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Date: Saturday, June 15, 2024 0:43

Description: 2015-Elanco-logo
Telephone: 01256 353131 (24 hr response) Veterinary Technical Services
Release 2.139
ZOLVIX 25 mg/ml oral solution for sheep
 
Species: Sheep
Therapeutic indication: Pharmaceuticals: Endoparasiticides: Anthelmintics for sheep
Active ingredient: Monepantel
Product:ZOLVIX 25 mg/ml oral solution for sheep
Product index: ZOLVIX 25 mg/ml oral solution for sheep
Sheep - meat: 7 days
Withdrawal notes: Not authorised for use in animals producing milk for human consumption.
Incorporating:
Qualitative and quantitative composition
Active substance:
Each ml contains 25 mg of monepantel
Excipients:
Qualitative composition of excipients and other constituents
RRR-α-tocopherol
Beta-carotene
Maize oil
Propylene glycol
Macrogolglycerol hydroxystearate
Polysorbate 80
Propylene glycol monocaprylate
Propylene glycol dicaprylocaprate
Orange clear oral solution
Pharmaceutical form
Oral solution.
Orange clear solution.
Clinical particulars
Target species
Sheep
Indications for use, specifying the target species
ZOLVIX oral solution is a broad spectrum anthelmintic for the treatment of gastro- intestinal 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 trifucrcata*
Teladorsagia davtiani*
Trichostrongylus axei*
Trichostrongylus colubriformis
Trichostrongylus vitrinus
Cooperia curticei
Cooperia oncophora
Nematodirus battus
Nematodirus filicolllis
Nematodirus spathiger
Chabertia ovina
Oesophagostomum venulosum
*including inhibited larvae
Contraindications
None.
Special warnings for each target species
The efficacy has not been established in sheep weighing less than 10 kg.
Unnecessary use of antiparasitics or use deviating from the instructions given in the SPC may increase the resistance selection pressure and lead to reduced efficacy. The decision to use the product should be based on confirmation of the parasitic species and burden, or of the risk of infection based on its epidemiological features, for each flock.
Repeated use for an extended period, particularly when using the same class of substances, increases the risk of resistance development. Within a flock, maintenance of susceptible refugia is essential to reduce that risk. Systematically applied interval-based treatment and treatment of a whole flock should be avoided. Instead, if feasible, only selected individual animals or subgroups should be treated (targeted selective treatment). This should be combined with appropriate husbandry and pasture management measures. Guidance for each specific flock should be sought from the responsible veterinarian.
Isolated cases of resistance against monepantel have been identified within the European Union.
The use of this product should take into account local information about susceptibility of the target parasites, where available.
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). It is recommended to further investigate cases of suspected resistance, using an appropriate diagnostic method (e.g. Faecal Egg Count Reduction Test). 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.
Confirmed resistance should be reported to the marketing authorisation holder or to the competent authorities.
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.
Special precautions for the protection of the environment:
Not applicable.
Adverse reactions (frequency and seriousness)
Sheep:
None known.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See also section ‘Contact details’ of the package leaflet.
Use during pregnancy, lactation or lay
Pregnancy and lactation:
The veterinary medicinal product can be used in pregnant and lactating ewes.
Fertility:
The veterinary medicinal product can be used in breeding sheep.
Interaction with other medicinal products and other forms of interaction
None known.
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. The need for and frequency of re-treatment(s) should be based on professional advice and should take into account the local epidemiological situation and the animal’s lifestyle.
It is recommended that the veterinary medicinal product is used not more than twice in one year.
Underdosing could result in ineffective use and may favour resistance development. To ensure a correct dosage, body weight should be determined as accurately as possible. If animals are to be treated collectively, reasonably homogeneous groups should be set up, and all animals of a group should be dosed at the rate corresponding to the heaviest one.
The use of suitably calibrated measuring equipment is recommended. Accuracy of the dosing device should be thoroughly checked.
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
Overdose (symptoms, emergency procedures, antidotes), if necessary
No adverse effects were observed after a 10-fold overdose.
Withdrawal period(s)
Meat and offal: 7 days.
Not authorised for use in animals producing milk for human consumption.
Pharmacological particulars
Pharmacotherapeutic group: anthelmintics. ATCvet code: QP52AX09.
Pharmacodynamic properties
NI SPC ONLY - 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 3.2, 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.
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.
Pharmaceutical particulars
List of excipients
RRR-α-tocopherol
Beta-carotene
Maize oil
Propylene glycol
Macrogolglycerol hydroxystearate
Polysorbate 80
Propylene glycol monocaprylate
Propylene glycol dicaprylocaprate
Major incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years
Shelf life after first opening the immediate packaging: 1 year
Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
Nature and composition of immediate packaging
Fluorinated high density polyethylene (HDPE) bottles with a polypropylene cap.
Pack sizes: carton box containing 1 x 250 ml, 500 ml, 1 l, 2.5 l, or 5 l bottle.
Not all pack sizes may be marketed.
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.
NI SPC ONLY
Medicines should not be disposed of via wastewater or household waste.
Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.
Marketing Authorisation Holder (if different from distributor)
Elanco GmbH
Heinz-Lohmann-Str. 4
27472 Cuxhaven
Germany
Marketing Authorisation Number
UK (Great Britain): Vm 52127/5029
UK (Northern Ireland): EU/2/09/101/001-010
Significant changes
Date of the first authorisation or date of renewal
Date of first authorisation: 04/11/2009
Date of revision of the text
August 2023
Any other information
Veterinary medicinal product subject to prescription.
Legal category
Legal category: POM-VPS
GTIN
GTIN description:ZOLVIX 25 mg/ml oral solution for sheep 0.5L
GTIN:05037694091156
GTIN description:ZOLVIX 25 mg/ml oral solution for sheep 1L
GTIN:05037694053314
GTIN description:ZOLVIX 25 mg/ml oral solution for sheep 2.5L
GTIN:05037694053338