Amphen 200 mg/g Granules for Use in Drinking Water for Pigs

Composition

Each gram contains:

Active substance:

Florfenicol 200.0 mg

Excipients:

White to cream waxy granules.

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Pharmacological properties

4.1 ATCvet code:

QJ01BA90

4.2 Pharmacodynamics

Florfenicol is a broad-spectrum synthetic antibiotic in the phenicol group that is active against most Gram-positive and Gram-negative bacteria isolated from domestic animals. Florfenicol acts by inhibition of 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 1 µg/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.

4.3 Pharmacokinetics

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.

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Target species

Pigs

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Indications

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.

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Dosage

In drinking water use.

10 mg florfenicol/kg bodyweight per day in drinking water for 5 consecutive days.

The daily amount of veterinary medicinal product to be mixed with drinking water can be calculated based on the Total Body Weight (TBW) of the group to be treated with the following formula:

Amount of veterinary medicinal product (in grams) per day* = Total Body Weight of the group (TBW) in kg / 20

* to be mixed with the estimated total water consumption of the group in 24 hours.

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.

The maximum solubility of the veterinary medicinal product granules is 2.5 g/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 100 L drinking water (temperature not below 10 °C).

2. Add 250 g of veterinary medicinal 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 group 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.

Medicated drinking water should be replaced every 24 hours.

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Contraindications

Do not administer to 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 case of known resistance to florfenicol.

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Adverse reactions

1 transient, 2 peri-anal or rectal, 3 resolves without treatment, 4 slight, 5 dark brown

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 its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

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Warnings

Special precautions for safe use in the target species:

Use of the veterinary medicinal product should be based on susceptibility testing of the bacteria isolated from the animal. If this 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 veterinary medicinal product is used.

Use of the veterinary medicinal 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.

Do not use the veterinary medicinal product with chlorinated water.

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, polysorbate 80 or polyethylene glycol should avoid contact with the veterinary medicinal product. Personal protective equipment consisting of protective gloves, safety glasses and clothing should be worn when handling the veterinary medicinal 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 veterinary medicinal 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 veterinary medicinal product may be harmful after ingestion. Do not smoke, eat or drink when handling the veterinary medicinal product or mixing the medicated drinking water.

Special precautions for the protection of the environment:

Manure from treated animals may be harmful to terrestrial plants.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

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Use during pregnancy, lactation or lay

Pregnancy and lactation 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.

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Interactions

None known.

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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.

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Special warnings

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 veterinary medicinal product is not intended to be used together with other antibiotics.

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Withdrawal period

Meat and offal: 20 days.

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Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

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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.

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Storage

Store in the original container in order to protect from light.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 4 years. Shelf life after first opening 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.

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Disposal of unused product

Medicines should not be disposed of via wastewater or household waste.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

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Additional information

Vm 30282/4043

8 DATE OF FIRST AUTHORISATION

04 December 2019

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

October 2024

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS

Veterinary medicinal product subject to prescription.

Detailed information on this veterinary medicinal product is available in the Union Product Database (https://medicines.health.europa.eu/veterinary).

Approved 19 December 2024

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Registration holder

Huvepharma NV

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