Gonazon
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
15-08-2012
Charakterystyka produktu
(SPC)
15-08-2012
Sprawozdanie z oceny publicznego
(PAR)
15-08-2012
Składnik aktywny:
azagly-nafarelin
Dostępny od:
Intervet International BV
Kod ATC:
QH01CA
INN (International Nazwa):
azagly-nafarelin
Grupa terapeutyczna:
Dogs; Salmonidae (Salmonid fish)
Dziedzina terapeutyczna:
Pituitary and hypothalamic hormones and analogues
Wskazania:
Female salmonid fish such as Atlantic salmon (Salmo salar), rainbow trout (Oncorhynchus mykiss), brown trout (Salmo trutta) and Arctic charr (Salvelinus alpinus)Induction and synchronisation of ovulation for the production of eyed-eggs and fry.Dogs (bitches)Prevention of gonadal function in bitches via long term blockade of gonadotrophin synthesis.
Podsumowanie produktu:
Revision: 7
Status autoryzacji:
Withdrawn
Data autoryzacji:
2003-07-20
Ulotka dla pacjenta
29/37
B. PACKAGE LEAFLET
Medicinal product no longer authorised
30/37
PACKAGE LEAFLET
GONAZON CONCENTRATE FOR SOLUTION FOR INJECTION OF FEMALE SALMONID FISH
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
Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Gonazon concentrate for solution for injection of female salmonid fish
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Azagly-nafarelin 1600
g/ml as azagly-nafarelin acetate.
Excipient: Benzyl alcohol
4.
INDICATION(S)
Induction and synchronisation of ovulation for the production of
eyed-eggs and fry.
5.
CONTRAINDICATIONS
Do not use Gonazon before approximately 10% of the specific broodstock
population has ovulated
naturally.
The product should not be used in fish maintained in water
temperatures that would normally inhibit
ovulation as this can result in a decrease in egg quality.
6.
ADVERSE REACTIONS
If you notice any serious effects or other effects not mentioned in
this leaflet, please inform your
veterinary surgeon.
7.
TARGET SPECIES
Female salmonid fish such as Atlantic salmon (_Salmo salar_), rainbow
trout (_Oncorhynchus mykiss_),
brown trout (_Salmo trutta_) and Arctic charr (_Salvelinus alpinus_).
Medicinal product no longer authorised
31/37
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
9.
ADVICE ON CORRECT ADMINISTRATION
Inject intraperitoneally along the central line, 1/2 to 1 fin length
in front of the pelvic fin base. Fish
should be anaesthetised.
The dose should be administered in the preferred volume for the
particular body weight of fish. The
supplied solvent is used to dilute the concentrate to the correct
dilution to allow for optimisation of
the preferred injection volumes for fish of widely varying body
weights.
The empty, sterile vial is intended to be used for mixing the
concentrate
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Charakterystyka produktu
1/37
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2/37
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Gonazon concentrate for solution for injection of female salmonid fish
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
V
IAL CONTAINING
C
ONCENTRATE
:
ACTIVE SUBSTANCE(S)
Azagly-nafarelin 1600
g/ml as azagly-nafarelin acetate.
EXCIPIENTS
Benzyl alcohol (1%)
V
IAL CONTAINING
S
OLVENT
:
EXCIPIENTS
Benzyl alcohol (1%)
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for injection
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Female salmonid fish such as Atlantic salmon (_Salmo salar_), rainbow
trout (_Oncorhynchus mykiss_),
brown trout (_Salmo trutta_) and Arctic charr (_Salvelinus alpinus_).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Induction and synchronisation of ovulation for the production of
eyed-eggs and fry.
4.3
CONTRAINDICATIONS
Do not use Gonazon before approximately 10% of the specific broodstock
population has ovulated
naturally.
The product should not be used in fish maintained in water
temperatures that would normally inhibit
ovulation as this can result in a decrease in egg quality.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Reductions in fecundity, egg quality and survival to the eyed-egg
stage have been observed in fish
treated with azagly-nafarelin. In some cases this can be related to
the use of the compound too early in
the spawning season.
Medicinal product no longer authorised
3/37
It is recommended to strip fish after injection at intervals of
approximately 50-100 degree days.
For Arctic charr, injections should be given only if the water
temperature is < 8°C.
The long term effects of azagly-nafarelin on treated broodstock fish
have not been studied.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
High
standards
of
biosecurity
must
be
observed
at
the
time
of
injection
in
order
to
prevent
introduction and spread of infectious diseases between broodstock
fish.
SPECIAL PRECAUTIONS
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