SOLUBENOL 100 MG/G ORAL EMULSION FOR PIGS AND CHICKENS

Ireland - English - HPRA (Health Products Regulatory Authority)

Active ingredient:
FLUBENDAZOLE
Available from:
Elanco Animal Health, Eli Lilly and Company Limited
ATC code:
QP52AC12
INN (International Name):
FLUBENDAZOLE
Dosage:
100 mg/g
Pharmaceutical form:
Oral Emulsion
Prescription type:
POM: Prescription Only Medicine as defined in relevant national legislation
Therapeutic group:
Fowl - Chicken, Porcine
Therapeutic area:
flubendazole
Therapeutic indications:
Endoparasiticide
Authorization status:
Authorised
Authorization number:
VPA10047/040/001
Authorization date:
2012-09-14

Read the complete document

Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT

Solubenol 100 mg/g oral emulsion for pigs and chickens.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

3 PHARMACEUTICAL FORM

Oral emulsion.

White homogeneous viscous fluid.

4 CLINICAL PARTICULARS

4.1 Target Species

Pigs (piglets, pigs for fattening and pregnant sows) and chickens (layer hens, chickens for reproduction and pullets).

4.2 Indications for use, specifying the target species

In chickens:

Treatment of helminthiasis caused by:

- Ascaridia galli (mature stages)

- Heterakis gallinarum (mature stages)

- Capillaria spp.(mature stages)

In pigs:

Treatment of infection by mature stages and intestinal larval stages of Ascaris suum in piglets,

pigs for fattening and

pregnant sows.

4.3 Contraindications

Do not use in the case of hypersensitivity to the active substance or to any of the excipients.

Each gram contains:

Active substance

Flubendazole

100.0 mg

Excipients

Propyl parahydroxybenzoate (E216)

Methyl parahydroxybenzoate (E218)

Butylhydroxytoluene (E321)

Propylene glycol (E1520)

50.0

For a full list of excipients, see section 6.1.

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4.4 Special warnings for each target species

In chickens,

optimal

results can only be achieved if strict

rules of hygiene are respected in the maintenance of the

cages.

In both species:

Care should be taken to avoid the following practices because they increase the risk of development of resistance and

could ultimately result in ineffective therapy:

Too frequent and repeated use of anthelmintics from the same class, over an extended period of time.

Underdosing, which may be due to underestimation of body weight, misadministration of the product, or lack of

calibration of the dosing device (if any).

Suspected clinical cases of resistance to anthelmintics should be further investigated using appropriate tests (e.g. Faecal

Egg Count Reduction Test). Where the results of the test(s) strongly suggest resistance to a particular anthelmintic, an

anthelmintic belonging to another pharmacological class and having a different mode of action should be used.

4.5 Special precautions for use

Special precautions for use in animals

Development disorders of the feathers can not be fully excluded after the administration of flubendazole.

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

Direct contact with product should be avoided.

It is advisable to wear gloves when handling the product. Wash hands after use.

People with known hypersensitivity to flubendazole should avoid contact with the veterinary medicinal product.

In the event of eye contact, rinse thoroughly with water and if conjunctival redness persists, seek medical advice.

Other special precautions

Due to concerns for the environment when the product is used in free range poultry or pigs, animals must be kept

indoors during the treatment period and for 1 day after last treatment.

4.6 Adverse reactions (frequency and seriousness)

No undesirable effects have been demonstrated after administration of the therapeutic dose in pigs or in chickens.

4.7 Use during pregnancy, lactation or lay

The safety of the product has been demonstrated in layer hens. The product can be administered to these animals.

At the dose regimen of 1 mg flubendazole/kg/day for 5 days, the product can be used in pregnant sows.

The safety of the product has not been demonstrated at the dose regimen of 2.5 mg flubendazole/kg/day for 2 days. Do

not use in pregnant sows at this dose regimen.

The safety of the product has not been assessed in lactating sows. The use of the product during the lactation should be

subject to benefit/risk ratio assessment by the responsible veterinarian.

4.8 Interaction with other medicinal products and other forms of interaction

None known.

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4.9 Amounts to be administered and administration route

Posology:

Chickens:

1.43 mg flubendazole (= 14.3 mg product) per kg body weight daily via oral administration during 7 days, i.e. 1 g of

the product per 70 kg body weight daily for 7 days.

Pigs:

Treatment of mature stages and intestinal larval stages of Ascaris suum in piglets, pigs for fattening and pregnant

sows

1 mg flubendazole (= 10 mg product) per kg body weight daily via oral administration during 5 days, i.e. 1 g of

the product per 100 kg body weight daily for 5 days

Treatment of mature stages of Ascaris suum in piglets and pigs for fattening

2.5 mg flubendazole (= 25 mg product) per kg body weight daily via oral administration during 2 days, i.e. 2.5 g

of the product per 100 kg body weight daily for 2 days.

Pigs should be grouped according to their bodyweight and dosed accordingly, in order to prevent under or overdosing.

Calculate the dosage accurately with the following formula:

This will result in a concentration of flubendazole between 20 and 200 mg per litre.

Method of administration

Administration in drinking water:

The required quantity of the product is in function of the estimated body weight of the total group animals (see

table below for approximate amounts needed).

7 day treatment for chickens:

5 day treatment for pigs:

…mg [product ]

per kg bw/day

Average bw (kg) of the

treated animals

.... mg [product]

per litre drinking water

average quantity of drinking water (litre/animal)

consumed in 4 h

Total weight of

chickens

Amount of medication to be

used (g/ day)

Total amount of

medication used (g/ 7 days)

1400 kg

7000 kg

35000 kg

20 g

100 g

500 g

7 x 20 g

7 x 100g

7 x 500 g

Total weight of pigs

Amount of medication to be

used (g/ day)

Total amount of medication

used (g/ 5 days)

2000 kg

10000 kg

50000 kg

20 g

100 g

500 g

5 x 20 g

5 x 100g

5 x 500 g

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2 day treatment for pigs:

Each day a predilution is prepared containing the daily required dose of the product admixed in 10 to 100 times

its weight in water depending on the distribution system. For example: for 500 g of the product, add 5 litres to

50 litres of water.

Squeeze the sachet gently before use and then empty the contents into the predilution recipient.

Stir the predilution vigorously with a manual mixer (whisk) for at least 3 minutes to obtain a white milky

homogenous mixture.

This predilution must be distributed via the general water supply system:

Tanks: add the predilution to the quantity of water usually consumed by the animals over a period of up to 4

hours, homogenize the contents of the reservoir at least every 30 minutes with an electric or manual mixer.

Dosing pumps: adjust the flow rate of the pump to distribute the predilution over a period of up to 4 hours.

Homogenize the predilution every 30 minutes with an automatic mixer or manually.

In order to ensure administration of the correct dose, a substantial water flow must be present in the drinking water

system and mixing of the solution in the delivery system (tank or dosing pump) is essential during application.

Administration of the product over a period of up to 4 hours on each treatment day, at times when water

consumption is likely to be highest, prevents precipitation of flubendazole in the water delivery system and allows

washing out of the drinking water system within a 24 hour period after the period of drug administration is

finished.

Prior to and after the period of treatment make sure the water distribution system is cleaned.

Make sure that all animals in the group receive enough drinking water with the product. Withhold drinking

water for 2 hours before treatment to stimulate thirst.

The corresponding dose must always be distributed when the water consumption of the animals is highest.

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

In chickens, no undesirable effects have been observed after administration of up to

4 times the recommended dose for 14 days.

Even at doses 4 times the recommended dose, egg quality is not altered.

Only a reduction in egg weight

and a slight

decrease in egg production can be observed with doses of twice the

recommended dose and over.

Egg weight returns to normal when treatment is discontinued.

In pigs,

no undesirable effects have been observed at the highest dose; 5 x 2.5 mg per kg body weight during 3 x 2

consecutive days (or 12.5 mg during 6 consecutive days).

In the event of a massive overdose, mild transient diarrhoea can occur by the 2

day of treatment, possibly lasting for

7 to 12 days without affecting the behaviour or performance of the animals.

Total weight of pigs

Amount of medication to be

used (g/ day)

Total amount of medication

used (g/ 2 days)

2000 kg

10000 kg

50000 kg

50 g

250 g

1250 g

2 x 50 g

2 x 250g

2 x 1250 g

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4.11 Withdrawal Period(s)

Meat and offal:

chickens: 4 days.

pigs: 4 days.

Eggs:

zero days.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anthelmintic agent

ATCvet code: QP52AC12.

5.1 Pharmacodynamic properties

Flubendazole is a benzimidazole anthelmintic.

It acts by binding to tubulin of the parasite, the dimeric subunit protein

of the microtubules.

It inhibits micro tubular assembly in absorptive cells: i.e.

in intestinal cells of nematodes or the

tegumental cells of cestodes.

This is shown by disappearance of cytoplasmic microtubules, accumulation of secretory

granules in the cytoplasm due to a block in their transport, leading to an impaired coating of the cellular membrane and

a decreased digestion and absorption of nutrients. Irreversible lytic degeneration of the cell, due to the accumulation of

secretory substances (hydrolytic and proteolytic enzymes),

results in the death of

the parasite.

These changes are

relatively fast and are primarily seen in those organelles directly involved in the secretory and absorptive functions of

the cells.

In contrast the changes are not seen in cells of the host.

Another tubulin-related effect is the strong inhibition of egg hatch by inhibition of microtubule-dependent processes in

the developing worm egg (cell division).

5.2 Pharmacokinetic properties

Flubendazole is poorly soluble in aqueous systems, such as the gastrointestinal tract, which results in a low dissolution

rate and a low absorption.

This is reflected by the high faecal excretion of unchanged parent drug.

The small fraction

absorbed is extensively metabolised by first-pass metabolism in the liver,

involving carbamate hydrolysis and ketone

reduction.

The biotransformation products are conjugated to glucuronides or sulphate conjugates and excreted with the

bile and the urine.

The excretion with urine is relatively low and consists almost exclusively of metabolites with only small amounts of

unchanged compound.

In pigs and chicken, the half-life of flubendazole and its metabolites in plasma is 12 hours to 2 days.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Butylhydroxytoluene (E 321)

Propyl parahydroxybenzoate (E 216)

Methyl parahydroxybenzoate (E 218)

Propylene glycol (E 1520)

High oleic sunflower oil

Acacia

Monoglyceride citrate

Xanthan gum

Citric acid monohydrate

Disodium edetate

Sodium hydroxide

Purified water

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6.2 Incompatibilities

Do not mix with any other veterinary medicinal products.

6.3 Shelf-life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years

Shelf life after dilution or reconstitution according to directions: 1 day

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Sachets consisting of four layers PE/PET/ALU/PET in cardboard box :

Box containing 2 sachets of 20 g

Box containing 24 sachets of 20 g

Box containing 1 sachet of 100 g

Box containing 5 sachets of 100 g

Box containing 1 sachet of 500 g

Box containing 5 sachets of 500 g.

Not all pack sizes may be marketed.

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

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

disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

Eli Lilly & Company Limited

Elanco Animal Health

Lilly House

Priestly Road

Basingstoke

Hampshire

England

RG24 9NL

8 MARKETING AUTHORISATION NUMBER(S)

VPA 10047/040/001

9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 31

August 2007

Date of last renewal: 29

March 2011

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10 DATE OF REVISION OF THE TEXT

October 2014

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