SELECTAN ORAL 23 mg/ml solution for use in drinking water for pigs

Ireland - English - HPRA (Health Products Regulatory Authority)

Active ingredient:
Florfenicol
Available from:
Laboratorios Hipra S.A.
ATC code:
QJ01BA90
INN (International Name):
Florfenicol
Dosage:
23 milligram(s)/millilitre
Pharmaceutical form:
Concentrate for use in drinking water
Prescription type:
POM: Prescription Only Medicine as defined in relevant national legislation
Therapeutic group:
Pigs
Therapeutic area:
florfenicol
Therapeutic indications:
Antibacterial
Authorization status:
Authorised
Authorization number:
VPA10846/012/001
Authorization date:
2011-04-15

Read the complete document

Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT

SELECTAN ORAL 23 mg/ml solution for use in drinking water for pigs

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains:

Active substance:

Florfenicol …………………………………………………………………………… 23 mg

Excipients:

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Solution for use in drinking water.

A slightly yellowish and clear solution.

4 CLINICAL PARTICULARS

4.1 Target Species

Pigs.

4.2 Indications for use, specifying the target species

Pigs:

Treatment

and metaphylaxis at

the group level

where clinical

signs are present

swine respiratory disease

associated with Actinobacillus pleuropneumoniae and Pasteurella multocida susceptible to florfenicol.

The presence of the disease should be established in the herd before initiating preventive treatment.

4.3 Contraindications

Do not use in boars intended for breeding purposes.

Do not use in cases of known hypersensitivity to the active substance or to the excipient.

4.4 Special warnings for each target species

The treated pigs should be placed under

special

observation.

On each of

the five days of

treatment,

unmedicated

drinking water should not be given until the full daily amount of medicated drinking water has been ingested by pigs.

If there are no signs of improvement after three days of treatment, the diagnosis should be reviewed and, if necessary,

the treatment changed.

Animals showing a decreased water intake and/or a poor general condition should be treated by the parenteral route.

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4.5 Special precautions for use

Special precautions for use in animals

The veterinary medicinal product should be used in conjunction with susceptibility testing.

Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to

the florfenicol.

Official and local antimicrobial policies should be taken into account when the product is used.

Treatment should not exceed 5 days.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

People with known hypersensitivity to florfenicol

or polyethylene glycols should avoid contact

with the veterinary

medicinal product.

In case of accidental spillage onto skin, rinse with water.

Other precautions:

Manure from treated pigs should be stored for 3 months prior to spreading and incorporating into land.

4.6 Adverse reactions (frequency and seriousness)

In very rare cases a slight reduction of water consumption by the animals, dark brown faeces and constipation may be

observed during treatment.

Commonly,

observed adverse effects are diarrhoea and/or

peri-anal

and rectal

erythema/oedema which may affect

approximately 40 % of the animals. These effects are transient.

In very rare cases, prolapse of the rectum, that resolves without treatment, may be observed.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)

- common (more than 1 but less than 10 animals in 100 animals)

- uncommon (more than 1 but less than 10 animals in 1,000 animals)

- rare (more than 1 but less than 10 animals in 10,000 animals)

- very rare (less than 1 animal in 10,000 animals, including isolated reports).

4.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation.

Pregnancy:

Laboratory studies in animals have not produced any evidence of potential embryotoxic or foetotoxic effects.

The use is not recommended during pregnancy.

Lactation:

The use is not recommended during lactation.

4.8 Interaction with other medicinal products and other forms of interaction

No data available.

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4.9 Amounts to be administered and administration route

Oral route in drinking water.

Pigs: 10 mg florfenicol per kg body weight per day for 5 consecutive days.

This dose is equivalent to 0.44 ml of the

product per kg body weight per day.

The uptake of medicated water depends on several factors including the clinical state of the animals and local conditions

such as ambient temperature and humidity. In order to obtain the correct dosage water uptake has to be monitored and the

concentration of florfenicol

has to be adjusted accordingly.

If however it

is not

possible to obtain sufficient

uptake of

medicated water animals should be treated parenterally.

The required amount of the florfenicol concentrate solution can be calculated based on the total body weight of herd to

be treated and the total water consumption of the herd in 24 hr with the following formula:

Considering that a pig drinks approximately 10 % of its body weight per day, the following dose is recommended: 4.4

ml of the product / L water.

After

calculation of

the required amount

product,

use a graduated device to measure the exact

amount

thoroughly mix the volume of

the product

with the appropriate quantity of

water

immediately before use.

Only

sufficient medicated drinking water should be prepared to cover the daily requirements.

To ensure a correct dosage,

measurements should be determined as accurately as possible to avoid underdosing.

Treatment should continue for 5 consecutive days.

Medicated drinking water should be replaced every 24 hours.

If a proportioner set at P % is used, then the formula is:

Instructions are given below:

If electric pumps are used instead of hydraulic ones, the flow must be controlled in order to avoid underdosing.

Bulk tank

Proportioners

1. Measure Volume of product per litre

of water and empty it in the bulk tank.

1. Check the concentration according to

the warning below.

2. Mix thoroughly and begin

administration.

2. Measure Volume product and empty

it in the proportioner.

3. Measure Volume water and empty it

in the proportioner.

4. Mix thoroughly.

5. Set the proportioner on your setting

(i.e. 10 % or 1 %) and turn it on.

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Warning: Solutions with concentrations comprised between 1.2 and 12 g of florfenicol

per litre precipitate.

In this

casse mix the product directly in the bulk tank or change the proportioner setting. Use the following formula to check

the concentration:

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

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.

4.11 Withdrawal Period(s)

Meat and offal: 20 days.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Antimicrobials for systemic use, amphenicols.

ATCvet code: QJ01BA90.

5.1 Pharmacodynamic properties

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

ribosomal

level

bacteriostatic.

However,

bactericidal

activity

been

demonstrated

in-vitro

against

Actinobacillus pleuropneumoniae and Pasteurella multocida when florfenicol

is present

concentrations above the

MIC for up to 12 hours.

In-vitro testing has

shown that

florfenicol

active against

the bacterial

pathogens

most

commonly isolated in

respiratory diseases in pigs, including Actinobacillus pleuropneumoniae and Pasteurella multocida.

Reported MIC

values (2008 – 2010) for Actinobacillus pleuropneumoniae and Pasteurella multocida were found to

be 0.5 µg/mL.

For A.

pleuropneumoniae and P.

multocida,

the CLSI breakpoint

of resistance for swine respiratory

disease is

8 µg/ml.

Cross-resistance to chloramphenicol and florfenicol mediated by a gene (floR) that codes for an

efflux protein and is carried on plasmids has been observed in isolated cases of porcine Pasteurellae.

5.2 Pharmacokinetic properties

After

administration to pigs by gavage at

15 mg/kg under

experimental

conditions,

absorption of

florfenicol

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 the product

a concentration of

100 mg florfenicol

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,

been shown that

lung concentrations

are similar

to serum

concentrations.

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6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Macrogol 300.

6.2 Incompatibilities

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

medicinal products.

6.3 Shelf-life

Shelf-life of the veterinary medicinal product as packaged for sale: 1 year.

Shelf-life after first opening the immediate packaging: 28 days.

Shelf life after dilution according to directions: 24 hours.

6.4 Special precautions for storage

Do not store above 25

6.5 Nature and composition of immediate packaging

The product is filled in 5 L HDPE plastic barrels closed with HDPE plastic screw-on caps and a polyethylene safety

seal.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be

disposed of in accordance with local requirements.

The product should not be allowed to enter surface water as it has harmful effects on aquatic organisms.

7 MARKETING AUTHORISATION HOLDER

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170 Amer (Girona)

Spain

8 MARKETING AUTHORISATION NUMBER(S)

VPA 10846/012/001

9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 15

April 2011

Date of last renewal: 15

April 2016

10 DATE OF REVISION OF THE TEXT

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