intolerance (tremor, vomiting, fever) are frequently observed.

INTERACTIONS WITH OTHER PRODUCTS:
• Do not use simultaneously with other antibiotics, particularly tetracyclines and aminoglycosides.

STORAGE:
• Store in a dark, dry place at a temperature from 2°C to 8°C.

SHELF LIFE:
• 2 years from the date of manufacture.
• After first opening — 28 days.

PRESENTATION:
• 100 ml and 250 ml glass vials.