SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Espacox, 50 mg/ml oral suspension for pigs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains:

Active substance:

Toltrazuril 50 mg

Excipients:

Sodium benzoate (E211) 2.1 mg

Sodium propionate (E281) 2.1 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral suspension

White or yellowish suspension

4. CLINICAL PARTICULARS

4.1 Target species

Pigs (Piglets, 3 - 5 days old).

4.2 Indications for use, specifying the target species

For the prevention of clinical signs of coccidiosis in neonatal piglets (3 - 5 days old) on farms with a confirmed history of coccidiosis caused by Isospora suis.

4.3 Contraindications

Do not use in case of hypersensitivity to the active substance or to any of the excipients.

4.4 Special warnings for each target species

It is recommended to treat all animals in a pen.

Hygienic measures may reduce the risk of coccidiosis. It is therefore, recommended to improve concomitantly the hygienic conditions in the concerned facility, particularly dryness and cleanliness.

4.5 Special precautions for use

Special precautions for use in animals

To alter the course of an established clinical coccidial infection, in individual animals already showing signs of diarrhoea, additional supportive therapy may be required.

As with any antiparasiticide, frequent and repeated use of antiprotozoals from the same class may lead to the development of resistance.

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

In case of accidental ingestion seek medical advice immediately and show the package leaflet or the label to the physician.

People with known hypersensitivity to toltrazuril, or any of the excipients, should avoid contact with the veterinary medicinal product.

Avoid skin and eye contact with the product.

Wash any splashes from skin or eyes immediately with water.

Do not eat, drink or smoke whilst using the product.

4.6 Adverse reactions (frequency and seriousness)

None known.

4.7 Use during pregnancy, lactation or lay

Not applicable.

4.8 Interaction with other medicinal products and other forms of interaction

None known.

There is no interaction in combination with iron supplementation.

4.9 Amounts to be administered and administration route

Oral use.

Individual animal treatment.

Each pig to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0.4 ml oral suspension per kg body weight.

Due to the small volumes required to treat individual piglets, use of dosing equipment with a dose accuracy of 0.1 ml is recommended.

The oral suspension must be shaken before use.

Treatment during an outbreak will be of limited value for the individual piglet because of damage to the small intestine having already occurred.

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

No signs of intolerance were observed in piglets up to threefold overdose.

4.11 Withdrawal period

Meat and offal: 73 days

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group:Antiprotozoals.

ATCvet code: QP51AJ01

5.1 Pharmacodynamic properties

Toltrazuril is a triazinon derivative. It acts against coccidia of the genus Isospora. It isacting against all intracellular development stages of coccidia of the merogony (asexual multiplication) and gamogony (sexual phase). All stages are destroyed, thus the mode of action is coccidiocidal.

5.2 Pharmacokinetic particulars

After oral administration toltrazuril is slowly absorbed with a bioavailability of 70%. The maximum concentration (Cmax) of toltrazuril is of 15.1 µg/ml and is obtained after around 24 h. The main metabolite is characterised as toltrazuril sulfone. The elimination of toltrazuril is slow with a half-life elimination time around 3 days. The major route of excretion is via the faeces.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium benzoate (E211)

Sodium propionate (E281)

Docusate sodium

Bentonite

Xanthan gum

Propylene glycol

Citric acid, anhydrous

Simethicone emulsion

Purified water

6.2 Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life after first opening the immediate packaging: 6 months.

6.4. Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

The product is filled into high density polyethylene (HDPE) bottles with a nominal capacity of 250 or 1000 ml. The bottles are heat-sealed with a polyethylene (PE) foil and are closed with a screw cap made of HDPE equipped with a security system to give an airtight sealing.

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

Industrial Veterinaria, S.A.

Esmeralda, 19

E-08950 Esplugues de Llobregat (Barcelona) Spain

Tel: +34 934 706 270

Fax: +34 933 727 556

e-mail: invesa@invesa.eu

8. MARKETING AUTHORISATION NUMBER

Vm 36547/4004

9. DATE OF FIRST AUTHORISATION

23 June 2014

10. DATE OF REVISION OF THE TEXT

June 2014

PROHIBITION OF SALE, SUPPLY AND/OR USE

To be supplied only on veterinary prescription

Administration by a veterinary surgeon, or under their direct responsibility

Approved: 23/06/2014