ReproCyc ParvoFLEX

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

Porcine parvovirus, strain 27a, viral protein 2

Saatavilla:

Boehringer Ingelheim Vetmedica GmbH

ATC-koodi:

QI09AA02

INN (Kansainvälinen yleisnimi):

porcine parvovirosis vaccine (inactivated)

Terapeuttinen ryhmä:

Pigs

Terapeuttinen alue:

Immunologicals for suidae

Käyttöaiheet:

For active immunisation of gilts and sows from the age of 5 months to protect progeny against transplacental infection caused by porcine parvovirus.

Tuoteyhteenveto:

Revision: 1

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2019-04-26

Pakkausseloste

15
B. PACKAGE LEAFLET
16
PACKAGE LEAFLET:
REPROCYC PARVOFLEX 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:
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ReproCyc ParvoFLEX suspension for injection for pigs
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
Each dose (2 ml) contains:
Porcine Parvovirus strain 27a VP2 subunit antigen: ≥ 1.0 RP*
* Relative potency (ELISA).
Adjuvant: Carbomer 2 mg.
Colourless to slightly brown, opalescent suspension for injection.
4.
INDICATION(S)
For active immunisation of gilts and sows from the age of 5 months to
protect progeny against
transplacental infection caused by porcine parvovirus..
Onset of immunity:
from the beginning of the gestational period.
Duration of immunity:
6 months
5.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
Transient redness or swelling (up to 4 cm) caused by the injection
procedure is very common. Local
reactions resolve within two to five days without treatment. An
elevation in the body temperature after
vaccination is common which resolves spontaneously within 24 to 48
hours.
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).
17
If you notice any side effects, even those not already listed in this
package leaflet or you think that the
medicine has not worked, please inform your veterinary surgeon.
7.
TARGET SPECIES
Pigs
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ReproCyc ParvoFLEX suspension for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (2 ml) contains:
ACTIVE SUBSTANCE:
Porcine Parvovirus strain 27a VP2 subunit antigen ≥ 1.0 RP*
* Relative Potency (ELISA)
ADJUVANT:
Carbomer 2 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Colourless to slightly brown, opalescent suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of gilts and sows from the age of 5 months to
protect progeny against
transplacental infection caused by porcine parvovirus.
Onset of immunity:
from the beginning of the gestational period.
Duration of immunity:
6 months
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.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
Not applicable.
3
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Transient redness or swelling (up to 4 cm) caused by the injection
procedure is very common. Local
reactions resolve within two to five days without treatment. An
elevation in the body temperature after
vaccination is common which resolves spontaneously within 24 to 48
hours.
The frequency of adverse reactions is defined using the following
convention:
- very common (more than 1 in 10 animals treated displaying adverse
reaction(s))
- 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).
4.7
USE DURING PREGNANCY, LACTATION AND LAY
Can be used during pregnancy and lactation.
4.8
INT