Nobivac Rabies

Țară: Noua Zeelandă

Limbă: engleză

Sursă: Ministry for Primary Industries

Ingredient activ:

rabies virus (inactivated)

Disponibil de la:

Schering-Plough Animal Health Limited

INN (nume internaţional):

rabies virus (inactivated)

Compoziție:

rabies virus (inactivated) 0 vaccine

Zonă Terapeutică:

Vaccine

Statutul autorizaţiei:

ACVM Registered

Data de autorizare:

2005-04-05

Caracteristicilor produsului

NOBIVAC RABIES
1x1 dose (1 mL) – Leaflet, Carton and Label
A009450
Page 1 of 8
NOBIVAC RABIES
02-Mar-22
Leaflet (multiple country)
PACKAGE LEAFLET FOR:
NOBIVAC
® RABIES
SUSPENSION FOR INJECTION
1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF
DIFFERENT
Marketing authorisation holder
MSD Animal Health UK Ltd.
Walton Manor, Walton
Milton Keynes
Buckinghamshire
MK7 7AJ
Manufacturer for the batch release:
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands
2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobivac Rabies Suspension for injection
3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
Each 1 ml dose contains:
ACTIVE SUBSTANCE:
Inactivated rabies virus strain Pasteur RIV: ≥ 0.95 AIU* equivalent
to 2 IU**
*
Batch control is performed with an _in vitro_ potency test according
to Ph. Eur. monograph 451.
AIU = rabies antigenic mass AlphaLISA International Units.
** Corresponding potency in the _in vivo _mouse challenge test
according to Ph. Eur. monograph
451.
ADJUVANT:
Aluminium phosphate (adjuvant):
0.60 - 0.88 mg Al
3+
EXCIPIENTS:
Thiomersal (preservative):
0.1 mg
Light yellow/orange to slightly red/purple with a whitish sediment.
4. INDICATION(S)
For the active immunisation against rabies to reduce clinical signs
and mortality.
Onset of immunity:
an adequate serological response (≥ 0.5 IU) has been demonstrated 2
to 3
weeks after vaccination.
Duration of immunity: 3 years.
NOBIVAC RABIES
1x1 dose (1 mL) – Leaflet, Carton and Label
A009450
Page 2 of 8
NOBIVAC RABIES
02-Mar-22
5. CONTRAINDICATIONS
None.
6. ADVERSE REACTIONS
Transient local reactions such as non-painful diffuse to firm
swellings of approximately 1 cm in
diameter may be observed for up to 3 weeks after subcutaneous
vaccination.
A transient acute hypersensitivity reaction - with signs that may
include, facial oedema, vomiting,
pruritus or diarrhoea - may occur shortly after vaccination in very
rare cases. Such rea