Letifend

Helstu upplýsingar

  • Heiti vöru:
  • Letifend
  • Lyf við lungum:
  • Dýr
  • Lyfjaform:
  • Allópatísk lyf

Skjöl

Staðsetning

  • Fáanlegt í:
  • Letifend
    Evrópusambandið
  • Tungumál:
  • enska

Meðferðarupplýsingar

  • Meðferðarhópur:
  • Dogs
  • Lækningarsvæði:
  • Immunologicals for Canidae – dog
  • Ábendingar:
  • For active immunisation of dogs from 6 months of age to reduce the risk of developing a clinical case of leishmaniasis.,
  • Vörulýsing:
  • Revision: 5

Staða

  • Heimild:
  • EMA - European Medicines Agency
  • Leyfisstaða:
  • Authorised
  • Leyfisnúmer:
  • EMEA/V/C/003865
  • Leyfisdagur:
  • 19-04-2016
  • EMEA númer:
  • EMEA/V/C/003865
  • Síðasta uppfærsla:
  • 27-03-2019

Opinber matsskýrsla

30 Churchill Place

Canary Wharf

London E14 5EU

United Kingdom

An agency of the European Union

Telephone

+44 (0)20 3660 6000

Facsimile

+44 (0)20 3660 5555

Send a question via our website

www.ema.europa.eu/contact

© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

EMA/159853/2016

EMEA/V/C/003865

EPAR summary for the public

Letifend

canine leishmaniasis vaccine (recombinant protein)

This is a summary of the European public assessment report (EPAR) for Letifend. It explains how

the Agency assessed this veterinary medicine to recommend its authorisation in the European Union

(EU) and its conditions of use. It is not intended to provide practical advice on how to use Letifend.

For practical information about using Letifend, animal owners or keepers should read the package

leaflet or contact their veterinarian or pharmacist.

What is Letifend and what is it used for?

Letifend is a veterinary vaccine used in dogs to protect them against leishmaniasis due to the

parasite Leishmania infantum. The parasite is widespread in countries bordering the Mediterranean

Sea and is transmitted by the bites of sand flies. Dogs that have been infected may show no signs

of infection, but some have active disease with symptoms such as fever, hair and weight loss, and

skin sores. Infected dogs can help spread the disease to humans.

Letifend contains the active substance protein Q, which is made of different fragments of proteins

from Leishmania infantum.

For further information, see the package leaflet.

How is Letifend used?

Letifend is available as a freeze-dried powder (lyophilisate) and solvent that are made up into a

solution for injection, and can only be obtained with a prescription.

Before vaccination, dogs should be tested for Leishmania infection. Only non-infected animals

should be vaccinated.

The vaccine is given to dogs from 6 months of age as a single injection under the skin. A ‘booster’

injection should be given every year to maintain the vaccine’s effect. Protection starts four weeks

after vaccination and lasts one year. Measures should be taken to reduce exposure to sand flies in

Letifend

EMA/159853/2016

Page 2/2

vaccinated dogs since the vaccine does not prevent Leishmania infection.

For further information, see the package leaflet.

How does Letifend work?

Letifend is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences)

how to defend itself against a disease. When Letifend is given to dogs the immune system

recognises the Leishmania protein as ‘foreign’ and makes defences against it. In the future, if the

animals are exposed to the parasite, the immune system will be able to respond more quickly. This

will help to protect against the disease.

What benefits of Letifend have been shown in studies?

In a field study in France and Spain 275 dogs were vaccinated with Letifend and 274 dogs received

placebo (a dummy vaccination). The dogs were exposed to natural infection with Leishmania

infantum. Over a two year period there were 8 confirmed cases of leishmaniasis in the vaccinated

group compared with 19 cases in the placebo group, showing that Letifend was effective in reducing

the occurrence of the disease.

What are the risks associated with Letifend?

The most common side effect with Letifend (which may affect more than 1 in 10 animals) is

scratching at the injection site which resolves within four hours.

For the full list of restrictions, see the package leaflet.

What are the precautions for the person who gives the medicine or comes

into contact with the animal?

None.

Why is Letifend approved?

The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Letifend’s

benefits are greater than its risks and recommended that it be approved for use in the EU.

Other information about Letifend?

The European Commission granted a marketing authorisation valid throughout the EU for Letifend

on 20.04.2016.

The full EPAR for Letifend can be found on the Agency’s website: ema.europa.eu/Find

medicine/Veterinary medicines/European public assessment reports. For more information about

treatment with Letifend, animal owners or keepers should read the package leaflet or contact their

veterinarian or pharmacist.

This summary was last updated in February 2016.

Upplýsingar um fylgiseðil sjúklinga: samsetning, vísbendingar, aukaverkanir, skammtar, milliverkanir, aukaverkanir, meðgöngu, brjóstagjöf

B. PACKAGE LEAFLET

PACKAGE LEAFLET:

LETIFEND, lyophilisate and solvent for solution 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 responsible for batch release:

Laboratorios LETI, S.L.unipersonal

C/ Del Sol 5, Polígono Industrial Norte

Tres Cantos

28760 Madrid

SPAIN

2.

NAME OF THE VETERINARY MEDICINAL PRODUCT

LETIFEND, lyophilisate and solvent for solution for injection for dogs

3.

STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

Each dose of 0.5 ml vaccine contains:

Lyophilisate

(white lyophilisate)

Active substance:

Recombinant Protein Q from Leishmania infantum MON-1: ≥ 36.7 ELISA units (EU)*

* Antigen content determined in an ELISA against an internal standard.

Excipients:

Sodium chloride

Arginine hydrochloride

Boric acid.

Solvent

Water for injections: q.s. 0.5 ml.

4.

INDICATION(S)

For active immunisation of non-infected dogs from 6 months of age to reduce the risk of developing an

active infection and/or clinical disease after exposure to Leishmania infantum.

The efficacy of the vaccine was demonstrated in a field study where dogs were naturally exposed to

Leishmania infantum in zones with high infection pressure over a two year period.

In laboratory studies including experimental challenge with Leishmania infantum, the vaccine reduced

the severity of the disease, including clinical signs and parasite burden in spleen and lymph nodes.

Onset of immunity: 4 weeks after vaccination.

Duration of immunity: 1 year after vaccination.

5.

CONTRAINDICATIONS

None.

6.

ADVERSE REACTIONS

After vaccination, scratching at the injection site has been observed very commonly in dogs.

Spontaneous resolution of such reaction was observed within 4 hours.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reaction(s))

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports)

If you notice any side effects, even those not already listed in this package leaflet or you think that the

medicine has not worked, please inform your veterinary surgeon.

7.

TARGET SPECIES

Dogs.

8.

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

Subcutaneous use.

Primary vaccination scheme:

A single dose of the vaccine (0.5 ml) to be administered to dogs from 6 months of age.

Re-vaccination scheme:

A single dose of the vaccine (0.5 ml) to be given annually thereafter.

9.

ADVICE ON CORRECT ADMINISTRATION

Reconstitute one vial of the white lyophilisate using 0.5 ml of the solvent. Shake gently to give a clear

solution, and administer immediately the entire content (0.5 ml) of the reconstituted product.

10.

WITHDRAWAL PERIOD(S)

Not applicable.

11.

SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Store in a refrigerator (2 ºC – 8 ºC).

Do not freeze.

Shelf life after reconstitution according to directions: use immediately

Do not use this veterinary medicinal product after the expiry date which is stated on the label after

EXP.

12.

SPECIAL WARNING(S)

Special warnings for each target species:

The vaccine is safe in infected dogs. Re-vaccination of infected dogs did not worsen the course of the

disease (during the 2-month observation period). No efficacy has been demonstrated in these animals.

A test for the detection of Leishmania infection is recommended prior to vaccination.

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 in animals:

Vaccinate healthy and non-infected animals only.

De-worming of infested dogs prior to vaccination is recommended.

It is essential that measures to reduce exposure to sand-flies are employed in vaccinated animals.

Special precautions to be taken by the person administering the veterinary medicinal product to

animals:

None.

Pregnancy and lactation:

The safety of the veterinary medicinal product has not been established during pregnancy or lactation.

Therefore, the use is not recommended during pregnancy and lactation.

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.

Overdose (symptoms, emergency procedures, antidotes) if necessary:

Following administration of a double dose, reactions are similar in nature to those observed following

the administration of a single dose.

Incompatibilities:

Do not mix with any other veterinary medicinal product, except solvent supplied for use with the

medicinal product.

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 or pharmacist how to dispose of medicines no longer required. These

measures should help to protect the environment.

14.

DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this veterinary medicinal product is available on the website of the European

Medicines Agency (http://www.ema.europa.eu/).

15.

OTHER INFORMATION

Lyophilisate vial

Type I glass vials containing 1 dose of vaccine;

Solvent vial

Type I glass vials containing 0.8 ml of solvent. Vials are both closed with a bromobutyl stopper and an

aluminium cap.

Pack sizes:

Plastic box containing 1 vial of 1 dose of lyophilisate and 1 vial of 0.8 ml of solvent.

Plastic box containing 4 vials of 1 dose of lyophilisate and 4 vials of 0.8 ml of solvent.

Plastic box containing 5 vials of 1 dose of lyophilisate and 5 vials of 0.8 ml of solvent.

Plastic box containing 10 vials of 1 dose of lyophilisate and 10 vials of 0.8 ml of solvent.

Plastic box containing 20 vials of 1 dose of lyophilisate and 20 vials of 0.8 ml of solvent.

Plastic box containing 25 vials of 1 dose of lyophilisate and 25 vials of 0.8 ml of solvent.

Plastic box containing 50 vials of 1 dose of lyophilisate and 50 vials of 0.8 ml of solvent.

Plastic box containing 100 vials of 1 dose of lyophilisate and 100 vials of 0.8 ml of solvent.

Not all pack sizes may be marketed.

The manufacture, import, possession, sale, supply and/or use of LETIFEND may be prohibited in a

Member State on the whole or part of its territory pursuant to national legislation. Any person

intending to manufacture, import, possess, sell, supply and use LETIFEND must consult the relevant

Member State’s competent authority on the current vaccination policies prior to the manufacture,

import, possession, 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

Laboratorios LETI, S.L. unipersonal

C/ Del Sol 5, Polígono Industrial Norte

Tres Cantos 28760 Madrid

(SPANJE/ESPAGNE/SPANIEN)

Tél/Tel: + 34 91 771 17 90

Lietuva

Laboratorios LETI, S.L. unipersonal

C/ Del Sol 5, Polígono Industrial Norte

Tres Cantos 28760 Madridas (ISPANIJA)

Tel: +34 91 771 17 90

Република България

Laboratorios LETI, S.L. unipersonal

C/ Del Sol 5, Polígono Industrial Norte

Tres Cantos 28760 Мадрид (ИСПАНИЯ)

Teл: + 34 91 771 17 90

Luxembourg/Luxemburg

Laboratorios LETI, S.L. unipersonal

C/ Del Sol 5, Polígono Industrial Norte

Tres Cantos 28760 Madrid

(ESPAGNE/SPANIEN)

Tél/Tel: + 34 91 771 17 90

Česká republika

Laboratorios LETI, S.L. unipersonal

C/ Del Sol 5, Polígono Industrial Norte

Tres Cantos 28760 Madrid (ŠPANĚLSKO)

Tel: + 34 91 771 17 90

Magyarország

Laboratorios LETI, S.L. unipersonal

C/ Del Sol 5, Polígono Industrial Norte

Tres Cantos 28760 Madrid (SPANYOLORSZÁG)

Tel.: + 34 91 771 17 90

Danmark

Laboratorios LETI, S.L. unipersonal

C/ Del Sol 5, Polígono Industrial Norte

Tres Cantos 28760 Madrid (SPANIEN)

Tlf: + 34 91 771 17 90

Malta

Laboratorios LETI, S.L. unipersonal

C/ Del Sol 5, Polígono Industrial Norte

Tres Cantos 28760 Madrid (SPAIN)

Tel: + 34 91 771 17 90

Deutschland

Laboratorios LETI, S.L. unipersonal

C/ Del Sol 5, Polígono Industrial Norte

Tres Cantos 28760 Madrid (SPANIEN)

Nederland

Laboratorios LETI, S.L. unipersonal

C/ Del Sol 5, Polígono Industrial Norte

Tres Cantos 28760 Madrid (SPANJE)

Tel: + 34 91 771 17 90

Tel: + 34 91 771 17 90

Eesti

Laboratorios LETI, S.L. unipersonal

C/ Del Sol 5, Polígono Industrial Norte

Tres Cantos 28760 Madrid (HISPAANIA)

Tel: + 34 91 771 17 90

Norge

Laboratorios LETI, S.L. unipersonal

C/ Del Sol 5, Polígono Industrial Norte

Tres Cantos 28760 Madrid (SPANIA)

Tlf: + 34 91 771 17 90

Ελλάδα

Intervet Hellas AE

Αγίου Δημητρίου 63,

174 56 Άλιμος, Αττική, ΕΛΛΆΔΑ

Τηλ: +30 210 9897430

Österreich

Laboratorios LETI, S.L. unipersonal

C/ Del Sol 5, Polígono Industrial Norte

Tres Cantos 28760 Madrid (SPANIEN)

Tel: + 34 91 771 17 90

España

Laboratorios LETI, S.L. unipersonal

C/ Del Sol 5, Polígono Industrial Norte

Tres Cantos 28760 Madrid (ESPAÑA)

Tel: + 34 91 771 17 90

Polska

Laboratorios LETI, S.L. unipersonal

C/ Del Sol 5, Polígono Industrial Norte

Tres Cantos 28760 Madryt (HISZPANIA)

Tel.: + 34 91 771 17 90

France

INTERVET

Rue Olivier de Serres, Angers Technopole

40971 Beaucouze CEDEX (FRANCE)

Tél: + 33 (0) 2 41 22 83 83

Portugal

Laboratorios LETI, S.L. unipersonal

C/ Del Sol 5, Polígono Industrial Norte

Tres Cantos 28760 Madrid (ESPANHA)

Tel: + 34 91 771 17 90

Hrvatska

Laboratorios LETI, S.L. unipersonal

C/ Del Sol 5, Polígono Industrial Norte

Tres Cantos 28760 Madrid (ŠPANJOLSKA)

Tel: + 34 91 771 17 90

România

Laboratorios LETI, S.L. unipersonal

C/ Del Sol 5, Polígono Industrial Norte

Tres Cantos 28760 Madrid (SPANIA)

Tel: + 34 91 771 17 90

Ireland

Laboratorios LETI, S.L. unipersonal

C/ Del Sol 5, Polígono Industrial Norte

Tres Cantos 28760 Madrid (SPAIN)

Tel: + 34 91 771 17 90

Slovenija

Laboratorios LETI, S.L. unipersonal

C/ Del Sol 5, Polígono Industrial Norte

Tres Cantos 28760 Madrid (ŠPANIJA)

Tel: + 34 91 771 17 90

Ísland

Laboratorios LETI, S.L. unipersonal

C/ Del Sol 5, Polígono Industrial Norte

Tres Cantos 28760 Madrid (SPÁNN)

Sími: + 34 91 771 17 90

Slovenská republika

Laboratorios LETI, S.L. unipersonal

C/ Del Sol 5, Polígono Industrial Norte

Tres Cantos 28760 Madrid (ŠPANIELSKO)

Tel: + 34 91 771 17 90

Italia

MSD Animal Health S.r.l.

via Fratelli Cervi snc, Centro Direzionale Milano

Due, Palazzo Canova

20090 Segrate (MI) (ITALIA)

Tel: + 39 02 516861

Suomi/Finland

Laboratorios LETI, S.L. unipersonal

C/ Del Sol 5, Polígono Industrial Norte

Tres Cantos 28760 Madrid (ESPANJA)

Puh/Tel: + 34 91 771 17 90

Κύπρος

Laboratorios LETI, S.L. unipersonal

C/ Del Sol 5, Polígono Industrial Norte

Tres Cantos 28760 Μαδρίτη (

ΙΣΠΑΝΙΑ

Τηλ: + 34 91 771 17 90

Sverige

Laboratorios LETI, S.L. unipersonal

C/ Del Sol 5, Polígono Industrial Norte

Tres Cantos 28760 Madrid (SPANIEN)

Tel: + 34 91 771 17 90

Latvija

Laboratorios LETI, S.L. unipersonal

C/ Del Sol 5, Polígono Industrial Norte

Tres Cantos 28760 Madride (SPĀNIJA)

Tel: + 34 91 771 17 90

United Kingdom

Intervet UK Ltd

Walton Manor, Walton,

Milton Keynes,

Buckinghamshire, MK7 7AJ (UNITED

KINGDOM)

Tel: + 44 (0) 1908 685685