SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

ZORABEL 50 mg/ml Oral Suspension for pigs [CZ, DE, DK, ES, EE, FR, HU, LT, LV, PL, PT, SK, UK]

ZORABEL vet 50 mg/ml Oral Suspension for pigs [SE]

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance:

Toltrazuril 50 mg

Excipients:

Sodium Benzoate (E 211) 2.1 mg

Sodium Propionate (E 281) 2.1 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral suspension

White or cream suspension

4. CLINICAL PARTICULARS

4.1 Target species

Pigs (Piglet 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

None

4.4 Special warnings for each target species

None

4.5 Special precautions for use

Special precautions for use in animals

It is recommended to treat all piglets in a litter.

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

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

People with known sensitivity to toltrazuril, or any of the excipients, should avoid contact with this 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, e.g there is no interaction in combination with iron supplementation.

4.9 Amounts to be administered and administration route

For 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 requires to treat individual piglets, use of dosing equipment with a dose accuracy of 0.1 ml is recommended.

The oral suspension must be shaken well 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

4.11 Withdrawal period(s)

Meat and offal: 73 days

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Antiprotozoal

ATCvet code: QP 51AJ01

5.1 Pharmacodynamic properties

Toltrazuril is a triazinon derivative. It acts against coccidian of the genus Isospora. It is acting against all intracellular development stages of coccidian of 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 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)

Sodium docusate

Simethicone emulsion

Bentonite

Citric acid, anhydrous

Xanthan gum

Propylene glycol

Purified water

6.2 Incompatibilities

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

6.3 Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 18 months

Shelf-life after first opening the immediate packaging: 3 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 veterinary medicinal product is packaged in high polyethylene density bottle with high-density polyethylene cap with strapping and welding disk of 100 ml, 250 ml or 1L.

The bottles are placed into cardboard box, container of 1 unit of 100 ml bottle, container of 1 unit of 250 ml bottle and clinical container of 15 units of 250 ml bottles.

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 products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

VETPHARMA ANIMAL HEALTH, S.L

Les Corts, 23

08028 Barcelona

SPAIN

8. MARKETING AUTHORISATION NUMBER

Vm 32509/4014

9. DATE OF FIRST AUTHORISATION

19 December 2013

10. DATE OF REVISION OF THE TEXT

April 2016

PROHIBITION OF SALE, SUPPLY AND/OR USE

Veterinary medicinal product subject to prescription.

To be administered by a veterinary surgeon or under their direct responsibility.

Approved: 20 April 2016