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Zolvix

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Summary for the public


What is Zolvix?

Zolvix is a medicine that contains the active substance monepantel. Zolvix is available as an orange clear oral solution (25 mg/ml).


What is Zolvix used for?

Zolvix is used for the treatment and control of worm infections of the gut and associated diseases in sheep. Zolvix is effective against a wide range of strains of worms.

Zolvix is given as a single dose of 2.5 mg per kilogram body weight. The amount to use is calculated based on the weight of the sheep. The oral solution is given directly on the back of the tongue.


How does Zolvix work?

The active substance in Zolvix, monepantel, is an anthelmintic, a substance that is active against helminths. Helminths, also known as nematodes, are worm-like parasites that live in the gut of animals. Monepantel blocks part of a receptor, the nicotinic acetylcholine receptor, that is specific to the nematodes. Monepantel is effective against nematodes resistant to other anthelmintics.


How has Zolvix been studied?

A number of laboratory studies and field trials in various countries were performed. Two main studies were carried out, one in Europe and one in New Zealand, in sheep suffering from a range of infections by nematodes. The New Zealand study compared the effectiveness of Zolvix to that of other anthelmintics. In both studies, the effectiveness of Zolvix was measured by looking for parasite eggs in the sheep faeces at different time points during the trials.


What benefit has Zolvix shown during the studies?

The studies showed that Zolvix is effective against infections of all of the major gastrointestinal nematodes, including effectiveness against strains of parasites resistant to the currently available broad-spectrum anthelmintics.


What is the risk associated with Zolvix?

The effectiveness of Zolvix has not been established in sheep weighing less than 10 kg and safety has not been established in sheep weighing less than 10 kg or under two weeks of age. To help delay the development of resistance, users are advised to check the success of the treatment by examining the sheep’s clinical appearance, or by testing whether any parasite eggs can be found in the faeces.


What are the precautions for the person who gives the medicine or comes into contact with the animal?

Users who are administering this medicine to sheep should wear protective gloves. 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 doctor. Do not eat, drink or smoke whilst handling the product and wash hands and exposed skin after handling the product.


What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?

Sheep: The withdrawal period for meat and offal is seven days.


What is the time to allow before milk can be taken from the animal for human consumption?

Zolvix is not authorised for use in lactating animals producing milk for human consumption.


Why has Zolvix been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Zolvix exceed the risks for its use as a broad spectrum anthelmintic for the treatment and control of gastro-intestinal nematode infections and associated diseases in sheep including lambs, hoggets, breeding rams and ewes, and recommended that Zolvix be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.


Other information about Zolvix

The European Commission granted a marketing authorisation valid throughout the European Union, for Zolvix to Novartis Healthcare A/S on 4 November 2009. Information on the prescription status of this product may be found on the label/outer package.

Authorisation details
Name: Zolvix
EMEA Product number: EMEA/V/C/000154
Active substance: monepantel
INN or common name: monepantel
Species: Sheep
ATCvet Code: QP52AX09
Marketing Authorisation Holder: Novartis Healthcare A/S
Revision: 3
Date of issue of Market Authorisation valid throughout the European Union: 04/11/2009
Contact address:
Novartis Healthcare A/S
Lyngbyvej 172
DK-2100 Copenhagen
Denmark



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    • Product Characteristics

    ANNEX I

    SUMMARY OF PRODUCT CHARACTERISTICS


    1.
    NAME OF VETERINARY THE 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-α-tocopherol
    For a full list of excipients, see section 6.1.
    3.
    PHARMACEUTICAL FORM
    Oral solution.
    Orange clear solution.
    4.
    CLINICAL PARTICULARS
    4.1 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 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 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
    The veterinary medicinal product is effective against strains of these parasites resistant to
    (pro)benzimidazoles, levamisole, morantel and macrocyclic lactones.
    2/19
     
    4.3 Contraindications
    None.
    4.4 Special warnings
    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.
    Underdosage, which may be due to underestimation of body weight, misadministration of the
    veterinary medicinal product, or lack of calibration of the dosage 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). 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.
    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
    Wear protective gloves while 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.
    3/19
    4.9 Amounts to be administered and administration route
    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 dosage 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.
    Dosage table
    Body weight
    Dose
    10 – 15 kg
    1.5 ml
    21 – 25 kg
    2.5 ml
    26 – 30 kg
    3.0 ml
    31 – 35 kg
    3.5 ml
    36 – 40 kg
    4.0 ml
    41 – 50 kg
    5.0 ml
    51 – 60 kg
    6.0 ml
    61 – 70 kg
    7.0 ml
    > 70 kg
    1.0 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 Withdrawalperiod(s)
    7 days.
    Not authorised for use in lactating 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.
    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.
    4/19
    16 – 20 kg
    2.0 ml
     
    6.
    PHARMACEUTICAL PARTICULARS
    6.1 List of excipients
    RRR-α-tocopherol
    Beta-carotene
    Maize oil
    Propylene glycol
    Macrogolglycerol hydroxystearate
    Polysorbate 80
    Propylene glycol monocaprylate
    Propylene glycol dicaprylocaprate
    6.2 Incompatibilities
    None known.
    6.3 Shelf life
    Shelf life of the veterinary medicinal product as packaged for sale:
    Bag (aluminium): 2 years
    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
    Aluminium bags coated with polyethylene terephthalate on one side and low density polyethylene on
    the other.
    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
    Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
    products should be disposed of in accordance with local requirements.
    Aluminium bags may be recycled after rinsing with water.
    7.
    MARKETING AUTHORISATION HOLDER
    Novartis Healthcare A/S
    Lyngbyvej 172
    DK-2100 Copenhagen
    Denmark
    5/19
    8.
    MARKETING AUTHORISATION NUMBER(S)
    EU/2/09/101/001-010
    9.
    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
    04/11/2009
    10. DATE OF REVISION OF THE TEXT
    17/01/2011
    Detailed information on this veterinary medicinal product is available on the website of the European
    Medicines Agency (EMA) http://www.ema.europa.eu / .
    PROHIBITION OF SALE, SUPPLY AND/OR USE
    Not applicable.
    6/19
    ANNEX II
    A.
    MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR
    BATCH RELEASE
    B.
    CONDITIONS OR RESTRICTIONS OF THE MARKETING
    AUTHORISATION REGARDING SUPPLY OR USE
    C.
    CONDITIONS OR RESTRICTIONS OF THE MARKETING
    AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
    D.
    STATEMENT OF THE MRLs
    7/19
    A. MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH
    RELEASE
    Name and address of the manufacturers responsible for batch release
    Vericore Ltd.
    Kinnoull road
    Kingsway West
    Dundee, DD2 3XR
    United Kingdom
    Novartis Santé Animale S.A.S.
    Usine de Huningue
    26, rue de la Chapelle
    BP 224, 68332
    Huningue cedex
    France
    B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
    REGARDING SUPPLY OR USE
    To be supplied only on veterinary prescription.
    C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
    REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
    Not applicable.
    D. STATEMENT OF THE MRLs
    The active substance in ZOLVIX is an allowed substance as described in table 1 of the annex to
    Commission Regulation (EU) No 37/2010:
    Pharmacologically
    active substance(s)
    Marker
    residue
    Animal
    species
    MRLs
    Target
    tissues
    Other
    provisions
    Therapeutic
    classification
    Monepantel
    Monepantel-
    sulfone
    Ovine 700 µg/kg
    7000 µg/kg
    5000 µg/kg
    2000 µg/kg
    Muscle
    Fat
    Liver
    Kidney
    Not for use in
    animals
    producing
    milk for
    human
    consumption
    Antiparasitic
    products/
    Anthelmintics/
    Other
    anthelmintic
    agents
    The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the
    annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are
    considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this
    product.
    8/19
    ANNEX III
    LABELLING AND PACKAGE LEAFLET
    9/19
    A. LABELLING
    10/19
    PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
    HDPE bottle and Aluminium bag
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    ZOLVIX 25mg/ml oral solution for sheep
    Monepantel
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Each ml contains 25mg of monepantel
    3.
    PHARMACEUTICAL FORM
    Oral solution
    4.
    PACKAGE SIZE
    250ml
    500ml
    1l
    2.5l
    5l
    5.
    TARGET SPECIES
    Sheep
    6.
    INDICATION(S)
    Read the package leaflet before use.
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    Read the package leaflet before use.
    8.
    WITHDRAWAL PERIOD
    7 days
    Not authorised for use in lactating animals producing milk for human consumption.
    11/19
     
    9.
    SPECIAL WARNING(S), IF NECESSARY
    Read the package leaflet before use.
    10. EXPIRY DATE
    EXP {month/year}
    Once opened use within 1 year
    11. SPECIAL STORAGE CONDITIONS
    Not applicable
    12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
    WASTE MATERIALS, IF ANY
    Read the package leaflet before use.
    13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
    RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
    For animal treatment only - to be supplied only on veterinary prescription.
    14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
    Keep out of the reach and sight of children.
    15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
    Novartis Healthcare A/S
    Lyngbyvej 172
    DK-2100 Copenhagen
    Denmark
    16. MARKETING AUTHORISATION NUMBER(S)
    EU/2/09/101/001
    EU/2/09/101/002
    EU/2/09/101/003
    EU/2/09/101/004
    EU/2/09/101/005
    EU/2/09/101/006
    EU/2/09/101/007
    EU/2/09/101/008
    EU/2/09/101/009
    EU/2/09/101/010
    12/19
     
    17. MANUFACTURER’S BATCH NUMBER
    Lot
    13/19
     
    B. PACKAGE LEAFLET
    14/19
    PACKAGE LEAFLET FOR:
    ZOLVIX 25mg/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:
    Novartis Healthcare A/S
    Lyngbyvej 172
    DK-2100 Copenhagen
    Denmark
    Manufacturer for the batch release :
    Vericore Ltd.
    Kinnoull road
    Kingsway West
    Dundee, DD2 3XR
    United Kingdom
    and
    Novartis Santé Animale S.A.S.
    Usine de Huningue
    26, rue de la Chapelle
    BP 224, 68332
    Huningue cedex
    France
    2.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    ZOLVIX 25mg/ml oral solution for sheep
    Monepantel
    3.
    STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
    Each ml of ZOLVIX oral solution contains 25mg of monepantel
    4.
    INDICATION
    ZOLVIX oral solution is a broad spectrum anthelmintic for the treatment and control 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*
    T. trifurcata*
    T. davtiani*
    Trichostrongylus axei*
    T. colubriformis
    15/19
     
    T. vitrinus
    Cooperia curticei
    C. oncophora
    Nematodirus battus
    N. filicollis
    N. spathiger
    Chabertia ovina
    Oesophagostomum venulosum
    *Including inhibited larvae
    The veterinary medicinal product is effective against strains of these parasites resistant to
    (pro)benzimidazoles, levamisole, morantel and macrocyclic lactones.
    5.
    CONTRAINDICATIONS
    None.
    6.
    ADVERSE REACTIONS
    None known. If you notice any serious effects or other effects not mentioned in this leaflet, please inform
    your veterinary surgeon.
    7.
    TARGET SPECIES
    Sheep
    8.
    DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
    Dosage table
    Bodyweight
    Dose
    10 – 15 kg
    1.5 ml
    16 – 20 kg
    2.0 ml
    26 – 30 kg
    3.0 ml
    31 – 35 kg
    3.5 ml
    36 – 40 kg
    4.0 ml
    41 – 50 kg
    5.0 ml
    51 – 60 kg
    6.0 ml
    61 – 70 kg
    7.0 ml
    > 70 kg
    1.0 ml for each additional 10 kg
    Administer orally with a suitable dosage device.
    16/19
    21 – 25 kg
    2.5 ml
     
    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 maybe
    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 dosage 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.
    10. WITHDRAWAL PERIOD
    7 days
    Not authorised for use in lactating animals producing milk for human consumption.
    11. SPECIAL STORAGE PRECAUTIONS
    Do not use after the expiry date stated on the label.
    Once opened, use within 1 year.
    12. SPECIAL WARNINGS
    The efficacy has not been established in sheep weighing less than 10kg.
    The safety has not been established in sheep weighing less than 10kg or under 2 weeks of age.
    Can be used in breeding sheep including pregnant and lactating ewes.
    No interaction with other medicinal products and other forms of interaction are known.
    No adverse effects were observed after a 10-fold overdose.
    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.
    Underdosage, which may be due to underestimation of body weight, misadministration of the
    product, or lack of calibration of the dosing 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). 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.
    Wear protective gloves while 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
    17/19
    Do not eat, drink or smoke whilst handling the veterinary medicinal product. Wash hands and exposed
    skin after handling the veterinary medicinal product.
    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.
    Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products
    should be disposed of in accordance with local requirements.
    Aluminium bags may be recycled after rinsing with water.
    14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
    17/01/2011
    Detailed information on this product is available on the website of the European Medicines Agency (EMA)
    15. OTHER INFORMATION
    Monepantel is an anthelmintic belonging to the amino-acetonitrile derivative (AAD) class of molecules.
    Pack sizes of 250 ml, 500 ml, 1 l, 2.5 l, and 5 l
    Not all pack sizes may be marketed.
    For any information about this veterinary medicinal product, please contact the local representative of the
    marketing authorisation holder.
    België /Belgique/Belgien,
    Luxembourg/Luxemburg, Nederland:
    Novartis Consumer Health B.V.
    Tel /Tél: +31-76 533 00 20
    France :
    Novartis Santé Animale S.A.S.
    Tél: +33-(0)1 55 47 87 47
    Česká republika :
    Novartis s.r.o.
    Tel: + 420 2 257 75 331
    Italia :
    Novartis Animal Health S.p.A.
    Tel: +39-02 96542205
    Danmark , Ísland , Norge , Suomi/Finland ,
    Sverige :
    Novartis Healthcare A/S
    Tlf/Sími/Tel/Puh: +45-39 16 84 00
    United Kingdom, Ireland, Malta :
    Novartis Animal Health UK Ltd.
    Tel: +44-(0)1 763 850 500
    Deutschland :
    Novartis Tiergesundheit GmbH
    Tel: +49-(0)89 7877 713
    Magyarország :
    Novartis Hungária Kft
    Tel: +36 1 457 6691
    18/19
     
    Eesti, Latvija , Lietuva , Република България,
    România, Slovenija, Slovenská republika :
    Novartis Animal Health d.o.o.
    Tel/ Teл: + 386 1 580 2884
    Österreich :
    Novartis Animal Health GmbH
    Tel: +43-(0)5338 2000
    Ελλάδα :
    Premier Shukuroglou Hellas SA
    Tηλ: +30-(210)6538-061/181
    Polska :
    Novartis Poland Sp. z.o.o.
    Tel: +48 22 550 8 790
    Κύπρος :
    Premier Shukuroglou Ltd
    Tηλ: +357 22 81 53 53
    Portugal :
    Novartis Farma-Produtos Farmacêuticos, S.A.
    Tel: +351-21 000 86 00
    España :
    Novartis Sanidad Animal, S.L.
    Tel: +34-93 306 4700
    19/19
     


    Source: European Medicines Agency


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