Coxevac
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
21-07-2020
Charakterystyka produktu
(SPC)
21-07-2020
Sprawozdanie z oceny publicznego
(PAR)
18-03-2015
Składnik aktywny:
inactivated Coxiella burnetii vaccine, strain Nine Mile
Dostępny od:
CEVA Santé Animale
Kod ATC:
QI02AB
INN (International Nazwa):
inactivated Coxiella burnetii vaccine
Grupa terapeutyczna:
Goats; Cattle
Dziedzina terapeutyczna:
Immunologicals for bovidae, Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia)
Wskazania:
Cattle: , For the active immunisation of cattle to lower the risk for non-infected animals vaccinated when non-pregnant to become shedder (5 times lower probability in comparison with animals receiving a placebo), and to reduce shedding of Coxiella burnetii in these animals via milk and vaginal mucus., Onset of immunity: not established., Duration of immunity: 280 days after completion of the primary vaccination course. , Goats: , For the active immunisation of goats to reduce abortion caused by Coxiella burnetii and to reduce shedding of the organism via milk, vaginal mucus, faeces and placenta., Onset of immunity: not established., Duration of immunity: one year after completion of the primary vaccination course.
Podsumowanie produktu:
Revision: 7
Status autoryzacji:
Authorised
Data autoryzacji:
2010-09-30
Ulotka dla pacjenta
16
B. PACKAGE LEAFLET
17
PACKAGE LEAFLET:
COXEVAC SUSPENSION FOR INJECTION FOR CATTLE AND GOATS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
CEVA Sante Animale
10 avenue de la Ballastiere
33500 Libourne
FRANCE
Manufacturer responsible for batch release:
CEVA-Phylaxia Veterinary Biologicals Co. Ltd.
Szállás u. 5
1107 Budapest
HUNGARY
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
COXEVAC suspension for injection for cattle and goats
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each ml contains:
ACTIVE SUBSTANCE:
Inactivated
_Coxiella burnetii,_
strain Nine Mile
>
72 QF Units*
*QF (Q fever) Unit: relative potency of phase I antigen measured by
ELISA in comparison with a
reference item.
EXCIPIENTS:
Thiomersal
< 120 μg.
Whitish, opalescent, homogeneous suspension.
4.
INDICATION(S)
Cattle:
For the active immunisation of cattle to lower the risk for
non-infected animals vaccinated when non-
pregnant to become shedder (5 times lower probability in comparison
with animals receiving a
placebo), and to reduce shedding of
_Coxiella burnetii_
in these animals via milk and vaginal mucus.
Onset of immunity: not established.
Duration of immunity: 280 days after completion of the primary
vaccination course.
Goats:
For the active immunisation of goats to reduce abortion caused by
_Coxiella burnetii_
and to reduce
shedding of the organism via milk, vaginal mucus, faeces and placenta.
Onset of immunity: not established.
Duration of immunity: one year after completion of the primary
vaccination course.
18
5.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
Cattle:
It was very common to see in laboratory trials a palpable reaction of
maximum diameter of 9 to 10 cm
at the injection site, which may last for 17 days. The reaction
gradually reduces and disappears without
need for treatment.
Systemic signs as lethargy, hyperthermia and/or anorexia have been
observed rarely in post marketing
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Charakterystyka produktu
1
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
COXEVAC suspension for injection for cattle and goats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Inactivated
_Coxiella burnetii,_
strain Nine Mile
>
72 QF Units*
*QF (Q fever) Unit: relative potency of phase I antigen measured by
ELISA in comparison with a
reference item.
EXCIPIENT:
Thiomersal
< 120 μg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Whitish, opalescent, homogeneous suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle and goats
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cattle:
For the active immunisation of cattle to lower the risk for
non-infected animals vaccinated when non-
pregnant to become shedder (5 times lower probability in comparison
with animals receiving a
placebo), and to reduce shedding of
_Coxiella burnetii_
in these animals via milk and vaginal mucus.
Onset of immunity: not established.
Duration of immunity: 280 days after completion of the primary
vaccination course.
Goats:
For the active immunisation of goats to reduce abortion caused by
_Coxiella burnetii_
and to reduce
shedding of the organism via milk, vaginal mucus, faeces and placenta.
Onset of immunity: not established.
Duration of immunity: one year after completion of the primary
vaccination course.
4.3
CONTRAINDICATIONS
None.
3
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccination of animals already infected at the time of vaccination
will have no adverse effect.
No efficacy data are available concerning the use of COXEVAC in male
animals. However, in safety
laboratory trials, the use of COXEVAC in males proved to be safe. In
the case that it is decided to
vaccinate the whole herd, it is advisable to vaccinate the male
animals at the same time.
There are no benefits of the vaccine (as described in the indications
for cattle), when used in infected
and/or pregnant cows.
The biological significance of the levels of r
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