Startvac
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
07-05-2018
Charakterystyka produktu
(SPC)
07-05-2018
Sprawozdanie z oceny publicznego
(PAR)
17-02-2009
Składnik aktywny:
Escherichia coli J5 inactivated, Staphylococcus aureus (CP8) strain SP 140 inactivated, expressing slime-associated antigenic complex
Dostępny od:
Laboratorios Hipra S.A.
Kod ATC:
QI02AB
INN (International Nazwa):
adjuvanted inactivated vaccine for cattle against Staphylococcus aureus, coliforms and coagulase-negative staphylococci
Grupa terapeutyczna:
Cattle (cows and heifers)
Dziedzina terapeutyczna:
Immunologicals for bovidae
Wskazania:
For herd immunisation of healthy cows and heifers, in dairy cattle herds with recurring mastitis problems, to reduce the incidence of sub-clinical mastitis and the incidence and the severity of the clinical signs of clinical mastitis caused by Staphylococcus aureus, coliforms and coagulase-negative staphylococci.The full immunisation scheme induces immunity from approximately day 13 after the first injection until approximately day 78 after the third injection (equivalent to 130 days post-parturition).
Podsumowanie produktu:
Revision: 3
Status autoryzacji:
Authorised
Data autoryzacji:
2009-02-11
Ulotka dla pacjenta
15
B. PACKAGE LEAFLET
16
PACKAGE LEAFLET FOR:
STARTVAC EMULSION FOR INJECTION FOR CATTLE
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:
Laboratorios Hipra S.A.
Avda. la Selva, 135
17170 Amer (Girona)
SPAIN
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
STARTVAC emulsion for injection for cattle
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
_ _
One dose (2 ml) contains:
_Escherichia coli _
(J5) inactivated
..........................................................................
> 50 RED
60
*
_Staphylococcus aureus_
(CP8) strain SP 140 inactivated, expressing slime associated antigenic
complex
(SAAC)........................................................................
........................................ > 50 RED
80
**
* RED
60
: Rabbit effective dose in 60% of the animals (serology).
** RED
80
: Rabbit effective dose in 80% of the animals (serology).
Liquid paraffin: 18.2 mg
Benzyl alcohol: 21 mg.
STARTVAC is an ivory-coloured homogeneous emulsion for injection.
4.
INDICATION(S)
For herd immunisation of healthy cows and heifers, in dairy cattle
herds with recurring mastitis
problems, to reduce the incidence of sub-clinical mastitis and the
incidence and the severity of the
clinical signs of clinical mastitis caused by
_Staphylococcus aureus_
, coliforms and coagulase-negative
staphylococci.
The full immunisation scheme induces immunity from approximately day
13 after the first injection
until approximately day 78 after the third injection.
5.
CONTRAINDICATIONS
None.
17
6.
ADVERSE REACTIONS
Very rare adverse reactions:
- Slight to moderate transient local reactions may occur after the
administration of one dose of vaccine
based on post-authorisation pharmacovigilance reporting. They would
mainly be: swelling (up to 5
cm
2
on average), which disappears within 1 or 2 weeks at most. In some
cases, there may also be pa
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
STARTVAC emulsion for injection for cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (2 ml) contains:
ACTIVE SUBSTANCES:
_Escherichia coli _
J5 inactivated
.............................................................................
> 50 RED
60
*
_Staphylococcus aureus_
(CP8) strain SP 140 inactivated, expressing slime associated
antigenic complex (SAAC) .............
…………………………………………… > 50 RED
80
**
* RED
60
: Rabbit effective dose in 60% of the animals (serology).
** RED
80
: Rabbit effective dose in 80% of the animals (serology).
ADJUVANT:
Liquid
paraffin..............................................................................
18.2 mg
EXCIPIENT:
Benzyl
alcohol……………..........................................................
21 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Emulsion for injection.
Ivory-coloured homogeneous emulsion.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle (cows and heifers).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For herd immunisation of healthy cows and heifers, in dairy cattle
herds with recurring mastitis
problems, to reduce the incidence of sub-clinical mastitis and the
incidence and the severity of the
clinical signs of clinical mastitis caused by
_Staphylococcus aureus_
, coliforms and coagulase-negative
staphylococci.
The full immunisation scheme induces immunity from approximately day
13 after the first injection
until approximately day 78 after the third injection.
4.3
CONTRAINDICATIONS
None.
3
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
The whole herd should be immunised.
Immunisation has to be considered as one component in a complex
mastitis control program that
addresses all important udder health factors (e.g. milking technique,
dry-off and breeding
management, hygiene, nutrition, housing, bedding, cow comfort, air and
water quality, health
monitoring) and other management pra
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