Product Name: ENROZONE-10

Type: Oral Liquid Solution - Fluoroquinolone Antibiotic

COMPOSITION

Each ml contains:

• Enrofloxacin (BP Vet) ...... 100 mg (10% w/v)

DESCRIPTION

ENROZONE-10 is a broad-spectrum antibiotic oral solution containing enrofloxacin 10% for the treatment of bacterial infections in poultry. Enrofloxacin is a synthetic chemotherapeutic agent belonging to the fluoroquinolone class, known for its rapid bactericidal action against a wide range of gram-negative and gram-positive bacteria as well as mycoplasmas

Enrofloxacin is a first-generation fluoroquinolone developed specifically for veterinary use. It exhibits excellent bioavailability after oral administration and achieves high tissue concentrations, particularly in the lungs, liver, kidneys, and lymphatic system, often 2-3 times higher than serum levels .

MECHANISM OF ACTION

Enrofloxacin exerts its bactericidal effect through inhibition of bacterial DNA gyrase (topoisomerase II), an enzyme critical for DNA replication, transcription, and repair. By interfering with DNA supercoiling, it disrupts bacterial cell division and leads to rapid bacterial death .

Enrofloxacin is partially metabolized in the body to ciprofloxacin, an active metabolite that contributes to its antibacterial activity . The combination of the parent drug and its active metabolite provides sustained antimicrobial action throughout the dosing interval.

ANTIMICROBIAL SPECTRUM

ENROZONE-10 is effective against a broad range of microorganisms

Gram-Negative Bacteria:

• Escherichia coli - colibacillosis, airsacculitis, pericarditis, septicemia
• Salmonella spp. - fowl typhoid, pullorum disease, paratyphoid infections
• Pasteurella multocida - fowl cholera
• Avibacterium paragallinarum (Haemophilus paragallinarum) - infectious coryza
• Klebsiella spp., Proteus spp., Bordetella avium, Pseudomonas spp., Campylobacter spp.

Gram-Positive Bacteria:

• Staphylococcus spp. - staphylococcosis
• Streptococcus spp. - streptococcal infections
• Erysipelothrix rhusiopathiae - erysipelas (particularly in turkeys)

Mycoplasma:

• Mycoplasma gallisepticum - chronic respiratory disease (CRD)
• Mycoplasma synoviae - infectious synovitis, respiratory disease
• Mycoplasma meleagridis - in turkeys

INDICATIONS

ENROZONE-10 is indicated for the treatment of infections caused by enrofloxacin-sensitive bacteria in poultry

Disease Conditions:

• Colibacillosis - E. coli infections, including airsacculitis, pericarditis, perihepatitis, and septicemia
• Salmonellosis - fowl typhoid, pullorum disease, paratyphoid infections
• Chronic Respiratory Disease (CRD) - mycoplasmosis caused by Mycoplasma gallisepticum
• Fowl Cholera - Pasteurella multocida infection
• Infectious Coryza - Avibacterium paragallinarum infection
• Necrotic Enteritis - Clostridium perfringens infection
• Staphylococcal and Streptococcal Infections
• Secondary bacterial infections associated with viral diseases (Newcastle disease, Infectious Bronchitis, etc.)

PHARMACOKINETIC PROPERTIES

• Absorption: Enrofloxacin is rapidly and well absorbed after oral administration, reaching peak concentrations in 1-3 hours
• Bioavailability: Excellent oral bioavailability (approximately 80-100%)
• Distribution: Widely distributed throughout the body. Tissue levels in lungs, liver, kidneys, and bones are 2-3 times higher than serum levels
• Metabolism: Partially metabolized in the liver to ciprofloxacin, an active metabolite that contributes to overall antimicrobial activity
• Elimination: Excreted primarily in urine and bile, with small amounts in feces
• Half-life: Approximately 6-10 hours in poultry, with prolonged elimination from skin and adipose tissue

DOSAGE & ADMINISTRATION

ENROZONE-10 is administered via drinking water. For optimal results, fresh solution should be prepared daily

Recommended Dosage:

• Chickens and Turkeys: 10 mg enrofloxacin per kg body weight per day, equivalent to 0.1 ml of ENROZONE-10 per kg body weight per day
• Drinking Water Concentration: 0.5 - 1 ml per liter of drinking water (1 ml per 1-2 liters) for 3-5 days
• Treatment Duration: 3-5 consecutive days. Treatment for 5 days is recommended in cases of mixed infections, chronic processes, salmonellosis, and pasteurellosis

Dosage Calculation:

• Total daily dose (ml) = (Total body weight in kg × 0.1)
• Alternatively: For every 100 kg body weight, administer 10 ml of ENROZONE-10 daily

Administration Guidelines:

• Calculate total daily water consumption based on flock size, age, and environmental temperature. Prepare medicated water corresponding to approximately one-third of the daily water intake to ensure complete consumption within 4-8 hours
• Withhold water for 1-2 hours before administering medicated water to encourage rapid consumption
• Prepare fresh medicated water daily; discard any unused solution after 24 hours
• Ensure medicated water is the only source of drinking water during treatment
• If no clinical improvement is observed within 2-3 days, reconsider therapy based on susceptibility testing

EFFICACY DATA

Clinical Efficacy:

• Enrofloxacin is highly effective against colibacillosis, reducing mortality and improving clinical outcomes in affected flocks
• Excellent efficacy against Mycoplasma infections, with rapid resolution of respiratory signs
• Effective against salmonellosis, including treatment of carrier birds to reduce shedding

Pharmacokinetic Studies:

• Studies show that enrofloxacin is rapidly absorbed and widely distributed, achieving therapeutic concentrations in target tissues within 1-2 hours of oral administration
• The maximum concentration in blood is reached in 1-2 hours and persists for 6 hours; therapeutic concentration persists for 24 hours

RESISTANCE CONSIDERATIONS

Mechanisms of Resistance:

• Point mutations in genes encoding for DNA gyrase and/or topoisomerase IV leading to alterations of the respective enzyme
• Alterations of drug permeability in gram-negative bacteria
• Efflux mechanisms
• Plasmid-mediated resistance
• Cross-resistance within the fluoroquinolone class of antimicrobials is common

Responsible Use Recommendations:

• Veterinary consultation and susceptibility testing are recommended where available
• Use only for confirmed bacterial infections susceptible to enrofloxacin
• Adhere strictly to recommended dosages and treatment durations; avoid subtherapeutic dosing which promotes resistance
• Avoid use in healthy animals for prophylaxis

DRUG INTERACTIONS

• Antagonistic: Do not use concurrently with bacteriostatic antibiotics (tetracyclines, macrolides, chloramphenicol, lincosamides) due to potential antagonism
• Interactions: Avoid concurrent use with theophylline, polyether ionophores, nonsteroidal anti-inflammatory drugs, and magnesium/calcium supplements which may reduce absorption
• Synergistic: May be used in combination with colistin for enhanced gram-negative coverage

CONTRAINDICATIONS & PRECAUTIONS

• Egg production: Do not use in laying hens producing eggs for human consumption. Do not administer to layer replacement birds within 14 days of coming into lay
• Young birds: Use with caution in very young chicks; fluoroquinolones may cause articular cartilage lesions in growing animals
• Liver and kidney dysfunction: Use with caution or avoid in animals with impaired hepatic or renal function
• Hypersensitivity: Do not use in animals with known hypersensitivity to fluoroquinolones
• Keep out of reach of children
• Store in a cool, dry place below 25-30°C, protected from direct sunlight
• Shake well before use
• Use within 28 days after first opening

ADVERSE REACTIONS

• In hypersensitive animals: convulsions, tremor, vomiting, anorexia, hemolytic anemia may occur
• Articular cartilage lesions in young animals with prolonged or high-dose use
• Digestive disturbances such as intestinal dysbiosis, mild diarrhea
• In case of overdose: excitation followed by apathy, rapid breathing (polypnea), and rapid heartbeat
• If adverse reactions occur, discontinue use and consult a veterinarian

WITHDRAWAL PERIOD

• Meat (Chickens): 7 days
• Meat (Turkeys): 10-13 days (varies by regulatory jurisdiction)
• Eggs: Not for use in laying hens producing eggs for human consumption
• Note: Withdrawal periods may vary by country; always follow local regulatory requirements

STORAGE

• Store in a cool, dry place below 25-30°C
• Protect from direct sunlight and freezing
• Keep container tightly closed when not in use
• Do not freeze

Target Species: Poultry (Chickens, Turkeys, Ducks, Geese, Quail, Pigeons)

Pack Sizes: 1 Liter HDPE bottle

PRODUCT SUMMARY
ENROZONE-10 Liquid Antibiotic Enrofloxacin (BP Vet) 100 mg per ml Poultry 1 Liter

FOR VETERINARY USE ONLY