Letifend (recombinant protein Q from Leishmania...) – Summary of product characteristics - QI07A
Updated on site: 20-Sep-2017
|Substance:||recombinant protein Q from Leishmania infantum MON-1|
|Manufacturer:||Laboratorios LETI, S.L.U.|
- 1. NAME OF THE VETERINARY MEDICINAL PRODUCT
- 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
- 3. PHARMACEUTICAL FORM
- 4. CLINICAL PARTICULARS
- 4.1 Target species
- 4.2 Indications for use, specifying the target species
- 4.3 Contraindications
- 4.4 Special warnings for each target species
- 4.5 Special precautions for use
- 4.6 Adverse reactions (frequency and seriousness)
- 4.7 Use during pregnancy, lactation or lay
- 4.8 Interaction with other medicinal products and other forms of interaction
- 4.9 Amounts to be administered and administration route
- 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
- 4.11 Withdrawal period(s)
- 5. IMMUNOLOGICAL PROPERTIES
- 6. PHARMACEUTICAL PARTICULARS
- 7. MARKETING AUTHORISATION HOLDER
- 8. MARKETING AUTHORISATION NUMBER(S)
- 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
1.NAME OF THE VETERINARY MEDICINAL PRODUCT
LETIFEND, lyophilisate and solvent for solution for injection for dogs
2.QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 0.5 ml vaccine contains:
Recombinant Protein Q from Leishmania infantum
For the full list of excipients, see section 6.1.
Lyophilisate and solvent for solution for injection.
4.2Indications for use, specifying the target species
For active immunisation of
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.
4.4Special warnings for each target species
The vaccine is safe in infected dogs.
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.
4.5Special precautions for use
Special precautions for use in animals
Vaccinate healthy and
It is essential that measures to reduce exposure to
Special precautions to be taken by the person administering the veterinary medicinal product to animals
4.6Adverse reactions (frequency and seriousness)
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)
4.7Use during pregnancy, lactation or lay
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.
4.8Interaction 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.
4.9Amounts to be administered and administration route
Primary vaccination scheme:
A single dose of the vaccine (0.5 ml) to be administered to dogs from 6 months of age.
A single dose of the vaccine (0.5 ml) to be given annually thereafter.
Method of administration:
Reconstitute one vial of the white lyophilisate using 0.5 ml of solvent. Shake gently to give a clear solution, and administer immediately the entire content (0.5 ml) of the reconstituted product.
4.10 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 (see section 4.6).
4.11 Withdrawal period(s)
Pharmacotherapeutic group: Immunologicals for Canidae – dog – inactivated parasitic vaccines – leishmania.
ATCvet code: QI07AO01
To stimulate active immunity against disease caused by Leishmania infantum parasites.
Diagnostic tools designed to detect Leishmania antibodies (SLA or IFAT or
The efficacy of the vaccine was demonstrated in a field study where seronegative dogs from a variety of breeds were naturally exposed to Leishmania infantum in zones with high infection pressure over a two year period. The data has shown that a vaccinated dog has 9.8 times less risk to develop clinical signs, 3.5 times less risk of having detectable parasites and 5 times less risk to develop clinical disease than a
6.1List of excipients
Water for injections.
Do not mix with any other veterinary medicinal product, except solvent supplied for use with the veterinary medicinal product.
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life of the solvent: 3 years.
Shelf life after reconstitution according to directions: use immediately.
6.4.Special precautions for storage
Store in a refrigerator (2 ºC – 8 ºC).
Do not freeze.
6.5Nature and composition of immediate packaging
Type I glass vials containing 1 dose of vaccine;
Type I glass vials containing the 0.8 ml of solvent. Vials are both closed with a bromobutyl stopper and an aluminium cap.
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.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
7.MARKETING AUTHORISATION HOLDER
Laboratorios LETI, S.L.unipersonal C/ Del Sol 5,
Polígono Industrial Norte Tres Cantos
28760 Madrid SPAIN
+34 91 771 17 90
8.MARKETING AUTHORISATION NUMBER(S)
9.DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 20/04/2016
10 DATE OF REVISION OF THE TEXT
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
PROHIBITION OF SALE, SUPPLY AND/OR USE
Any person intending to manufacture, import, possess, sell, supply and use this veterinary medicinal product must first consult the relevant Member State’s competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.