Nobivac Bb
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
04-11-2014
Fachinformation
(SPC)
04-11-2014
Öffentlichen Beurteilungsberichts
(PAR)
05-11-2007
Wirkstoff:
live Bordetella bronchiseptica bacteria strain B-C2
Verfügbar ab:
Intervet International BV
ATC-Code:
QI06AE02
INN (Internationale Bezeichnung):
live vaccine against Bordetella bronchiseptica in cats
Therapiegruppe:
Cats
Therapiebereich:
Immunologicals for felidae,
Anwendungsgebiete:
For active immunisation of cats, of 1 month of age or older to reduce clinical signs of Bordetella bronchiseptica associated upper respiratory tract disease.Onset of immunity: Onset of immunity was established in 8 week old cats as early as 72 hours after vaccination.Duration of immunity: The duration of immunity is up to 1 year.No data on the influence of maternal antibodies on the effect of vaccination with Nobivac Bb for cats are available. From literature it is considered that this type of intranasal vaccine is able to induce an immune response without interference from maternally derived antibodies.
Produktbesonderheiten:
Revision: 9
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2002-09-10
Gebrauchsinformation
14
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS_ _
_ _
_LABEL FOR THE SOLVENT VIAL: _
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Solvent for Nobivac Bb
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
1 dose
3.
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
0.5 ml
4.
ROUTE OF ADMINISTRATION
See package leaflet.
5.
WITHDRAWAL PERIOD
Not applicable
6.
BATCH NUMBER
Lot {number}
7.
EXPIRY DATE
EXP {month/year}
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
15
B.
PACKAGE LEAFLET
16
PACKAGE LEAFLET FOR
NOBIVAC BB LYOPHILISATE AND SOLVENT FOR SUSPENSION FOR CATS
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:
Intervet International B.V.
Wim de Körverstraat 35
NL - 5831 AN Boxmeer
The Netherlands
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobivac Bb lyophilisate and solvent for suspension for cats
3.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
Each dose (0.2 ml) of reconstituted suspension contains:
Lyohpilisate:
10
6.3
-10
8.3
colony forming units (CFU) of live
_Bordetella bronchiseptica_
strain B-C2
Solvent:
Water for injections
Lyophilisate: Off-white or cream-coloured pellet
Solvent: clear colourless solution
4.
INDICATION(S)
For active immunisation of cats, of 1 month of age or older, to reduce
clinical signs of
_Bordetella _
_bronchiseptica_
associated upper respiratory tract disease.
The onset of immunity was established in 8 week old cats as early as
72 hours after vaccination.
The duration of immunity is up to 1 year.
5.
CONTRAINDICATIONS
Do not use in pregnant or lactating queens.
6.
ADVERSE REACTIONS
After administration, occasionally sneezing, coughing, mild and
transient discharge from the eyes or
nose may occur. After overdose, identical signs appear particularly in
very young susceptible kittens.
In cats that show more severe signs, appropriate antibiotic treatment
may be indicated.
17
If you notice any serio
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobivac Bb lyophilisate and solvent for suspension for cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (0.2 ml) of reconstituted suspension contains:
Lyophilisate:
ACTIVE SUBSTANCE:
10
6.3-
10
8.3
colony forming units (CFU) of live
_Bordetella bronchiseptica_
bacteria strain B-C2
Solvent:
Water for injection
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension.
Lyophilisate: Off-white or cream-coloured pellet
Solvent: clear colourless solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of cats, of 1 month of age or older to reduce
clinical signs of
_Bordetella _
_bronchiseptica_
associated upper respiratory tract disease.
Onset of immunity: Onset of immunity was established in 8 week old
cats as early as 72 hours after
vaccination.
Duration of immunity: The duration of immunity is up to 1 year.
No data on the influence of maternal antibodies on the effect of
vaccination with Nobivac Bb for cats are
available. From literature it is considered that this type of
intranasal vaccine is able to induce an immune
response without interference from maternally derived antibodies.
4.3
CONTRAINDICATIONS
None known.
4.4
SPECIAL WARNINGS
If any antibiotic is administered within one week after vaccination,
the vaccination should be repeated
after the antibiotic treatment has been completed.
3
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Only healthy cats should be vaccinated.
Sneezing by cats after administration does not adversely affect the
efficacy of the veterinary medicinal
product.
Do not administer during antibiotic treatment or in conjunction with
any other intranasal veterinary
medicinal products.
Vaccinated animals can spread the vaccine strain of
_Bordetella bronchiseptica_
for six weeks, and there
may be intermittent shedding for at least
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