SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Johnson's Veterinary Easy Round Wormer Granules for Cats & Kittens 222.2 mg

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 1 g sachet contains:

Active substance:

Fenbendazole 222.2 mg

Excipient(s):

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Granules

A free flowing white to greyish white granular powder

4. CLINICAL PARTICULARS

4.1 Target species

Cat.

4.2 Indications for use, specifying the target species

The product is indicated for the treatment of immature and mature stages of common roundworm of cats. It also has an ovicidal effect on nematode eggs.

4.3 Contraindications

None known.

4.4 Special warnings for each target species

For the treatment of pregnant cats seek the advice of a veterinary surgeon.

None

Direct contact with the skin should be kept to a minimum. Avoid inhalation of granule dust. Wash hands after use.

4.6 Adverse reactions (frequency and seriousness)

None known

4.7 Use during pregnancy, lactation or lay

Not recommended.

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; sprinkled onto food or by mouth.

For the routine treatment of adult cats a dosage of 100 mg/kg is recommended.

For the treatment of weaned kittens (over 12 weeks old and under 6 months old) 50 mg/kg daily for 3 days is recommended. Very small or unweaned kittens should be treated with a suitable licensed product up to 12 weeks of age.

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

Benzimidazoles have a wide margin of safety.

4.11 Withdrawal period(s)

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Anthelminthics (Benzimidazoles and related substances)

ATC Vet code: QP52AC13

Contains fenbendazole which is a member of the benzimidazole family of anthelmintics and has been in veterinary use for a number of years. Fenbendazole acts against parasites by disrupting the formation of microtubules by binding to tubulin in parasitic intestinal cells hence preventing the absorption of glucose, parasites are gradually starved to death. Fenbendazole displays preference for parasitic as opposed to mammalian tubulin; this appears to be due to the fact that the formation of the parasitic tubulin-fenbendazole complex is more favourable kinetically under physiological conditions than the mammalian complex.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lactose monohydrate

Povidone K30

Sodium Lauryl Sulphate

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

Store in a dry place.

Add to feed immediately before administration. Discard any remaining medicated feed.

6.5 Nature and composition of immediate packaging

Sachet consisting of paper, low density polyethylene and foil containing 1 g of granules, with a heat-seal closure.

Carton containing 3 x 1g sachets.

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

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool

L1 9HZ

8. MARKETING AUTHORISATION NUMBER

Vm11990/4014

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date: 15 August 1995

10 DATE OF REVISION OF THE TEXT

Date:July 2013

Approved: 10/07/2013