Composition

Each 1 ml contains:

• Florfenicol: 300 mg

Pharmaceutical Form

Sterile injectable solution for intramuscular (IM) or subcutaneous (SC) administration.

Pharmacological Properties

Florfenicol is a synthetic, broad-spectrum antibiotic belonging to the amphenicol group. It is a fluorinated derivative of thiamphenicol and acts primarily as a bacteriostatic agent by inhibiting bacterial protein synthesis. Florfenicol exhibits enhanced in vitro activity compared to chloramphenicol against a wide range of Gram-positive and Gram-negative bacteria, including common respiratory pathogens in livestock.

Target Species

• Cattle
• Sheep

Indications for Use

Cattle:
For the preventive and therapeutic treatment of respiratory tract infections caused by florfenicol-susceptible organisms such as Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni.

Sheep:
For the treatment of respiratory infections caused by Mannheimia haemolytica and Pasteurella multocida susceptible to florfenicol.

Contraindications

• Do not use in adult breeding bulls or rams.
• Do not use in animals with known hypersensitivity to florfenicol or any excipients.

Undesirable Effects

Cattle:

• Temporary reduction in feed intake and softening of feces may occur, but resolve fully after treatment.
• Local reactions such as inflammatory lesions at the injection site may persist for up to 14 days.
• In rare cases, anaphylactic shock has been reported.

Sheep:

• A decrease in appetite may occur during treatment.
• Injection site reactions may persist up to 28 days.

Posology and Method of Administration

Shake well before use. Administer using a sterile 16-gauge needle.

Cattle:

• IM route: 20 mg florfenicol/kg body weight (1 ml per 15 kg), given twice, 48 hours apart.
• SC route: 40 mg florfenicol/kg body weight (2 ml per 15 kg), given as a single dose.
• Inject only in the neck; maximum volume per injection site should not exceed 10 ml.

Sheep:

• 20 mg florfenicol/kg body weight (1 ml per 15 kg) via intramuscular injection once daily for three consecutive days.
• Maximum volume per injection site: 4 ml.

Overdose

Avoid exceeding the recommended dosage or duration of treatment.

Withdrawal Periods

• Cattle (IM, 20 mg/kg, 2 doses): 28 days
• Cattle (SC, 40 mg/kg, 1 dose): 44 days
• Sheep: 39 days
• Milk: Not approved for use in lactating animals producing milk for human consumption.

Special Safety Precautions for the Person Administering the Product

None under normal conditions of use. Follow standard hygiene and handling practices.

Special Precautions for Storage

Store in a dry place below 30°C.
Do not refrigerate or freeze.
Keep out of reach of children.

Nature of Product

Clear, yellowish sterile solution.

Packaging

Amber glass vial – 100 ml

For veterinary use only. Consult a veterinarian before use.