Target species
Pigs
Indications for use
Treatment and metaphylaxis of swine respiratory disease associated with Actinobacillus pleuropneumoniae and Pasteurella multocida susceptible to florfenicol. The presence of the disease must be established in the group before metaphylactic treatment.
Contra-indications
Do not administer to boars intended for breeding purposes.
Do not administer in cases of hypersensitivity to the active substance or any of the excipients.
Do not use in cases of known resistance to florfenicol.
Special warnings for each target species
In case of insufficient water intake, animals should be treated parenterally. During treatment, unmedicated drinking water should only be administered after the daily amount of medicated drinking water has been ingested by pigs. The product is not intended to be used together with other antibiotics.
Special precautions for use
i)Special precautions for use in animals
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 and local 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 florfenicol and may decrease the effectiveness of treatment with amphenicols due to the potential for cross-resistance.
Treatment should not exceed 5 days. During treatment, increased serum calcium may also be observed.
ii)Special precautions for the person administering the veterinary medicinal product to animals
This product may cause hypersensitivity reactions. If you have known hypersensitivity to florfenicol, polysorbate 80 or polyethylene glycol, avoid skin contact with this product. Wear protective gloves and clothing when handling and mixing this product. 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.
This product may be slightly irritating to the eyes and/or skin. Avoid contact with the skin and eyes, including hand-to-eye-contact. Wear safety glasses. In case of accidental spillage onto eyes, wash them immediately with water. In case of contact with the skin, wash immediately the affected area and take the contaminated clothes off.
This product may be harmful after ingestion. Do not smoke, eat or drink when handling the product or mixing the medicated drinking water.
iii)Special precautions for the environment
Manure from treated animals may be harmful to terrestrial plants.
Adverse reactions
A slight reduction of water consumption by the animals, inappetance, dark brown faeces and constipation may be observed during treatment. .
Diarrhoea and/or peri-anal and rectal erythema/oedema have been observed very commonly in treated animals. These effects are transient. Prolapse of the rectum, that resolves without treatment, has been observed very rarely in affected animals.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated )
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Use during pregnancy, lactation or lay
Studies in laboratory animals have not produced any evidence of potential embryotoxic or foetotoxic effect of florfenicol. The safety of the veterinary medicinal product in sows has not been established during pregnancy and lactation. The use is not recommended during pregnancy and lactation.
Interactions
None known.
Amounts to be administered and administration route
In drinking water use.
10 mg florfenicol /kg bodyweight per day in drinking water for 5 consecutive days.
The daily amount of product to be mixed with drinking water can be calculated based on the Total Body Weight (TBW) of the herd to be treated with the following formula:
Amount of product (in grams) per day* | = | Total Body Weight of the herd (TBW) in Kg |
| 20 |
*to be mixed with the estimated total water consumption of the herd in 24 hr |
The examples of medicated drinking water in the table below are calculated by applying the formula and by assuming that pigs drink 8% or 10% of their bodyweight.
Dosage Guide: Amphen 200mg/g granules for use in drinking water for pigs |
| TBW of the herd (Kg) | Product (g) | Estimated daily water consumption (L) | Product grams per 10 litres of water |
Pigs drinking 8% of their bodyweight | 500 kg | 25 g | 40 L | 6.25 g/10L |
1000 kg | 50 g | 80 L |
5000 kg | 250 g | 400 L |
Pigs drinking 10% of their bodyweight | 500 kg | 25 g | 50 L | 5 g/10L |
1000 kg | 50 g | 100 L |
5000 kg | 250 g | 500 L |
The maximum solubility of the product granules is 2.5g/L at 10°C and 20°C and 2.0 g/L at 5°C. Dissolution may take up to 30 minutes. During dissolution the solution should be stirred for at least 5 minutes at 50 RPM.Solutions should be checked visually for complete dissolution.
FOR BULK TANK:
Any solution for use in a header tank must be limited to not more than the maximum solubility.
FOR PROPORTIONER:
For stock solutions and when using a proportioner, take care not to exceed the maximum solubility which can be achieved under the given conditions. Adjust flow rate settings of the dosing pump according to concentration of the stock solution and water intake of the animals to be treated.
To treat 5,000 kg of pigs, drinking 10% of their bodyweight, at the dose rate of 10 mg/kg:
1. Fill the proportioner with 100L drinking water (temperature not below 10°C).
2. Add 250g of product to the proportioner.
3. Mix thoroughly until visually dissolved.
4. Set the proportioner to 20%.
5. Turn on the proportioner.
In order to ensure correct dosing and to prevent underdosing, the body weight of the herd should be calculated as precisely as possible and water consumption should be monitored. The required quantity of granules should be measured by suitably calibrated weighing equipment.
The uptake of water depends on several factors including the age, the clinical state of the animals and the local conditions such as ambient temperature and humidity. The daily water consumption can be underestimated (e.g. reduced to 6% of bodyweight) in order to ensure total consumption of medicated water during the day (fresh drinking water can be made available following the consumption of the medicated water). If it is not possible to obtain sufficient uptake of medicated water animals should be treated parenterally. The maximum solubility of the product granules is 5g/L at 20°C and 2.0 g/L at 5°C. Any solutions for use in header tank must be limited to no more than 2.5 g/L. Dissolution may take up to 30 minutes and solutions should be checked visually for complete dissolution.
Medicated drinking water should be replaced every 24 hours.
Overdose
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 periods
Meat and offal: 20 days