CaniLeish (Leishmania infantum excreted secreted...) – Package leaflet - QI070AO

Updated on site: 08-Feb-2018

Medication name: CaniLeish
ATC: QI070AO
Substance: Leishmania infantum excreted secreted proteins
Manufacturer: Virbac S.A

Article Contents

PACKAGE LEAFLET

CaniLeish lyophilisate and solvent for suspension for injection for dogs

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

2.NAME OF THE VETERINARY MEDICINAL PRODUCT

CaniLeish lyophilisate and solvent for suspension for injection for dogs

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 µg

Adjuvant:

 

Purified extract of Quillaja saponaria (QA-21)

60 µg

Solvent:

 

Sodium chloride solution 9 mg/ml (0.9%)

1 ml

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.

5.CONTRAINDICATIONS

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

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:

-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.

7.TARGET SPECIES

Dogs.

8.DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

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.

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.

10.WITHDRAWAL PERIOD

Not applicable.

11.SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

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

Protect from light.

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.

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.

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 http://www.ema.europa.eu/.

15.OTHER INFORMATION

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.

België/Belgique/Belgien

VIRBAC BELGIUM

Esperantolaan 4

B-3001 Leuven

Tel: 32 (0) 16 38 72 60

Република България

VIRBAC

1ère avenue 2065 m – L.I.D F-06516 Carros

Tel: 33 (0) 4 92 08 73 00

Česká republika

VIRBAC

1ère avenue 2065 m – L.I.D F-06516 Carros

Tel: 33 (0) 4 92 08 73 00

Danmark

VIRBAC Danmark A/S

Profilvej 1

6000 Kolding

Tel: 45 75521244

Deutschland

VIRBAC Tierarzneimittel GmbH

Rögen 20

D-22843 Bad Oldesloe

Tel: 49 (4531) 805 111

Eesti

OÜ ZOOVETVARU Uusaru 5

ET -76505 Saue/Harjumaa, ESTONIA Tel: + 372 6 709 006

E-mail: margus@zoovet.ee

Ελλάδα

VIRBAC HELLAS A.E.

13th Klm National Road Athens-Lamia 14452 Metamorfosi

Athens - GREECE Tel: +30 210 6219520 E-mail: info@virbac.gr

España

VIRBAC ESPAÑA S.A. ES-8950 Esplugues de Llobregat (Barcelona).

Tél. : + 34 93 470 79 40

Luxembourg/Luxemburg

VIRBAC BELGIUM

Esperantolaan 4

B-3001 Leuven

Tel: 32 (0) 16 38 72 60

Magyarország

VIRBAC

1ère avenue 2065 m – L.I.D F-06516 Carros

Tel: 33 (0) 4 92 08 73 00

Malta

VIRBAC

1ère avenue 2065 m – L.I.D F-06516 Carros

Tel: 33 (0) 4 92 08 73 00

Nederland

VIRBAC NEDERLAND BV

Hermesweg 15

NL-3771 ND-Barneveld

Tel: 31 (0) 342 427 100

Norge

VIRBAC

1ère avenue 2065 m – L.I.D F-06516 Carros

Tel: 33 (0) 4 92 08 73 00

Österreich

VIRBAC Österreich GmbH Hildebrandgasse 27 A-1180 Wien

Tel: 43 (0) 1 21 834 260

Polska

VIRBAC

1ère avenue 2065 m – L.I.D F-06516 Carros

Tel: 33 (0) 4 92 08 73 00

Portugal

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

France

VIRBAC France

13ème rue – L.I.D – BP 27 F-06517 Carros

Ísland

România

VIRBAC

1ère avenue 2065 m – L.I.D F-06516 Carros

Tel: 33 (0) 4 92 08 73 00

Slovenija

VIRBAC

VIRBAC

1ère avenue 2065 m – L.I.D

1ère avenue 2065 m – L.I.D

F-06516 Carros

F-06516 Carros

Tel: 33 (0) 4 92 08 73 00

Tel: 33 (0) 4 92 08 73 00

Italia

Slovenská republika

VIRBAC SRL

VIRBAC

Via Ettore Bugatti, 15

1ère avenue 2065 m – L.I.D

20142 Milano - Italia

F-06516 Carros

Tel: 00 39 02 40 92 47 1

Tel: 33 (0) 4 92 08 73 00

Κύπρος

Suomi/Finland

GEO. PAVLIDES & ARAOUZOS LTD

VIRBAC

25-27 Dimostheni Severi, 1080

1ère avenue 2065 m – L.I.D

CY-1080 Nicosia - CYPRUS

F-06516 Carros

Τηλ: + 357 22456117

Tel: 33 (0) 4 92 08 73 00

E-mail: theodosiou.vet@gpa.com.cy

 

Latvija

Sverige

OÜ ZOOVETVARU

VIRBAC

Uusaru 5

1ère avenue 2065 m – L.I.D

ET - 76505 Saue/Harjumaa, ESTONIA

F-06516 Carros

Tel: + 372 6 709 006

Tel: 33 (0) 4 92 08 73 00

E-mail: margus@zoovet.ee

 

Lietuva

United Kingdom

OÜ ZOOVETVARU

VIRBAC Ltd

Uusaru 5

UK-Suffolk IP30 9 UP

ET - 76505 Saue/Harjumaa, ESTONIA

Tel: 44 (0) 1359 243243

Tel: + 372 6 709 006

 

E-mail: margus@zoovet.ee

 

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