Porcilis Glässer Suspension for injection for pigs

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Inactivated whole cells of Haemophilis parasuis serotype 5, strain 4800

제공처:

Intervet Ireland Limited

ATC 코드:

QI09AB07

INN (International Name):

Inactivated whole cells of Haemophilis parasuis serotype 5, strain 4800

복용량:

. enzyme-linked immunosorbent assay unit/dose

약제 형태:

Suspension for injection

처방전 유형:

POM: Prescription Only Medicine as defined in relevant national legislation

치료 그룹:

Pigs

치료 영역:

actinobacillus/haemophilus vaccine

치료 징후:

Immunological - Inactivated Vaccine

승인 상태:

Authorised

승인 날짜:

2004-03-04

제품 특성 요약

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