CaniLeish Suspension for Injection for Dogs (3 dose)

CaniLeish Suspension for Injection for Dogs (3 dose).

Target species

Dogs

Indications for use

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.

Contra-indications

Do not use in case of hypersensitivity to the active substance, to the adjuvant or to any of the excipients.

Special warnings for each target species

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

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.

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.

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

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.

Amounts to be administered and administration route

Subcutaneous use.

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.

Annual re-vaccination:

One booster injection of a single dose should be given 1 year after the third injection and annually thereafter.

Overdose

No adverse reactions other than those mentioned above were observed after the administration of a double-dose of the vaccine.

Withdrawal periods

Not applicable

Pharmacological particulars

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.

Pharmaceutical particulars

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

Major incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

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.

Special precautions for storage

Store and transport refrigerated (2°C – 8°C).

Protect from light.

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 3 vials of 1 dose of lyophilisate and 3 vials of 1 ml of solvent.

Disposal

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.