ReproCyc ParvoFLEX
Authorised
This medicine is authorised for use in the European Union
porcine parvovirosis vaccine (inactivated)
MedicineVeterinaryAuthorised
- Application under evaluation
- CVMP opinion
- European Commission decision
Overview
ReproCyc ParvoFLEX is a veterinary vaccine given to female pigs to protect their unborn piglets from porcine parvovirus infection via the placenta. Porcine parvovirus causes infertility, still births and small litters in female pigs. ReproCyc ParvoFLEX contains inactivated (killed) porcine parvovirus strain 27a viral protein 2.
ReproCyc ParvoFLEX can only be obtained with a prescription and is available as an injection. It is given into the muscle of female pigs from 5 months of age. The initial vaccination course is two injections given 3 weeks apart, with the second injection given at least 3 weeks before mating. Protection starts at the beginning of pregnancy and lasts for 6 months. A single booster injection can be given every 6 months to maintain immunity.
For more information about using ReproCyc ParvoFLEX, see the package leaflet or contact your veterinarian or pharmacist.
ReproCyc ParvoFLEX is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. The vaccine contains a porcine parvovirus protein that does not cause disease. When ReproCyc ParvoFLEX is given to female pigs the animals’ immune system recognises the viral protein as ‘foreign’ and makes antibodies against it. If the animals come into contact with the virus the immune system will be able to respond quickly. This will help protect the unborn piglets against porcine parvovirus infections during pregnancy.
ReproCyc ParvoFLEX also contains the adjuvant (ingredient that strengthens the immune response) carbomer.
Three laboratory studies showed that ReproCyc ParvoFLEX protects against transplacental porcine parvovirus infection, since more than 95% of piglets from vaccinated female pigs were protected from infection, as shown by absence of parvovirus.
A field study in Spain showed that ReproCyc ParvoFLEX, when given to female pigs, was as effective as an authorised porcine parvovirus vaccine, Parvoseng, as measured by the fertility of vaccinated animals, the number of still births and the size of the litters.
The most common side effect with ReproCyc ParvoFLEX (which may affect more than 1 in 10 animals) is short lived redness or swelling (up to 4 cm) at the injection site. These reactions resolve without treatment in 2 to 5 days.
An increase in body temperature can occur after vaccination (which may affect up to 1 in 10 animals) but this resolves within 24 to 48 hours.
None.
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 ReproCyc ParvoFLEX is ‘zero’ days, which means that there is no mandatory waiting time.
The European Medicines Agency decided that ReproCyc ParvoFLEX’s benefits are greater than its risks and it can be authorised for use in the EU.
ReproCyc ParvoFLEX received a marketing authorisation valid throughout the EU on 26 April 2019.
Product information
Latest procedure affecting product information:
IA/0002/G
30/10/2019
Product details
- Name of medicine
- ReproCyc ParvoFLEX
- Active substance
- Porcine parvovirus, strain 27a, viral protein 2
- International non-proprietary name (INN) or common name
- porcine parvovirosis vaccine (inactivated)
- Species
- Pigs
- Anatomical therapeutic chemical veterinary (ATCvet) code
- QI09AA02
Pharmacotherapeutic group
Immunologicals for suidaeTherapeutic indication
For active immunisation of gilts and sows from the age of 5 months to protect progeny against transplacental infection caused by porcine parvovirus.
News on ReproCyc ParvoFLEX
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