Duramune pi + lc
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
15-05-2024
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Active ingredient:
canine parainfluenza virus, strain fdl leptospira interrogans bacteria: serogroup canicola, serovar canicola canine coronavirus strain tn449 leptospira icterohaemorrhagiae serovar icterohaemorrhagiae (strain 117)
Available from:
Zoetis Ireland Limited
ATC code:
QI07AJ12
Dosage:
Unknown
Pharmaceutical form:
Lyophilisate and solvent for suspension for injection
Therapeutic group:
Canine
Therapeutic area:
Immunological - Live Vaccine
Authorization status:
Authorised
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Duramune Pi + LC
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
Lyophilisate: Cream-yellow colour powder
Solvent: Opaque White liquid
Reconstituted vaccine: orange or yellowish colour with light opalescence.
QUALITIVE COMPOSITION:
Combined canine parainfluenza virus vaccine (live), lyophilisate, canine leptospirosis vaccine
(inactivated) and canine coronavirus vaccine (inactivated).
QUANTITATIVE COMPOSITION:
1. LYOPHILISATE FRACTION:
ACTIVE SUBSTANCES
PER 1ML DOSE
canine Parainfluenza virus, Strain FDL
10
5.1
to 10
7.4
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)
0.01ml
Neocryl
0.03ml
Excipients
For a full list of excipients, see section 6.1
* hamster 80% protective dose according to Ph. Eur.
** RP = Relative Potency
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 20/01/2014_
_CRN 7014038_
_page number: 1_
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of dogs to reduce clinical signs due to infection with canine parainfluenza virus and reduce
shedding of canine parainfluenza virus; to prevent mortality and reduce clinical signs due to _Leptospi
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