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Date: Saturday, May 18, 2024 23:08

Release 12.71
Amphen 200mg/g granules for use in drinking water for pigs
 
Species: Pigs
Therapeutic indication: Pharmaceuticals: Antimicrobials: Oral preparations: Others
Active ingredient: Florfenicol
Product:Amphen 200mg/g granules for use in drinking water for pigs
Product index: Amphen 200mg/g granules for use in drinking water for pigs
Pig - meat: 20 days
Incorporating:
Qualitative and quantitative composition
Each g contains:
Active substance:
Florfenicol 200.0 mg
Excipient(s):
Butylhydroxytoluene (E321)1.0 mg
Disodium Edetate 1.0 mg
Pharmaceutical form
Granules for use in drinking water.
White to cream waxy granules
Clinical particulars
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
Pharmacological particulars
Pharmacotherapeutic group: Antibacterials for systemic use, amphenicols
ATC Vet Code: QJ01BA90
Pharmacodynamic properties
Florfenicol is a synthetic, broad-spectrum antibiotic in the phenicol group active against most Gram-positive and Gram-negative organisms isolated from domestic animals. Florfenicol acts by inhibiting protein synthesis at the ribosomal level and is bacteriostatic. However, bactericidal activity has been demonstrated in-vitro against Actinobacillus pleuropneumoniae and Pasteurella multocida when florfenicol is present at concentrations above the MIC for up to 12 hours.
In-vitro testing has shown that florfenicol is active against the bacterial pathogens most commonly isolated in respiratory diseases in pigs, including Actinobacillus pleuropneumoniae and Pasteurella multocida. The MIC50 and MIC90 values for Actinobacillus pleuropneumoniae were 0.5 µg/ml and 0.5µg/ml. The MIC50 and MIC90 values for Pasteurella multocida were 0.5 µg/ml and 1µg/ml. These strains were isolated from European countries during 2015-2016. Observed resistance was low based on the clinical breakpoints (CLSI): sensitive ≤ 2 µg/ml, intermediate 4 µg/ml and resistant ≥ 8 µg/ml. Resistance to florfenicol mainly comes from the presence of specific (e.g. FloR) or multi-substance (e.g. AcrAB-TolC) efflux pumps. The genes corresponding to these mechanisms are coded on genetic elements such as plasmids, transposons or gene cassettes. Cross resistance with chloramphenicol is possible.
Pharmacokinetic properties
After administration to pigs by gavage at 15 mg/kg under experimental conditions, absorption of florfenicol was variable but peak serum concentrations of approximately 5 μg/mL were reached approximately 2 hours after dosing. The terminal half-life was between 2 and 3 hours. When pigs were given free access, for 5 days, to water medicated with 100 mg florfenicol per litre of water, serum concentrations of florfenicol exceeded 1 μg/mL for the entire 5 day treatment period except for a couple of short excursions below 1 μg/mL. After absorption and distribution, florfenicol is extensively metabolised by pigs and rapidly eliminated, primarily in urine. After parenteral dosing of florfenicol to pigs, it has been shown that lung concentrations are similar to serum concentrations.
Environmental properties
Manure from treated animals may be harmful to terrestrial plants.
Pharmaceutical particulars
Excipients
Butylhydroxytoluene (E321)
Disodium Edetate
Macrogol 4000
Macrogol 400
Maltodextrin
Polysorbate 80
Major incompatibilities
In the absence of compatibility studied this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 4 years
Shelf life after first opening of the immediate packaging: 3 months. The bag is opened and closed by unzipping respectively zipping.
Shelf life after dilution or reconstitution according to directions: 24 hours
Special precautions for storage
Store in the original package in order to protect from light.
Immediate packaging
Resealable block bottom zipped bags made of polyethylene /aluminium/polyethylene terephthalate laminate containing 0.5 kg and 1 kg of granules.
Not all pack sizes may be marketed.
Disposal
Any unused veterinary medicinal product or waste material derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Huvepharma NV
Uitbreidingstraat 80
2600 Antwerp
Belgium
Marketing Authorisation Number
Vm 30282/4043
Significant changes
Date of the first authorisation or date of renewal
December 2019
Date of revision of the text
March 2023
Any other information
Nil
Legal category
Legal category: POM-V
GTIN
GTIN description:Amphen 1kg:
GTIN:5414916101013