Patient leaflet - CaniLeish
B. PACKAGE LEAFLET
PACKAGE LEAFLET
CaniLeish lyophilisate and solvent for suspension for injection for dogs
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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
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
CaniLeish lyophilisate and solvent for suspension for injection for dogs
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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) at least 100 ^g
Adjuvant :
Purified extract of Quillaja saponaria (QA-21) 60 ^g
Solvent:
Sodium chloride solution 9 mg/ml (0.9%) 1 ml
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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.
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5. CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance, to the adjuvant or to any of the excipients.
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6. ADVERSE REACTIONS
After injection, moderate and transient local reactions such as swelling, nodule, pain on palpation or erythema are common, but these reactions resolve spontaneously within 2 to 15 days. In very rare cases a more severe reaction at the injection site (injection site necrosis, vasculitis) has been reported.
Other transient signs seen following vaccination such as hyperthermia, apathy and digestive disorders lasting 1 to 6 days are common. In rare cases anorexia and emesis have been reported.
Allergic-type reactions are rare. In very rare cases, serious hypersensitivity reactions have been observed which could be fatal. A symptomatic treatment should be rapidly implemented and clinical monitoring should be maintained until symptoms resolve.
The frequency of adverse reactions is defined using the following convention:
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– Very common (more than 1 in 10 animals displaying adverse reactions during the course of one
treatment),
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– Common (more than 1 but less than 10 animals in 100 animals),
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– Uncommon (more than 1 but less than 10 animals in 1,000 animals),
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– Rare (more than 1 but less than 10 animals in 10,000 animals),
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– Very rare (less than 1 animal in 10,000 animals, including isolated reports).
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
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7. TARGET SPECIES
Dogs.
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8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Subcutaneous use.
Primary vaccination course:
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– First dose from 6 months of age,
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– Second dose 3 weeks later,
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– Third dose 3 weeks after the 2nd injection.
Annual re-vaccination:
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– One booster injection of a single dose should be given 1 year after the third injection and annually thereafter.
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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.
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10. WITHDRAWAL PERIOD
Not applicable.
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11. SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
Store and transport refrigerated (2 °C – 8 °C).
Protect from light.
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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 vaccine to dogs already infected by Leishmania infantum did not show any specific adverse reactions other than those described in section 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 and clinical monitoring should be maintained until symptoms resolve. In order to facilitate the quick implementation of such treatment, should an anaphylactic reaction occur, an observation of the dog by the owner during the hours following vaccination is recommended.
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.
Pregnancy and lactation
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 6 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.
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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. Ask your veterinary surgeon how to dispose of medicines no longer required.
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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.
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15. OTHER INFORMATION