Zolvix - Patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

PACKAGE LEAFLET:

ZOLVIX 25 mg/ml oral solution for sheep

• 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder:

Elanco GmbH

Heinz-Lohmann-Str. 4

27472 Cuxhaven

Germany

Manufacturer responsible for batch release :

Elanco France S.A.S

26 Rue de la Chapelle

F-68330 Huningue

France

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

ZOLVIX 25 mg/ml oral solution for sheep

Monepantel

• 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS

Each ml of ZOLVIX orange clear oral solution contains 25 mg of monepantel

Other ingredients:

RRR-a-tocopherol

Beta-carotene

Maize oil

Propylene glycol

Macrogolglycerol hydroxystearate

Polysorbate 80

Propylene glycol monocaprylate

Propylene glycol dicaprylocaprate

• 4. INDICATION(S)

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

T. trifurcata*

T. davtiani*

Trichostrongylus axei*

T. colubriformis

T. vitrinus

Cooperia curticei

• C. oncophora

Nematodirus battus

N. filicollis

N. spathiger

Chabertia ovina

Oesophagostomum venulosum

*Including inhibited larvae

• 5. CONTRAINDI­CATIONS

None.

• 6. ADVERSE REACTIONS

None known.

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

• 7. TARGET SPECIES

Sheep

• 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Dose table

Bodyweight, 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 kg	1 ml for each additional 10 kg

Administer orally with a suitable dose device.

• 9. ADVICE ON CORRECT ADMINISTRATION

The dose rate 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 underdosage.

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

7 days.

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

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Do not use this veterinary medicinal product after the expiry date which is stated on the label.

Shelf life after first opening the container: 1 year.

• 12. SPECIAL WARNING(S)

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.
• Underdosage, which may be due to underestimation of body weight, misadministration of the 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 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.

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.

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.

Pregnancy and lactation:

Can be used in breeding sheep including pregnant and lactating ewes.

Interaction with other medicinal products and other forms of interaction:

No interaction with other medicinal products and other forms of interaction are known.

Overdose (symptoms, emergency procedures, antidotes):

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

Incompatibili­ties:

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

• 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Medicines should not be disposed of via wastewater or household waste.

Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

• 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED