Duramune DAPPi+LC Lyophilisate and Solvent for Suspension for Injection for Dogs

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: VMD (Veterinary Medicines Directorate)

Aktiivinen ainesosa:

Canine adenovirus, Canine coronovirus, Canine distemper virus, Canine parainfluenza virus, Canine parvovirus, Leptospira canicola, Leptospira icterohaemorrhagiae

Saatavilla:

Zoetis UK Limited

ATC-koodi:

QI07AJ10

INN (Kansainvälinen yleisnimi):

Canine adenovirus, Canine coronovirus, Canine distemper virus, Canine parainfluenza virus, Canine parvovirus, Leptospira canicola, Leptospira icterohaemorrhagiae

Lääkemuoto:

Lyophilisate for suspension for injection

Prescription tyyppi:

POM-V - Prescription Only Medicine – Veterinarian

Terapeuttinen ryhmä:

Dogs

Terapeuttinen alue:

Live Viral and Inactivated Viral and Bacterial Vaccine

Valtuutuksen tilan:

Expired

Valtuutus päivämäärä:

2002-07-11

Valmisteyhteenveto

Revised: October 2015
AN: 00643/2015
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCT
Duramune DAPPi+LC Lyophilisate and Solvent for Suspension for
Injection for
Dogs.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1. LYOPHILISATE FRACTION:
Active Substances
Per 1 ml dose
Canine distemper virus, strain Onderstepoort
10
1.1
to 10
3.4
TCID
50
*
Canine adenovirus type 2, strain V197
10
4.0
to 10
6.2
TCID
50
*
Canine parvovirus, strain SAH
10
4.7
to 10
6.5
TCID
50
*
Canine parainfluenza virus, strain FDL
10
4.5
to 10
6.8
TCID
50
*
*TCID
50
= tissue culture 50% infective dose
Excipients
For a full list of excipients, see section 6.1.
2. LIQUID SOLVENT FRACTION:
Active Substances
Per 1 ml dose
Inactivated _Leptospira interrogans _bacteria (outer membrane coat)
Serogroup _canicola_, Serovar _canicola_
Potency according to
Ph.Eur.*
Serogroup _icterohaemorrhagiae_, serovar
_icterohaemorrhagiae_
Potency according to
Ph.Eur.*
Canine coronavirus, strain TN449 (inactivated)
RP* 1.0-2.0**
Adjuvants
Ethylene/Maleic anhydride (EMA-31)
0.1 mg
Neocryl
0.015 ml
Excipients
For a full list of excipients, see section 6.1.
*
hamster 80% protective dose according to Ph.Eur.
**
RP = Relative Potency
Revised: October 2015
AN: 00643/2015
Page 2 of 7
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
Lyophilisate: Cream-yellow colour powder
Solvent: opaque liquid.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For
active
immunisation
of
dogs
to
prevent
mortality
and
disease
caused by canine distemper virus; to prevent mortality and disease and
reduce virus shedding caused by canine parvovirus infection; to
prevent
mortality and reduce clinical signs caused by infectious canine
hepatitis
and
_Leptospira _
_interrogans _
serogroups
_canicola_
and
_icterohaemorrhagiae_; and to reduce clinical signs and infection
caused
by canine adenovirus 2; to reduce clinical signs and shedding caused
by
infection with canin