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Canileish is a vaccine for dogs used to provide protection against Leishmaniasis, a disease found around the Mediterranean transmitted by the bites of sand flies.
Each dose of 1 ml vaccine contains:
Leishmania infantum Excreted Secreted Proteins (ESP) at least 100 μg
Purified extract of Quillaja saponaria (QA-21): 60 μg
Sodium chloride 9 mg/ml (0.9%) 1 ml
Lyophilisate and solvent for suspension for injection.
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.
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.
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.
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.
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.
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.
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 2nd injection.
One booster injection of a single dose should be given 1 year after the third injection and annually thereafter.
No adverse reactions other than those mentioned above were observed after the administration of a double-dose of the vaccine.
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.
List of excipients
Purified extract of Quillaja saponaria (QA-21)
Sodium chloride 9 mg/ml (0.9%)
Water for injections
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
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.
Store and transport refrigerated (2°C – 8°C).
Protect from light.
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.
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.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
1ère avenue – 2065 m – L.I.D.
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.
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