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Date: Saturday, May 18, 2024 12:54

Description: 2015-Elanco-logo
Telephone: 01256 353131 (24 hr response) Veterinary Technical Services
Release 2.54
Flubenol 5 % w/w Premix for Medicated Feeding Stuff
 
Species: Pigs
Therapeutic indication: Medicinal feed additives: In-feed wormers, Pharmaceuticals: Endoparasiticides: Anthelmintics for pigs
Active ingredient: Flubendazole
Product:Flubenol 5 % w/w Premix for Medicated Feeding Stuff
Product index: Flubenol 5 % w/w Premix
Pig - meat: 7 days
Incorporating:
Qualitative and quantitative composition
Each gram contains:
Active substance:
Flubendazole 50 mg
Excipient:
Titanium dioxide 20 mg
For full list of excipients, see section Pharmaceutical Particulars
Pharmaceutical form
Premix for medicated feeding stuff
White to slightly yellow powder.
Clinical particulars
Target species
Pigs
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.
Contra-indications
Not applicable.
Special warnings for target species
None.
Special precautions for use
None.
Special precautions for use in animals
None.
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.
Adverse reactions (frequency and seriousness)
None known.
Use during pregnancy, lactation or lay
Not applicable.
Interaction with other medicinal products and other forms of interaction
None known.
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.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Flubendazole is an analog of mebendazole for which the side effects of overdose include transient gastrointestinal abnormalities.
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.
Pharmacological particulars
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.
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
Pharmaceutical particulars
List of excipients
Titanium dioxide (E171)
Lactose monohydrate
Sodium lauryl sulphate
Incompatibilities
None known
Shelf life
Shelf life of product as packaged for sale: 5 years
Shelf life after incorporation into meal or pelleted feed: 8 weeks
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.
Nature and composition of immediate packaging
Container: Low density polyethylene bag (in fibreboard drum or multi-walled paper sack).
OR: Laminated polyethylene (PE) / polyethylene-terephthalate (PET) bag
Container size: 25 kg.
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.
Marketing Authorisation Holder (if different from distributor)
N/A
Marketing Authorisation Number
Vm 00879/4179
Significant changes
Date of the first authorisation or date of renewal
17th September 1985
Date of revision of the text
June 2012
Any other information
Legal category
Legal category: POM-VPS
GTIN
GTIN description:Flubenol 5 % w/w Premix for Medicated Feeding Stuff 25kg
GTIN:05420036902195