Respiporc FLUpan H1N1
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
13-05-2018
Charakterystyka produktu
(SPC)
13-05-2018
Sprawozdanie z oceny publicznego
(PAR)
20-06-2017
Składnik aktywny:
inactivated influenza A virus/human
Dostępny od:
IDT Biologika GmbH
Kod ATC:
QI09AA03
INN (International Nazwa):
inactivated influenza A virus/human strain: A/Jena/VI5258/2009(H1N1)pdm09
Grupa terapeutyczna:
Pigs
Dziedzina terapeutyczna:
Immunologicals, inactivated viral vaccines for pigs, porcine influenza virus
Wskazania:
Active immunisation of pigs from the age of 8 weeks onwards against pandemic H1N1 porcine influenza virus to reduce viral lung load and viral excretion.
Status autoryzacji:
Authorised
Data autoryzacji:
2017-05-17
Ulotka dla pacjenta
13
B. PACKAGE LEAFLET
14
PACKAGE LEAFLET FOR:
RESPIPORC FLUPAN H1N1 SUSPENSION 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:
IDT Biologika GmbH
Am Pharmapark
06861 Dessau-Rosslau
GERMANY
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
RESPIPORC FLUpan H1N1 suspension for injection for pigs
3.
STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS
Each dose of 1 ml contains:
ACTIVE SUBSTANCE:
Inactivated Influenza A virus/human
Strain:
A/Jena/VI5258/2009(H1N1)pdm09
16–64 HU
1
1
HU – haemagglutinating units in the vaccine.
ADJUVANT:
Carbomer 971 P NF
2 mg
EXCIPIENT:
Thiomersal
0.1 mg
Clear to slightly turbid, reddish to pale-pink coloured suspension.
4.
INDICATION(S)
Active immunisation of pigs from the age of 8 weeks onwards against
pandemic H1N1 porcine
influenza virus to reduce viral lung load and virus excretion.
Onset of immunity:
7 days after primary vaccination.
Duration of immunity:
3 months after primary vaccination.
5.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
A transient increase in rectal temperature, not exceeding 2 °C, is
common after vaccination and this
does not persist for more than one day.
15
A transient swelling up to 2 cm
3
may occur at the site of injection, these reactions are common but
resolve within 5 days.
The frequency of adverse reactions is defined using the following
convention:
- very common (more than 1 in 10 animals treated displaying adverse
reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- 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 serious effects or other effects not mentioned in
this package leaflet, please inform
your veterinary surg
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
RESPIPORC FLUpan H1N1 suspension for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 1 ml contains:
ACTIVE SUBSTANCE:
Inactivated influenza A virus/human
Strain:
A/Jena/VI5258/2009(H1N1)pdm09
16–64 HU
1
1
HU – haemagglutinating units in the vaccine.
ADJUVANT:
Carbomer 971 P NF
2 mg
EXCIPIENT:
Thiomersal
0.1 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Clear to slightly turbid, reddish to pale-pink coloured suspension.
4.
CLINICAL PARTICULARS
4.1.
TARGET SPECIES
Pigs.
4.2.
INDICATION FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of pigs from the age of 8 weeks onwards against
pandemic H1N1 porcine
influenza virus to reduce viral lung load and viral excretion.
Onset of immunity:
7 days after primary vaccination.
Duration of immunity:
3 months after primary vaccination.
4.3.
CONTRAINDICATIONS
None.
4.4.
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
4.5.
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Not applicable.
3
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
In case of accidental self-injection only a minor injection site
reaction is expected.
4.6.
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
A transient increase in rectal temperature, not exceeding 2 °C, is
common after vaccination and this
does not persist for more than one day.
A transient swelling up to 2 cm
3
may occur at the site of injection, these reactions are common but
resolve within 5 days.
The frequency of adverse reactions is defined using the following
convention:
- very common (more than 1 in 10 animals treated displaying adverse
reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- 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
treate
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