PORCILIS AUJESZKY
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
02-05-2024
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Active ingredient:
AUJESZKY DISEASE VIRUS (PORCINE HERPESVIRUS TYPE I) STRAIN PHYLAXIA (GLYCOPROTEIN GE DELETED)
Available from:
Intervet Ireland Limited
ATC code:
QI09AA01
Pharmaceutical form:
Suspension for Injection
Therapeutic group:
Immunological - Inactivated vaccine
Therapeutic area:
Porcine
Authorization date:
2001-04-10
Summary of Product characteristics
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis Aujeszky
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Aqueous suspension for injection
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs (fattening and breeding pigs)
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of pigs to prevent mortality and clinical signs of Aujeszky's Disease and to reduce the spreading
of Aujeszky's Disease virus.
Passive immunisation of the progeny of vaccinated sows, to prevent mortality and to reduce the clinical signs of
Aujeszky's Disease.
Duration of active immunity: 5-6 months after the last (re)-vaccination.
Maternal antibodies provide passive immunity to the progeny for at least 1 week.
4.3 CONTRAINDICATIONS
None
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
Per dose of 2 ml:
ACTIVE SUBSTANCE(S)
Aujeszky Disease Virus (porcine Herpesvirus type 1) strain Phylaxia:
equivalent to
8,2 log
10
CCID
50
(before inactivation)
ADJUVANT
dl- -Tocopherol acetate:
150,00 mg
PRESERVATIVE
Formalin
1,08 mg
EXCIPIENT(S) KNOWLEDGE OF WHICH IS ESSENTIAL FOR THE PROPER ADMINISTRATION OF THE VETERINARY
MEDICINAL PRODUCT
Excipients to:
2,00 ml
For a full list of excipients see section 6.1.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 01/11/2006_
_CRN 7002333_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
None.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE MEDICINAL PRODUCT TO ANIMALS
In case of accidental self-injection, seek medical advice immediately and show the package insert or label to the
physician.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
A transient rise in body temperature may occur
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