Porcilis Glässer Suspension for Injection for Pigs

Kraj: Wielka Brytania

Język: angielski

Źródło: VMD (Veterinary Medicines Directorate)

Składnik aktywny:

Haemophilus parasuis

Dostępny od:

MSD Animal Health UK Limited

Kod ATC:

QI09AB

INN (International Nazwa):

Haemophilus parasuis

Forma farmaceutyczna:

Suspension for injection

Typ recepty:

POM-V - Prescription Only Medicine – Veterinarian

Grupa terapeutyczna:

Pigs

Dziedzina terapeutyczna:

Inactivated Bacterial Vaccine

Status autoryzacji:

Authorized

Data autoryzacji:

2004-03-22

Charakterystyka produktu

Revised: March 2022
AN: 01619/2021 & 01621/2021
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis Glässer Suspension for injection for pigs
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.
*
ELISA units = mean antibody titre (log2 value) in the potency test in
mice.
Revised: March 2022
AN: 01619/2021 & 01621/2021
Page 2 of 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
MEDICINAL PRODUCT TO ANIMALS
In case of accidental self-injection, seek medical advice immediately
and show the
package leaflet or the label t