Suvaxyn Parvo ST
Country: Romania
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
09-03-2013
Summary of Product characteristics
(SPC)
09-03-2013
Active ingredient:
porcine parvovirus inactivated 2 ml
Available from:
Pfizer GmbH
ATC code:
QI09AA02
Pharmaceutical form:
Solution for injection
Therapeutic group:
Porcine parvovirus vaccine
Therapeutic area:
Pigs Females
Authorization date:
2011-08-16
Patient Information leaflet
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
Read the complete document
Summary of Product characteristics
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
Read the complete document
