1. Name of the veterinary medicinal product
EXABIOPEN 200 mg/ml + 250 mg/ml suspension for injection for cattle, sheep and pigs.
 
2. Composition
Each ml contains:
Benzylpenicillin procaine monohydrate – 200 mg.
Dihydrostreptomycin – 250 mg.
Sodium formaldehyde sulfoxylate – 3.70 mg.
Homogeneous white suspension.
 
3. Target species
Cattle, sheep and pigs.
 
4. Indications
Treatment of acute infections caused by microorganisms susceptible to benzylpenicillin procaine and dihydrostreptomycin.
 
5. Contraindications
Do not use in animals allergic to penicillins, cephalosporins, aminoglycosides, procaine, PABA or other ingredients. Do not use in animals with renal, liver or heart disease, cochleovestibular lesions, or in animals under 30 days old. Do not use in rabbits, guinea pigs or hamsters. Do not administer intravenously or subcutaneously.
 
6. Special warnings
Maintain aseptic conditions and disinfect the injection site. Use cautiously in animals with allergies and monitor kidney function, especially in young animals.
Antibiotics should only be used when necessary and according to bacterial identification and susceptibility testing. Incorrect use may increase bacterial resistance.
People allergic to penicillins, cephalosporins or dihydrostreptomycin should not handle the product. Wear gloves, avoid skin and eye contact and accidental self-injection. Wash hands after use. In case of exposure, rinse with water and seek medical advice if symptoms occur. Breathing difficulties or facial swelling require urgent medical attention.
Do not administer to pregnant animals due to potential foetal toxicity.
Do not combine with bacteriostatic antibiotics, other aminoglycosides, pentobarbital, inhalant anaesthetics, muscle relaxants, diuretics or certain other medicines.
Overdose: May cause respiratory difficulties, loss of awareness and kidney toxicity. Stop treatment and seek veterinary assistance.
Administration should be under veterinary supervision. Do not mix with other veterinary medicines.
 
7. Adverse events
Very rare reactions in cattle, sheep and pigs include allergic reactions, excessive salivation, fever, vomiting, breathing difficulties, tremors, skin reactions, kidney problems, hearing impairment, behavioural changes and injection-site reactions.
In severe allergic cases, treatment should be stopped and emergency treatment administered. Consult a veterinarian if side effects occur or worsen.
 
8. Dosage and administration
Intramuscular administration. Shake well before use.
Cattle, sheep and pigs: 0.4 ml per 10 kg body weight once daily for 3 consecutive days.
Maximum injection volume:
Cattle: 20 ml per injection site.
Sheep and pigs: 3 ml per injection site.
Divide larger volumes between several injection sites. Determine body weight accurately.
9. Advice on correct administration
Shake well and maintain aseptic conditions.
10. Withdrawal periods
Cattle: Meat – 26 days; milk – 5 days (120 hours).
Sheep: Meat – 64 days; milk – 4.5 days (108 hours).
Pigs: Meat – 37 days.
 
11. Storage
Keep out of children's reach. Store below 25°C, protected from light in its outer packaging. Shelf life after first opening: 28 days. Do not use after the expiry date.
 
12. Disposal
Do not dispose of medicines in wastewater or household waste. Dispose of unused products according to local regulations. Consult a veterinarian or pharmacist for disposal instructions.