Product Name: NORA ZONE

Type: Oral Liquid Solution - Antibiotic with Respiratory Support

COMPOSITION

Each 100 ml contains:

• Norfloxacin ...... 20 g (20% w/v, 200 mg/ml)
• Aminophylline ...... 8 g (8% w/v, 80 mg/ml)
• Guaifenesin ...... 20 g (20% w/v, 200 mg/ml)

DESCRIPTION

NORA ZONE is a unique combination oral solution that integrates norfloxacin, a broad-spectrum fluoroquinolone antibiotic, with aminophylline (a bronchodilator) and guaifenesin (an expectorant) for the comprehensive management of respiratory and gastrointestinal infections in poultry. This multi-component formulation addresses both the bacterial etiology of disease and the associated clinical signs of respiratory distress

Norfloxacin 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

MECHANISM OF ACTION

Norfloxacin:

• Inhibits bacterial DNA gyrase (topoisomerase II), an enzyme critical for DNA replication, transcription, and repair
• Disrupts DNA supercoiling, leading to rapid bacterial cell death
• Rapidly absorbed after oral administration, reaching peak concentrations within 2 hours

Aminophylline:

• Acts as a bronchodilator, relaxing bronchial smooth muscle by inhibiting phosphodiesterase and increasing intracellular cAMP
• Reduces bronchospasm and improves airflow in respiratory infections
• Provides symptomatic relief for animals with respiratory distress

Guaifenesin:

• Acts as an expectorant, reducing the viscosity of bronchial secretions and facilitating their expulsion
• Increases respiratory tract fluid volume, loosening mucus and phlegm
• Enhances clearance of infectious material from airways

ANTIMICROBIAL SPECTRUM

Norfloxacin exhibits potent bactericidal activity against a wide range of microorganisms

Gram-Negative Bacteria:

• Escherichia coli - colibacillosis, enteritis, airsacculitis
• Salmonella spp. - salmonellosis, fowl typhoid, pullorum disease
• Pasteurella multocida - fowl cholera
• Campylobacter spp.
• Klebsiella spp., Proteus spp., Haemophilus spp., Bordetella avium

Gram-Positive Bacteria:

• Staphylococcus spp.
• Streptococcus spp.

Mycoplasma:

• Mycoplasma gallisepticum - chronic respiratory disease (CRD)
• Mycoplasma synoviae - infectious synovitis

INDICATIONS

NORA ZONE is indicated for the treatment of respiratory and gastrointestinal infections in poultry caused by norfloxacin-sensitive bacteria

Disease Conditions:

• Chronic Respiratory Disease (CRD) - caused by Mycoplasma gallisepticum
• Colibacillosis - E. coli infections, including airsacculitis and septicemia
• Salmonellosis - fowl typhoid, pullorum disease, paratyphoid infections
• Fowl Cholera - Pasteurella multocida infection
• Infectious Coryza - Haemophilus paragallinarum infection
• Enteritis - bacterial gastrointestinal infections
• Secondary bacterial infections associated with viral respiratory diseases (Newcastle disease, Infectious Bronchitis)

PHARMACOKINETIC PROPERTIES

• Absorption: Norfloxacin is rapidly absorbed after oral administration. In broiler chickens, following a single oral dose of 10 mg/kg, maximum serum concentrations are reached within 2 hours
• Distribution: Widely distributed throughout the body; achieves therapeutic concentrations in respiratory and gastrointestinal tissues
• Plasma Levels: Plasma levels remain above the MIC90 for major poultry pathogenic gram-negative and gram-positive bacteria for up to 10 hours following administration
• Elimination: Excreted primarily in urine and bile
• Aminophylline and Guaifenesin: Rapidly absorbed and distributed, providing bronchodilation and expectorant effects within hours of administration

DOSAGE & ADMINISTRATION

NORA ZONE is administered via drinking water. For optimal results, fresh solution should be prepared daily.

Recommended Dosage:

• Poultry (Broilers, Layers, Breeders): 0.5 - 1 ml per liter of drinking water
• Treatment Duration: 3-5 consecutive days. For chronic or severe respiratory infections, up to 7-10 days may be required
• Alternative Dosage (based on norfloxacin): 10-15 mg norfloxacin per kg body weight per day

Dosage Based on Body Weight:

• For every 100 kg body weight, administer 5-7.5 ml of NORA ZONE daily (based on 10-15 mg norfloxacin/kg)

Administration Guidelines:

• Calculate total daily water consumption based on flock size, age, and environmental temperature
• Prepare fresh medicated water daily; discard any unused solution after 24 hours
• Ensure medicated water is the only source of drinking water during treatment
• For best results, administer over 4-8 hours; may withhold water for 1-2 hours before treatment to encourage rapid consumption
• In severe respiratory disease cases, pulse dosing (once-daily administration at higher concentration) may be more effective than continuous dosing
• Do not use water containing heavy mineral salts, as this may reduce absorption

EFFICACY DATA

Clinical Efficacy in Colibacillosis:

• A controlled study in 18-day-old broiler chickens experimentally infected with E. coli serotype O78 demonstrated that norfloxacin treatment (10 mg/kg/day for 3 days) reduced mortality from 75% (untreated controls) to 8.33%
• Air sacculitis lesions were found in 86.67% of untreated chickens, while treated groups showed significantly reduced lesion scores

Dosing Regimen Studies:

• Research in broiler chickens with experimental colibacillosis showed that once-per-day pulse dosing of norfloxacin (15 mg/kg body weight via drinking water) was more efficacious than continuous dosing (100 mg/L for 5 days)
• The rapid absorption and relatively short half-life of norfloxacin support pulse dosing strategies to achieve higher peak concentrations

Pharmacokinetic Data:

• Following a single oral dose of 10 mg/kg norfloxacin in broiler chickens, maximum serum concentration (1.39 μg/ml) is achieved at 2 hours post-administration
• Therapeutic plasma levels are maintained above the MIC90 for major poultry pathogens for up to 10 hours

RESISTANCE CONSIDERATIONS

Mechanisms of Resistance:

• Point mutations in genes encoding DNA gyrase and/or topoisomerase IV
• Alterations in drug permeability (efflux pumps)
• Plasmid-mediated resistance
• Cross-resistance within the fluoroquinolone class is common

Responsible Use Recommendations:

• Veterinary consultation and susceptibility testing are recommended where available
• Use only for confirmed bacterial infections susceptible to norfloxacin
• Adhere strictly to recommended dosages and treatment durations; avoid subtherapeutic dosing which promotes resistance
• Avoid use in healthy animals for prophylaxis
• Norfloxacin is classified as a fluoroquinolone antibiotic; responsible use is essential to preserve its efficacy

DRUG INTERACTIONS

• Antagonistic: Do not use concurrently with bacteriostatic antibiotics (tetracyclines, macrolides, chloramphenicol) due to potential antagonism
• Interactions: Avoid concurrent use with magnesium/calcium supplements which may reduce absorption
• Synergistic: May be used in combination with colistin for enhanced gram-negative coverage
• Aminophylline Caution: Aminophylline may have additive effects with other xanthine derivatives; use with caution in animals with cardiac conditions

CONTRAINDICATIONS & PRECAUTIONS

• Egg production: Do not use in laying hens producing eggs for human consumption
• 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 or xanthine derivatives
• Cardiac conditions: Use with caution in animals with cardiac disease due to aminophylline content
• Keep out of reach of children
• Store in a cool, dry place below 30°C, protected from direct sunlight
• Shake well before use
• Use within 28 days after first opening

ADVERSE REACTIONS

• In hypersensitive animals: skin reactions, fever, or respiratory distress may occur
• Articular cartilage lesions in young animals with prolonged or high-dose use
• Digestive disturbances such as intestinal dysbiosis, mild diarrhea
• Aminophylline may cause restlessness, tachycardia, or increased respiratory rate at high doses
• If adverse reactions occur, discontinue use and consult a veterinarian

WITHDRAWAL PERIOD

• Meat (Poultry): 7 days
• Eggs: Not for use in laying hens producing eggs for human consumption
• Note: Withdrawal periods may vary by country; always follow local regulatory requirements. Studies indicate that a 7-day withdrawal period is sufficient for norfloxacin residues to fall below maximum residue limits in poultry tissues

STORAGE

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

Target Species: Poultry (Broilers, Layers, Breeders, Turkeys, Ducks, Geese, Quail)

Pack Sizes: 1 Liter HDPE bottle

PRODUCT SUMMARY
NORA ZONE Liquid Antibiotic Norfloxacin 20g, Aminophylline 8g, Guaifenisin 20g per 100ml Poultry 1 Liter

FOR VETERINARY USE ONLY