SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Harkers Carnidazole Tablets 10 mg

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Qualitative composition Quantitative composition

Active ingredient:
Carnidazole 10 mg per tablet

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Tablet.

Round white uncoated tablet with one side scored “Janssen”.

4. CLINICAL PARTICULARS

4.1 Target species

Pigeons

4.2 Indications for use, specifying the target species

Therapeutic and routine treatment of trichomoniasis (canker) in pigeons caused by Trichomonas columbae.

4.3 Contraindications

None

4.4 Special warnings for each target species

None

4.5 Special precautions for use

All birds in the loft should preferably be treated before feeding. At the time of treatment no drinking troughs should be present until 2 hours after treatment when they can be returned to the loft after being thoroughly disinfected. Repeat the treatment when the possibility of re-infection is high, at the start of the reproductive period, at the beginning

of brooding, when bringing in new birds, etc.

Direct contact with the product must be avoided. Wear impermeable gloves when handling the product.

Do not use the product if you are allergic to ingredients in the product.
Wash hands immediately after using the product.

If after handling the product irritation develops, wash the affected area thoroughly with water. If irritation persists, seek medical attention.

Do not touch eyes whilst handling the product. In case of accidental eye contact, wash the eyes thoroughly with water. Seek medical attention if irritation persists.

4.6 Adverse reactions (frequency and seriousness)

None known

4.7 Use during pregnancy, lactation or lay

Harkers Carnidazole Tablets 10 mg are safe for use in breeding birds with and without young.

4.8 Interaction with other medicinal products and other forms of interaction

None known

4.9 Amount(s) to be administered and administration route

Posology

20 mg/kg body mass.

One tablet orally per adult pigeon; ½ tablet orally for young weaned pigeons.

Method of administration

The tablet is placed directly into the mouth. All pigeons in the loft should be treated simultaneously to prevent untreated birds acting as a source of re-infection for the treated birds.

Routine treatment:

Young pigeons: - at weaning

Adult pigeons: - before mating

- during the first part of the brooding period

- after return from races when the birds have been in the travel boxes for a long time.

Therapeutic treatment: when Trichomonasinfection has been diagnosed.

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

Overdosing has not been seen to cause any symptoms, even after 32 times the recommended therapeutic dose. At these high dosage rates vomiting can occur in a few pigeons 3 to 6 hours after dosing.

4.11 Withdrawal period(s)

Harkers Carnidazole Tablets 10 mg must not be used in pigeons intended for human consumption.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Agents against protozoal diseases

ATC Vet Code: QP51AA09

Carnidazole is a trichomonacide belonging to the 5-nitro-imidazole group.

5.1 Pharmacodynamic properties

Nitroimidazoles are thought to interact with the parasite's DNA, thereby destroying its ability to act as a template for protein synthesis.

5.2 Pharmacokinetic properties

Not known

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lactose monohydrate

Cellulose microcrystalline

Silica colloidal anhydrous

Sodium lauryl sulphate

Magnesium stearate

6.2 Incompatibilities

None known

6.3 Shelf life

Shelf life of veterinary medicinal product as packaged for sale: 4 years.

6.4 Special precautions for storage

Do not store above 25ºC.

Protect from light.

Store in a dry place.

6.5 Nature and composition of immediate packaging

Two green polyvinyl chloride/aluminium blister packs containing 25 tablets each, in an outer carton (50 tablets per box).

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 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

Harkers Limited

Unit 2, Cavendish Road

Bury St Edmunds

Suffolk

IP33 3TE

8. MARKETING AUTHORISATION NUMBER(S)

Vm11245/4002

9. DATE OF FIRST AUTHORISATION

Date: 15 September 1992

10. DATE OF REVISION OF THE TEXT

Date:June 2013

APPROVED 14/06/13