Suvaxyn Parvo/E

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Inactivated porcine parvovirus, strain s-80; Inactivated erysipelothrix rhusiopathiae, strain b-7 (serotype 2)

Inapatikana kutoka:

Zoetis Belgium S.A.

ATC kanuni:

QI09AL01

INN (Jina la Kimataifa):

Inactivated porcine parvovirus, strain s-80; Inactivated erysipelothrix rhusiopathiae, strain b-7 (serotype 2)

Kipimo:

160/ >1.8 haemagglutination inhibiting antibody / Relative Potency

Dawa fomu:

Emulsion for injection

Dawa ya aina:

POM: Prescription Only Medicine as defined in relevant national legislation

Kundi la matibabu:

Pigs

Eneo la matibabu:

porcine parvovirus + erysipelothrix

Matibabu dalili:

Immunological - Inactivated Vaccine

Idhini hali ya:

Authorised

Idhini ya tarehe:

2013-12-09

Tabia za bidhaa

Health Products Regulatory Authority
27 July 2017
CRN000V13
Page 1 of 5
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Suvaxyn Parvo/E
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Per dose of 2 ml
ACTIVE SUBSTANCES:
Inactivated porcine parvovirus, strain S-80: Inducing an HIA* titre of
at least 160 (in
rabbits).
Inactivated Erysipelothrix rhusiopathiae,
strain B-7 (serotype 2): RP** >1.8 in accordance with the EP Monograph
*HIA: haemagglutination inhibiting antibody
**Relative Potency compared to a reference serum obtained from a
vaccine that has
given satisfactory protection in vaccinated pigs.
ADJUVANTS:
Marcol 52 (Mineral oil) 730.14 mg
Montanide 888 (Emulsifier) 74.32 mg
Simulsol 5100 (Emulsifier) 69.95 mg
EXCIPIENTS:
Thiomersal 0.2 mg
Formaldehyde ≤ 0.05 %
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Emulsion for injection. Appearance: Ivory white oil emulsion.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs (gilts and sows).
Health Products Regulatory Authority
27 July 2017
CRN000V13
Page 2 of 5
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of pigs (gilts and sows) to:
Prevent reproductive disorders caused by porcine parvovirus.
Reduce clinical signs caused by _Erysipelothrix rhusiopathiae
_infections, serotype 2 and
serotype 1.
The onset of immunity starts 3 weeks after vaccination and duration of
the protection
is 6 months.
4.3 CONTRAINDICATIONS
Do not use less than 3 weeks before mating.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
-Avoid stress in the animals around the time of vaccination.
-Administer only to animals in good health condition
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY
MEDICINAL PRODUCT TO ANIMALS
To the user:
This product contains mineral oil. Accidental injection/self injection
may result in
severe pain and swelling, particularly if injected into a joint or
finger, and in rare
cases could result in the loss of the affected