Respiporc FLUpan H1N1

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  • Heiti vöru:
  • Respiporc FLUpan H1N1
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Staðsetning

  • Fáanlegt í:
  • Respiporc FLUpan H1N1
    Evrópusambandið
  • Tungumál:
  • enska

Meðferðarupplýsingar

  • Meðferðarhópur:
  • Pigs
  • Lækningarsvæði:
  • Immunologicals, inactivated viral vaccines for pigs, porcine influenza virus
  • Ábendingar:
  • 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.

Staða

  • Heimild:
  • EMA - European Medicines Agency
  • Leyfisstaða:
  • Authorised
  • Leyfisnúmer:
  • EMEA/V/C/003993
  • Leyfisdagur:
  • 17-05-2017
  • EMEA númer:
  • EMEA/V/C/003993
  • Síðasta uppfærsla:
  • 05-09-2017

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Canary Wharf

London E14 5EU

United Kingdom

An agency of the European Union

Telephone

+44 (0)20 3660 6000

Facsimile

+44 (0)20 3660 5555

Send a question via our website

www.ema.europa.eu/contact

© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

EMA/188700/2017

EMEA/V/C/003993

EPAR summary for the public

Respiporc FLUpan H1N1

Porcine influenza vaccine (inactivated)

This is a summary of the European public assessment report (EPAR) for Respiporc FLUpan H1N1. It

explains how the Agency assessed this veterinary medicine to recommend its authorisation in the

European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to

use Respiporc FLUpan H1N1.

For practical information about using Respiporc FLUpan H1N1, animal owners or keepers should read

the package leaflet or contact their veterinarian or pharmacist.

What is Respiporc FLUpan H1N1 and what is it used for?

Respiporc FLUpan H1N1 is a vaccine used to protect pigs from eight weeks of age against swine

influenza caused by pandemic subtype H1N1. Swine influenza or swine flu is a disease of the lungs and

airways in pigs. Signs can include fever, depression, coughing, sneezing, difficulty breathing and loss

of appetite.

The vaccine contains inactivated (killed) influenza A virus/Jena/VI5258/2009(H1N1)pdm09, a strain of

the virus that causes swine influenza.

How is Respiporc FLUpan H1N1 used?

Respiporc FLUpan H1N1 is available as a suspension for injection and can only be obtained with a

prescription. It is given as two injections into the muscle three weeks apart. The vaccine starts to be

effective one week after the second injection and protection lasts for three months.

For further information, see the package leaflet.

How does Respiporc FLUpan H1N1 work?

Respiporc FLUpan H1N1 is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s

natural defences) how to defend itself against a disease. Respiporc FLUpan H1N1 contains influenza A

Respiporc FLUpan H1N1

EMA/188700/2017

Page 2/2

virus (Pan H1N1) which has been inactivated so it cannot cause the disease. When a pig is given the

vaccine the pig’s immune system recognises the virus as ‘foreign’ and reacts by building up an active

immune response. In the future, the immune system will be able to react against the virus more

quickly when it is exposed to the virus. This active immune response will help to protect the pig against

the disease caused by this virus.

Respiporc FLUpan H1N1 contains an adjuvant (carbomer) to enhance the immune response.

What benefits of Respiporc FLUpan H1N1 have been shown in studies?

The effectiveness of Respiporc FLUpan H1N1 was shown in three laboratory studies and one combined

field/laboratory study. The studies showed that pigs vaccinated with Respiporc FLUpan H1N1 had a

reduction of virus in the lung and excreted from the nose.

What are the risks associated with Respiporc FLUpan H1N1?

The most common side effects with Respiporc FLUpan H1N1 (which may affect up to 1 in 10 animals)

are a short-lived increase in rectal temperature, not exceeding 2 °C, which does not last for more than

one day and a transient swelling up to 2 cm

at the site of injection which usually resolves within

5 days.

What are the precautions for the person who gives the medicine or comes

into contact with the animal?

No special precautions are required. In case of accidental self-injection only a minor injection site

reaction is expected.

What is the withdrawal period in food-producing animals?

The withdrawal period is the time required after administration of a medicine before an animal can be

slaughtered and the meat used for human consumption.

The withdrawal period for meat from pigs treated with Respiporc FLUpan H1N1 is ‘zero’ days, which

means there is no mandatory waiting time.

Why is Respiporc FLUpan H1N1 approved?

The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Respiporc

FLUpan H1N1’s benefits are greater than its risks and recommended that it be approved for use in the

Other information about Respiporc FLUpan H1N1:

The European Commission granted a marketing authorisation valid throughout the EU for Respiporc

FLUpan H1N1 on 17 May 2017.

The full EPAR for Respiporc FLUpan H1N1 can be found on the Agency’s website: ema.europa.eu/Find

medicine/Veterinary medicines/European public assessment reports. For more information about

treatment with Respiporc FLUpan H1N1, animal owners or keepers should read the package leaflet or

contact their veterinarian or pharmacist.

This summary was last updated in March 2017.

Upplýsingar um fylgiseðil sjúklinga: samsetning, vísbendingar, aukaverkanir, skammtar, milliverkanir, aukaverkanir, meðgöngu, brjóstagjöf

B. PACKAGE LEAFLET

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

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.

A transient swelling up to 2 cm

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 surgeon.

7.

TARGET SPECIES

Pigs

8.

DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION

For intramuscular use.

Vaccination: 2 injections of one dose (1 ml) from the age of 56 days, with an interval of 3 weeks

between injections.

The efficacy of revaccination has not been investigated and therefore no revaccination schedule is

proposed.

Maternally-derived antibodies in piglets interfere with the RESPIPORC FLUpan H1N1 mediated

immunity. Generally, maternally-derived antibodies induced by vaccination last for approximately 5-8

weeks after birth.

In case of exposure of sows with antigens (field infections and/or vaccination) the antibodies

transmitted to the piglets can interfere with active vaccination at 12 weeks of age. In this case piglets

should be vaccinated after the age of 12 weeks.

9.

ADVICE ON CORRECT ADMINISTRATION

None.

10.

WITHDRAWAL PERIOD

Zero days.

11.

SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Store in a refrigerator (2 ºC−8 ºC). Do not freeze.

Keep the vial in the outer carton in order to protect from light.

Shelf life after first opening the bottle: 10 hours.

Do not use this veterinary medicinal product after the expiry date which is stated on the label and

carton after EXP.

12.

SPECIAL WARNINGS

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.

Pregnancy and lactation:

The safety of the veterinary medicinal product has not been established during pregnancy and

lactation.

Interaction with other medicinal products and other forms of interaction:

No information is available on the safety and efficacy of this vaccine when used with any other

veterinary medicinal product. A decision to use this vaccine before or after any other veterinary

medicinal product therefore needs to be made on a case by case basis.

Incompatibilities:

Do not mix with any other veterinary medicinal product.

13.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE

MATERIALS, IF ANY

Medicines should not be disposed of via wastewater or household waste.

Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help

to protect the environment.

14.

DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this veterinary medicinal product is available on the website of the European

Medicines Agency http://www.ema.europa.eu/

15.

OTHER INFORMATION

The vaccine stimulates an active immunity against pandemic porcine influenza A/Jena/VI5258/2009

(H1N1)pandemic09-like virus. It induces neutralising and haemagglutination- inhibiting antibodies

against this subtype. The antibody responses mentioned in the following have been documented in

pigs without maternally derived immunity. Neutralising antibodies in serum have been detected in

more than 75% of the immunised pigs on day 7 after primary immunisation, lasting in more than 75%

of the pigs for over 3 months. Hemagglutination inhibiting antibodies have been detected in 15-100%

of the immunised pigs on day 7 after primary immunisation which disappeared in the majority of

animals within 1 to 4 weeks thereafter.

Efficacy of the vaccine was examined in laboratory challenge studies in pigs without maternally

derived antibodies and was demonstrated against the following strains;

FLUAV/Hamburg/NY1580/2009(H1N1)pdm09 (human origin),

FLUAV/swine/Schallern/IDT19989/2014 (H1N1)pdm09 (swine origin) and

FLUAV/sw/Teo(Spain)/AR641/2016 (H1N1)pdm09 (swine origin).

Package sizes:

Cardboard box with 1 polyethylene terephthalate (PET) bottle of 25 doses (25 ml) or 50 doses (50 ml)

with a rubber stopper and flanged cap.

Not all pack sizes may be marketed.