Patient leaflet - Letifend
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 :
LETI Pharma, S.L.U.
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 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 years 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
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
-
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.
Hypersensitivity reactions (e.g. anaphylaxis, skin manifestations such as oedema, urticaria, pruritus) have been reported in very rare cases. In case of such an allergic or anaphylactic reaction, appropriate symptomatic treatment should be administered.
Lethargy, vomiting, diarrhoea and hyperthermia following vaccination have each been reported to occur very rarely based on post-marketing safety experience. Treatment should be administered as needed.
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 0.5 ml to be administered to dogs from 6 months of age.
Re-vaccination scheme:
A single dose of 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 °C – 8 °C).
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:
Vaccinate healthy and non-infected animals only.
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 :.
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) :
Following administration of a double dose of the vaccine, no adverse reactions other than those mentioned in section 6 were observed.
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 ( ).
-
15. OTHER INFORMATION