SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Troscan 100 mg film-coated tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substances:

Nitroscanate 100 mg

Excipient(s):

Titanium Dioxide (E171) 0.8038 mg

Ferric Oxide Yellow (E172) 0.0257 mg

Ferric Oxide Black (E172) 0.00003 mg

Ferric Oxide Red (E172) 0.00003 mg

As constituents of Opadry OY-GM 7900

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Film-coated tablets.

Round convex tablets, yellow coloured, film coated.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs

4.2 Indications for use, specifying the target species

Is a broad spectrum anthelmintic for use in puppies and adult dogs. Is highly effective in the control of cestodes and common intestinal nematodes: Toxocara canis, Toxascaris leonina, Uncinaria stenocephala, Ancylostoma caninum, Taenia hydatigena, Taenia pisiformis, and Dipylidium caninum. Gives a limited level of control of Echinococcus granulosus.

4.3 Contraindications

When administered as recommended is unlikely to cause vomiting. Do not repeat treatment if vomiting occurs shortly after dosing. Do not administer if your pet is sick or recovering from an illness. If a hypersensitivity reaction occurs treatment should be discontinued.

Is not indicated for the treatment of Trichuris vulpis

It is recommended that adult dogs should be wormed routinely 2 - 4 times a year. Since the most common tapeworm of the dog (Dipylidium caninum) is transmitted by a flea and has a very short pre-patent period, it is important to pay attention to flea control to reduce the incidence of tapeworm in your pet.

It is important to worm young puppies very regularly for roundworm with Troscan 100 at 2 weekly intervals from the age of 2 weeks for pups less than 8 weeks of age. It is then recommended that Troscan 100 be used at 8, 12, 16, and 24 weeks of age. Nursing bitches should be treated at the same time and as frequently as puppies up to 12 weeks of age. Thereafter the adult worming regime of 2 - 4 times a year is recommended.

If symptoms of disease persist or appear, consult your veterinary surgeon.

4.5 Special precautions for use

Special precautions for use in animals

Is irritant, tablet should not be broken.

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

This product can be an irritant to the skin and eyes. Tablets are film-coated and should not be broken or divided.

4.6 Adverse reactions (frequency and seriousness)

None known.

4.7 Use during pregnancy, lactation or lay

Can be safely used during pregnancy and lactation.

4.8 Interaction with other medicinal products and other forms of interaction

None known

4.9 Amounts to be administered and administration route

The dose of the product for the routine treatment of puppies and adult dogs is nitroscanate 50 mg/kg bodyweight, which is equivalent to 1 x 100 mg tablet per 2 kg (4.4 lb) bodyweight. Puppies should be dosed at 2, 4, 6, 8, 12, 16 and 24 weeks. Adult dogs should be dosed 2 - 4 times a year.

Should be administered orally in the morning after overnight fasting with approximately one-fifth of the daily food ration. The remaining food ration should be withheld for at least 8 hours.

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

When administered as recommended is unlikely to cause vomiting. Do not repeat treatment if vomiting occurs shortly after dosing. Do not administer if your pet is sick or recovering from an illness. If a hypersensitivity reaction occurs treatment should be discontinued. Treat symptomatically.

4.11 Withdrawal period(s)

Not applicable

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anthelmintic

ATCvet code: QP52AX01

Nitroscanate is a broad spectrum anthelmintic effective against gastrointestinal nematodes and cestodes.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Opadry-Oy_Gm 7900 Consisting of:

Titanium Dioxide (E171)

Ferric Oxide Yellow (E172)

Ferric Oxide Black (E172)

Ferric Oxide Red (E172)

Maize Starch

Microcrystalline Cellulose

Sodium Starch Glycollate

Sodium Lauryl Sulphate

Magnesium Stearate

6.2 Incompatibilities

None known

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 5 years.

6.4. Special precautions for storage

Store in a dry place.

Do not store above 25°C

6.5 Nature and composition of immediate packaging

Aluminium foil, low density polyethylene strips in outer carton containing

100 tablets (for sale to veterinary surgeons only)

1 x 6 tablets for OTC sale

1 x 4 tablets for OTC sale

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

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Chanelle Animal Health Ltd.,

7 Rodney Street,

Liverpool L19 HZ,

England.

8. MARKETING AUTHORISATION NUMBER(S)

Vm 11990/4009

9. DATE OF FIRST AUTHORISATION:

27 January 1994

10 DATE OF REVISION OF THE TEXT

September 2008