SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Telmin 2 g Granules

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each sachet contains:

Active substance(s) gram

Mebendazole 2.00

For full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Granules

Slightly amber granules.

4. CLINICAL PARTICULARS

Horse and donkey

An oral broad spectrum anthelmintic for the treatment of helminthiasis in the horse and donkey. The product is effective against benzimidazole - susceptible strains of the following worms:

Large strongyles:Strongylus vulgaris

Strongylus edentatus

Strongylus equinus

Triodontophorus spp.

Small strongyles: Cyathostomes

Stomach worms: Trichostrongylus axei

Ascarids: Parascaris equorum

Pinworms: Oxyuris equi

Probstmayria vivipara

Lungworms: Dictyocaulus arnfieldi

4.3 Contraindications

When used in donkeys at the higher dose rate of 15-20 mg/kg daily, the product should not be administered within the first 4 months after service.

4.4 Special warnings for each target species

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.

• Underdosing, which may be due to underestimation of bodyweight, 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, an anthelmintic belonging to another pharmacological class and having a different mode of action should be used.

Resistance to mebendazole (a benzimidazole) has been reported in cyathostomes in horses within the EU. Therefore the use of this product should be based on local (regional, farm) epidemiological information about susceptibility of nematodes and recommendations on how to limit further selection for resistance to anthelmintics.

To reduce this risk dosing programmes should be discussed with your veterinary surgeon.

i. Special precautions for use in animals

None known.

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

Wash hands after use

Persons with known hypersensitivity to ingredients in the product should not handle the product.

Avoid contact with skin and eyes. Wash off any contact with the product immediately with clean running water. Seek medical attention if irritation persists.

4.6 Adverse reactions (frequency and seriousness)

None reported.

4.7 Use during pregnancy, lactation or lay

Animals should not be treated with a dose of 15 mg/kg or over during the first 4 months of pregnancy.

4.8 Interaction with other medicinal products and other forms of interaction

None known.

Add to feed immediately before administration.

Discard any remaining medicated feed.

To ensure administration of a correct dose, bodyweight should be determined as accurately as possible.

Horses

The dose rate is 5-10 mg mebendazole per kg bodyweight orally.

Repeat this dose every 6 weeks.

Horses 200-400 kg 1 sachet

Horses 401-800 kg 2 sachets

Donkeys

For the treatment of Dictyocaulus arnfieldi infections give orally at the rate of 15-20 mg mebendazole per kg bodyweight daily for 5 consecutive days.

Donkey 151-200 kg 1 ½ sachets daily for 5 days

Donkey 201-250 kg 2 sachets daily for 5 days

Donkey 251-300 kg 2 ½ sachets daily for 5 days

Donkey 301-350 kg 3 sachets daily for 5 days

Administer the granules with the normal feed. Concentrated feed can be moistened a little if necessary.

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

Supportive therapy if required.

4.11 Withdrawal period(s)

Not to be used in horses intended for human consumption.

Treated horses may never be slaughtered for human consumption.

The horse must have been declared as not intended for human consumption under national horse passport legislation.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group:Anthelmintics: Benzimidazoles and related substances

ATCvet code:QP52AC09

5.1 Pharmacodynamic properties

Mebendazole is an anthelmintic belonging to the benzimidazole group of compounds with efficacy against certain gastrointestinal roundworms and lungworms in horses and donkeys.

Mebendazole acts selectively against the gastrointestinal and lung parasites in the host. It is based on an interaction with the microtubular system of the absorptive cells of the worm, leading to an irreversible lytic necrosis of those cells and death of the worm.

5.2 Pharmacokinetic particulars

The pharmacokinetic profile of mebendazole is similar in various animal species, including horses. Mebendazole has a poor oral bioavailability, due to a low solubility in aqueous systems, a slow dissolution rate in the gastrointestinal tract and first-pass metabolism in the gut wall and the liver. This causes a high faecal excretion of parent drug and low levels in plasma and tissues. Absorption is not linearly dependent of dose. Highest concentrations of mebendazole-related residues are found in the liver and kidneys and these consist mainly of metabolites. The biotransformation of mebendazole involves carbamate hydrolysis, ketone reduction and conjugation. The elimination from plasma and tissues is rapid, although there is some retention of residues in the liver.

The systemic bioavailability of mebendazole in horses is very low, irrespective of the oral dosage form. After a 6.5 mg/kg dose, the concentrations in plasma never exceed 10 ng/ml.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lactose Monohydrate

Maize Starch

Acacia

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

No special precautions for storage.

6.5 Nature and composition of immediate packaging

Carton containing 2 x 20 g paper/low density polyethylene/aluminium foil/low density polyethylene sachets with heat seal closure.

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 a veterinary medicinal product should be disposed of in accordance with local requirements .

7. MARKETING AUTHORISATION HOLDER

Eli Lilly and Company Limited

Elanco Animal Health

Lilly House

Priestley Road

Basingstoke

RG24 9NL

UK

8. MARKETING AUTHORISATION NUMBER(S)

Vm00006/4138

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 13 August 1985.

10. DATE OF REVISION OF THE TEXT

Date:August 2012