Circovac

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

inactivated porcine circovirus type 2 (PCV2)

MAH:

CEVA-Phylaxia Oltóanyagtermelõ Zrt.

ATC_code:

QI09AA07

INN:

adjuvanted inactivated vaccine against porcine circovirus type 2

therapeutic_group:

Pigs (gilts and sows)

therapeutic_area:

Immunologicals for suidae

therapeutic_indication:

Sows and giltsPassive immunisation of piglets via the colostrum, after active immunisation of sows and gilts, to reduce lesions in lymphoid tissues associated with PCV2 infection and as an aid to reduce PCV2-linked mortality.PigletsActive immunisation of piglets to reduce faecal excretion of PCV2 and virus load in blood, and as an aid to reduce PCV2-linked clinical signs, including wasting, weight loss and mortality, as well as to reduce virus load and lesions in lymphoid tissues associated with PCV2 infection.

leaflet_short:

Revision: 12

authorization_status:

Authorised

authorization_date:

2007-06-21

PIL

17
B. PACKAGE LEAFLET
18
PACKAGE LEAFLET FOR:
CIRCOVAC EMULSION AND SUSPENSION FOR EMULSION FOR INJECTION FOR PIGS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
CEVA-Phylaxia Veterinary Biologicals Co. Ltd., Szállás u. 5.,
Budapest, 1107, Hungary
Manufacturer for batch release:
MERIAL, Laboratoire Porte des Alpes, Rue de l'Aviation, F-69800 Saint
Priest, France
CEVA-Phylaxia Veterinary Biologicals Co. Ltd., Szállás u. 5.,
Budapest, 1107, Hungary
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Circovac
Emulsion and suspension for emulsion for injection for pigs
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Pale opalescent liquid prior to reconstitution
Each ml of reconstituted vaccine contains:
ACTIVE SUBSTANCE:
Inactivated porcine circovirus type 2 (PCV2)
.................................................

1.8 log10 ELISA Units
EXCIPIENT:
Thiomersal
...................................................................................................................................
0.10 mg
ADJUVANT:
Light paraffin oil
............................................................................................................
247 to 250.5 mg
4.
INDICATION(S)
PIGLETS
: Active immunisation of piglets to reduce faecal excretion of PCV2
and virus load in blood,
and as an aid to reduce PCV2 linked clinical signs, including wasting,
weight loss and mortality as
well as to reduce virus load and lesions in lymphoid tissues
associated with PCV2 infection.
Onset of immunity: 2 weeks.
Duration of immunity: at least 14 weeks after vaccination.
SOWS AND GILTS:
Passive immunisation of piglets via the colostrum, after active
immunisation of sows
and gilts, to reduce lesions in lymphoid tissues associated with PCV2
infection and as an aid to reduce
PCV2-linked mortality.
Duration of immunity: up to 5 weeks after transfer of passive
antibodies through colostrum intake.
5.
CONTRAINDI

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Circovac emulsion and suspension for emulsion for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of reconstituted vaccine contains:
ACTIVE SUBSTANCE:
Inactivated porcine circovirus type 2 (PCV2)
.................................................

1.8 log10 ELISA Units
EXCIPIENT:
Thiomersal
...................................................................................................................................
0.10 mg
ADJUVANT:
Light paraffin oil
............................................................................................................
247 to 250.5 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Emulsion and suspension for emulsion for injection.
Pale opalescent liquid prior to reconstitution.
The reconstituted vaccine is a homogeneous white emulsion.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs (gilts, sows and piglets from 3 weeks of age).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
PIGLETS
: Active immunisation of piglets to reduce faecal excretion of PCV2
and virus load in blood,
and as an aid to reduce PCV2-linked clinical signs, including wasting,
weight loss and mortality as
well as to reduce virus load and lesions in lymphoid tissues
associated with PCV2 infection.
Onset of immunity: 2 weeks
Duration of immunity: at least 14 weeks after vaccination.
SOWS AND GILTS
: Passive immunisation of piglets via the colostrum, after active
immunisation of sows
and gilts, to reduce lesions in lymphoid tissues associated with PCV2
infection and as an aid to reduce
PCV2-linked mortality.
Duration of immunity: up to 5 weeks after transfer of passive
antibodies through colostrum intake.
4.3
CONTRAINDICATIONS
None.
3
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Sows: None.
Piglets: The efficacy of the vaccine in the face of intermediate to
high levels of maternally derived
antibodies has been demonstrated.
4.5
SPECIAL PRECAUTIONS FOR USE
SPE