Letifend
Riik: Euroopa Liit
keel: inglise
Allikas: EMA (European Medicines Agency)
Infovoldik
(PIL)
22-02-2022
Toote omadused
(SPC)
22-02-2022
Avaliku hindamisaruande
(PAR)
02-06-2016
Toimeaine:
Recombinant protein Q from Leishmania infantum MON-1
Saadav alates:
LETI Pharma, S.L.U.
ATC kood:
QI07A
INN (Rahvusvaheline Nimetus):
Canine leishmaniasis vaccine (recombinant protein)
Terapeutiline rühm:
Dogs
Terapeutiline ala:
Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia)
Näidustused:
For active immunisation of dogs from 6 months of age to reduce the risk of developing a clinical case of leishmaniasis.
Toote kokkuvõte:
Revision: 11
Volitamisolek:
Authorised
Loa andmise kuupäev:
2016-04-20
Infovoldik
15
B. PACKAGE LEAFLET
16
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.
17
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
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Toote omadused
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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 contains:
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.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for solution for injection.
White lyophilisate.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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.
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
4.4
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.
3
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.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
De-worming
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