Summary of Product Characteristics s7

Revised: August 2009 AN: 00643/2009

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE V ETERINARY MEDICINAL PRODUCT FOLLOWED BY THE STRENGTH AND THE PHARMACEUTICAL FORM

Panacur 4% Powder Premix for medicated feed

2. NAME AND PROPORTION OF EACH ACTIVE SUBSTANCE, AND OF ANY EXCIPIENT, IF KNOWLEDGE OF THE EXCIPIENT IS NEEDED FOR SAFETY REASONS

Active substances %w/w

Fenbendazole 4.0

Other substances

For full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Powder for premix for medicated feed.

4. CLINICAL PARTICULARS

4.1 Target species

Pigs and Cattle

4.2 Indications for use, specifying the target species

Pigs : A broad spectrum anthelmintic for the treatment of pigs infected with immature and mature forms of gastro-intestinal and respiratory nematodes, including: Hyostrongylus rubidus (red stomach worm) Oesophagostomum spp (nodular worm) Ascaris suum (roundworm) Trichuris suis (whipworm) Metastrongylus apri (lungworm) (as an aid in its control).

Cattle : For the treatment of cattle infected with mature and developing immature forms of nematodes of the gastro-intestinal and respiratory tracts, including : Ostertagia spp Haemonchus spp Cooperia spp Oesophagostomum spp Trichostrongylus spp Strongyloides spp Bunostomum spp Trichuris spp Nematodirus spp Dictyocaulus viviparus Panacur is usually effective against inhibited larvae of Ostertagia spp and against Moniezia spp of tapeworm.

Panacur has an ovicidal effect on nematode eggs. Revised: August 2009 AN: 00643/2009

4.3 Contra-indications

4.4 Special warning for each target species

The product may not be effective against Trichuris and Strongyloides species when given by divided dosage in cattle.

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.

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

5.1. Special precautions for use i. Special precautions for use in animals

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

Incorporation into the feed must be done by a suitably approved manufacturer.

Impervious gloves must be worn when handling this product or feed containing this product

When handling or mixing, care should be taken to avoid direct contact with the skin and inhalation of any dust by wearing protective clothing, rubber gloves and a disposable half-mask respirator conforming to European Standard EN149 or a non- disposable respirator to European Standard EN 140 with a filter to EN 143.

Wash hands and exposed skin after handling medicated feedstuffs.

4.6 Adverse reactions (frequency and seriousness)

4.7 Use during pregnancy, lactation or lay

The product can be safely administered to pregnant animals. Revised: August 2009 AN: 00643/2009

4.8 Interaction with other medicinal products and other forms of interaction

None known.

4.9 Amounts to be administered and administration route

When incorporated at a rate of below 2kg/tonne of final feed, the product must only be mixed by a manufacturer who is approved to mix at that level.

No dietary control is required before or after treatment.

Pigs : The product is suitable for herd medication of pigs. The standard dose rate is 5 mg fenbendazole per kg bodyweight.

Routine treatment - herd medication :

May be administered to pigs either as a single dose or by divided dosage over 7 days. It may also be administered to sows over 14 days. All methods of treatment are equally effective. To avoid underdosing, all incorporation rate calculations should be based on the heaviest pig in the group.

a) Single dose treatment

Use the following formula to calculate how much product to add per tonne of feed:

Kg = Bodyweight (kg) Powder per tonne (Daily feed intake (kg) x 8)

b) 7 day treatment

The standard dose rate can be divided and administered in feed over 7 days. Use the following formula to calculate how much product to add per tonne of feed:

kg = Bodyweight (kg) Powder per tonne (Daily feed intake (kg) x 56)

c) 14 day treatment of sows

The standard dosage can be divided and administered to sows in the feed over 14 days. Use the following formula to calculate how much product to add per tonne of feed:

Kg = Bodyweight (kg) Powder per tonne (Daily feed intake (kg) x 112)

Treatment for specific infections

For the treatment of Metastrongylus apri (lungworm) and/or Trichuris suis, it is recommended that the dosage is divided and administered over 7 days for most effective treatment. Revised: August 2009 AN: 00643/2009

Suggested dosing programmes for pigs:

Sows and boars : Treat sows before entering farrowing accommodation and again after weaning. This will maintain the sow's condition and reduce the risk of infection to her piglets.

Boars should be treated every 6 months.

Growing and Finishing pigs : Dose weaners on purchase or on movement to finishing house. Where there is a high risk of Ascariasis ("Milk Spot Liver"), repeat treatment at monthly intervals.

Whole herd treatment : Treatment of the whole herd (all adult and young stock) simultaneously every 6 months will minimise the risk of reinfestation. This should be carried out routinely unless recommended otherwise by a veterinary surgeon. It should also be combined with careful attention to environmental hygiene which is especially important for control of "Milk Spot Liver".

Outdoor pigs : When clean grazing is available, dose before moving stock onto it. If clean land is not available then pigs should be treated monthly from July to October.

Cattle : Cattle can be treated by dividing the dose over 5 or 10 consecutive days: a) 5-day treatment

Administer a daily dose of 1.5 mg fenbendazole per kg bodyweight for 5 consecutive days. This is most easily achieved by mixing 18.75 g product with 5 kg feed and feeding 1 kg medicated feed per 100 kg bodyweight daily for 5 days.

Practical dosage recommendations:

Total quantity of Cattle Daily amount of medicated medicated feed Bodyweight feed required per animal required for 5 days 100 kg 1 kg 5 kg 150 kg 1.5 kg 7.5 kg 200 kg 2 kg 10 kg 250 kg 2.5 kg 12.5 kg b) 10-day treatment

Administer a daily dose of 0.75 mg fenbendazole per kg bodyweight for 10 consecutive days. This is most easily achieved by mixing 18.75 g product into 10 kg feed and feeding 1 kg medicated feed per 100 kg bodyweight daily for 10 days. Revised: August 2009 AN: 00643/2009

Practical dosage recommendations:

Total quantity of Cattle Daily amount of medicated medicated feed Bodyweight feed required per animal required for 10 days 100 kg 1 kg 10 kg 150 kg 1.5 kg 15 kg 200 kg 2 kg 20 kg 250 kg 2.5 kg 25 kg

To ensure administration of a correct dose, body weight should be determined as accurately as possible; accuracy of the dosing device should be checked.

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

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

Benzimidazoles have a wide margin of safety.

4.11 Withdrawal periods for the various foodstuffs, including those for which the withdrawal period is zero

Animals must not be slaughtered for human consumption during treatment.

Pigs meat - 3 days Cattle meat - 14 days milk - 120 hours

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Fenbendazole is an anthelmintic belonging to the benzimidazole carbamates group. It acts by interfering with the energy metabolism of the nematode. The anthelmintic affects both adult and immature stages of gastro-intestinal and respiratory nematodes. The anthelmintic efficacy is based on inhibition of the polymerisation of tubulin to microtubuli.

ATC Code: QP52AC13

5.2 Pharmacokinetic particulars

Fenbendazole is only partly absorbed after oral administration and is then metabolised in the liver. The half-life of fenbendazole in serum after oral application of the recommended dose in cattle is 10 - 18 hours, in sheep 21 - 33 hours and in pigs 10 hours. Fenbendazole and its metabolites are distributed throughout the body and high concentrations can be found in the liver. The elimination of fenbendazole and its metabolites occurs primarily via the faeces (>90%) and to a small extent in the urine and milk.

Fenbendazole is metabolised to its sulphoxide, then to sulphone and amines. Revised: August 2009 AN: 00643/2009

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Calcium Carbonate, Maize Starch, Lactose Monohydrate, Silica Colloidal Anhydrous

6.2 Major incompatibilities

Do not add to liquid feeds or supplements.

6.3 Shelf life, when necessary after reconstitution of the medicinal product or when the immediate packaging is opened for the first time

5 years The product will remain stable in finished feed for 3 months.

6.4 Special precautions for storage

When preparing medicated feeds for pigs or cattle, which are to be administered over a number of days, to ensure a thorough dispersion a pre-mix should be prepared first. For example, for pig feeds the product should first be mixed with 2.5 kg of feed for every tonne of medicated feed being manufactured. Once mixed, this should then be incorporated with the remaining feed.

The product can be incorporated into pelleted feed preconditioned with steam at a temperature not greater than 75°C.

When incorporated at a rate of below 2kg/tonne of final feed, the product must only be mixed by a manufacturer who is approved to mix at that level.

6.5 Nature and composition of immediate packaging

25 kg polyethylene-lined fibre drums. 25 kg cardboard box containing two 12.5 kg heat sealed low density polyethylene bags. 2.5 kg buckets with polythene bag with push-fit lid.

Not all pack sizes may be marketed.

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

Any unused product or waste material should be disposed of in accordance with national requirements. Dangerous to aquatic life. Do not contaminate ponds, waterways or ditches with the product or used container.

7. MARKETING AUTHORISATION HOLDER

Intervet UK Ltd. Walton Milton Keynes Bucks. MK7 7AJ Revised: August 2009 AN: 00643/2009

8. MARKETING AUTHORISAT I O N NUMBER

Vm 01708/4449

9. DATE OF FIRST AUTHORIS ATION OR DATE OF RENEWAL OF THE AUTHORISATION

Date of last renewal: 27 June 2004

10. DATE OF REVISION OF TEXT

August 2009