Porcilis Glässer Suspension for Injection for Pigs

देश: यूनाइटेड किंगडम

भाषा: अंग्रेज़ी

स्रोत: VMD (Veterinary Medicines Directorate)

सक्रिय संघटक:

Haemophilus parasuis

थमां उपलब्ध:

Intervet International BV

ए.टी.सी कोड:

QI09AB

INN (इंटरनेशनल नाम):

Haemophilus parasuis

फार्मास्यूटिकल फॉर्म:

Suspension for injection

प्रिस्क्रिप्शन प्रकार:

POM-V - Prescription Only Medicine – Veterinarian

चिकित्सीय समूह:

Pigs

चिकित्सीय क्षेत्र:

Inactivated Bacterial Vaccine

प्राधिकरण का दर्जा:

Authorized

प्राधिकरण की तारीख:

2004-03-22

उत्पाद विशेषताएं

Revised: 15 July 2009
AN: 01836/2008
SUMMARY OF PRODUCT CHARACTERISTICS
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.
**
ELISA units = mean antibody titre (log2 value) in the potency test in
mice.
Revised: 15 July 2009
AN: 01836/2008
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.
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
MED