Improvac
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
05-04-2022
Produktets egenskaber
(SPC)
05-04-2022
Offentlige vurderingsrapport
(PAR)
05-04-2022
Aktiv bestanddel:
Synthetic peptide analogue of GnRF conjugated to diptheria toxoid
Tilgængelig fra:
Zoetis Belgium SA
ATC-kode:
QI09AX
INN (International Name):
Gonadotropin releasing factor (GnRF) analogue-protein conjugate
Terapeutisk gruppe:
Male pigs (from 8 weeks of age); Female pigs (from 14 weeks of age)
Terapeutisk område:
Immunologicals for suidae
Terapeutiske indikationer:
Male pigs:Induction of antibodies against GnRF to produce a temporary immunological suppression of testicular function. For use as an alternative to physical castration for the reduction of boar taint caused by the key boar taint compound androstenone, in entire male pigs following the onset of puberty. Another key contributor to boar taint, skatole, may also be reduced as an indirect effect. Aggressive and sexual (mounting) behaviours are also reduced.Female pigs:Induction of antibodies against GnRF to produce a temporary immunological suppression of ovarian function (suppression of oestrus) in order to reduce the incidence of unwanted pregnancies in gilts intended for slaughter, and to reduce the associated sexual behaviour (standing oestrus).
Produkt oversigt:
Revision: 20
Autorisation status:
Authorised
Autorisation dato:
2009-05-11
Indlægsseddel
18
B. PACKAGE LEAFLET
19
PACKAGE LEAFLET:
IMPROVAC SOLUTION FOR INJECTION FOR PIGS
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
Improvac solution for injection for pigs
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
One dose (2 ml) contains:
ACTIVE SUBSTANCE:
Gonadotropin releasing factor (GnRF) analogue-protein conjugate
min. 300 µg.
(a synthetic peptide analogue of GnRF conjugated to diphtheria toxoid)
ADJUVANT:
Diethylaminoethyl (DEAE)-Dextran, an aqueous, non-mineral oil-based
adjuvant
300 mg.
EXCIPIENT:
Chlorocresol
2.0 mg.
4.
INDICATION(S)
Male pigs:
Induction of antibodies against GnRF to produce a temporary
immunological suppression of testicular
function. For use as an alternative to physical castration for the
reduction of boar taint caused by the
key boar taint compound androstenone, in entire male pigs following
the onset of puberty.
Another key contributor to boar taint, skatole, may also be reduced as
an indirect effect. Aggressive
and sexual (mounting) behaviours are also reduced.
The onset of immunity (induction of anti-GnRF antibodies) can be
expected within 1 week post
second vaccination. Reduction of androstenone and skatole levels has
been demonstrated from 4 to 6
weeks post second vaccination. This reflects the time needed for
clearance of boar taint compounds
already present at the time of vaccination as well as the variability
of response between individual
animals. Reduction of aggressive and sexual (mounting) behaviours can
be expected from 1 to 2
weeks post second vaccination.
Female pigs:
Induction of antibodies against GnRF to produce a temporary
immunological suppression of ovarian
function (suppression of oestrus) in order to reduce the incidence of
unwanted pregnancies in gilts
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Improvac solution for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (2 ml) contains:
ACTIVE SUBSTANCE:
Gonadotropin releasing factor (GnRF) analogue-protein conjugate
min. 300 μg.
(a synthetic peptide analogue of GnRF conjugated to diphtheria toxoid)
ADJUVANT:
Diethylaminoethyl (DEAE)-Dextran, an aqueous, non-mineral oil-based
adjuvant
300 mg.
EXCIPIENT:
Chlorocresol
2.0 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Male pigs (from 8 weeks of age). Female pigs (from 14 weeks of age).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Male pigs:
Induction of antibodies against GnRF to produce a temporary
immunological suppression of testicular
function. For use as an alternative to physical castration for the
reduction of boar taint caused by the
key boar taint compound androstenone, in entire male pigs following
the onset of puberty.
Another key contributor to boar taint, skatole, may also be reduced as
an indirect effect. Aggressive
and sexual (mounting) behaviours are also reduced.
The onset of immunity (induction of anti-GnRF antibodies) can be
expected within 1 week post
second vaccination. Reduction of androstenone and skatole levels has
been demonstrated from 4 to 6
weeks post second vaccination. This reflects the time needed for
clearance of boar taint compounds
already present at the time of vaccination as well as the variability
of response between individual
animals. Reduction of aggressive and sexual (mounting) behaviours can
be expected from 1 to 2
weeks post second vaccination.
Female pigs:
Induction of antibodies against GnRF to produce a temporary
immunological suppression of ovarian
function (suppression of oestrus) in order to reduce the incidence of
unwanted pregnancies in gilts
intended for slaughter, and to reduce the associated sexual behaviour
(standing oestrus).
The onset of
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