Procyon Dog DA2PPi/CvL Lyophilisate and Solvent for Suspension for Injection
Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Summary of Product characteristics
(SPC)
12-11-2009
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Active ingredient:
Canine adenovirus, Canine coronovirus, Canine distemper virus, Canine parainfluenza virus, Canine parvovirus, Leptospira canicola, Leptospira icterohaemorrhagiae
Available from:
Schering-Plough Ltd
ATC code:
QI07AJ10
INN (International Name):
Canine adenovirus, Canine coronovirus, Canine distemper virus, Canine parainfluenza virus, Canine parvovirus, Leptospira canicol
Authorization status:
Expired
Summary of Product characteristics
Revised 12/11/2009 – AN 02313/2008
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT:
Quantum Dog DA
2
PPi/CvL
CMS except:
Procyon Dog DA
2
PPi/CvL
UK and Ireland
Procyon DA
2
PPi/CvL vet
Finland, Norway, Sweden
Quantum Perro DA
2
PPi/CvL
Spain
Quantum Cão DA
2
PPi/CvL
Portugal
Quantum DA
2
PPi/CvL für Hunde
Germany, Austria
Lyophilisate and solvent for suspension for injection
1.
QUALITATIVE AND QUANTITATIVE COMPOSITION
i.
DA
2
PPi – freeze dried fraction
ACTIVE SUBSTANCES (LIVE ATTENUATED)
Quantity per dose
(log
10
TCID
50
1
)
Canine distemper virus (Distemperoid strain)
4.5 – 6.0
Canine adenovirus-2 (Ditchfield strain)
3.9 - 6.0
Canine parvovirus (SAH 2b strain)
5.2 – 6.0
Canine parainfluenza virus (Philips Roxane strain)
4.8 – 7.0
ii.
CvL – liquid diluent fraction
ACTIVE SUBSTANCES (INACTIVATED)
Quantity per 1 ml dose
Feline corona virus (strain FEC-SAH)
> 6.3 log
2
SN units
2
_Leptospira interrogans _serovar_ icterohaemorrhagiae_
(strain 115)_ _
> 40 Hamster PD
80
3
_Leptospira interrogans _serovar_ canicola_
(strain 117)
> 40 Hamster PD
80
3
Adjuvant
Aluminium Hydroxide
1.63 -2.21 mg
1
Tissue culture infective dose 50%
2
Serum Neutralisation value in guinea pig potency test
3
Hamster protective dose 80% (Ph. Eur.monograph)
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
1/5
Revised 12/11/2009 – AN 02313/2008
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of dogs from 6 weeks of age:
-
to prevent mortality and reduce clinical signs of disease caused by canine distemper
virus, canine parvovirus and infectious canine hepatitis
-
to prevent mortality and reduce clinical signs of disease ca
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