CaniLeish - summary of medicine characteristics

SUMMARY OF PRODUCT CHARACTERISTICS

NAME OF THE VETERINARY 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 ^g

Adjuvant :

Purified extract of Quillaja saponaria (QA-21): 60 ^g

Solvent:

Sodium chloride solution 9 mg/ml (0.9%)       1 ml

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Lyophilisate and solvent for suspension for injection.

Lyophilisate: beige freeze-dried fraction

Solvent: colourless liquid

4. CLINICAL PARTICULARS4.1 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 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.

• 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 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.

• 4.6 Adverse reactions (frequency and seriousness)

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:

• – Very common (more than 1 in 10 animals displaying adverse reactions during the course of one

treatment),

• – Common (more than 1 but less than 10 animals in 100 animals),

• – Uncommon (more than 1 but less than 10 animals in 1,000 animals),

• – Rare (more than 1 but less than 10 animals in 10,000 animals),

• – Very rare (less than 1 animal in 10,000 animals, including isolated reports).

• 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.

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.

The appearance of the reconstituted product is reddish-brown.

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 Withdrawal period

Not applicable.

• 5. IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Immunologicals for canidae – dog – inactivated parasitic vaccine.

ATC vet code : QI07AO01.

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.

6.1 List of excipients

Lyophilisate

Purified extract of Quillaja saponaria (QA-21)

Trometamol

Sucrose

Mannitol

Solvent

Sodium chloride

Water for injections

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:

Plastic box containing 1 vial of 1 dose of lyophilisate and 1 vial of 1 ml of solvent.

Plastic box containing 1 vial of 1 dose of lyophilisate, 1 vial of 1 ml of solvent, 1 syringe and 1 needle.

Plastic box containing 3 vials of 1 dose of lyophilisate and 3 vials of 1 ml of solvent.

Plastic box containing 5 vials of 1 dose of lyophilisate and 5 vials of 1 ml of solvent.

Plastic box containing 10 vials of 1 dose of lyophilisate and 10 vials of 1 ml of solvent.

Plastic box containing 15 vials of 1 dose of lyophilisate and 15 vials of 1 ml of solvent.

Plastic box containing 25 vials of 1 dose of lyophilisate and 25 vials of 1 ml of solvent.

Plastic box containing 30 vials of 1 dose of lyophilisate and 30 vials of 1 ml of solvent.

Plastic 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

VIRBAC

1ere avenue – 2065 m – LID

06516 Carros

France

Tel. 0033/4.92.08.73.00

Fax. 0033/4.92.08.73.48

E-mail.

8. MARKETING AUTHORISATION NUMBER(S)

EU/2/11/121/001–009

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

14/03/2011