Open menu Close menu Open Search Close search

AMERICAN DRUGS | ANATOMY | HEALTH TOPICS | HIV/AIDS GLOSSARY | DISEASES | HEALTH ARTICLES | GENOME | OCCUPATIONS

Eurican Herpes 205

Spanish Simplified Chinese French German Russian Hindi Arabic Portuguese















Summary for the public


What is Eurican Herpes 205?

Eurican Herpes 205 is a powder and solvent that is made into an emulsion for injection. Eurican Herpes 205 contains the active substance canine herpes virus (F205 strain) antigens in a dose of 0.3 to 1.75 μg.


What is Eurican Herpes 205 used for?

Eurican Herpes 205 is used to immunise pregnant bitches to prevent mortality, clinical signs and lesions in puppies caused by canine herpes virus infections acquired in the first few days of life.

Eurican Herpes 205 is given as two 1 ml subcutaneous (under the skin) doses. The first injection is given either when the bitch is on heat or 7 –10 days after the date of mating. The second injection is given 1 to 2 weeks before the expected date of whelping. The bitch should be revaccinated in the same way during each pregnancy.


How does Eurican Herpes 205 work?

Eurican Herpes 205 contains small amounts of canine herpes virus antigens. When injected, this small exposure helps the dog’s immune system to synthesize antibodies against the canine herpes virus and to neutralize it. Once vaccinated, bitches will, through colostrum, give those antibodies to puppies. When exposed to canine herpes virus later in life, the puppies will either not become infected or have a much less serious infection. Eurican Herpes 205 is intended to protect the puppies from this infection during the first few days of life.


How has the effectiveness of Eurican Herpes 205 been studied?

Eurican Herpes 205 has been studied in three laboratory studies and two field trials. In one field trial the serological response (antibody production) was measured. In the other, a study was made of the effect of vaccination on the ability of bitches to breed in an infected kennel. The first laboratory study tested the dose needed to provide protection. The second study was carried out to show the protection of puppies from vaccinated bitches from canine herpe svirus. Here Eurican Herpes 205 was compared with no vaccination (controls). The last one has demonstrating that induction of antibodies is equivalent when bitches are vaccinated the day of heat or 7-10 days after mating.


What benefit has Eurican Herpes 205 shown during the studies?

Eurican Herpes 205 showed good protection from canine herpes virus. In the study to show the protection of puppies (from vaccinated bitches) from canine herpes virus, over 80% of the pups from the vaccinated bitches survived.


What are the side effects of Eurican Herpes 205?

The injection of Eurican Herpes 205 may cause temporary oedema (fluid under the skin) at the injection site in up to 10% of animals. This side effect usually disappears within one week. Rarely, hypersensitivity (allergic) reactions may occur, which require treatment.


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

Eurican Herpes 205 contains mineral oil. Accidental injection may cause severe pain and swelling, particularly if injected into a joint or finger – rarely causing the loss of a finger. If someone is accidentally injected with this product, they must seek immediate medical advice even if only a very small amount is injected. The Package Leaflet should be taken to the doctor. If pain persists for more than 12 hours after medical examination, the doctor should be contacted again.


Why has Eurican Herpes 205 been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Eurican Herpes 205 are greater than any risks to immunise healthy bitches against canine herpes virus. They recommended that Eurican Herpes 205 should be given a marketing authorisation. The benefitrisk balance may be found in module 6 of this EPAR.


Other information about Eurican Herpes 205

The European Commission granted a marketing authorisation valid throughout the European Union, for Eurican Herpes 205 to Merial on 26 March 2001. Information on the prescription status of this product may be found on the labelling.

Authorisation details
Name: Eurican Herpes 205
EMEA Product number: EMEA/V/C/000059
Active substance: Canine herpesvirus (F205 strain) antigens
INN or common name: Live adjuvanted vaccine against canine herpes virus
Species: Dogs
ATCvet Code: QI07AA
Marketing Authorisation Holder: Merial
Revision: 6
Date of issue of Market Authorisation valid throughout the European Union: 26/03/2001
Contact address:
Merial
29, avenue Tony Garnier
69007 Lyon
FRANCE



  • Drugs Alphabetically





    • Product Characteristics

    ANNEX I

    SUMMARY OF PRODUCT CHARACTERISTICS


    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Eurican Herpes 205 powder and solvent for emulsion for injection.
    2.
    QUALITATIVE AND QUANTITATIVE COMPOSITION
    Active substance
    Per 1-ml dose: Canine herpesvirus (F205 strain) antigens ..............................................0.3 to 1.75 µg*
    * expressed in µg of gB glycoproteins
    Adjuvant(s)
    Light paraffin oil ........................................................................................................224.8 to 244.1 mg
    For a full list of excipients, see section 6.1.
    3.
    PHARMACEUTICAL FORM
    Powder and solvent for emulsion for injection
    4.
    CLINICAL PARTICULARS
    4.1 Target species
    Dogs (pregnant bitches)
    4.2 Indications for use, specifying the target species
    Active immunisation of bitches to prevent mortality, clinical signs and lesions in puppies resulting
    from canine herpes virus infections acquired in the first few days of life.
    4.3 Contraindications
    None.
    4.4 Special warnings
    None.
    4.5 Special precautions for use
    Special precautions for use in animals
    Vaccinate only healthy animals.
    Special precautions to be taken by the person administering the veterinary medicinal product to
    animals
    To the user:
    This product contains mineral oil. Accidental injection/self injection may result in severe pain
    and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of
    the affected finger if prompt medical attention is not given.
    If you are accidentally injected with this product, seek prompt medical advice even if only a very small
    amount is injected and take the package leaflet with you.
    If pain persists for more than 12 hours after medical examination, seek medical advice again.
    2/19
    To the physician:
    This product contains mineral oil. Even if small amounts have been injected, accidental injection with
    this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even
    the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision
    and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
    4.6 Adverse reactions (frequency and seriousness)
    The injection of the vaccine may cause a transient oedema at the site of injection in up to 10% of
    animals. These reactions usually regress within one week.
    Hypersensitivity reactions may occur. These are rare and appropriate symptomatic treatment should be
    administered.
    4.7
    Use during pregnancy, lactation or lay
    Eurican Herpes 205 is specifically indicated during pregnancy.
    4.8 Interaction with other medicinal products and other forms of interaction
    No information is available on the efficacy from the concurrent use of this vaccine with any other
    product. It is therefore recommended that no other vaccines should be administered within 14 days
    before or after vaccination with the product.
    4.9 Amounts to be administered and administration route
    Two 1-ml doses of vaccine, administered by subcutaneous route, according to the following schedule:
    First injection : Either during heat or 7 –10 days after the presumed date of mating.
    Second injection : 1 to 2 weeks before the expected date of whelping.
    Revaccination : during each pregnancy, according to the same schedule.
    4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
    No undesirable effects other than those observed and mentioned in the “Adverse reactions” section
    have been observed after the administration of several doses.
    4.11 Withdrawalperiod(s)
    Not applicable.
    5.
    IMMUNOLOGICAL PROPERTIES
    ATCvet code: QI07AA06
    Purified subunit vaccine for the active immunisation of pregnant bitches to induce the passive
    protection of puppies against herpesvirus-induced fatal neonatal disease.
    6.
    PHARMACEUTICAL PARTICULARS
    6.1 List of excipients
    Sucrose
    Sorbitol
    Dextran 40
    3/19
    Casein hydrolysate
    Collagen hydrolysate
    Salts
    Polyoxyethylene fatty acids
    Ether of fatty alcohols and of polyols
    Triethanolamine
    6.2 Incompatibilities
    Do not mix with any other immunological product except the solvent supplied.
    6.3 Shelf life
    24 months.
    Use immediately after reconstitution.
    6.4. Special precautions for storage
    Store in a refrigerator (2
    °
    C – 8
    °
    C). Do not freeze. Protect from light.
    6.5 Nature and composition of immediate packaging
    Type I glass bottle containing powder of 1-dose and glass bottle containing 1-ml of solvent.
    The bottles are closed with a butyl elastomer closure and sealed with an aluminium cap
    Box of 2 x 1 bottle, 2 x 10 bottles and 2 x 50 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 the local requirements.
    7.
    MARKETING AUTHORISATION HOLDER
    MERIAL
    29 Avenue Tony Garnier
    F-69007 Lyon
    FRANCE
    8.
    MARKETING AUTHORISATION NUMBER(S)
    EU/2/01/029/001- 003
    9.
    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
    26.03.06
    4/19
    10 DATE OF REVISION OF THE TEXT
    Detailed information on this veterinary medicinal product is available on the website of the European
    Medicines Agency (EMEA) http://www.emea.eu.int/
    PROHIBITION OF SALE, SUPPLY AND/OR USE
    Not applicable.
    5/19
    ANNEX II
    A.
    MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND
    MANUFACTURING AUTHORISATION HOLDER(S) 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
    6/19
    A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND
    MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
    RELEASE
    Name and address of the manufacturer(s) of the biological active substance(s)
    Merial, Laboratory of Lyon Gerland
    254, Avenue Marcel Mérieux, 69007 Lyon, France
    Name and address of the manufacturer(s) responsible for batch release
    MERIAL
    Laboratoire Porte des Alpes
    Rue de l'Aviation
    F-69800 Saint Priest
    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
    Not applicable.
    7/19
    ANNEX III
    LABELLING AND PACKAGE LEAFLET
    8/19
    A. LABELLING
    9/19
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    {NATURE/TYPE}
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Eurican Herpes 205 powder and solvent for emulsion for injection
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Per 1-ml dose: Canine herpesvirus (F205 strain) antigens ..............................................0.3 to 1.75 µg*
    * expressed in µg of gB glycoproteins
    Light paraffin oil
    3.
    PHARMACEUTICAL FORM
    Powder and solvent for emulsion for injection.
    4.
    PACKAGE SIZE
    1 dose: powder (1 bottle) + solvent (1 bottle)
    50 doses: powder (50 bottles) + solvent (50 bottles)
    5.
    TARGET SPECIES
    Dogs (pregnant bitches)
    6.
    INDICATION(S)
    Active immunisation of bitches to prevent mortality, clinical signs and lesions in puppies resulting
    from canine herpes virus infections acquired in the first few days of life.
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    Subcutaneous use.
    Read the package leaflet before use.
    8.
    WITHDRAWAL PERIOD
    Not applicable.
    10/19
     
    9.
    SPECIAL WARNING(S), IF NECESSARY
    Accidental injection is dangerous – read the package leaflet before use.
    10. EXPIRY DATE
    EXP {month/year}
    Use immediately after reconstitution.
    11. SPECIAL STORAGE CONDITIONS
    Store in a refrigerator (2
    °
    C – 8
    °
    C). Do not freeze. Protect from light.
    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
    MERIAL
    29 Avenue Tony Garnier
    F-69007 Lyon
    France
    16. MARKETING AUTHORISATION NUMBER(S)
    EU/2/01/029/002 50 doses: powder (50 bottles) + solvent (50 bottles)
    EU/2/01/029/003 1 dose: powder (1 bottle) + solvent (1 bottle)
    17. MANUFACTURER’S BATCH NUMBER
    Lot
    11/19
     
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    {NATURE/TYPE}
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Eurican Herpes 205 powder and solvent for emulsion for injection
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Per 1-ml dose: Canine herpesvirus (F205 strain) antigens ..............................................0.3 to 1.75 µg*
    * expressed in µg of gB glycoproteins
    Light paraffin oil
    3.
    PHARMACEUTICAL FORM
    Powder and solvent for emulsion for injection.
    4.
    PACKAGE SIZE
    10 doses: powder (10 bottles) + solvent (10 bottles)
    5.
    TARGET SPECIES
    Dogs (pregnant bitches)
    6.
    INDICATION(S)
    Active immunisation of bitches to prevent mortality, clinical signs and lesions in puppies resulting
    from canine herpes virus infections acquired in the first few days of life.
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    Subcutaneous use.
    Read the package leaflet before use.
    8.
    WITHDRAWAL PERIOD
    Not applicable.
    9.
    SPECIAL WARNING(S), IF NECESSARY
    Accidental injection is dangerous – read the package leaflet before use.
    12/19
     
    10. EXPIRY DATE
    EXP {month/year}
    Use immediately after reconstitution.
    11. SPECIAL STORAGE CONDITIONS
    Store in a refrigerator (2
    °
    C – 8
    °
    C). Do not freeze. Protect from light.
    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
    MERIAL
    29 Avenue Tony Garnier
    F-69007 Lyon
    France
    16. MARKETING AUTHORISATION NUMBER(S)
    EU/2/01/029/001 10 doses: powder (10 bottles) + solvent (10 bottles)
    17. MANUFACTURER’S BATCH NUMBER
    Lot
    13/19
     
    MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
    {NATURE/TYPE}
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Eurican Herpes 205 powder for injection
    2.
    QUANTITY OF THE ACTIVE SUBSTANCE(S)
    Read the package leaflet before use
    3.
    CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
    1 dose
    4.
    ROUTE(S) OF ADMINISTRATION
    SC
    5.
    WITHDRAWAL PERIOD
    Withdrawal period: Not applicable.
    6.
    BATCH NUMBER
    Lot
    7.
    EXPIRY DATE
    EXP {month/year}
    Use immediately after reconstitution.
    8.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only.
    14/19
     
    MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
    {NATURE/TYPE}
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Eurican Herpes 205 solvent
    2.
    QUANTITY OF THE ACTIVE SUBSTANCE(S)
    Read the package leaflet before use
    3.
    CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
    1 ml
    4.
    ROUTE(S) OF ADMINISTRATION
    SC
    5.
    WITHDRAWAL PERIOD
    Withdrawal period: Not applicable.
    6.
    BATCH NUMBER
    Lot
    7.
    EXPIRY DATE
    EXP {month/year}
    Use immediately after reconstitution.
    8.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only.
    15/19
     
    B. PACKAGE LEAFLET
    16/19
    PACKAGE LEAFLET
    Eurican Herpes 205 powder and solvent for emulsion for injection
    1.
    NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
    THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
    RELEASE, IF DIFFERENT
    Marketing authorisation holder :
    MERIAL, 29 Avenue Tony Garnier, F-69007 Lyon, France
    Manufacturer for the batch release :
    MERIAL, Laboratoire Porte des Alpes, Rue de l’Aviation, F-69800 Saint Priest, France
    2.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Eurican Herpes 205 powder and solvent for emulsion for injection
    3.
    STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
    Per 1-ml dose: Canine herpesvirus (F205 strain) antigens ..............................................0.3 to 1.75 µg*
    * expressed in µg of gB glycoproteins
    Light paraffin oil
    4.
    INDICATION(S)
    Active immunisation of bitches to prevent mortality, clinical signs and lesions in puppies resulting
    from canine herpes virus infections acquired in the first few days of life.
    5.
    CONTRAINDICATIONS
    None.
    6.
    ADVERSE REACTIONS
    Hypersensitivity reactions may occur. These are rare and appropriate symptomatic treatment should be
    administered.
    The injection of the vaccine may cause a transient oedema at the site of injection in up to 10% of
    animals. These reactions usually regress within one week.
    If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
    veterinary surgeon.
    7.
    TARGET SPECIES
    Dogs (pregnant bitches)
    17/19
    8.
    DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
    Two 1-ml doses of vaccine, administered by subcutaneous route, according to the following schedule:
    First injection : Either during heat or 7 –10 days after the presumed date of mating.
    Second injection : 1 to 2 weeks before the expected date of whelping.
    Revaccination : during each pregnancy, according to the same schedule.
    9.
    ADVICE ON CORRECT ADMINISTRATION
    None.
    10. WITHDRAWAL PERIOD
    Not applicable
    11. SPECIAL STORAGE PRECAUTIONS
    C). Do not freeze. Protect from light.
    Use immediately after reconstitution.
    Do not use after the expiry date stated on the label.
    °
    C – 8
    °
    12. SPECIAL WARNING(S)
    •
    Vaccinate only healthy animals.
    •
    Do not mix with any other immunological product except the solvent supplied.
    •
    Eurican Herpes 205 is specifically indicated during pregnancy.
    •
    No information is available on the efficacy from the concurrent use of this vaccine with any
    other product. It is therefore recommended that no other vaccines should be administered within
    14 days before or after vaccination with the product
    •
    No undesirable effects other than those observed and mentioned in the “Adverse reactions”
    section have been observed after the administration of several doses.
    •
    To the user:
    This product contains mineral oil. Accidental injection/self injection may result in severe pain
    and swelling, particularly if injected into a joint or finger, and in rare cases could result in the
    loss of the affected finger if prompt medical attention is not given.
    If you are accidentally injected with this product, seek prompt medical advice even if only a
    very small amount is injected and take the package insert with you.
    If pain persists for more than 12 hours after medical examination, seek medical advice again.
    •
    To the physician:
    This product contains mineral oil. Even if small amounts have been injected, accidental
    injection with this product can cause intense swelling, which may, for example, result in
    ischaemic necrosis and even the loss of a digit. Expert, PROMPT, surgical attention is required
    and may necessitate early incision and irrigation of the injected area, especially where there is
    involvement of finger pulp or tendon.
    18/19
    Keep out of the reach and sight of children
    Store in a refrigerator (2
    13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
    MATERIALS, IF ANY
    Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
    products should be disposed of in accordance with the local requirements.
    14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
    Detailed information on this product is available on the website of the European Medicines Agency
    (EMEA) http://www.emea.eu.int/
    15. OTHER INFORMATION
    Purified subunit vaccine for the active immunisation of pregnant bitches to induce the passive
    protection of puppies against herpesvirus-induced fatal neonatal disease.
    Box of 2 x 1 bottle, 2 x 10 bottles and 2 x 50 bottles.
    Not all pack sizes may be marketed.
    To be supplied only on veterinary prescription.
    19/19


    Source: European Medicines Agency


    - Please bookmark this page (add it to your favorites).
    - If you wish to link to this page, you can do so by referring to the URL address below this line.

    https://theodora.com/drugs/eu/eurican_herpes_205_veterinary.html

    Copyright © 1995-2021 ITA all rights reserved.