SUVAXYN PARVO ST SUSPENSION FOR INTRAMUSCULAR INJECTION FOR PIGS

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Compra

Scarica Scheda tecnica (SPC)
29-01-2016

Principio attivo:

PORCINE PARVOVIRUS, STRAIN NADL-2, INACTIVATED

Commercializzato da:

Zoetis Ireland Limited

Codice ATC:

QI09AA02

INN (Nome Internazionale):

PORCINE PARVOVIRUS, STRAIN NADL-2, INACTIVATED

Dosaggio:

Unknown

Forma farmaceutica:

Suspension for Injection

Tipo di ricetta:

LM-Licensed Merchant

Gruppo terapeutico:

Porcine

Area terapeutica:

Porcine parvovirus vaccine

Indicazioni terapeutiche:

Immunological - Inactivated vaccine

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2013-12-09

Scheda tecnica

                                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
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.
Quantitative composition (2 ml dose)
ACTIVE SUBSTANCES:
Inactivated porcine parvovirus,
Antibody titre by Haemagglutination Inhibi-
strain NADL-2
tion (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
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 13/01/2016_
_CRN 7022518_
_page number: 1_
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 ANIMALS
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 slight vis
                                
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