Respiporc FLUpan H1N1

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

inactivated influenza A virus/human

Available from:

IDT Biologika GmbH

ATC code:

QI09AA03

INN (International Name):

inactivated influenza A virus/human strain: A/Jena/VI5258/2009(H1N1)pdm09

Therapeutic group:

Pigs

Therapeutic area:

Immunologicals, inactivated viral vaccines for pigs, porcine influenza virus

Therapeutic indications:

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.

Authorization status:

Authorised

Authorization date:

2017-05-17

Patient Information leaflet

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

Summary of Product characteristics

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