Fevaxyn Pentofel
Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
Uputa o lijeku
(PIL)
01-03-2022
Svojstava lijeka
(SPC)
01-03-2022
Izvješće o ocjeni javnog
(PAR)
07-06-2013
Aktivni sastojci:
inactivated feline rhinotracheitis virus, inactivated feline calicivirus, inactivated feline Chlamydophila felis, inactivated feline leukaemia virus, inactivated feline panleukopenia virus
Dostupno od:
Zoetis Belgium SA
ATC koda:
QI06AL01
INN (International ime):
inactivated feline panleukopenia virus, calicivirus, rhinotracheitis virus, leukaemia virus and Chlamydophila felis
Terapijska grupa:
Cats
Područje terapije:
Immunologicals
Terapijske indikacije:
For the active immunisation of healthy cats nine weeks or older against feline panleukopenia and feline leukaemia viruses and against respiratory diseases caused by feline rhinotracheitis virus, feline calicivirus and Chlamydophila felis.
Proizvod sažetak:
Revision: 20
Status autorizacije:
Authorised
Datum autorizacije:
1997-02-05
Uputa o lijeku
14
B. PACKAGE LEAFLET
15
PACKAGE LEAFLET:
FEVAXYN PENTOFEL, SUSPENSION FOR INJECTION 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 responsible for batch
release:
Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
BELGIUM
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Fevaxyn Pentofel, suspension for injection for cats
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Per dose of 1 ml (single dose syringe):
ACTIVE COMPONENTS
RELATIVE POTENCY (R.P.)
Inactivated feline panleucopenia virus, strain CU4
Inactivated feline calicivirus, strain 255
Inactivated feline rhinotracheitis virus, strain 605
Inactivated
_Chlamydophila felis_
,
_ _
strain Cello
Inactivated feline leukaemia virus, strain 61E
≥ 8.50
≥ 1.26
≥ 1.39
≥ 1.69
≥ 1.45
ADJUVANTS
Ethylene/maleic anhydride (EMA-31)
Neocryl
Emulsigen SA
1% (v/v)
3% (v/v)
5% (v/v)
4.
INDICATION(S)
For the active immunisation of healthy cats 9 weeks or older against
feline panleucopenia and feline leukaemia
viruses and against respiratory diseases caused by feline
rhinotracheitis virus, feline calicivirus and
_Chlamydophila felis._
5.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
Vaccinated cats may develop post-vaccinal reactions including
transient fever, vomiting, anorexia and/or
depression which usually disappear within 24 hours.
16
A local reaction with swelling, pain, pruritus or hair loss at the
injection site may be observed.
Anaphylactic reactions with oedema, pruritus, respiratory and cardiac
distress, severe gastrointestinal signs
(including haematemesis and haemorrhagic diarrhoea) or shock have been
seen during the first hours after
vaccination in very rare cases.
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 tre
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Svojstava lijeka
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Fevaxyn Pentofel, suspension for injection for cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per dose of 1 ml (single dose syringe):
ACTIVE COMPONENTS
RELATIVE POTENCY (R.P.)
Inactivated feline panleucopenia virus, strain CU4
Inactivated feline calicivirus, strain 255
Inactivated feline rhinotracheitis virus, strain 605
Inactivated
_Chlamydophila felis_
,
_ _
strain
_ _
Cello
Inactivated feline leukaemia virus, strain 61E
≥ 8.50
≥ 1.26
≥ 1.39
≥ 1.69
≥ 1.45
ADJUVANTS
Ethylene/maleic anhydride (EMA-31)
Neocryl
Emulsigen SA
1% (v/v)
3% (v/v)
5% (v/v)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Vaccine appearance is a pale milky pink liquid which should be free
from solid particles.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of healthy cats 9 weeks or older against
feline panleucopenia and feline leukaemia
viruses and against respiratory diseases caused by feline
rhinotracheitis virus, feline calicivirus and
_Chlamydophila felis._
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccination does not affect the course of feline leukaemia virus
(FeLV) infection in cats already infected with
FeLV at the time of vaccination, implying that such cats will excrete
FeLV irrespective of vaccination;
consequently, these animals will constitute a hazard to susceptible
cats in their environment. It is therefore
recommended that cats with a significant risk of having been exposed
to FeLV be tested for FeLV antigen prior
to vaccination. Test negative animals can be vaccinated, while
test-positive cats should be isolated from other
3
cats and retested within 1–2 months. Cats positive at the second
testing should be considered as being
permanently infected with FeLV and should be handled accordingly. Cats
negative at second testing can be
vaccinated since, in all
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