Eurican DAP Lyophilisate and Solvent for Suspension for Injection

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: VMD (Veterinary Medicines Directorate)

Aktiivinen ainesosa:

Canine adenovirus, Canine distemper virus, Canine parvovirus

Saatavilla:

Boehringer Ingelheim Animal Health UK Ltd

ATC-koodi:

QI07AD02

INN (Kansainvälinen yleisnimi):

Canine adenovirus, Canine distemper virus, Canine parvovirus

Lääkemuoto:

Lyophilisate and solvent for suspension for injection

Prescription tyyppi:

POM-V - Prescription Only Medicine – Veterinarian

Terapeuttinen ryhmä:

Dogs

Terapeuttinen alue:

Live Viral Vaccine

Valtuutuksen tilan:

Authorized

Valtuutus päivämäärä:

2016-05-26

Valmisteyhteenveto

Revised: February 2021
AN: 00814/2020
Page 1 of 5
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 vaccine (1 ml) contains:
Lyophilisate:
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:
Sterilised water for injections 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 liquid.
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)*.
Revised: February 2021
AN: 00814/2020
Page 2 of 5
Onset of immunity: 2 weeks after the second injection of the primary
vaccination
course 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 histo