Purevax Rabies
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
20-08-2020
Valmisteyhteenveto
(SPC)
20-08-2020
Julkisesta arviointikertomuksesta
(PAR)
17-02-2021
Aktiivinen ainesosa:
vCP65 virus
Saatavilla:
Boehringer Ingelheim Vetmedica GmbH
ATC-koodi:
QI06AX
INN (Kansainvälinen yleisnimi):
rabies recombinant canarypox virus (vCP65)
Terapeuttinen ryhmä:
Cats
Terapeuttinen alue:
Immunologicals
Käyttöaiheet:
Active immunisation of cats 12 weeks of age and older to prevent mortality due to rabies infection.Onset of immunity: 4 weeks after the primary vaccination course.Duration of immunity after primary vaccination: 1 year.Duration of immunity after revaccination: 3 years.
Tuoteyhteenveto:
Revision: 7
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2011-02-18
Pakkausseloste
13
B. PACKAGE LEAFLET
14
PACKAGE LEAFLET:
PUREVAX RABIES SUSPENSION FOR INJECTION
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY
Manufacturer responsible for batch release:
Boehringer Ingelheim Animal Health France SCS
Laboratoire Porte des Alpes
Rue de l'Aviation
69800 Saint Priest
FRANCE
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Purevax Rabies suspension for injection
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT
Each dose of 1 ml contains:
ACTIVE SUBSTANCE:
Rabies recombinant canarypox virus (vCP65)
≥
10
6.8
FAID*
50
*Fluorescent assay infectious dose 50 %
Light pink to pale yellow homogeneous suspension
4.
INDICATION
Active immunisation of cats 12 weeks of age and older to prevent
mortality due to rabies infection.
Onset of immunity: 4 weeks after the primary vaccination course.
Duration of immunity after primary vaccination: 1 year.
Duration of immunity after revaccination: 3 years.
5.
CONTRAINDICATIONS
None
6.
ADVERSE REACTIONS
In very rare cases, transient and slight apathy may occur, as well as
mild anorexia or hyperthermia
(above 39.5 °C), usually lasting 1 or 2 days. Most of these reactions
were noted during the 2 days
following the vaccine injection.
15
A transient local reaction may very rarely occur (pain at palpation,
limited swelling that may become
nodular, heat at the injection site, and in some cases erythema), that
usually disappears within 1 or
2 weeks at most.
Very rarely, a hypersensitivity reaction may occur, which may require
appropriate symptomatic
treatment.
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 th
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Purevax Rabies suspension for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 1 ml contains:
ACTIVE SUBSTANCE:
Rabies recombinant canarypox virus (vCP65)
≥
10
6.8
FAID*
50
*Fluorescent assay infectious dose 50 %
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Light pink to pale yellow homogeneous suspension
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of cats 12 weeks of age and older to prevent
mortality due to rabies infection.
Onset of immunity: 4 weeks after the primary vaccination course.
Duration of immunity after primary vaccination: 1 year.
Duration of immunity after revaccination: 3 years.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
None.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
Canarypox recombinants are known to be safe for humans. Mild local
and/or systemic adverse
reactions related to the injection itself may be observed
transitorily.
In case of accidental self-injection, seek medical advice immediately
and show the package leaflet or
the label to the physician.
3
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
In very rare cases, transient and slight apathy may occur, as well as
mild anorexia or hyperthermia
(above 39.5 °C), usually lasting 1 or 2 days. Most of these reactions
were noted during the 2 days
following the vaccine injection.
A transient local reaction may very rarely occur (pain at palpation,
limited swelling that may become
nodular, heat at the injection site, and in some cases erythema), that
usually disappears within 1 or
2 weeks at most.
Very rarely, a hypersensitivity reaction may occur, which may require
appropriate symptomatic
treatment
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