DURAMUNE DAPPI + LC LYOPHILISATE AND SOLVENT FOR SUSPENSION FOR INJECTION FOR DOGS

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

CANINE DISTEMPER VIRUS, STRAIN ONDERSTEPOORT, CANINE ADENOVIRUS TYPE 2, STRAIN V197, CANINE PARAINFLUENZA VIRUS, STRAIN FDL, CANINE PARVOVIRUS SAH 2B STRAIN, LEPTOSPIRA INTERROGANS BACTERIA: SEROGROUP CANICOLA, SEROVAR CANICOLA, LEPTOSPIRA INTERROGANS BACTERIA: SEROGROUP ICTEROHAEMORRHAGIAE, SEROVAR ICTEROHAEMORRHAGIAE, CANINE CORONAVIRUS STRAIN TN449

Tilgjengelig fra:

Zoetis Ireland Limited

ATC-kode:

QI07AJ10

INN (International Name):

CANINE DISTEMPER VIRUS, STRAIN ONDERSTEPOORT, CANINE ADENOVIRUS TYPE 2, STRAIN V197, CANINE PARAINFLUENZA VIRUS, STRAIN FDL, CAN

Dosering :

Unknown

Legemiddelform:

Lyophilisate and solvent for suspension for injection

Resept typen:

POM

Terapeutisk gruppe:

Canine

Terapeutisk område:

Live Canine distemper virus vaccine + live Canine adenovirus vaccine + live parainfl.virus vaccine +

Indikasjoner:

Immunological - Mixed vaccine (live and inactivated)

Autorisasjon status:

Authorised

Autorisasjon dato:

2013-12-09

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Duramune DAPPi + LC Lyophilisate and solvent for suspension for injection for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
Lyophilisate: Cream-yellow colour powder
Solvent: opaque liquid.
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**
AJUVANTS
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.
**Relative Potency
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 30/10/2015_
_CRN 7021631_
_page number: 1_
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