Porcilis Glässer Suspension for injection for pigs

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Inactivated whole cells of Haemophilis parasuis serotype 5, strain 4800

Διαθέσιμο από:

Intervet Ireland Limited

Φαρμακολογική κατηγορία (ATC):

QI09AB07

INN (Διεθνής Όνομα):

Inactivated whole cells of Haemophilis parasuis serotype 5, strain 4800

Δοσολογία:

. enzyme-linked immunosorbent assay unit/dose

Φαρμακοτεχνική μορφή:

Suspension for injection

Τρόπος διάθεσης:

POM: Prescription Only Medicine as defined in relevant national legislation

Θεραπευτική ομάδα:

Pigs

Θεραπευτική περιοχή:

actinobacillus/haemophilus vaccine

Θεραπευτικές ενδείξεις:

Immunological - Inactivated Vaccine

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2004-03-04

Αρχείο Π.Χ.Π.

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis Glässer Vet Suspension for injection for pigs (DK-FI-NO)
Porcilis Glässer Suspension for injection for pigs
(AT-BE-DE-EL-ES-FR-IE-LU-NL-PT-UK-CY-
CZ-SK-SI-HU-PL-EE-LV)
Porsilis Glässer Suspension for injection for pigs (IT)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per dose of 2 ml
ACTIVE SUBSTANCE(S):
Inactivated whole bacterial cells of
_Haemophilus parasuis_
serotype 5, strain 4800: 0.05 mg total
nitrogen, inducing

9.1 Elisa Units
*
.
ADJUVANT:
150 mg dl-

-tocopheryl acetate
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection
Appearance: aqueous, white or nearly white suspension
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs and sows.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Pigs:
Active immunisation of pigs to reduce typical lesions of Glässer’s
disease caused by
_Haemophilus _
_parasuis_
serotype 5.
Onset of immunity: 2 weeks after completion of vaccination.
Duration of immunity: 14 weeks after completion of vaccination.
Sows:
For passive immunisation of the progeny of vaccinated sows and gilts
to reduce infection, mortality,
clinical signs and typical lesions of Glässer disease caused by
_Haemophilus parasuis_
serotype 5 and
to reduce clinical signs and mortality caused by
_Haemophilus parasuis_
serotype 4.
Onset of immunity: After birth and sufficient uptake of colostrum.
Duration of immunity has been demonstrated at 4 weeks of age against
serotype 4 and at 6 weeks
of age against serotype 5.
4.3
CONTRAINDICATIONS
None.
*
ELISA units = mean antibody titre (log2 value) in the potency test in
mice.
4.4
SPECIAL WARNINGS
None
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Vaccinate only healthy animals. In the event of anaphylactic reaction
consult your veterinarian.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT
TO ANIMALS
In case of accidental self-injection, seek medical advice immediately
and show th