Fenbenor 2.5%

​Active Ingredient: Fenbendazole

Target Species: Sheep

Treats and Controls: Gastrointestinal roundworms, lungworms

Administration Method: Oral Drench

Withdrawal Time:28 days for animals intended for meat and offal, not permitted for use on animals producing milk for human consumption.

Dosage:2 ml per 10 kg of bodyweight

Always read the label and all enclosed information for Fenbenor 2.5% before administering to animals!

What are the signs and effects of livestock infected with worms?

1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Fenbenor 2.5% w/v Oral Drench.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients see section 6.1.
Each ml contains:
Active substance
Fenbendazole 25.0 mg
Excipients
Methyl Parahydroxybenzoate (E218) 2.0 mg
Propyl Parahydroxybenzoate (E216) 0.2 mg
SodiumMetabisulphite 1.0 mg

3 PHARMACEUTICAL FORM
Oral suspension. A white to off-white suspension.

4 CLINICAL PARTICULARS
4.1 Target Species
Sheep.

4.2 Indications for use, specifying the target species
Fenbenor 2.5% w/v Drench is a broad spectrum anthelmintic for control of benzimidazole susceptible mature and
developing immature forms of the following nematodes of the gastrointestinal and respiratory tracts of sheep.
For the treatment of sheep infected with:
Haemonchus spp.
Ostertagia spp.
Trichostrongylus spp.
Cooperia spp.
Nematodirus spp.
Bunostomum spp.
Trichuris spp.
Strongyloides spp.
Oesophagostomum spp.
Dictyocaulus spp
Moniezia spp.
Each ml contains:
Active substance
Fenbendazole 25.0 mg
Excipients
Methyl Parahydroxybenzoate (E218) 2.0 mg
Propyl Parahydroxybenzoate (E216) 0.2 mg
SodiumMetabisulphite 1.0 mg

4.3 Contraindications
Do not use in animals with known hypersensitivity to the active ingredient.

4.4 Special warnings for each target species
When dosing sheep, care must be taken not to damage the mouth or pharyngeal region with drenching equipment.
As with other anthelmintics, veterinary advice should be sought on appropriate dosing programmes and stock management
to achieve adequate parasite control and reduce the likelihood of anthelmintic resistance developing. If the product does
not achieve the desired clinical effect, other diseases, nutritional disturbances or anthelmintic resistance may be involved.

4.5 Special precautions for use
Special precautions for use in animals
None.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Estimate bodyweight carefully.
Use only properly calibrated dosing equipment.

4.6 Adverse reactions (frequency and seriousness)
None known.

4.7 Use during pregnancy, lactation or lay
Sheep have been reported to be sensitive to benzimidazoles during the first quarter of gestation.

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 in sheep.
Shake well before use.
The recommended treatment dose is 5 mg Fenbendazole per kg bodyweight.
Practical dosage recommendations are as follows:
Bodyweight (kg) Dose (ml) Number of doses per pack
10 2.0 500
50 10.0 100

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Not applicable.

4.11 Withdrawal Period(s)
Sheep must not be slaughtered for human consumption during treatment or for 28 days thereafter.
This product should not be used in ewes producing milk for human consumption.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic Group: Anthelmintic, fenbendazole,
ATCvet Code: QP52AC13.
Summary presentation of the active ingredient
Fenbendazole is an anthelmintic belonging to the benzimidazole group which acts by blocking fumarate reductase which
results in the inhibition of the formation of adenosine triphosphate (involved in mitochondrial energy).

5.1 Pharmacodynamic properties
Fenbendazole, like many benzimidazoles, blocks fumarate reductase which results in the inhibition of the formation of
adenosine triphosphate (involved in mitochondrial energy). There is also evidence that it inhibits glucose uptake and
therefore increases glycogen utilization and depletes the worm’s glycogen reserves. The overall effect of this action is
to effectively starve the parasite to death. Furthermore this action results in the detachment of the parasites but in the
case of intestinal helminths this detachment does not result in loss of contact with the drug whereas in the case of the
liver fluke such detachment would reduce such contact. This probably explains its limited effect on the liver fluke and
the good effect on intestinal helminths.

5.2 Pharmacokinetic properties
Fenbendazole is poorly soluble in water and consequently is poorly absorbed; something which is reflected in the relatively
low plasma levels.
The scheme for the known metabolic pathways is given by Short, Flory, Hsieh and Barker (1988) together with the relative
rates of breakdown in various species. The main breakdown products are the sulphoxide (oxfendazole) and sulphone.

6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Polysorbate 80
Sodium metabisulphite
Methyl Parahydroxybenzoate (E218)
Propyl Parahydroxybenzoate (E216)
Sodium Citrate
Citric Acid
Simeticone emulsion
Xanthan Gum
PurifiedWater

6.2 Incompatibilities
None known.

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

6.4 Special precautions for storage
Do not store above 25oC.
Do not freeze.

6.5 Nature and composition of immediate packaging
1 L (jerrican, flat bottom flexi), 2.5 L (jerrican, back pack), 5 L (jerrican) HDPE white rigid containers closed with a HDPP
screw cap with a wood pulp PVDC liner.
Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials
Empty containers must be rinsed with water before disposal.
Dispose of used containers safely.
Do not contaminate ponds, waterways or ditches with product or used containers.
Unused product or waste material should be disposed of in accordance with current practice for pharmaceutical waste
under national waste disposal regulations

7 MARKETING AUTHORISATION HOLDER
Pharvet (Ireland) Ltd.,
29 Cookstown Industrial Estate,
Dublin 24,
Ireland.

8 MARKETING AUTHORISATION NUMBER(S)
VPA: 10462/002/002

9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
3rd August 2007

10 DATE OF REVISION OF THE TEXT
October 2012

At Agridirect we have joined forces with Fastway & DPD, to ensure your products are delivered to your door within 2-4 working days from time of order.

Our delivery charges are as follows:

Ireland

€4.99 for all orders UNDER €70

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Agridirect
Drumrahan Retail Ltd
Church Street
Ballyconnell
Co. Cavan

....and we will either replace the product(s) or refund you the cost of the original product(s).

Before returning any products please contact our office on 049 9527944 within the 14 day period as stated above. Residents outside Ireland please call +353 49 9527944.

Once the goods have been received by us and are in the same condition as when despatched we will refund all monies due to you. 

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