Poulvac Flufend H5N3 RG
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
08-05-2012
Valmisteyhteenveto
(SPC)
08-05-2012
Julkisesta arviointikertomuksesta
(PAR)
07-05-2012
Aktiivinen ainesosa:
recombinant inactivated avian influenza virus
Saatavilla:
Pfizer Limited
ATC-koodi:
QI01AA23
INN (Kansainvälinen yleisnimi):
recombinant inactivated avian influenza virus
Terapeuttinen ryhmä:
Chicken; Ducks
Terapeuttinen alue:
Immunologicals
Käyttöaiheet:
For active immunisation of chickens and ducks against avian influenza virus type A, subtype H5.Chickens:Reduction of mortality and virus excretion after challenge.Onset of immunity: 3 weeks after the second injection.Duration of immunity in chickens has not been established yet.Ducks: Reduction of clinical signs and virus excretion after challenge.Onset of immunity: 3 weeks after the second injection.Duration of immunity in ducks : 14 weeks after the second injection.
Tuoteyhteenveto:
Revision: 8
Valtuutuksen tilan:
Withdrawn
Valtuutus päivämäärä:
2006-09-01
Pakkausseloste
Medicinal product no longer authorised
B. PACKAGE LEAFLET
18
Medicinal product no longer authorised
PACKAGE LEAFLET FOR:
POULVAC FLUFEND H5N3 RG
EMULSION FOR INJECTION FOR CHICKENS AND DUCKS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing Authorisation Holder:
Pfizer Limited
Ramsgate Road
Sandwich, Kent
CT13 9NJ
United Kingdom
Manufacturer for the batch release:
Pfizer Global Manufacturing Weesp
CJ van Houtenlaan 36
1381 CP Weesp
The Netherlands
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Poulvac FluFend H5N3 RG
Emulsion for injection for chickens and ducks
3.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
One dose of 0.5 ml contains:
ACTIVE SUBSTANCE
:
Inactivated recombinant avian influenza virus
of H5N3 subtype (strain rg-A/ck/VN/C58/04)
> 1:40 HI Units
ADJUVANTS:
White Oil
Sorbitan sesquioleate
Polysorbate 80
EXCIPIENTS:
Thiomersal
Phosphate Buffer Saline
4.
INDICATIONS
For active immunisation of chickens and ducks against avian influenza
virus type A, subtype H5.
CHICKENS
:
Reduction of mortality and virus excretion after challenge.
Onset of immunity: 3 weeks after the second injection.
Duration of immunity in chickens has not been established yet.
19
Medicinal product no longer authorised
DUCKS:
Reduction of clinical signs and virus excretion after challenge.
Onset of immunity: 3 weeks after the second injection.
Duration of immunity in ducks : 14 weeks after the second injection.
5.
CONTRAINDICATIONS
None
6.
ADVERSE REACTIONS
A transient local site reaction (swelling) may occasionally occur as
is normal with oil adjuvanted
vaccines.
If you notice any serious effects or other effects not mentioned in
this leaflet, please inform your
veterinary surgeon.
7.
TARGET SPECIES
Chickens and ducks
8.
DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION
CHICKENS
3 weeks of age or older: 0.5 ml intramuscularly in the breast muscle.
Revaccinate after 3 weeks.
The vaccination schedule should be
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Valmisteyhteenveto
Medicinal product no longer authorised
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
Medicinal product no longer authorised
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Poulvac FluFend H5N3 RG emulsion for injection for chickens and ducks
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose of 0.5 ml contains:
ACTIVE SUBSTANCE
:
Inactivated recombinant avian influenza virus
of H5N3 subtype (strain rg-A/ck/VN/C58/04) > 1:40 HI units per dose
ADJUVANTS:
White Oil
Sorbitan sesquioleate
Polysorbate 80
EXCIPIENTS:
Thiomersal
Phosphate Buffer Saline
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Emulsion for injection.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens and ducks.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of chickens and ducks against avian influenza
virus type A, subtype H5.
Chickens: Reduction of mortality and virus excretion after challenge.
Onset of immunity: 3 weeks after the second injection.
Duration of immunity in chickens has not been established yet.
Ducks: Reduction of clinical signs and virus excretion after
challenge.
Onset of immunity: 3 weeks after the second injection.
Duration of immunity in ducks : 14 weeks after the second injection.
4.3
CONTRAINDICATIONS
None
2
Medicinal product no longer authorised
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
The level of efficacy attained may vary depending on the degree of
antigenic homology between the
vaccine strain and circulating field strains.
No information is available on the interference of maternally derived
antibodies on vaccination for
both target species.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Avoid stress in the birds around the time of vaccination.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO
ANIMALS
TO THE USER:_ _
This product contains mineral oil. Accidental injection/self injection
may result in severe pain and
swelling, particularly if injected into a joint or finger, and in rare
cases co
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