Porcilis Glässer Suspension for injection for pigs

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Inactivated whole cells of Haemophilis parasuis serotype 5, strain 4800

Boleh didapati daripada:

Intervet Ireland Limited

Kod ATC:

QI09AB07

INN (Nama Antarabangsa):

Inactivated whole cells of Haemophilis parasuis serotype 5, strain 4800

Dos:

. enzyme-linked immunosorbent assay unit/dose

Borang farmaseutikal:

Suspension for injection

Jenis preskripsi:

POM: Prescription Only Medicine as defined in relevant national legislation

Kumpulan terapeutik:

Pigs

Kawasan terapeutik:

actinobacillus/haemophilus vaccine

Tanda-tanda terapeutik:

Immunological - Inactivated Vaccine

Status kebenaran:

Authorised

Tarikh kebenaran:

2004-03-04

Ciri produk

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