Target species
Pigs.
Indications for use, specifying the target species
Treatment and metaphylaxis at the group level where clinical signs of swine respiratory diseases associated with Actinobacillus pleuropneumoniae and Pasteurella multocida are present.
The presence of the disease in the group must be established before the product is used.
Contraindications
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Special warnings for each target species
Do not use the product with chlorinated water.
The uptake of medication by animals may be altered as a consequence of illness. In case of insufficient water intake, animals should be treated parenterally using a suitable injectable product prescribed by the veterinarian.
Special precautions for use
Special precautions for use in animals
In addition to medication, it is important to ensure proper husbandry conditions, including good hygiene, proper ventilation and avoiding crowded conditions
Use of the product should be based on identification and susceptibility testing of the target pathogens. If this is not possible, therapy should be based on epidemiological information and knowledge of susceptibility of the target pathogens at farm level, or at local/regional level.
Use of the product should be in accordance with official, national and regional antimicrobial policies.
An antibiotic with a lower risk of antimicrobial resistance selection (lower AMEG category) should be used for first line treatment where susceptibility testing suggests the likely efficacy of this approach.
Not for use for prophylaxis.
The duration of treatment should not exceed 5 days.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
This veterinary medicinal product may cause hypersensitivity reactions. People with known hypersensitivity to florfenicol or sodium benzoate should avoid contact with the veterinary medicinal product.
This veterinary medicinal product may be slightly irritating to the skin and eyes. Avoid skin or eye contact, including hand-to-eye-contact.
This veterinary medicinal product may be harmful when ingested, including effects on male fertility. Avoid oral ingestion, including hand-to-mouth-contact when preparing the product.
Do not eat, drink or smoke while handling this product. Personal protective equipment consisting of gloves, clothing and safety glasses should be worn when handling and mixing the veterinary medicinal product.
In case of accidental spillage onto eyes, wash them immediately with water. In case of accidental spillage onto skin, wash immediately the affected area and take the contaminated clothes off.
Wash hands after use.
If you develop symptoms following exposure such as skin rash, seek medical advice immediately and show the package leaflet or the label to the physician.
Special precautions for the protection of the environment
The use of the veterinary medicinal product poses a risk to terrestrial organisms (plants) and aquatic organisms (cyanobacteria), including groundwater organisms.
In order to prevent any adverse effects on terrestrial plants and algae and possible contamination of groundwater, manure from treated pigs must not be spread onto land without dilution with manure from untreated pigs. Manure from treated pigs must be diluted with at least 5 times the weight of manure from untreated pigs before it can be spread onto arable land or before the manure is traded.
Adverse reactions (frequency and seriousness)
Pigs:
Very common (>1 animal / 10 animals treated) | Diarrhoea Erythema (1) Oedema (1) |
Undetermined frequency (cannot be estimated from the available data) | Decreased drinking Constipation Abnormal stool colouration (2) Rectal prolapse (3) |
1 - perianal or rectal, 2 - dark brown, 3 - retroceding without treatment
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy or lactation.
Pregnancy and lactation:
Laboratory studies in rats and mice have not revealed any evidence of potential embryotoxic or foetotoxic effect of florfenicol.
The use in sows is not recommended during pregnancy and lactation.
Fertility:
Do not administer to boars intended for breeding.
Amount(s) to be administered and administration route
In drinking water use.
The recommended dose is 10 mg florfenicol per kg bodyweight per day (equivalent to 5 mL of the product/100 kg bw) for 5 consecutive days.
To ensure a correct dosage body weight should be determined as accurately as possible. In order to avoid under and over-dosing, treated animals should be divided into groups of similar bodyweight and the dose should be calculated for each group individually.
Medicated water intake depends on many factors including the clinical condition of the animal as well as local conditions such as ambient temperature and humidity.
All animals to be treated should have sufficient access to the water supply system to ensure adequate consumption of the medicated drinking water. In order to ensure consumption of the medicated water, animals should not have access to other water supplies whilst being treated. If, however, it is not possible to obtain a sufficient intake of medicated water, the animals should be treated parenterally.
The appropriate quantity of medicated water should be prepared based on the daily water consumption. In order to obtain the correct dosage, the water uptake has to be monitored and the concentration of florfenicol has to be adjusted accordingly.
Based on the recommended dose, and the number and weight of the animals to be treated, the exact daily concentration of the veterinary product should be calculated according to the following formula:
X mL veterinary medicinal product/kg body weight/dsay | x Average body weight (kg) of animals to be treated | = mL veterinary product per L drinking water |
Average daily water consumption (litre) per animal |
If a weighing scale is used the required volume can be converted based considering the following calculation:
quantity in g of product required per day = number of ml of product required per day x 1.075.
Accuracy of the dosing device should be thoroughly checked.
Shake the bottle vigorously for 60 seconds before use. The product should be added to the water. Prepare the solution with fresh potable water.
For water tanks:
The maximal solubility is reached at concentrations of 2 mL/L (0.4 g of florfenicol/L), 2.5 mL/L (0.5 g of florfenicol/L) and 3 ml/L (0.6 g of florfenicol/L) at respectively 4°C, 10°C and 20°C. Solutions should be checked visually for complete dissolution.
To treat pigs drinking 10% of their bodyweight, at the dose of 10 mg/kg, add the veterinary medicinal product to the drinking water in the tank.
Use 1 L of product for every 2000 L of water. This corresponds to a concentration of 0.10 g florfenicol /L in the drinking water.
Mix thoroughly, to achieve full dissolution the solution should be stirred vigorously using a manual whisk for 10 minutes. When using a magnetic stirrer at 100 rpm, the mixing time is of 5 minutes.
For dosing pumps:
The veterinary medicinal product can only be used at a concentration of 50 mL/L i.e. 10 g of florfenicol per litre of water of stock solution.
To treat pigs drinking 10% of their bodyweight, at the dose of 10 mg/kg, add the veterinary medicinal product to the water in the reservoir of the dosing pump. Add 1 L of product to 20 L of unmedicated water. This corresponds to a concentration of 10 g/L in the stock solution.
Mix thoroughly using a manual whisk for 10 minutes or automatic stirring device operating 840 rpm for 5 min until a homogeneous white milky suspension is obtained.
Set the dosing pump on 1 % and turn on the dosing pump.
Medicated drinking water should be replaced every 24 hours.
After the end of the medication period the water supply system should be cleaned appropriately to avoid intake of sub-therapeutic amounts of the active substance.
Overdose (symptoms, emergency procedures, antidotes), if necessary
In case of overdosing, a decrease in weight gain, food and water consumption, peri-anal erythema and oedema and modification of some haematological and biochemical parameters indicative of dehydration may be observed.
Withdrawal period(s)
Meat and offal: 20 days