Letifend (recombinant protein Q from Leishmania...) – Package leaflet - QI07A

Updated on site: 20-Sep-2017

Medication name: Letifend
ATC: QI07A
Substance: recombinant protein Q from Leishmania infantum MON-1
Manufacturer: Laboratorios LETI, S.L.U.

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

Lietuva

Laboratorios LETI, S.L. unipersonal

Laboratorios LETI, S.L. unipersonal

C/ Del Sol 5, Polígono Industrial Norte

C/ Del Sol 5, Polígono Industrial Norte

Tres Cantos 28760 Madrid

Tres Cantos 28760 Madridas (ISPANIJA)

(SPANJE/ESPAGNE/SPANIEN)

Tel: +34 91 771 17 90

Tél/Tel: + 34 91 771 17 90

 

Република България

Luxembourg/Luxemburg

Laboratorios LETI, S.L. unipersonal

Laboratorios LETI, S.L. unipersonal

C/ Del Sol 5, Polígono Industrial Norte

C/ Del Sol 5, Polígono Industrial Norte

Tres Cantos 28760 Мадрид (ИСПАНИЯ)

Tres Cantos 28760 Madrid

Teл: + 34 91 771 17 90

(ESPAGNE/SPANIEN)

 

Tél/Tel: + 34 91 771 17 90

Česká republika

Magyarország

Laboratorios LETI, S.L. unipersonal

Laboratorios LETI, S.L. unipersonal

C/ Del Sol 5, Polígono Industrial Norte

C/ Del Sol 5, Polígono Industrial Norte

Tres Cantos 28760 Madrid (ŠPANĚLSKO)

Tres Cantos 28760 Madrid (SPANYOLORSZÁG)

Tel: + 34 91 771 17 90

Tel.: + 34 91 771 17 90

Danmark

Malta

Laboratorios LETI, S.L. unipersonal

Laboratorios LETI, S.L. unipersonal

C/ Del Sol 5, Polígono Industrial Norte

C/ Del Sol 5, Polígono Industrial Norte

Tres Cantos 28760 Madrid (SPANIEN)

Tres Cantos 28760 Madrid (SPAIN)

Tlf: + 34 91 771 17 90

Tel: + 34 91 771 17 90

Deutschland

Nederland

Laboratorios LETI, S.L. unipersonal

Laboratorios LETI, S.L. unipersonal

C/ Del Sol 5, Polígono Industrial Norte

C/ Del Sol 5, Polígono Industrial Norte

Tres Cantos 28760 Madrid (SPANIEN)

Tres Cantos 28760 Madrid (SPANJE)

Tel: + 34 91 771 17 90

Tel: + 34 91 771 17 90

Eesti

Norge

Laboratorios LETI, S.L. unipersonal

Laboratorios LETI, S.L. unipersonal

C/ Del Sol 5, Polígono Industrial Norte

C/ Del Sol 5, Polígono Industrial Norte

Tres Cantos 28760 Madrid (HISPAANIA)

Tres Cantos 28760 Madrid (SPANIA)

Tel: + 34 91 771 17 90

Tlf: + 34 91 771 17 90

Ελλάδα

Österreich

Laboratorios LETI, S.L. unipersonal

Laboratorios LETI, S.L. unipersonal

C/ Del Sol 5, Polígono Industrial Norte

C/ Del Sol 5, Polígono Industrial Norte

Tres Cantos 28760 Μαδρίτη (ΙΣΠΑΝΙΑ)

Tres Cantos 28760 Madrid (SPANIEN)

Τηλ: + 34 91 771 17 90

Tel: + 34 91 771 17 90

España

Polska

Laboratorios LETI, S.L. unipersonal

Laboratorios LETI, S.L. unipersonal

C/ Del Sol 5, Polígono Industrial Norte

C/ Del Sol 5, Polígono Industrial Norte

Tres Cantos 28760 Madrid (ESPAÑA)

Tres Cantos 28760 Madryt (HISZPANIA)

Tel: + 34 91 771 17 90

Tel.: + 34 91 771 17 90

France

Portugal

Laboratorios LETI, S.L. unipersonal

Laboratorios LETI, S.L. unipersonal

C/ Del Sol 5, Polígono Industrial Norte

C/ Del Sol 5, Polígono Industrial Norte

Tres Cantos 28760 Madrid (ESPAGNE)

Tres Cantos 28760 Madrid (ESPANHA)

Tél: + 34 91 771 17 90

Tel: + 34 91 771 17 90

Hrvatska

România

Laboratorios LETI, S.L. unipersonal

Laboratorios LETI, S.L. unipersonal

C/ Del Sol 5, Polígono Industrial Norte

C/ Del Sol 5, Polígono Industrial Norte

Tres Cantos 28760 Madrid (ŠPANJOLSKA)

Tres Cantos 28760 Madrid (SPANIA)

Tel: + 34 91 771 17 90

Tel: + 34 91 771 17 90

Ireland

Slovenija

Laboratorios LETI, S.L. unipersonal

Laboratorios LETI, S.L. unipersonal

C/ Del Sol 5, Polígono Industrial Norte

C/ Del Sol 5, Polígono Industrial Norte

Tres Cantos 28760 Madrid (SPAIN)

Tres Cantos 28760 Madrid (ŠPANIJA)

Tel: + 34 91 771 17 90

Tel: + 34 91 771 17 90

Ísland

Slovenská republika

Laboratorios LETI, S.L. unipersonal

Laboratorios LETI, S.L. unipersonal

C/ Del Sol 5, Polígono Industrial Norte

C/ Del Sol 5, Polígono Industrial Norte

Tres Cantos 28760 Madrid (SPÁNN)

Tres Cantos 28760 Madrid (ŠPANIELSKO)

Sími: + 34 91 771 17 90

Tel: + 34 91 771 17 90

Italia

Suomi/Finland

Laboratorios LETI, S.L. unipersonal

Laboratorios LETI, S.L. unipersonal

C/ Del Sol 5, Polígono Industrial Norte

C/ Del Sol 5, Polígono Industrial Norte

Tres Cantos 28760 Madrid (SPAGNA)

Tres Cantos 28760 Madrid (ESPANJA)

Tel: + 34 91 771 17 90

Puh/Tel: + 34 91 771 17 90

Κύπρος

Sverige

Laboratorios LETI, S.L. unipersonal

Laboratorios LETI, S.L. unipersonal

C/ Del Sol 5, Polígono Industrial Norte

C/ Del Sol 5, Polígono Industrial Norte

Tres Cantos 28760 Μαδρίτη (ΙΣΠΑΝΙΑ)

Tres Cantos 28760 Madrid (SPANIEN)

Τηλ: + 34 91 771 17 90

Tel: + 34 91 771 17 90

Latvija

United Kingdom

Laboratorios LETI, S.L. unipersonal

Laboratorios LETI, S.L. unipersonal

C/ Del Sol 5, Polígono Industrial Norte

C/ Del Sol 5, Polígono Industrial Norte

Tres Cantos 28760 Madride (SPĀNIJA)

Tres Cantos 28760 Madrid (SPAIN)

Tel: + 34 91 771 17 90

Tel: + 34 91 771 17 90

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