Eurican DHPPi lyophilisate for suspension for injection

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Attenuated canine distemper virus, strain ba5; Attenuated canine adenovirus type 2, strain dk13; Attenuated canine parvovirus, strain cag2; Attenuated canine parainfluenza virus type 2, strain cgf 2004/75

Fáanlegur frá:

Boehringer Ingelheim Vetmedica GmbH

ATC númer:

QI07AD04

INN (Alþjóðlegt nafn):

Attenuated canine distemper virus, strain ba5; Attenuated canine adenovirus type 2, strain dk13; Attenuated canine parvovirus, strain cag2; Attenuated canine parainfluenza virus type 2, strain cgf 2004/75

Skammtar:

.

Lyfjaform:

Lyophilisate for suspension for injection

Gerð lyfseðils:

POM: Prescription Only Medicine as defined in relevant national legislation

Lækningarsvæði:

canine distemper virus + canine adenovirus + canine parvovirus + canine parainfluenza virus

Leyfisstaða:

Authorised

Leyfisdagur:

2005-10-28

Vara einkenni

Health Products Regulatory Authority
15 July 2020
CRN009VN8
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Eurican DHPPi lyophilisate for suspension for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose of lyophilisate contains:
ACTIVE SUBSTANCES
MINIMUM
MAXIMUM
Attenuated canine distemper virus, strain BA5
10
4.0
CCID
50
*
10
6.0
CCID
50
Attenuated canine adenovirus type 2, strain DK13
10
2.5
CCID
50
10
6.3
CCID
50
Attenuated canine parvovirus type 2, strain CAG2
10
4.9
CCID
50
10
7.1
CCID
50
Attenuated canine parainfluenza virus type 2, strain CGF 2004/75
10
4.7
CCID
50
10
7.1
CCID
50
(*CCID
50
: 50% cell culture infective dose)
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Beige to pale yellow lyophilisate for suspension for injection
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of dogs to:
- prevent mortality and clinical signs caused by canine distemper
virus (CDV),
- prevent mortality and clinical signs caused by infectious canine
hepatitis virus (CAV),
- reduce viral excretion during respiratory disease caused by canine
adenovirus type 2 (CAV-2),
- prevent mortality, clinical signs and viral excretion caused by
canine parvovirus (CPV)*,
- reduce viral excretion caused by canine parainfluenza virus type 2
(CPiV),
Onset of immunity: 2 weeks for all strains
Duration of immunity: at least one year after the second injection of
the primary vaccination course for all strains.
Current available challenge and serological data show that protection
for distemper virus, adenovirus and parvovirus* lasts for
2 years after primary vaccination course followed by a first annual
booster.
Any decision to adapt the vaccination schedule of this veterinary
medicinal product needs to be made on a case by case basis,
taking into account the vaccination history of the dog and the
epidemiological context. *Protection has been demonstrated
against canine parvovirus type 2a, 2b