Nobilis Influenza H5N2
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
25-03-2021
Valmisteyhteenveto
(SPC)
25-03-2021
Julkisesta arviointikertomuksesta
(PAR)
19-09-2006
Aktiivinen ainesosa:
inactivated whole avian influenza virus antigen of H5N2 subtype (strain A/duck/Potsdam/1402/86)
Saatavilla:
Intervet International BV
ATC-koodi:
QI01AA23
INN (Kansainvälinen yleisnimi):
adjuvanted inactivated vaccine against avian influenza virus type A, subtype H5
Terapeuttinen ryhmä:
Chicken
Terapeuttinen alue:
Immunologicals for aves
Käyttöaiheet:
For active immunisation of chickens against avian influenza type A, subtype H5.Efficacy has been evaluated on the basis of preliminary results in chickens. Reduction of clinical signs, mortality and excretion of virus after challenge were shown by three weeks after vaccination.Serum antibodies could be expected to persist for at least 12 months after administration of two doses of vaccine.
Tuoteyhteenveto:
Revision: 8
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2006-09-01
Pakkausseloste
15
B. PACKAGE LEAFLET
16
PACKAGE LEAFLET:
NOBILIS INFLUENZA H5N2 EMULSION FOR INJECTION FOR CHICKENS
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:
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobilis Influenza H5N2 emulsion of injection for chickens.
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
One dose of 0.5 ml contains:
ACTIVE SUBSTANCE:
Inactivated whole avian influenza virus antigen of H5N2 subtype
(strain A/duck/Potsdam/1402/86),
inducing an HI titre of ≥6.0 log
2
as tested according to the potency test.
ADJUVANT:
Liquid light paraffin: 234.8 mg.
4.
INDICATION(S)
For active immunisation of chickens against avian influenza type A,
subtype H5.
Efficacy has been evaluated on the basis of preliminary results in
chickens. Reduction of clinical signs,
mortality and excretion of virus after challenge were shown by three
weeks after vaccination.
Serum antibodies could be expected to persist for at least 12 months
after administration of two doses
of vaccine.
5.
CONTRAINDICATIONS
Do not administer intramuscularly in chickens less than 2 weeks old.
6.
ADVERSE REACTIONS
A transient diffuse swelling may very commonly occur at the
vaccination site, which persists for about
14 days.
The frequency of adverse reactions is defined using the following
convention:
- very common (more than 1 in 10 animals treated displaying adverse
reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
17
- uncommon (more than 1 but less than 10 animals in 1,000 animals
treated)
- rare (more than 1 but less than 10 animals in 10,000 animals
treated)
- very rare (less than 1 animal in 10,000 animals treated, including
isolated reports).
If you notice any side effects, even those not already listed in this
package leaflet or you think th
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobilis Influenza H5N2 emulsion for injection for chickens.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose of 0.5 ml contains:
ACTIVE SUBSTANCE:
Inactivated whole avian influenza virus antigen of H5N2 subtype
(strain A/duck/Potsdam/1402/86),
inducing an HI titre of ≥6.0 log
2
as tested according to the potency test.
ADJUVANT:
Liquid light paraffin 234.8 mg
EXCIPIENTS:
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Emulsion for injection.
White homogeneous emulsion.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of chickens against avian influenza type A,
subtype H5.
Serum antibodies could be expected to persist for at least 12 months
after administration of two doses
of vaccine.
4.3
CONTRAINDICATIONS
Do not administer intramuscularly in chickens less than 2 weeks old.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
This vaccine has been tested for safety in chickens. If used in other
avian species that are considered at
risk of infection, its use in these species should be undertaken with
care and it is advisable to test the
vaccine on a small number of birds prior to mass vaccination.
The level of efficacy for other species may differ from that observed
in chickens.
The level of efficacy attained may vary depending on the degree of
antigenic homology between the
vaccine strain and circulating field strains.
3
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
None.
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 could result in the loss of the
affected finger if prompt medical attention is not given. If you are
accidentally injected with this
produ
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