Rhiniseng

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

inactivated Bordetella bronchiseptica, strain 833CER / recombinant type-D Pasteurella-multocida toxin (PMTr)

MAH:

Laboratorios Hipra S.A.

ATC_code:

QI09AB04

INN:

inactivated Bordetella bronchiseptica, strain 833CER / recombinant type-D Pasteurella-multocida toxin (PMTr)

therapeutic_group:

Pigs (gilts and sows)

therapeutic_area:

Immunologicals

therapeutic_indication:

For the passive protection of piglets via colostrum after active immunisation of sows and gilts to reduce the clinical signs and lesions of progressive and non-progressive atrophic rhinitis, as well as to reduce weight loss associated with Bordetella-bronchiseptica and Pasteurella-multocida infections during the fattening period. Challenge studies have demonstrated that passive immunity lasts until piglets are six weeks of age while in clinical field trials, the beneficial effects of vaccination (reduction in nasal lesion score and weight loss) are observed until slaughter.

authorization_status:

Authorised

authorization_date:

2010-09-16

PIL

17
B. PACKAGE LEAFLET
18
PACKAGE LEAFLET:
RHINISENG suspension 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 and manufacturer responsible for batch
release:
LABORATORIOS HIPRA, S.A.
Avda la Selva, 135
17170 Amer (Girona)
SPAIN
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
RHINISENG suspension for injection for pigs.
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each dose of 2 ml contains:
ACTIVE SUBSTANCES:
Inactivated
_Bordetella bronchiseptica, _
strain 833CER: ........................................9.8 BbCC(*)
Recombinant Type D
_ Pasteurella multocida_
toxin (PMTr): ............................ ≥
_ _
1 MED
63
(**)
(*)
_Bordetella bronchiseptica _
Cell Count in log
10
.
(**) Murine Effective Dose 63: vaccination of mice with 0.2 ml of a
5-fold diluted vaccine by
subcutaneous route induces seroconversion in at least 63 % of the
animals.
ADJUVANTS:
Aluminium hydroxide gel
..........................................................................
6.4 mg (aluminium)
DEAE-Dextran
Ginseng
EXCIPIENT:
Formaldehyde
..................................................................................................................
0.8 mg
White homogeneous suspension.
4.
INDICATION(S)
For passive protection of piglets via colostrum after active
immunisation of sows and gilts to reduce
the clinical signs and lesions of progressive and non-progressive
atrophic rhinitis, as well as to reduce
weight loss associated with
_Bordetella bronchiseptica_
and
_Pasteurella multocida_
infections during the
fattening period.
Challenge studies have demonstrated that passive immunity lasts until
piglets are 6 weeks of age
while in clinical field trials, the beneficial effects of vaccination
(reduction in nasal lesion score and
weight loss) are observed until slaughter.
5.
CONTRAINDICATIONS
19
Do not use in case of hypersensitivity to the active substances, to
the adju

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
RHINISENG suspension for injection for pigs.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 2 ml contains:
ACTIVE SUBSTANCES:
Inactivated
_Bordetella bronchiseptica, _
strain 833CER: ........................................9.8 BbCC(*)
Recombinant Type D
_ Pasteurella multocida_
toxin (PMTr): ............................ ≥
_ _
1 MED
63
(**)
(*)
_Bordetella bronchiseptica _
Cell Count in log
10
.
(**) Murine Effective Dose 63: vaccination of mice with 0.2 ml of a
5-fold diluted vaccine by
subcutaneous route induces seroconversion in at least 63% of the
animals.
ADJUVANTS:
Aluminium hydroxide gel
..........................................................................
6.4 mg (aluminium)
DEAE-Dextran
Ginseng
EXCIPIENT:
Formaldehyde
..................................................................................................................
0.8 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
White homogeneous suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs (sows and gilts).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the passive protection of piglets via colostrum after active
immunisation of sows and gilts to
reduce the clinical signs and lesions of progressive and
non-progressive atrophic rhinitis, as well as to
reduce weight loss associated with
_Bordetella bronchiseptica_
and
_Pasteurella multocida_
infections
during the fattening period.
Challenge studies have demonstrated that passive immunity lasts until
piglets are 6 weeks of age
while in clinical field trials, the beneficial effects of vaccination
(reduction in nasal lesion score and
weight loss) are observed until slaughter.
4.3
CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substances, to
the adjuvants or to any of the
excipients.
3
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in a