Suvaxyn Parvo ST
Land: Portugal
Taal: Engels
Bron: HMA (Heads of Medicines Agencies)
Bijsluiter
(PIL)
09-03-2013
Productkenmerken
(SPC)
09-03-2013
Werkstoffen:
porcine parvovirus inactivated 2 ml
Beschikbaar vanaf:
Pfizer GmbH
ATC-code:
QI09AA02
farmaceutische vorm:
Solution for injection
Therapeutische categorie:
Porcine parvovirus vaccine
Therapeutisch gebied:
Pigs Females
Autorisatie datum:
2011-08-16
Bijsluiter
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Suvaxyn Parvo ST suspension for
intramuscular
injection
for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Quantitative composition (2 ml dose)
ACTIVE SUBSTANCES:
Inactivated porcine parvovirus,
strain NADL-2
Antibody titre by Haemagglutination Inhibition
(HI) in vaccinated rabbits ≥ 368
GMT
*
ADJUVANT:
Carbopol #941
2.0 mg
EXCIPIENTS:
Thiomersal
0.17 mg
* Geometric Mean Titre
For
the
full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Clear pink suspension.
4.
CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs of a minimum age of 6 months (gilts and sows).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of sows and gilts to reduce transplacental infection of progeny with porcine
parvovirus.
Onset of immunity: 8 weeks after primary vaccination.
Duration of immunity: 4 months after primary vaccination.
4.3 CONTRAINDICATIONS
None
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
In case of a return to service, a booster vaccination should be considered.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Vaccinate only clinically healthy animals.
Avoid stress in the animal around the time of injection.
Special precautions to be taken by the person administering the veterinary medicinal product to ani-
mals
In case of accidental self-administration, seek medical advice immediately and show the package
leaflet or the label to the physician.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Mild, transient local reactions, including slight visible redness, and
Lees het volledige document
Productkenmerken
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Suvaxyn Parvo ST suspension for
intramuscular
injection
for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Quantitative composition (2 ml dose)
ACTIVE SUBSTANCES:
Inactivated porcine parvovirus,
strain NADL-2
Antibody titre by Haemagglutination Inhibition
(HI) in vaccinated rabbits ≥ 368
GMT
*
ADJUVANT:
Carbopol #941
2.0 mg
EXCIPIENTS:
Thiomersal
0.17 mg
* Geometric Mean Titre
For
the
full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Clear pink suspension.
4.
CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs of a minimum age of 6 months (gilts and sows).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of sows and gilts to reduce transplacental infection of progeny with porcine
parvovirus.
Onset of immunity: 8 weeks after primary vaccination.
Duration of immunity: 4 months after primary vaccination.
4.3 CONTRAINDICATIONS
None
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
In case of a return to service, a booster vaccination should be considered.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Vaccinate only clinically healthy animals.
Avoid stress in the animal around the time of injection.
Special precautions to be taken by the person administering the veterinary medicinal product to ani-
mals
In case of accidental self-administration, seek medical advice immediately and show the package
leaflet or the label to the physician.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Mild, transient local reactions, including slight visible redness, and
Lees het volledige document
