Nobivac Piro
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
13-05-2018
Produktets egenskaber
(SPC)
13-05-2018
Offentlige vurderingsrapport
(PAR)
05-11-2007
Aktiv bestanddel:
babesia canis, inactivated, babesia rossi, inactivated
Tilgængelig fra:
Intervet International BV
ATC-kode:
QI07AO
INN (International Name):
vaccine against babesiosis in dogs
Terapeutisk gruppe:
Dogs
Terapeutisk område:
Immunologicals for canidae
Terapeutiske indikationer:
For active immunisation of dogs of six months of age or older against Babesia canis to reduce the severity of clinical signs associated with acute babesiosis (B. canis) and anaemia as measured by packed cell volume.Onset of immunity: Three weeks after the basic vaccination course.Duration of immunity: Six months after the last (re-)vaccination.
Produkt oversigt:
Revision: 4
Autorisation status:
Withdrawn
Autorisation dato:
2004-09-02
Indlægsseddel
Medicinal product no longer authorised
B. PACKAGE LEAFLET
14
Medicinal product no longer authorised
PACKAGE LEAFLET
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Intervet International B.V.
Wim de Körverstraat 35
NL - 5831 AN Boxmeer
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobivac Piro lyophilisate and solvent for suspension for injections
for dogs
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
Per 1 ml dose of the reconstituted product:
606 (301-911) total antigenic mass units of soluble parasite antigen
(SPA) from
_Babesia canis_
and
_Babesia rossi _
cultures
Adjuvant: 250 (225-275) μg saponin (from the solvent)
4.
INDICATION(S)
For active immunisation of dogs of 6 months of age or older against
_Babesia canis_
to reduce the
severity of clinical signs associated with acute Babesiosis (
_B. canis_
) and anaemia as measured by
Packed Cell Volume (PCV).
Onset of immunity: Three weeks after the basic vaccination course.
Duration of immunity: 6 months after the last (re-)vaccination .
5.
CONTRAINDICATIONS
Do not use in pregnant or lactating bitches.
6.
ADVERSE REACTIONS
Commonly reported post-vaccination reactions are a diffuse swelling
and/or hardened nodule,
accompanied by pain, at the site of vaccination. In general this
disappears within 4 days. In rare cases,
the reactions after the second dose of vaccine may remain for 14 days.
In addition, systemic signs,
such as lethargy and a reduction in appetite may also commonly occur,
sometimes accompanied by
pyrexia and a stiff gait. These reactions should disappear within 2-3
days.
If you notice any serious effects or other effects not mentioned in
this leaflet, please inform your
veterinary surgeon.
7.
TARGET SPECIES
Dogs
15
Medicinal product no longer authorised
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
1 ml reconstituted vaccine, via subcutaneous injection.
_ _
_Vaccination scheme: _
Basic vaccination course: First injec
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Produktets egenskaber
Medicinal product no longer authorised
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
Medicinal product no longer authorised
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobivac Piro lyophilisate and solvent for suspension for injection for
dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per 1 ml dose:
Active substance:
606 (301-911) total antigenic mass units of soluble parasite antigen
(SPA) from
_Babesia canis_
and
_Babesia rossi _
cultures
Adjuvant (in the solvent)
250 (225-275) μg saponin
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of dogs of 6 months of age or older against
_Babesia canis_
to reduce the
severity of clinical signs associated with acute Babesiosis (
_B. canis_
) and anaemia as measured by
Packed Cell Volume (PCV).
Onset of immunity
: Three weeks after the basic vaccination course.
Duration of immunity
: 6 months after the last (re-)vaccination.
4.3
CONTRA-INDICATIONS
See section 4.7.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Only healthy dogs should be vaccinated. In particular, chronic
asymptomatic carriers should be
identified and treated before vaccination, with substances that do not
compromise immunological
responsiveness.
It is recommended that vaccinations are given at least one month
before the tick season.
As active babesia infection might interfere with the development of
protective immunity, it is
recommended to reduce exposure to ticks during the period of
vaccination.
2
Medicinal product no longer authorised
Currently there is only evidence of the efficacy of the vaccine
against challenge with
_B. canis_
. There is
a possibility that vaccinated dogs facing a challenge with other
babesia's may develop disease and
require treatment.
Vaccination with Nobivac Piro does not prevent infection. As a
consequence a milder form of disease
caused by
_B. canis_
can occur. If mild babes
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