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CaniLeish

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Summary for the public


What is CaniLeish?

CaniLeish is a vaccine. It is available as a powder and solvent that is made up into suspension for injection. It contains Leishmania infantum excreted secreted proteins (ESP).


What is CaniLeish used for?

CaniLeish is used to vaccinate dogs from six months of age to reduce the risk of developing an active infection and clinical disease after contact with Leishmania infantum.

Leishmania infantum is a parasite that causes leishmaniosis. It is widespread in countries bordering the Mediterranean Sea. The parasite is transmitted from an infected dog to a non-infected dog by the bites of sand flies. Dogs that have been infected may show no signs of infection, but some do (fever, hair and weight loss, skin sores) and in the latter case the outcome of active infection can be fatal. Infected dogs play a central role in the accidental transmission of parasites to humans.

CaniLeish is to be used only in ‘leishmania-negative’ dogs. The detection of Leishmania infection using a rapid diagnostic test is recommended before vaccination.

The vaccine is given to dogs as three injections, three weeks apart, under the skin. The first injection can be given from six months of age, the second injection is given three weeks later and the third three weeks from the second one. Afterward a single ‘booster’ should be given every year to maintain the vaccine’s effect. Veterinarians should assess the benefit-risk balance before vaccinating dogs in areas with little or no Leishmania infantum.


How does CaniLeish work?

CaniLeish is a vaccine that contains a number of proteins that are released from the Leishmania infantum parasite during its growth.

CaniLeish is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. When CaniLeish is given to dogs the immune system recognises the proteins as ‘foreign’ and make defences against it. In the future, if the animals are exposed to Leishmania infantum parasite, the immune system will be able to respond more quickly. This will help to protect against the disease.

CaniLeish contains an ‘adjuvant’ (a highly purified fraction of Quillaja saponaria) to enhance the immune response.


How has CaniLeish been studied?

The safety of the vaccine was studied in two main laboratory safety studies carried out in leishmania-free dogs (overdose and single and repeated administration) and one field trial. The vaccine was generally well tolerated as shown by the absence of major adverse reactions.

The efficacy of the vaccine was studied in one main field trial that lasted for two years involving vaccinated and control dogs submitted to natural exposure to infection in zones where there is a high risk of infection. A number of laboratory trials where dogs were submitted to experimental infection were also presented.


What benefit has CaniLeish shown during the studies?

The studies showed that the vaccine is safe for both leishmania-negative and leishmania-infected dogs. The benefit of the vaccination was assessed in zones with a high risk of infection where it has been shown in leishmania free dogs to decrease the risk of developing an active infection and a symptomatic disease after contact with the parasite. The number of dogs developing an active infection and a symptomatic disease was significantly reduced in the vaccinated group.

The efficacy of vaccination in dogs already infected was not investigated and therefore cannot be recommended. In dogs developing leishmaniosis (active infection or disease) despite vaccination, proceeding with vaccine injections showed no benefit.

The risk of vaccine-induced infection can be excluded since the vaccine does not contain parasites.


What is the risk associated with CaniLeish?

After injection, some dogs can have moderate and temporary local reactions, such as swelling, nodule (hardening), pain on palpation or erythema (reddening). These reactions resolve spontaneously within two days to two weeks. Other temporary signs commonly seen following vaccination can also occur such as hyperthermia (raised body temperature), apathy (lack of vitality) and digestive disorders lasting one to six days. Allergic-type reactions are uncommon and if a dog shows signs of an allergic reaction, they should be given appropriate symptomatic treatment.

After vaccination transient antibodies against leishmania detected by immunofluorescence antibody test (IFAT) may appear but do not reflect an active infection.


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

In case of accidental self-injection, the advice of a doctor should be sought immediately.


Why has CaniLeish been approved?

The CVMP concluded that the benefits of CaniLeish outweigh the risks for the active immunisation of leishmania-negative dogs from six months of age to reduce the risk to develop an active infection and clinical disease after contact with Leishmania infantum and recommended that CaniLeish be given a marketing authorisation. The benefit-risk balance may be found in the scientific discussion module of this EPAR.


Other information about CaniLeish:

The European Commission granted a marketing authorisation valid throughout the European Union, for CaniLeish to Virbac S.A. on 14/03/2011. Information on the prescription status of this product may be found on the label/outer package.

Authorisation details
Name: CaniLeish
EMEA Product number: EMEA/V/C/002232
Active substance: Leishmania infantum excreted secreted proteins (ESP), Water for injections
INN or common name: Leishmania infantum excreted secreted proteins (ESP)
Species: Dogs
ATCvet Code: QI070AO
Marketing Authorisation Holder: Virbac S.A
Revision: 0
Date of issue of Market Authorisation valid throughout the European Union: 14/03/2011
Contact address:
Virbac S.A
1ère avenue
2065 m L.I.D.
06516 Carros
France



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    • Product Characteristics

    ANNEX I

    SUMMARY OF PRODUCT CHARACTERISTICS


    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    CaniLeish lyophilisate and solvent for suspension for injection for dogs
    2.
    QUALITATIVE AND QUANTITATIVE COMPOSITION
    Each dose of 1 ml vaccine contains:
    Lyophilisate:
    Active substances :
    Leishmania infantum Excreted Secreted Proteins (ESP) at least 100 µg
    Adjuvant :
    Purified extract of Quillaja saponaria (QA-21): 60 µg
    Solvent:
    Sodium chloride 9 mg/ml (0.9%)
    1 ml
    For a full list of excipients, see section 6.1.
    3.
    PHARMACEUTICAL FORM
    Lyophilisate and solvent for suspension for injection.
    4.
    CLINICAL PARTICULARS
    4.1 Target species
    Dogs.
    4.2 Indications for use, specifying the target species
    For the active immunization of Leishmania negative dogs from 6 months of age to reduce the risk to
    develop an active infection and clinical disease after contact with Leishmania infantum .
    The efficacy of the vaccine has been demonstrated in dogs submitted to multiple natural parasite exposure
    in zones with high infection pressure.
    Onset of immunity : 4 weeks after the primary vaccination course.
    Duration of immunity: 1 year after the last (re-)vaccination.
    4.3 Contraindications
    Do not use in case of hypersensitivity to the active substance, to the adjuvant or to any of the excipients.
    4.4 Special warnings
    Transient antibodies against Leishmania detected by immunofluorescence antibody test (IFAT) may
    appear after vaccination. Antibodies due to vaccination can be differentiated from antibodies due to
    natural infection by using a rapid diagnostic serological test as a first step to a differential diagnosis.
    2
    In areas of low or no infection pressure a benefit/risk assessment must be undertaken by the veterinarian
    before deciding to use the vaccine in dogs .
    The impact of the vaccine in terms of public health and control of the human infection cannot be estimated
    from available data.
    4.5 Special precautions for use
    Special precautions for use in animals
    Vaccinate only healthy animals. The efficacy of vaccination in dogs already infected has not been
    investigated and therefore cannot be recommended. In dogs developing a leishmaniosis (active infection
    and/or disease) despite vaccination, proceeding with vaccine injections showed no benefit. Injection of the
    vaccine to dogs already infected by Leishmania infantum did not show any specific adverse reactions
    other than those described in section 4.6. The detection of Leishmania infection using a rapid serological
    diagnostic test is recommended prior to vaccination.
    In case of anaphylactic reaction appropriate symptomatic treatment should be administered.
    De-worming of infested dogs prior to vaccination is recommended.
    Vaccination should not prevent other measures taken to reduce exposure to sandflies.
    Special precautions to be taken by the person administering the veterinary medicinal product to
    animals
    In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the
    label to the physician.
    4.6 Adverse reactions (frequency and seriousness)
    After injection, moderate and transient local reactions may occur such as swelling, nodule, pain on
    palpation or erythema. These reactions resolve spontaneously within 2 to 15 days. Other transient signs
    commonly seen following vaccination may be observed such as hyperthermia, apathy and digestive
    disorders lasting 1 to 6 days. Allergic-type reactions are uncommon and appropriate symptomatic
    treatment should then be administered.
    4.7 Use during pregnancy, lactation or lay
    The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
    Therefore, the use is not recommended during pregnancy and lactation.
    4.8 Interaction with other medicinal products and other forms of interaction
    No information is available on the safety and efficacy of this vaccine when used with any other veterinary
    medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product
    therefore needs to be made on a case by case basis.
    4.9 Amounts to be administered and administration route
    Subcutaneous use.
    3
    After reconstitution of the lyophilisate with the solvent, shake gently and administer immediately one dose
    of 1 ml subcutaneously according to the following vaccination schedule:
    Primary vaccination course:
    - First dose from 6 months of age,
    - Second dose 3 weeks later,
    - Third dose 3 weeks after the 2 nd injection.
    Annual re-vaccination:
    - One booster injection of a single dose should be given 1 year after the third injection and annually
    thereafter.
    4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
    No adverse reactions other than those mentioned in section 4.6 were observed after the administration of a
    double-dose of the vaccine.
    4.11 Withdrawalperiod
    Not applicable.
    5.
    IMMUNOLOGICAL PROPERTIES
    Pharmacotherapeutic group: Immunologicals for canidae – dog – inactivated parasitic vaccine.
    ATC vet
    code : QI07AO.
    Vaccination induces a cell-mediated immunity evidenced by:
    • the appearance of specific IgG2 antibodies to Leishmania infantum excreted secreted proteins,
    • an enhancement of the leishmanicidal activity of the macrophages,
    • a T-cell lymphoproliferation with the secretion of interferon gamma cytokine,
    • a positive T-cell-mediated immune response, directed against the Leishmanian antigen (skin test).
    Efficacy data have shown that a vaccinated dog has 3.6 times less risk to develop an active infection
    and 4 times less risk to develop a clinical disease than a non-vaccinated dog, on dogs submitted to
    multiple natural parasite exposure in zones with high infection pressure.
    6.
    PHARMACEUTICAL PARTICULARS
    6.1 List of excipients
    Lyophilisate
    Purified extract of Quillaja saponaria (QA-21)
    Trometamol
    Sucrose
    Mannitol
    Solvent
    Sodium chloride 9 mg/ml (0.9%)
    Water for injections
    4
    6.2 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: 2 years.
    Shelf life after first opening the immediate packaging: use immediately after reconstitution.
    6.4. Special precautions for storage
    Store and transport refrigerated (2C – 8C).
    Protect from light.
    6.5 Nature and composition of immediate packaging
    Type I glass vial containing 1 dose of lyophilisate and type I glass vial containing 1 ml of solvent,
    both closed with a butyl elastomer closure and sealed with an aluminium cap.
    Pack sizes:
    Box containing 1 vial of 1 dose of lyophilisate and 1 vial of 1 ml of solvent.
    Box containing 1 vial of 1 dose of lyophilisate, 1 vial of 1 ml of solvent, 1 syringe and 1 needle.
    Box containing 3 vials of 1 dose of lyophilisate and 3 vials of 1 ml of solvent.
    Box containing 5 vials of 1 dose of lyophilisate and 5 vials of 1 ml of solvent.
    Box containing 10 vials of 1 dose of lyophilisate and 10 vials of 1 ml of solvent.
    Box containing 15 vials of 1 dose of lyophilisate and 15 vials of 1 ml of solvent.
    Box containing 25 vials of 1 dose of lyophilisate and 25 vials of 1 ml of solvent.
    Box containing 30 vials of 1 dose of lyophilisate and 30 vials of 1 ml of solvent.
    Box containing 50 vials of 1 dose of lyophilisate and 50 vials of 1 ml of solvent.
    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.
    7.
    MARKETING AUTHORISATION HOLDER
    VIRBAC
    1ère avenue – 2065 m – L.I.D.
    06516 Carros
    France
    Tel. 0033/4.92.08.73.00
    Fax. 0033/4.92.08.73.48
    E-mail. dar@virbac.fr
    5
    8.
    MARKETING AUTHORISATION NUMBER(S)
    EU/2/11/121/001-009
    9.
    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
    14/03/2011
    10. DATE OF REVISION OF THE TEXT
    14/03/2011
    Detailed information on this veterinary medicinal product is available on the website of the European
    Medicines Agency http://www.ema.europa.eu / .
    PROHIBITION OF SALE, SUPPLY AND/OR USE
    The import, sale, supply and/or use of CaniLeish is or may be prohibited in certain Member States on the
    whole or part of their territory pursuant to national animal health policy. Any person intending to import,
    sell, supply and/or use CaniLeish must consult the relevant Member State’s competent authority on the
    current vaccination policies prior to the import, sale, supply and/or use.
    6
    ANNEX II
    A.
    MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
    MANUFACTURING AUTHORISATION HOLDER 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
    A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
    MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
    RELEASE
    Name and address of the manufacturer of the biological active substance
    VIRBAC
    1ère avenue – 2065 m – L.I.D.
    06516 Carros
    France
    Name and address of the manufacturer responsible for batch release
    VIRBAC
    1ère avenue – 2065 m – L.I.D.
    06516 Carros
    France
    B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
    REGARDING SUPPLY OR USE
    To be supplied only on veterinary prescription.
    According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as
    amended, Member States prohibit or may prohibit the import, sale, supply and/or use of the veterinary
    medicinal product on the whole or part of their territory if it is established that:
    a) the administration of the veterinary medicinal product to animals will interfere with the
    implementation of national programmes for the diagnosis, control and eradication of animal diseases,
    or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs
    or other products obtained from treated animals.
    b) the disease to which the veterinary medicinal product is intended to confer immunity is largely
    absent from the territory.
    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.
    8
    ANNEX III
    LABELLING AND PACKAGE LEAFLET
    9
    A. LABELLING
    10
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    Box of 1 vial of lyophilisate and 1 vial of solvent
    Box of 1 vial of lyophilisate, 1 vial of solvent, 1 syringe and 1 needle.
    Box of 3 vials of lyophilisate and 3 vials of solvent
    Box of 5 vials of lyophilisate and 5 vials of solvent
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    CaniLeish lyophilisate and solvent for suspension for injection for dogs
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    L. infantum Proteins (ESP) ≥ 100 µg
    Purified extract of Quillaja saponaria (QA-21)
    3.
    PHARMACEUTICAL FORM
    Lyophilisate and solvent for suspension for injection.
    4.
    PACKAGE SIZE
    1 dose.
    3 doses.
    5 doses.
    5.
    TARGET SPECIES
    Dogs.
    6.
    INDICATION
    For the active immunization of Leishmania negative dogs from 6 months of age to reduce the risk to
    develop an active infection and clinical disease after contact with L. infantum .
    7.
    METHOD AND ROUTE OF ADMINISTRATION
    Subcutaneous use.
    Read the package leaflet before use.
    11
     
    8.
    WITHDRAWAL PERIOD
    Not applicable.
    9.
    SPECIAL WARNING(S), IF NECESSARY
    Read the package leaflet before use.
    10. EXPIRY DATE
    EXP: {month/year}
    Use immediately after reconstitution.
    11. SPECIAL STORAGE CONDITIONS
    Store and transport refrigerated (2 C – 8 C).
    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 on veterinary subscription
    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
    VIRBAC
    1ère avenue – 2065 m – L.I.D.
    06516 Carros
    France
    12
     
    16. MARKETING AUTHORISATION NUMBER(S)
    EU/2/11/121/001
    EU/2/11/121/002
    EU/2/11/121/003
    EU/2/11/121/004
    17. MANUFACTURER’S BATCH NUMBER
    Batch: {number}
    13
     
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    Box of 10 vials of lyophilisate and 10 vials of solvent
    Box of 15 vials of lyophilisate and 15 vials of solvent
    Box of 25 vials of lyophilisate and 25 vials of solvent
    Box of 30 vials of lyophilisate and 30 vials of solvent
    Box of 50 vials of lyophilisate and 50 vials of solvent
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    CaniLeish lyophilisate and solvent for suspension for injection for dogs
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Each dose of 1 ml vaccine contains:
    L. infantum Proteins (ESP) ≥ 100 µg
    Purified extract of Quillaja saponaria (QA-21)
    3.
    PHARMACEUTICAL FORM
    Lyophilisate and solvent for suspension for injection.
    4.
    PACKAGE SIZE
    10 doses.
    15 doses.
    25 doses.
    30 doses.
    50 doses.
    5.
    TARGET SPECIES
    Dogs.
    6.
    INDICATION(S)
    For the active immunization of Leishmania negative dogs from 6 months of age to reduce the risk to
    develop an active infection and clinical disease after contact with L. infantum .
    Read the package leaflet before use.
    14
     
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    Subcutaneous use.
    After reconstitution of the lyophilisate with the solvent, shake gently and administer immediately one dose
    of 1 ml subcutaneously according to the vaccination schedule.
    Read the package leaflet before use.
    8.
    WITHDRAWAL PERIOD
    Not applicable.
    9.
    SPECIAL WARNING(S), IF NECESSARY
    Read the package leaflet before use.
    10. EXPIRY DATE
    EXP : {month/year}
    Use immediately after reconstitution.
    11. SPECIAL STORAGE CONDITIONS
    Store and transport refrigerated (2 C – 8 C).
    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
     
    15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
    VIRBAC
    1ère avenue – 2065 m – L.I.D.
    06516 Carros
    France
    16. MARKETING AUTHORISATION NUMBER(S)
    EU/2/11/121/005
    EU/2/11/121/006
    EU/2/11/121/007
    EU/2/11/121/008
    EU/2/11/121/009
    17. MANUFACTURER’S BATCH NUMBER
    Batch: {number}
    16
     
    MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
    Vial with 1 dose of lyophilisate
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    CaniLeish lyophilisate
    2.
    QUANTITY OF THE ACTIVE SUBSTANCE(S)
    L. infantum ESP ≥ 100 µg
    3.
    CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
    1 dose
    4.
    ROUTE(S) OF ADMINISTRATION
    SC use.
    5.
    WITHDRAWAL PERIOD
    Not applicable.
    6.
    BATCH NUMBER
    Batch: {number}
    7.
    EXPIRY DATE
    EXP: {month/year}
    Use immediately after reconstitution.
    8.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only.
    17
     
    MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
    Vial with 1 dose of solvent
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    CaniLeish solvent
    2.
    QUANTITY OF THE ACTIVE SUBSTANCE(S)
    Sodium chloride 9 mg/ml (0.9%)
    3.
    CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
    1 ml
    4.
    ROUTE(S) OF ADMINISTRATION
    SC use.
    5.
    WITHDRAWAL PERIOD
    Not applicable.
    6.
    BATCH NUMBER
    Batch: {number}
    7.
    EXPIRY DATE
    EXP: {month/year}
    8.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only.
    18
     
    B. PACKAGE LEAFLET
    19
    PACKAGE LEAFLET
    CaniLeish lyophilisate and solvent for suspension for injection for dogs
    1.
    NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
    THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
    RELEASE, IF DIFFERENT
    Marketing authorisation holder and manufacturer :
    VIRBAC
    1ère avenue – 2065 m – L.I.D.
    06516 Carros
    France
    2.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    CaniLeish lyophilisate and solvent for suspension for injection for dogs
    3.
    STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS
    Each dose of 1 ml vaccine contains:
    Lyophilisate:
    Active substance :
    Leishmania infantum Excreted Secreted Proteins (ESP) ≥ 100 µg
    Adjuvant :
    Purified extract of Quillaja saponaria (QA-21)
    60 µg
    Solvent:
    Sodium chloride 9 mg/ml (0.9%)
    1 ml
    4.
    INDICATIONS
    For the active immunization of Leishmania negative dogs from 6 months of age to reduce the risk to
    develop an active infection and clinical disease after contact with Leishmania infantum .
    The efficacy of the vaccine has been demonstrated in dogs submitted to multiple natural parasite exposure
    in zones with high infection pressure.
    Onset of immunity : 4 weeks after the primary vaccination course.
    Duration of immunity: 1 year after the last (re-)vaccination.
    Do not use in case of hypersensitivity to the active substance, to the adjuvant or to any of the excipients.
    CONTRAINDICATIONS
    20
    5.
    6.
    ADVERSE REACTIONS
    After injection, moderate and transient local reactions may occur such as swelling, nodule, pain on
    palpation or erythema. These reactions resolve spontaneously within 2 to 15 days. Other transient signs
    commonly seen following vaccination may be observed such as hyperthermia, apathy and digestive
    disorders lasting 1 to 6 days. Allergic-type reactions are uncommon and appropriate symptomatic
    treatment should then be administered.
    If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
    veterinary surgeon.
    7.
    TARGET SPECIES
    Dogs.
    8.
    DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
    Primary vaccination course:
    - First dose from 6 months of age,
    - Second dose 3 weeks later,
    - Third dose 3 weeks after the 2 nd injection.
    Annual re-vaccination:
    - One booster injection of a single dose should be given 1 year after the third injection and annually
    thereafter.
    9.
    ADVICE ON CORRECT ADMINISTRATION
    After reconstitution of the lyophilisate with the solvent, shake gently and administer immediately one dose
    of 1 ml subcutaneously according to the vaccination schedule.
    10. WITHDRAWAL PERIOD
    Not applicable.
    11. SPECIAL STORAGE PRECAUTIONS
    Keep out of the reach and sight of children.
    Store and transport refrigerated (2 C – 8 C).
    Protect from light.
    12. SPECIAL WARNINGS
    Special precautions for use in animals
    Vaccinate only healthy animals. The efficacy of vaccination in dogs already infected has not been
    investigated and therefore cannot be recommended. In dogs developing a leishmaniosis (active infection
    and/or disease) despite vaccination, proceeding with vaccine injections showed no benefit. Injection of the
    21
    vaccine to dogs already infected by Leishmania infantum did not show any specific adverse reactions
    other than those described under “adverse reactions”. The detection of Leishmania infection using a rapid
    serological diagnostic test is recommended prior to vaccination.
    In case of anaphylactic reaction, appropriate symptomatic treatment should be administered.
    De-worming of infested dogs prior to vaccination is recommended.
    Vaccination should not prevent other measures taken to reduce exposure to sandflies.
    Special precautions to be taken by the person administering the veterinary medicinal product to
    animals
    In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the
    label to the physician.
    Use during pregnancy, lactation or lay
    The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
    Therefore, the use is not recommended during pregnancy and lactation.
    Interactions with other medicinal products
    No information is available on the safety and efficacy of this vaccine when used with any other veterinary
    medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product
    therefore needs to be made on a case by case basis.
    Incompatibilities
    In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other
    veterinary medicinal products.
    Overdose
    No adverse reactions other than those mentioned in section “Adverse reactions” were observed after the
    administration of a double-dose of the vaccine.
    Other information
    Transient antibodies against Leishmania detected by immunofluorescence antibody test (IFAT) may
    appear after vaccination. Antibodies due to vaccination can be differentiated from antibodies due to
    natural infection by using a rapid diagnostic serological test as a first step to a differential diagnosis.
    In areas of low or no infection pressure a benefit/risk assessment must be undertaken by the veterinarian
    before deciding to use the vaccine in dogs.
    The impact of the vaccine in terms of public health and control of the human infection cannot be estimated
    from available data.
    Efficacy data have shown that a vaccinated dog has 3.6 times less risk to develop an active infection
    and 4 times less risk to develop a clinical disease than a non-vaccinated dog, on dogs submitted to
    multiple natural parasite exposure in zones with high infection pressure.
    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 local requirements.
    22
    14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
    14/03/2011
    Detailed information on this product is available on the website of the European Medicines Agency
    15. OTHER INFORMATION
    Type I glass vial containing 1 dose of lyophilisate and type I glass vial containing 1 ml of solvent,
    both closed with a butyl elastomer closure and sealed with an aluminium cap.
    Pack sizes:
    Box containing 1 vial of 1 dose of lyophilisate and 1 vial of 1 ml of solvent.
    Box containing 1 vial of 1 dose of lyophilisate, 1 vial of 1 ml of solvent, 1 syringe and 1 needle.
    Box containing 3 vials of 1 dose of lyophilisate and 3 vials of 1 ml of solvent.
    Box containing 5 vials of 1 dose of lyophilisate and 5 vials of 1 ml of solvent.
    Box containing 10 vials of 1 dose of lyophilisate and 10 vials of 1 ml of solvent.
    Box containing 15 vials of 1 dose of lyophilisate and 15 vials of 1 ml of solvent.
    Box containing 25 vials of 1 dose of lyophilisate and 25 vials of 1 ml of solvent.
    Box containing 30 vials of 1 dose of lyophilisate and 30 vials of 1 ml of solvent.
    Box containing 50 vials of 1 dose of lyophilisate and 50 vials of 1 ml of solvent.
    Not all pack sizes may be marketed.
    The import, sale, supply and/or use of CaniLeish is or may be prohibited in certain Member States
    on the whole or part of their territory pursuant to national animal health policy. Any person intending to
    import, sell, supply and/or use CaniLeish must consult the relevant Member State’s competent
    authority on the current vaccination policies prior to the import, sale, supply and/or use.
    For any information about this veterinary medicinal product, please contact the local representative of the
    marketing authorisation holder.
    België/Belgique/Belgien
    VIRBAC BELGIUM
    Rue de la station 17
    B-1300 WAVRE
    Tel: 32 (0) 10 47 06 35
    Luxembourg/Luxemburg
    VIRBAC BELGIUM
    Rue de la station 17
    B-1300 WAVRE
    Tel: 32 (0) 10 47 06 35
    Република България
    VIRBAC
    1 ère avenue 2065 m – L.I.D
    F-06516 Carros
    Tel: 33 (0) 4 92 08 73 00
    Magyarország
    VIRBAC
    1 ère avenue 2065 m – L.I.D
    F-06516 Carros
    Tel: 33 (0) 4 92 08 73 00
    Česká republika
    VIRBAC
    1 ère avenue 2065 m – L.I.D
    F-06516 Carros
    Tel: 33 (0) 4 92 08 73 00
    Malta
    VIRBAC
    1 ère avenue 2065 m – L.I.D
    F-06516 Carros
    Tel: 33 (0) 4 92 08 73 00
    23
    Danmark
    VIRBAC Danmark A/S
    Profilvej 1
    6000 Kolding
    Tel: 45 75521244
    Nederland
    VIRBAC NEDERLAND BV
    Hermesweg 15
    NL-3771 ND-Barneveld
    Tel: 31 (0) 342 427 100
    Deutschland
    VIRBAC Tierarzneimittel GmbH
    Rögen 20
    D-22843 Bad Oldesloe
    Tel: 49 (4531) 805 111
    Norge
    VIRBAC
    1 ère avenue 2065 m – L.I.D
    F-06516 Carros
    Tel: 33 (0) 4 92 08 73 00
    Eesti
    OÜ ZOOVETVARU
    Uusaru 5
    ET -76505 Saue/Harjumaa, ESTONIA
    Tel: + 372 6 709 006
    Österreich
    VIRBAC Österreich GmbH
    Hildebrandgasse 27
    A-1180 Wien
    Tel: 43 (0) 1 21 834 260
    Ελλάδα
    VIRBAC HELLAS A.E.
    23 rd Klm National Road Athens-Lamia
    145 65 Agios Stefanos
    Athens - GREECE
    Tel: +30 210 6219520
    Polska
    VIRBAC
    1 ère avenue 2065 m – L.I.D
    F-06516 Carros
    Tel: 33 (0) 4 92 08 73 00
    España
    VIRBAC ESPAÑA S.A.
    ES-8950 Esplugues de Llobregat
    (Barcelona).
    Tél. : + 34 93 470 79 40
    Portugal
    VIRBAC DE PORTUGAL
    LABORATÓRIOS LDA
    R.do Centro Empresarial
    Ed13-Piso 1- Esc.3
    Quinta da Beloura
    2710-693 Sintra
    00 351 219 245 020
    France
    VIRBAC France
    13 ème rue – L.I.D – BP 27
    F-06517 Carros
    România
    VIRBAC
    1 ère avenue 2065 m – L.I.D
    F-06516 Carros
    Tel: 33 (0) 4 92 08 73 00
    Ireland
    C&M Veterinary Distributors Limited
    IE-Limerick
    Tel: 353 61 314 933
    Slovenija
    VIRBAC
    1 ère avenue 2065 m – L.I.D
    F-06516 Carros
    Tel: 33 (0) 4 92 08 73 00
    Ísland
    VIRBAC
    1 ère avenue 2065 m – L.I.D
    F-06516 Carros
    Tel: 33 (0) 4 92 08 73 00
    Slovenská republika
    VIRBAC
    1 ère avenue 2065 m – L.I.D
    F-06516 Carros
    Tel: 33 (0) 4 92 08 73 00
    24
    Italia
    VIRBAC SRL
    Via Caldera 21
    20153 Milano
    Tel: 0039 02 409247.1
    Suomi/Finland
    VIRBAC
    1 ère avenue 2065 m – L.I.D
    F-06516 Carros
    Tel: 33 (0) 4 92 08 73 00
    Κύπρος
    GEO. PAVLIDES & ARAOUZOS LTD
    25-27 Dimostheni Severi, 1080
    CY-1080 Nicosia - CYPRUS
    Τηλ: + 357 22456117
    E-mail: theodosiou.vet@gpa.com.cy
    Sverige
    VIRBAC
    1 ère avenue 2065 m – L.I.D
    F-06516 Carros
    Tel: 33 (0) 4 92 08 73 00
    Latvija
    OÜ ZOOVETVARU
    Uusaru 5
    ET - 76505 Saue/Harjumaa, ESTONIA
    Tel: + 372 6 709 006
    United Kingdom
    VIRBAC Ltd
    UK-Suffolk IP30 9 UP
    Tel: 44 (0) 1359 243243
    Lietuva
    OÜ ZOOVETVARU
    Uusaru 5
    ET - 76505 Saue/Harjumaa, ESTONIA
    Tel: + 372 6 709 006
    E-mail: margus@zoovet.ee
    25


    Source: European Medicines Agency


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