Mhyosphere PCV ID

RSS

Mycoplasma hyopneumoniae and porcine circovirus vaccine (inactivated, recombinant)

Authorised
This medicine is authorised for use in the European Union.

Overview

Mhyosphere PCV ID is a veterinary vaccine used to protect pigs against two swine pathogens, Mycoplasma hyopneumoniae and Porcine circovirus, at the same time.

Mhyosphere PCV ID consists of the inactivated recombinant M. hyopneumoniaecpPCV2, strain Nexhyon, expressing the Porcine circovirus type 2 (PCV2) capsid protein.

  • Infection with the bacterium M. hyopneumoniae in pigs causes a disease of the airways called enzootic pneumonia. Affected pigs often have a cough and fail to thrive.
  • PCV2 infections can produce clinical signs such as weight loss or failure to grow, enlarged lymph nodes, difficulty in breathing, diarrhoea, pale skin and jaundice (yellowing of the skin).
This EPAR was last updated on 17/02/2021

Authorisation details

Product details
Name
Mhyosphere PCV ID
Agency product number
EMEA/V/C/005272
Active substance
Mycoplasma hyopneumoniae, strain 7304 (Nexhyon), expressing the capsid protein of porcine circovirus type 2a, inactivated
International non-proprietary name (INN) or common name
Mycoplasma hyopneumoniae and porcine circovirus vaccine (inactivated, recombinant)
Species
Pigs
Anatomical therapeutic chemical veterinary (ATCvet) codes
QI09AL08
Publication details
Marketing-authorisation holder
Laboratorios Hipra, S.A.
Date of issue of marketing authorisation valid throughout the European Union
18/08/2020
Contact address

Avda. La Selva, 135
17170 Amer (Girona)
Spain

Product information

18/08/2020 Mhyosphere PCV ID - EMEA/V/C/005272 -

Contents

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Pharmacotherapeutic group

  • Immunologicals for suidae

  • Inactivated viral and inactivated bacterial vaccines

Therapeutic indication

For the active immunisation of pigs:

  • to reduce lung lesions associated with porcine enzootic pneumonia caused by Mycoplasma hyopneumoniae. Also, to reduce the incidence of these lesions (as observed in field studies).
  • to reduce viraemia, virus load in lungs and lymphoid tissues and the duration of the viraemic period associated with diseases caused by Porcine circovirus type 2 (PCV2). Efficacy against PCV2 genotypes a, b and d has been demonstrated in field studies.
  • to reduce culling rate and the loss of daily weight gain caused by Mycoplasma hyopneumoniae and/or PCV2 related diseases (as observed at 6 months of age in field studies).

Mycoplasma hyopneumoniae:

Onset of immunity: 3 weeks after vaccination

Duration of immunity: 23 weeks after vaccination

Porcine circovirus type 2:

Onset of immunity: 2 weeks after vaccination

Duration of immunity: 22 weeks after vaccination

In addition, a reduction in nasal and faecal shedding and the duration of nasal excretion of PCV2 was demonstrated in animals challenged at 4 weeks and at 22 weeks after vaccination.

Assessment history

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