Amphen

1 x 1 kg

Granules for use in drinking water

Active substance

Florfenicol : 200 mg/g

ATC code

QJ01BA90 Florfenicol

QJ01BA Amphenicols

QJ01B Amphenicols

QJ01 Antibacterials for systemic use

QJ Antiinfectives for systemic use

Species

Pigs

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.

Dose 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 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:

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.

	TBW of the group (kg)	Veterinary medicinal product (g)	Estimated daily water consumption (L)	Veterinary medicinal product grams per 10 litres of water
Pigs drinking	500 kg	25 g	40 L
8% of their bodyweight	1000 kg	50 g	80 L	6.25 g/10 L
8% of their bodyweight	5000 kg	250 g	400 L	6.25 g/10 L
Pigs drinking 10% of their bodyweight	500 kg	25 g	50 L	5 g/10 L
	1000 kg	50 g	100 L
	5000 Kg	250 g	500 L

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.

Adverse reactions

(>1 animal / 10 animals treated):

Erythema^1,2, Oedema^1,2.

Very rare

(<1 animal / 10,000 animals treated, including isolated reports):

Rectal prolapse³.

Undetermined frequency (cannot be estimated from the available data):

Decreased drinking⁴, Inappetence

Unusual stool colour⁵, Constipation.

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.