Eurican DAP lyophilisate and solvent for suspension for injection

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Attenuated canine distemper virus, strain ba5, Attenuated canine adenovirus type 2, strain dk13, Attenuated canine parvovirus, strain cgf

Διαθέσιμο από:

Merial Animal Health Limited

Φαρμακολογική κατηγορία (ATC):

QI07AD02

INN (Διεθνής Όνομα):

Attenuated canine distemper virus, strain ba5, Attenuated canine adenovirus type 2, strain dk13, Attenuated canine parvovirus, s

Δοσολογία:

.

Φαρμακοτεχνική μορφή:

Lyophilisate and solvent for suspension for injection

Τρόπος διάθεσης:

POM: Prescription Only Medicine as defined in relevant national legislation

Θεραπευτική ομάδα:

Dogs

Θεραπευτική περιοχή:

canine distemper virus + canine adenovirus + canine parvovirus

Θεραπευτικές ενδείξεις:

Immunological - Live Vaccine

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2016-07-15

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Eurican DAP lyophilisate and solvent 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
*
* CCID
50
: 50 % cell culture infective dose
SOLVENT:
Sterile water 1 ml
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
Beige to pale yellow lyophilisate and colourless solution 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)*.
Onset of immunity: 2 weeks for all strains
Duration of immunity: at least one year after the second injection of
the primary vaccination course and at least 2 years
after the first annual booster 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 and 2c either by challenge (type 2b) or
serology (type 2a and 2c)