CANIGEN DHPPi/L
Country: France
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
24-01-2013
Summary of Product characteristics
(SPC)
24-01-2013
Active ingredient:
canine adenovirus 4 log10 CCID50, canine distemper virus 3.15 log10 CCID50, canine parainfluenza virus 5 log10 CCID50, canine parvovirus 5 log10 CCID50, leptospira interrogans serogroup canicola 8.33 8log10 bact/mL, leptospira interrogans serogroup icterohaemorragiae 8.33 8log10 bact/mL
Available from:
Virbac S.A.
ATC code:
QI07AI02
Pharmaceutical form:
Powder and solvent for suspension for injection
Therapeutic group:
live canine distemper virus + live canine adenovirus + live canine parainfluenza virus + live canine parvovirus + inactivated le
Therapeutic area:
Dogs
Authorization date:
2011-12-16
Patient Information leaflet
CANIGEN/CANIXIN DHPPI/L
– FR/V/0/0237/001/MR
The release requirements for the finished product are the following :
_FREEZE-DRIED FRACTION _
TEST
ACCEPTABILITY LIMITS
aspect
White pellet
pH
7.2 +/- 0.5
Solubility
Satisfactory
Titres
– in log
10
TCID
50
CDV
CAV-2
CPiV
CPV
≥ 4.1
≥ 5.1
≥ 5.9
≥ 5.3
Sterility
mycoplasma
extraneous agents
Sterile
Absence
absence
Residual humidity
0.1 - 3 %
_LIQUID FRACTION _
TEST
ACCEPTABILITY LIMITS
Aspect
Translucid liquid
pH
7.2 +/- 0.5
Volume
1.2 +/- 0.2
Mercurothiolate content
<6.35 µg/ml
potency
Conform to EP test described in
monograph 0447
Sterility
Sterile
Inactivation
Absence of leptopsirae
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
CANIGEN DHPPi/L (FR)
CANIXIN DHPPi/L (UK)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lyophilisate (before lyophilisation)
Canine distemper virus (CDV) - Lederle strain
10
3.15 -
10
4.9
CCID
50
*
Canine adenovirus type 2 (CAV-2) - Manhattan strain
10
4.0
-
10
6.0
CCID
50
*
Canine parvovirus (CPV) - CPV780916 strain
10
5.0
-
10
6.8
CCID
50
*
Canine parainfluenza virus (CPIV) - Manhattan strain
10
5. 0
-
10
6.9
CCID
50
*
Excipient QSF 1 dose
*
Cell culture infectious dose 50%
Suspension
Inactivated _Leptospira interrogans_ serogroup canicola serovar canicola
minimum titre not less than 8,33 10
8
bact/ml before inactivation conferring > 80% protection*
_ _
Inactivated _Leptospira interrogans_ serogroup icterohaemorrhagiae serovar icterohaemorrhagiae
minimum titre not less than 8,33 10
8
bact/ml before inactivation conferring > 80% protection*
Excipient QSF 1 dose of 1 ml
*According to Eur. pharmacopeia monograph 447, Hamster potency test
For full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Lyophilisate and suspension for suspension for injection.
Lyophilisate: White pellet
Suspension: Translucent liquid
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dog
4.2 INDICATIONS FOR USE
For active immunisation of dogs from 8 weeks of age to:
-
prevent mortality and clinical signs of canine distemper and infectious canine hepatitis caused by
canine adenovirus type 1;
-
prevent mortality and clinical signs and reduce excretion caused by canine parvovirus in a
challenge s
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