CaniLeish
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
24-10-2023
Charakterystyka produktu
(SPC)
24-10-2023
Sprawozdanie z oceny publicznego
(PAR)
24-10-2023
Składnik aktywny:
Leishmania infantum excreted secreted proteins
Dostępny od:
Virbac S.A.
Kod ATC:
QI07AO
INN (International Nazwa):
Leishmania infantum excreted secreted proteins
Grupa terapeutyczna:
Dogs
Dziedzina terapeutyczna:
Immunologicals
Wskazania:
For the active immunisation of Leishmania-negative dogs from six months of age to reduce the risk to develop an active infection and clinical disease after contact with Leishmania infantum.The efficacy of the vaccine has been demonstrated in dogs submitted to multiple natural parasite exposure in zones with high infection pressure.Onset of immunity: 4 weeks after the primary vaccination course.Duration of immunity: 1 year after the last re-vaccination.
Podsumowanie produktu:
Revision: 2
Status autoryzacji:
Withdrawn
Data autoryzacji:
2011-03-14
Ulotka dla pacjenta
17
B. PACKAGE LEAFLET
Medicinal product no longer authorised
18
PACKAGE LEAFLET
CANILEISH LYOPHILISATE AND SOLVENT FOR SUSPENSION 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:
VIRBAC
1ère avenue – 2065 m – L.I.D.
06516 Carros
France
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
CaniLeish lyophilisate and solvent for suspension for injection for
dogs
3.
STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS
Each dose of 1 ml vaccine contains:
Lyophilisate:
ACTIVE SUBSTANCE:
_Leishmania infantum_ Excreted Secreted Proteins (ESP) at least 100
µg
ADJUVANT:
Purified extract of _Quillaja saponaria_ (QA-21)
60 µg
Solvent:
Sodium chloride solution 9 mg/ml (0.9%)
1 ml
4.
INDICATIONS
For the active immunization of Leishmania negative dogs from 6 months
of age to reduce the risk to develop
an active infection and clinical disease after contact with
_Leishmania infantum_.
The efficacy of the vaccine has been demonstrated in dogs submitted to
multiple natural parasite exposure in
zones with high infection pressure.
Onset of immunity: 4 weeks after the primary vaccination course.
Duration of immunity: 1 year after the last (re-)vaccination.
5.
CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance, to the
adjuvant or to any of the excipients.
Medicinal product no longer authorised
19
6.
ADVERSE REACTIONS
After injection, moderate and transient local reactions such as
swelling, nodule, pain on palpation or
erythema are common, but these reactions resolve spontaneously within
2 to 15 days. In very rare cases a
more severe reaction at the injection site (injection site necrosis,
vasculitis) has been reported.
Other transient signs seen following vaccination such as hyperthermia,
apathy and digestive disorders lasting
1 to 6 days are common. In rare cases anorexia and emesis have been
reported.
Allergic-type reactions are rare.
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
CaniLeish lyophilisate and solvent for suspension for injection for
dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 1 ml vaccine contains:
Lyophilisate:
ACTIVE SUBSTANCES:
_Leishmania infantum_ Excreted Secreted Proteins (ESP) at least 100
µg
ADJUVANT:
Purified extract of _Quillaja saponaria_ (QA-21): 60 µg
Solvent:
Sodium chloride solution 9 mg/ml (0.9%)
1 ml
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
Lyophilisate: beige freeze-dried fraction
Solvent: colourless liquid
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunization of Leishmania negative dogs from 6 months
of age to reduce the risk to develop
an active infection and clinical disease after contact with
_Leishmania infantum_.
The efficacy of the vaccine has been demonstrated in dogs submitted to
multiple natural parasite exposure in
zones with high infection pressure.
Onset of immunity: 4 weeks after the primary vaccination course.
Duration of immunity: 1 year after the last (re-)vaccination.
4.3
CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance, to the
adjuvant or to any of the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Transient antibodies against Leishmania detected by immunofluorescence
antibody test (IFAT) may appear
after vaccination. Antibodies due to vaccination can be differentiated
from antibodies due to natural infection
by using a rapid diagnostic serological test as a first step to a
differential diagnosis.
Medicinal product no longer authorised
3
In areas of low or no infection pressure a benefit/risk assessment
must be undertaken by the veterinarian
before deciding to use the vaccine in dogs_. _
The impact of the vaccine in terms of public health and control of the
human infection cannot be esti
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