Zolvix - summary of medicine characteristics

Summary of medicine characteristics - Zolvix

SUMMARY OF PRODUCT CHARACTERISTICS

NAME OF THE VETERINARY MEDICINAL PRODUCT

ZOLVIX 25 mg/ml oral solution for sheep

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance:

Each ml contains 25 mg of monepantel

Excipient:

RRR-a-tocopherol

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral solution.

Orange clear solution.

4. CLINICAL PARTICULARS4.1 Target species

Sheep

4.2 Indications for use, specifying the target species

ZOLVIX oral solution is a broad spectrum anthelmintic for the treatment and control of gastrointestinal nematode infections and associated diseases in sheep including lambs, hoggets, breeding rams and ewes.

Spectrum of activity includes fourth larvae and adults of:

Haemonchus contortus * Teladorsagia circumcincta* Teladorsagia trifurcata* Teladorsagia davtiani* Trichostrongylus axei* Trichostrongylus colubriformis Trichostrongylus vitrinus Cooperia curticei Cooperia oncophora Nematodirus battus Nematodirus filicollis Nematodirus spathiger Chabertia ovina Oesophagostomum venulosum

* including inhibited larvae

4.3 Contraindications

None.

4.4 Special warnings for each target species

The efficacy has not been established in sheep weighing less than 10 kg.

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. It is recommended that product is used not more than twice in one year.
• Underdose, which may be due to underestimation of body weight, misadministration of the veterinary medicinal product, or lack of calibration of the dose device.

In order to help delay the development of resistance, users are advised to check the success of the treatment (e.g. clinical appearance, faecal egg counts). Suspected clinical cases of resistance to anthelmintics should be further investigated using appropriate tests (e.g. Faecal Egg Count Reduction Tests) in discussion with their animal health advisor. Where the results of the tests strongly suggest resistance to a particular anthelmintic, an anthelmintic belonging to another pharmacological class and having a different mode of action should be used.

Increasing refugia (i.e. a source of parasites which have not been exposed to the anthelmintic) has been demonstrated to delay the development of resistance. However, this should be considered only after advice has been taken from an animal health advisor.

4.5 Special precautions for use

Special precautions for use in animals

The safety has not been established in sheep weighing less than 10 kg or under 2 weeks of age.

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

Personal protective equipment consisting of gloves should be worn when handling the veterinary medicinal product.

In case of accidental spillage onto skin or into eyes, wash immediately with water. Take off any contaminated clothes. In case of accidental ingestion seek medical advice immediately and show the package leaflet or the label to the physician.

Do not eat, drink or smoke whilst handling the veterinary medicinal product. Wash hands and exposed skin after handling the veterinary medicinal product.

4.6 Adverse reactions (frequency and seriousness)

None.

4.7 Use during pregnancy, lactation or lay

The veterinary medicinal product can be used in breeding sheep including pregnant and lactating ewes.

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 is 2.5 mg/kg bodyweight of monepantel.

The veterinary medicinal product is administered as a single treatment.

However, the administration may be repeated, depending on the epidemiological situation in different areas.

To ensure administration of a correct dose, bodyweight should be determined as accurately as possible. Accuracy and proper functioning of the dose device should be checked.

If animals are to be treated collectively rather than individually, they should be grouped according to their bodyweight and dosed according to the heaviest animal within the group in order to avoid underdose.

To assure complete swallowing of this low volume solution, administer orally on the back of the tongue. Drenching equipment should be cleaned after use.

Dose table:

Body weight, kg	Dose, ml
10 – 15	1.5
16 – 20	2
21 – 25	2.5
26 – 30	3
31 – 35	3.5
36 – 40	4
41 – 50	5
51 – 60	6
61 – 70	7
> 70	1 ml for each additional 10 kg

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

No adverse effects were observed after a 10-fold overdose.

4.11 Withdrawal period(s)

7 days.

Not authorised for use in animals producing milk for human consumption.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: anthelmintics.

ATCvet code: QP52AX09.

5.1 Pharmacodynamic properties

Monepantel is an anthelmintic belonging to the amino-acetonitrile derivative (AAD) class of molecules. Monepantel acts on the nematode specific nicotinic acetylcholine receptor sub-unit Hco-MPTL-1. This is the first biological function to be described for the Hco-MPTL-1 receptor and therefore monepantel is effective against nematodes resistant to other anthelmintic classes.

ZOLVIX was shown to be effective against strains of gastro-intestinal parasites, listed in section 4.2, resistant to (pro)benzimidazoles, levamisole, morantel, macrocyclic lactones and H. contortus strains resistant to salicylanilides. In addition, the product was shown to be effective against 4th stage larvae of a strain of H. contortus in a laboratory study where a combination of abamectin with derquantel was not effective.

Isolated cases of resistance against monepantel have been identified within the European Union.

5.2 Pharmacokinetic particulars

After oral administration monepantel is readily absorbed and oxidised to a sulfone metabolite. Peak blood concentrations are reached within a day. Afterwards blood concentrations decrease with a half life of about five days. Excretion is mainly via the faeces but also via the urine. Feeding or fasting before or shortly after treatment does not influence efficacy.

6. PHARMACEUTICAL PARTICULARS6.1 List of excipients

RRR-a-tocopherol

Beta-carotene

Maize oil

Propylene glycol

Macrogolglycerol hydroxystearate

Polysorbate 80

Propylene glycol monocaprylate

Propylene glycol dicaprylocaprate

6.2 Major 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:

Bottle (HDPE): 3 years

Shelf life after first opening the immediate packaging: 1 year

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

Fluorinated high density polyethylene (HDPE) bottles with a polypropylene cap.

Pack sizes of 250 ml, 500 ml, 1 l, 2.5 l, and 5 l.

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

7. MARKETING AUTHORISATION HOLDER

Elanco GmbH

Heinz-Lohmann-Str. 4

27472 Cuxhaven

Germany

8. MARKETING AUTHORISATION NUMBER(S)

EU/2/09/101/002

EU/2/09/101/004

EU/2/09/101/006

EU/2/09/101/008

EU/2/09/101/010

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 04/11/2009

Date of last renewal: 07/11/2014