Procyon Dog Pi/CvL Lyophilisate and Solvent for Suspension for Injection for Dogs
Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Summary of Product characteristics
(SPC)
04-02-2011
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Active ingredient:
Canine parainfluenza virus, Feline coronavirus, Leptospira canicola, Leptospira icterohaemorrhagiae
Available from:
Intervet UK Ltd
ATC code:
QI07AJ12
INN (International Name):
Canine parainfluenza virus, Feline coronavirus, Leptospira canicola, Leptospira icterohaemorrhagiae
Authorization status:
Expired
Summary of Product characteristics
Revised: February 2011
AN: 01799/2009
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Quantum Dog Pi/CvL
CMS except:
Procyon Dog Pi/CvL
Ireland; UK
Procyon Pi/CvL vet
Norway
Quantum Perro Pi/CvL
Spain
Quantum Cão Pi/CvL
Portugal
Quantum Pi/CvL für Hunde Austria; Germany
Lyophilisate and solvent for suspension for injection for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
i.
Pi – freeze dried fraction
ACTIVE SUBSTANCE (LIVE ATTENUATED)
Quantity per dose
(log
10
TCID
50
1
)
Canine parainfluenza virus (Philips Roxane
strain)
4.8 – 6.1
ii.
CvL – liquid diluent fraction
ACTIVE SUBSTANCES (INACTIVATED)
Quantity per 1 ml dose
Feline coronavirus (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
Page 1 of 5
Revised: February 2011
AN: 01799/2009
4.2INDICATIONS 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 _Leptospira_
_interrogans_ serovars _canicola _and _icterohaemorrhagiae_;
to reduce viral shedding of canine parainfluenza virus
to reduce intestinal infection caused by canine coronavirus
Immunity has been demonstrated from:
3 weeks after the primary vaccination course for parainfluenza (serological
response on
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