CaniLeish
Leishmania infantum excreted secreted proteins
Marketing authorisation holder and manufacturer:
VIRBAC
1ère avenue – 2065 m – L.I.D. 06516 Carros
France
CaniLeish lyophilisate and solvent for suspension for injection for dogs
Each dose of 1 ml vaccine contains: Lyophilisate:
Leishmania infantum Excreted Secreted Proteins (ESP) at least 100 µg
Purified extract of Quillaja saponaria (QA-21) 60 µg
Solvent:
Sodium chloride solution 9 mg/ml (0.9%) 1 ml
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.
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).
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Dogs.
Subcutaneous use.
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.
After reconstitution of the lyophilisate with the solvent, shake gently and administer immediately one dose of 1 ml subcutaneously according to the vaccination schedule.
Not applicable.
Keep out of the sight and reach of children. Store and transport refrigerated (2 C – 8 C). Protect from light.
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.
Medicines should not be disposed of via wastewater or household waste. Ask your veterinary surgeon how to dispose of medicines no longer required.
Detailed information on this product is available on the website of the European Medicines Agency
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.
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.
VIRBAC BELGIUM
Esperantolaan 4 B-3001 Leuven
Tel: 32 (0) 16 38 72 60
VIRBAC BELGIUM
Esperantolaan 4 B-3001 Leuven
Tel: 32 (0) 16 38 72 60
VIRBAC
1ère avenue 2065 m – L.I.D F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
VIRBAC
1ère avenue 2065 m – L.I.D F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
VIRBAC
1ère avenue 2065 m – L.I.D F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
VIRBAC
1ère avenue 2065 m – L.I.D F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
VIRBAC Danmark A/S
Profilvej 1
6000 Kolding
Tel: 45 75521244
VIRBAC NEDERLAND BV
Hermesweg 15
NL-3771 ND-Barneveld Tel: 31 (0) 342 427 100
VIRBAC Tierarzneimittel GmbH
Rögen 20
D-22843 Bad Oldesloe Tel: 49 (4531) 805 111
VIRBAC
1ère avenue 2065 m – L.I.D F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
OÜ ZOOVETVARU
Uusaru 5
ET -76505 Saue/Harjumaa, ESTONIA Tel: + 372 6 709 006
E-mail: margus@zoovet.ee
VIRBAC Österreich GmbH
Hildebrandgasse 27 A-1180 Wien
Tel: 43 (0) 1 21 834 260
VIRBAC HELLAS A.E.
13th Klm National Road Athens-Lamia 14452 Metamorfosi
Athens - GREECE
Tel: +30 210 6219520
E-mail: info@virbac.gr
VIRBAC
1ère avenue 2065 m – L.I.D F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
VIRBAC ESPAÑA S.A.
ES-8950 Esplugues de Llobregat (Barcelona).
Tél. : + 34 93 470 79 40
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
VIRBAC France
13ème rue – L.I.D – BP 27 F-06517 Carros
VIRBAC
1ère avenue 2065 m – L.I.D F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
VIRBAC
1ère avenue 2065 m – L.I.D F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
VIRBAC
1ère avenue 2065 m – L.I.D F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
VIRBAC SRL
Via Ettore Bugatti, 15 20142 Milano - Italia
Tel: 00 39 02 40 92 47 1
VIRBAC
1ère avenue 2065 m – L.I.D F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
GEO. PAVLIDES & ARAOUZOS LTD
25-27 Dimostheni Severi, 1080 CY-1080 Nicosia - CYPRUS Τηλ: + 357 22456117
E-mail: theodosiou.vet@gpa.com.cy
VIRBAC
1ère avenue 2065 m – L.I.D F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
OÜ ZOOVETVARU
Uusaru 5
ET - 76505 Saue/Harjumaa, ESTONIA Tel: + 372 6 709 006
E-mail: margus@zoovet.ee
VIRBAC
1ère avenue 2065 m – L.I.D F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
OÜ ZOOVETVARU
Uusaru 5
ET - 76505 Saue/Harjumaa, ESTONIA Tel: + 372 6 709 006
VIRBAC Ltd
UK-Suffolk IP30 9 UP Tel: 44 (0) 1359 243243