Advasure

Země: Evropská unie

Jazyk: angličtina

Zdroj: EMA (European Medicines Agency)

Aktivní složka:

E2 glycoprotein of classical swine fever virus

Dostupné s:

Pfizer Limited

ATC kód:

QI09AA06

INN (Mezinárodní Name):

Adjuvanted vaccine against classical swine fever

Terapeutické skupiny:

Pigs

Terapeutické oblasti:

Immunologicals for suidae

Terapeutické indikace:

Active immunisation of pigs, over the age of 2 weeks, against Classical Swine Fever (CSF), to preventmortality, reduce clinical signs of the disease and the excretion of field virus.The onset of protection is 2 weeks.The duration of protection is 6 months.

Přehled produktů:

Revision: 5

Stav Autorizace:

Withdrawn

Datum autorizace:

2001-02-02

Informace pro uživatele

Medicinal Product no longer authorised
15/20
B. PACKAGE LEAFLET
Medicinal Product no longer authorised
16/20
PACKAGE LEAFLET
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
MARKETING AUTHORISATION HOLDER:
Pfizer Ltd.
Sandwich
Kent, CT13 9NJ
United Kingdom
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE:
Bayer AG
Business Group Animal Health
Osterather Strasse 1a
D-50739 Köln
Germany
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Advasure
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
Per dose of 2 ml:
ACTIVE SUBSTANCE
E2 glycoprotein of Classical Swine Fever (CSF) virus minimum 32 µg
ADJUVANT
Adjuvant composition - Double oil emulsion:
Mineral oil
0.64 ml
Emulsifiers
0.064 ml
Phosphate buffered saline
0.63 ml
PRESERVATIVE:
Thiomersal
maximum 1:10,000
4.
INDICATION(S)
Active immunisation of pigs, over the age of 2 weeks, against
Classical Swine Fever (CSF), to prevent
mortality, reduce clinical signs of the disease and the excretion of
field virus.
The onset of protection is 2 weeks.
The duration of protection is 6 months.
5.
CONTRAINDICATIONS
None
Medicinal Product no longer authorised
17/20
6.
ADVERSE REACTIONS
If you notice any serious effects or other effects not mentioned in
this leaflet, please inform your
veterinary surgeon.
7.
TARGET SPECIES
Pigs
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
The dosage for pigs, over 2 weeks, is 2 ml of the vaccine
Intramuscular injection
9.
ADVICE ON CORRECT ADMINISTRATION
The vaccine is to be administered aseptically by intramuscular
injection closely behind the ear of the
pig.
The pigs should be vaccinated in time before the expected exposure to
the field virus, preferably prior
to housing (crowding) or transfer to new groups. It is strongly
recommended to vaccinate all pigs in
the herd.
The dosage for pigs, over the age of 2 weeks, is 2 ml of the vaccine.
In emergency situations the basic immunisation consists of one
intramuscular injection w

Charakteristika produktu

Medicinal Product no longer authorised
1/20
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal Product no longer authorised
2/20
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Advasure emulsion for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per dose of 2 ml:
ACTIVE SUBSTANCE:
E2 glycoprotein of Classical Swine Fever (CSF) virus minimum 32 µg
ADJUVANT:
Adjuvant composition - Double oil emulsion:
Mineral oil
0.64 ml
Emulsifiers
0.064 ml
Phosphate buffered saline
0.63 ml
PRESERVATIVE:
Thiomersal
maximum 1:10,000
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Emulsion for injection.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of pigs, over the age of 2 weeks, against
Classical Swine Fever (CSF), to prevent
mortality, reduce clinical signs of the disease and the excretion of
field virus.
The onset of protection is 2 weeks.
The duration of protection is 6 months.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
The pigs should be vaccinated in time before the expected exposure to
the field virus, preferably prior
to housing (crowding) or transfer to new groups. It is strongly
recommended to vaccinate all pigs in
the herd.
4.5
SPECIAL PRECAUTIONS FOR USE
None known.
Medicinal Product no longer authorised
3/20
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
See section 4.4.
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 insert to a
physician.
To the user:
This product contains mineral oil. Accidental injection/self injection
may result in severe pain and
swelling, particularly if injected into a joint or finger, and in rare
cases could result in the loss of the
affected finger if prompt medical attention is not given. If you are
accidentally injected with this
product, seek prompt medical advice even if only a very small amount
is injected and tak