Target species
Cattle and Pigs.
Indications for use, specifying the target species
Cattle:
Treatment of respiratory tract infections in clinically diseased cattle due to Mannheimia haemolytica, Pasteurella multocida and Histophilus somni, susceptible to florfenicol.
Pigs:
Treatment of acute outbreaks of respiratory disease caused by strains of
Actinobacillus pleuropneumoniae and Pasteurella multocida susceptible to florfenicol.
Contraindications
Do not use in adult bulls or boars intended for breeding purposes.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in cases of known resistance to florfenicol.
Special warnings
None.
Special precautions for use
Special precautions for use in animals
Do not use in piglets of less than 2 kg.
Use a suitable draw-off needle or automatic dosing syringe to avoid excessive puncturing of the closure. Florfenicol should be used for treatment of severe infections only.
Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.
Official national and regional antimicrobial policies should be taken into account when the product is used.
Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the florfenicol and may decrease the effectiveness of treatment with other antimicrobials (e.g. ceftiofur) due to the potential for cross resistance.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
This product may cause allergic reactions in those that are sensitive.
People with known hypersensitivity to florfenicol or any of the excipients should avoid contact with the veterinary medicinal product.
Take care to avoid accidental self-injection. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
The product may cause irritation if it comes into contact with the skin, mucous membranes or eyes. Avoid direct contact with skin, mouth and eyes. In case of contact with the skin or eyes, rinse the affected area immediately with plenty of clean water. If accidental ingestion occurs, rinse the mouth with plenty of water and seek medical advice immediately.
Wash hands after use.
<Adverse reactions (frequency and seriousness)
Cattle:
Administration of the product by the intramuscular or subcutaneous route may cause inflammatory lesions (swelling and hardness) at the injection site which may persist for 31 days. A decrease in food consumption and transient softening of the faeces may occur during the treatment period. The treated animals recover quickly and completely upon termination of treatment.
In very rare cases, anaphylactic shock has been reported in cattle.
Pigs:
Commonly observed adverse effects are transient diarrhoea and/or peri-anal and rectal erythema/oedema which may affect 50 % of the animals.These effects can be observed for one week.
Under field conditions approximately 30 % of treated pigs presented with pyrexia (40˚C) associated with either moderate depression or moderate dyspnoea a week or more after administration of the second dose.
The frequency of adverse reactions is defined using the following convention:
•very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)
•common (more than 1 but less than 10 animals in 100 animals)
•uncommon (more than 1 but less than 10 animals in 1,000 animals )
•rare (more than 1 but less than 10 animals in 10,000 animals)
•very rare (less than 1 animal in 10,000 animals, including isolated reports)
Use during pregnancy, lactation or lay
Studies in laboratory animals have not revealed any evidence of embryo- or foeto-toxic effects for florfenicol. However, safety during pregnancy and lactation has not been investigated in the target species. Use only accordingly to the benefit/risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction
None known.
Amounts to be administered and administration route
To ensure correct dosage body weight should be determined as accurately as possible.
Swab septum before removing each dose.
Use a dry sterile needle and syringe.
Do not broach the vial more than 25 times.
Cattle:
Intramuscular Injection: 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart using a 16-gauge needle.
Subcutaneous Injection: 40 mg/kg bodyweight (2 ml/15 kg) to be administered once only using a 16-gauge needle.
The dose volume given at any one injection site should not exceed 10 ml.
The injection should only be given in the neck.
Pigs:
<Intramuscular Injection: 15 mg/kg bodyweight (1 ml per 20 kg) into the neck muscle twice at 48 hour intervals using a 16-gauge needle.
The volume administered per injection site should not exceed 3 ml.
It is recommended to treat cattle and Pigs in the early stages of disease and to evaluate the response to treatment within 48 hours after the second injection. If clinical signs of respiratory disease persist 48 hours after the last injection, treatment should be changed using another formulation or another antibiotic and continued until clinical signs have resolved.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Cattle:
None.
Pigs:
After administration of three times the recommended dose or more, a reduction in feeding, hydration and weight gain has been observed. After administration of five times the recommended dose or more, vomiting has also been noted.
Withdrawal period
Cattle
Meat and offal:
•By intramuscular injection (at 20 mg/kg, twice): 39 days
•By subcutaneous injection (at 40 mg/kg, once): 44 days
Milk:
•Not permitted for use in lactating animals producing milk for human consumption.
Pigs
Meat and offal:
•22 days