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 per 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.