Flubenol 5%

1 x 25 kg
Premix for medicated feeding
PA

Active substance

  • Flubendazole : 50 mg/g
  • Species

    Pigs

    Indications

    Flubendazole is a broad spectrum anthelmintic for oral administration, active against mature and immature stages of the following nematodes of the gastro-intestinal tract of the pig:

    Ascaris suum (large roundworm)

    Hyostrongylus rubidus (red stomach worm)

    Oesophagostomum dentatum (nodular worm)

    Trichuris suis (whip worm)

    Strongyloides ransomi (threadworm) (adult).

    Metastrongylus apri (lungworm).

    Flubendazole is ovicidal.

    Dose to be administered and administration route

    For oral administration only.

    For incorporation into dry feed at a registered mill.

    A manufacturer who is approved to incorporate directly at any concentration, veterinary medicinal products or premixtures containing such products, must be responsible for mixing when incorporation is less than 2 kg per tonne for final feed.

    Dosage

    The standard recommended total dosage is 5 mg flubendazole per kg bodyweight. The amount of the veterinary medicinal product to be incorporated should be calculated according to the average bodyweight of the pigs to be treated.

    Incorporation and dosing instructions

    If animals are to be treated collectively rather than individually, they should be grouped according to their bodyweight and dosed accordingly, in order to avoid under- or over-dosing.

    As a guide, the following incorporation rates are suggested:

    Standard dosing regime Incorporation:

    Add 600 g of the veterinary medicinal product to at least 5 kg of one of the feed ingredients and mix well. Thoroughly mix this premix with the remaining ingredients making in all one tonne of medicated feed, which can then be fed as mash or pellets. This gives 30 mg flubendazole per kg of finished feed.

    Breeding stock should be treated for 10 consecutive days. Weaners and fattening pigs –should be treated for 5 consecutive days, or the event of a heavy Trichuris infestation, for 10 consecutive days.

    Variable dosing regime

    To facilitate feeding for different lengths of time to suit the intervals between feed deliveries, the standard dosage can be divided and administered over differing periods of time, as shown below.

    Incorporation:

    Add the required amount of the veterinary medicinal product to at least 5kg of one of the feed ingredients. Thoroughly mix this premix with the remaining ingredients making in all one tonne of medicated feed, which can then be fed as mash or pellets.

    a) Breeding stock

    Amount of the veterinary medicinal product to add to each 5 kg premix for making up each tonne of final feed

    Flubendazole inclusion rate

    in final feed

    (mg/kg)

    Duration of treatment (days)

    Total dose of

    flubendazole (mg/kg bodyweight)

    Uses

    400 g

    20

    14

    5

    Ascaris suum,

    Oesophagostomum dentatum and Hyostrongylus rubidus

    300 g

    15

    21

    5

    200 g

    10

    28

    5

     

    b) Weaners and fattening pigs

    Amount of the veterinary medicinal

    Flubendazole inclusion rate

    Duration of

    Total dose of

    Uses

    product to add to each 5 kg premix for making up each tonne of final feed

    in final feed (mg/kg)

    treatment (days)

    flubendazole (mg/kg bodyweight)

     

    200 g

    10

    14

    5

    Ascaris suum,

    Oesophagostomum dentatum and Hyostrongylus rubidus

    150 g

    7.5

    21

    5

    In the event of a heavy Trichuris infestation, use 600 g/tonne (30 mg/kg final feed) for 10 days.

    Treatment frequency:

    Pigs should be treated twice a year unless recommended otherwise by a veterinary surgeon. Pigs brought onto the premises should be treated on arrival and before mixing with other animals.

    Treatment of clinical worm infestations:

    Treat relevant infestations at the following intervals:

    Lungworm

    every 3 - 4 weeks

    Nodular worm

    every 2 months

    Large round worm

    every 2 months

    Red stomach worm

    every month

    Whipworm

    every 6 weeks

    Consult a veterinary surgeon for initial identification of problem species.

    Adverse reactions

    Pigs:

    None known.

    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 the national competent authority via the national reporting system. See the package leaflet for respective contact details.

    Dispensing

    POM-VPS - Prescription Only Medicine – Veterinarian, Pharmacist, SQP

    SUMMARY OF PRODUCT CHARACTERISTICS

    1. NAME OF THE VETERINARY MEDICINAL PRODUCT

    Flubenol 5 % w/w Premix for Medicated Feeding Stuff

    2. QUALITATIVE AND QUANTITATIVE COMPOSITION

    Each gram contains:

    Active substance: Flubendazole 50 mg

    Excipient:

    Titanium dioxide 20 mg

    For full list of excipients, see section 6.1.

    3. PHARMACEUTICAL FORM

    Premix for medicated feeding stuff White to slightly yellow powder.

    4. CLINICAL PARTICULARS

    4.1 Target species

    Pigs

    4.2 Indications for use, specifying the target species

    Flubendazole is a broad spectrum anthelmintic for oral administration, active against mature and immature stages of the following nematodes of the gastro-intestinal tract of the pig:

    Ascaris suum (large roundworm)

    Hyostrongylus rubidus (red stomach worm)

    Oesophagostomum dentatum (nodular worm)

    Trichuris suis (whip worm)

    Strongyloides ransomi (threadworm) (adult). Metastrongylus apri (lungworm).

    Flubendazole is ovicidal.

    4.3 Contra-indications

    Not applicable.

    4.4 Special warnings for target species

    None. 4.5 Special precautions for use

    None.

    i. Special precautions for use in animals

    None.

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

    Accidental ingestion by humans should be avoided. May cause sensitisation by skin contact. May cause skin and eye irritation. Avoid direct skin contact. Wear overalls, safety glasses and impervious gloves when mixing and handling the product. Wash affected parts if skin contact occurs. If accidental eye contact occurs, immediately rinse thoroughly with water. If the operations involve potential exposure to dust, wear either a disposable filter and half-mask respirator conforming to European Standard EN149, or a non-disposable respirator to European Standard EN140 fitted with a filter to EN143.

    4.6 Adverse reactions (frequency and seriousness)

    None known.

    4.7 Use during pregnancy, lactation or lay

    Not applicable.

    4.8 Interaction with other medicinal products and other forms of interaction

    None known.

    4.9 Amounts to be administered and administration route

    For oral administration only.

    For incorporation into dry feed at a registered mill.

    A manufacturer who is approved to incorporate directly at any concentration, veterinary medicinal products or premixtures containing such products, must be responsible for mixing when incorporation is less than 2 kg per tonne for final feed.

    Dosage

    The standard recommended total dosage is 5 mg flubendazole per kg bodyweight. The amount of product to be incorporated should be calculated according to the average bodyweight of the pigs to be treated.

    Incorporation and dosing instructions

    If animals are to be treated collectively rather than individually, they should be grouped according to their bodyweight and dosed accordingly, in order to avoid under- or over-dosing.

    As a guide, the following incorporation rates are suggested:

    Standard dosing regime

    Incorporation:

    Add 600 g of Flubenol 5 %w/w Premix to at least 5 kg of one of the feed ingredients and mix well. Thoroughly mix this premix with the remaining ingredients making in all one tonne of medicated feed, which can then be fed as mash or pellets. This gives 30 mg flubendazole per kg of finished feed.

    Breeding stock should be treated for 10 consecutive days. Weaners and fattening pigs –should be treated for 5 consecutive days, or the event of a heavy Trichuris infestation, for 10 consecutive days.

    Variable dosing regime

    To facilitate feeding for different lengths of time to suit the intervals between feed deliveries, the standard dosage can be divided and administered over differing periods of time, as shown below.

    Incorporation:

    Add the required amount of Flubenol 5% Premix to at least 5kg of one of the feed ingredients. Thoroughly mix this premix with the remaining ingredients making in all one tonne of medicated feed, which can then be fed as mash or pellets.

    a) Breeding stock

    Amount of Flubenol 5

    % w/w to add to each 5 kg premix for making up each tonne of final feed

    Flubendazole inclusion rate

    in final feed

    (mg/kg)

    Duration of treatment (days)

    Total dose of

    flubendazole (mg/kg bodyweight)

    Uses

    400 g

    20

    14

    5

    Ascaris suum,

    Oesophagostomum dentatum and Hyostrongylus rubidus

    300 g

    15

    21

    5

    200 g

    10

    28

    5

    b) Weaners and fattening pigs

    Amount of Flubenol 5 % w/w to add to each 5 kg premix for making up each tonne of final feed

    Flubendazole inclusion rate

    in final feed

    (mg/kg)

    Duration of treatment (days)

    Total dose of

    flubendazole (mg/kg bodyweight)

    Uses

    200 g

    10

    14

    5

    Ascaris suum,

    Oesophagostomum dentatum and Hyostrongylus rubidus

    150 g

    7.5

    21

    5

    In the event of a heavy Trichuris infestation, use 600 g/tonne (30 mg/kg final feed) for 10 days.

    Treatment frequency:

    Pigs should be treated twice a year unless recommended otherwise by a veterinary surgeon. Pigs brought onto the premises should be treated on arrival and before mixing with other animals.

    Treatment of clinical worm infestations:

    Treat relevant infestations at the following intervals:

    Lungworm

    every 3 - 4 weeks

    Nodular worm

    every 2 months

    Large round worm

    every 2 months

    Red stomach worm

    every month

    Whipworm

    every 6 weeks

    Consult a veterinary surgeon for initial identification of problem species.

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

    Flubendazole is an analog of mebendazole for which the side effects of overdose include transient gastrointestinal abnormalities.

    4.11 Withdrawal period(s)

    Animals must not be slaughtered for human consumption during treatment. Pigs may be slaughtered for human consumption only after 7 days from the last treatment.

    5. PHARMACOLOGICAL PROPERTIES

    5.1 Pharmacodynamic properties Pharmacotherapeutic group: Anthelmintic

    ATCvet code: QP52AC12.

    Flubendazole is a synthetic anthelmintic belonging to the benzimidazole carbamates which acts by inhibiting the microtubular assembly in absorptive cells of nematodes.

    Flubendazole acts by binding to tubulin, the dimeric subunit protein of the microtubules. It inhibits microtubular assembly in absorptive cells: i.e. of intestinal cells of nematodes. 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 host cells.

    5.2 Pharmacokinetic particulars

    Flubendazole is very poorly soluble in aqueous systems, such as the gastrointestinal tract, which results in a low dissolution rate and a very low absorption. This is reflected by the high faecal excretion of unchanged parent drug. The very 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 in the bile and the urine.

    The excretion in urine is relatively low and consists almost exclusively of metabolites with only small amounts of unchanged compound. In pigs, highest tissue levels are measured in liver and kidneys. The half life of flubendazole in tissues is 1 - 2 days.

    6. PHARMACEUTICAL PARTICULARS

    6.1 List of excipients

    Titanium dioxide (E171)

    Lactose monohydrate

    Sodium lauryl sulphate

    6.2 Incompatibilities

    None known

    6.3 Shelf life

    Shelf life of product as packaged for sale: 5 years

    Shelf life after incorporation into meal or pelleted feed: 8 weeks

    6.4 Special precautions for storage

    Do not store above 25 °C.

    Store in tightly closed original containers.

    The product will remain stable in the finished feed for eight weeks.

    The product can be incorporated into pelleted feed, preconditioned with steam for up to

    5 minutes at a temperature of 77 °C and can withstand pelleting temperatures up to 116 °C. When used as recommended, this product should only be incorporated by approved manufacturers.

    6.5 Nature and composition of immediate packaging

    Container: Multilayered bag – LDPE/Aluminum/kraft paper Container size: 25 kg.

    6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

    Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

    7. MARKETING AUTHORISATION HOLDER

    Elanco Europe Ltd

    Form 2, Bartley Way

    Bartley Wood Business Park

    Hook

    RG27 9XA

    United Kingdom

    8. MARKETING AUTHORISATION NUMBER

    Vm 00879/4179

    9. DATE OF FIRST AUTHORISATION

    17 September 1985

    10. DATE OF REVISION OF THE TEXT

    September 2022

    image

    Approved: 01 September 2022

    Pig icon
    Product identification - 00879/4179
    Art. Nr. 00879/4179
    EAN 5420036902195
    PACKAGES
    Flubenol 5%
    Elanco Animal Health
    1 x 25 kg
    00879/4179

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    Flubenol 5% (1 x 25 kg)

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    50 mg/g Premix for medicated feeding
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    Flubenol 5% (1 x 25 kg)

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