Neocell

FLIMABEND 100 mg/g suspension for use in drinking water for chickens and pigs

STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

1 g of white to brownish white suspension contains 100 mg of flubendazole  with 2 mg of methyl parahydroxybenzoate (E218),  5 mg of sodium benzoate (E211) and 0,1 mg of disodium  edetate.


INDICATION(S)

In hens/chickens:
-    Treatment of helminthiasis caused by Ascaridia galli (adult stages), Heterak is gallinarum (adult
stages), Capillaria spp. (adult stages).

In pigs:
-    Treatment of helminthiasis  caused by Ascaris suum (adult and intestinal larval stages) in piglets, pigs for fattening, pregnant and lactating sows.



CONTRAINDICATIONS

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



ADVERSE REACTIONS

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

If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.


TARGET SPECIES

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


DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Oral use. Hens/chickens:
1.43 mg flubendazole (= 14.3 mg product) per kg body weight daily during 7 days i.e. 1 g of the product per 70 kg body weight daily for 7 days.

Pigs:
a)    Treatment  of  helminthiasis  caused  by  Ascaris  suum  (adult  stages  and  intestinal larval stages):
1 mg flubendazole (= 10 mg product) per kg body weight daily during 5 days, i.e. 1 g of the product per 100 kg body weight  daily for 5 days;
b)    Treatment of helminthiasis  caused by Ascaris suum (adult stages):
2.5 mg flubendazole (= 25 mg product) per kg body weight daily 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.


ADVICE ON CORRECT ADMINISTRATION

Administration  in drinking  water

1)    The required quantity of the product is in function of the estimated body weight of the total group animals (see table below for guidance).

Hens/chickens, 7 days of treatment

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 100 g 7 x 500 g

Pigs, 5 days of treatment

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 100 g 5 x 500 g

Pigs, 2 days of treatment

Total weight of pigs	Amount of medication to be used (g/ day)	Total amount of medication used (g/ 2 days)
2000 kg 4000 kg 40000 kg	50 g 100 g 1000 g	2 x 50 g 2 x 100 g 2 x 1000 g

2)    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.

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

4)    If less than entire sachet is required, the required dose should be measured by suitably calibrated weighing  equipment.

5)    Stir the predilution vigorously with a manual mixer (whisk) for 2 minutes to obtain a white milky  homogenous  mixture.

6)    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.
Dosing pumps: adjust the flow rate of the pump to distribute the predilution over a period of up to 4 hours.

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

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

8)    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.

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


WITHDRAWAL PERIOD

Meat and offal: chickens: 2 days pigs:
-    dose 1 mg/kg body weight for 5 days: 3 days
-    dose 2.5 mg/kg body weight for 2 days: 4 days
Eggs: zero days



SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

This veterinary medicinal product does not require any special storage conditions.
Do not use this veterinary  medicinal  product after the expiry date which is stated on the packaging after {EXP}.
Shelf life after dilution  according to directions: 24 hours.


SPECIAL WARNING(S)

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.

Special precautions for use in animals
Development   disorders   of   the   feathers   cannot   be   fully  excluded  after  the   administration  of
flubendazole.

Use during pregnancy, lactation or lay
Laboratory   studies   in   rabbits   and   rats   have   not   produced   any   evidence   of   embryotoxicity,
teratogenicity at therapeutic doses. High dosages gave equivocal results. In laboratory studies in rats, there were no effects on pups during lactation.
The  safety  of  the product has been demonstrated in laying hens, pregnant and lactating sows. The
product can be administered to these animals.

Interaction and incompatibilities
None known.
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal  products.

Overdose (symptoms, emergency procedures, antidotes), if necessary
Flubendazole  has a low acute oral toxicity.
In hens, no undesirable effects have been observed after administration of up to 15 mg/kg b.w./day flubendazole.
In porcine, no adverse effects have been observed after administration of up to 50 mg/kg b.w./day flubendazole.
In  situation  when  accidental  overdose  is  suspected  of  having  occurred,  there  is  no antidote  and treatment should be symptomatic.

User warnings
Direct contact with product should be avoided. Wear protective gloves while using 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. In case of appearance and persistence of conjunctival redness, seek medical advice and show the package leaflet to the physician.
Box containing 2 sachets  (sachet  PE/PET/aluminium/PET)  of  20  g  suspension  for  use  in  drinking water.
Box  containing  24  sachets  (sachet  PE/PET/aluminium/PET)  of 20 g suspension for use in drinking water.
Box containing 2 sachets  (sachet  PE/PET/aluminium/PET)  of  50  g  suspension  for  use  in  drinking
water.
Box  containing  24  sachets  (sachet  PE/PET/aluminium/PET)  of 50 g suspension for use in drinking water.
Box containing  1 sachet (sachet PE/PET/aluminium/PET) of 100 g suspension for use in drinking water.
Box containing  5 sachets (sachet PE/PET/aluminium/PET) of 100 g suspension for use in drinking water.
Box containing  25 sachets (sachet PE/PET/aluminium/PET) of 100 g suspension for use in drinking water.
Not all pack sizes may be marketed.

For any information  about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.