Duramune Pi + LC

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: VMD (Veterinary Medicines Directorate)

Aktiivinen ainesosa:

Canine coronovirus, Canine parainfluenza virus, Leptospira canicola, Leptospira icterohaemorrhagiae

Saatavilla:

Zoetis UK Limited

ATC-koodi:

QI07AJ12

INN (Kansainvälinen yleisnimi):

Canine coronovirus, Canine parainfluenza virus, Leptospira canicola, Leptospira icterohaemorrhagiae

Lääkemuoto:

Suspension for injection

Prescription tyyppi:

POM-V - Prescription Only Medicine – Veterinarian

Terapeuttinen ryhmä:

Dogs

Terapeuttinen alue:

Live Viral and Inactivated Viral and Bacterial Vaccine

Valtuutuksen tilan:

Expired

Valtuutus päivämäärä:

2007-04-02

Valmisteyhteenveto

Revised: October 2015
AN. 00644/2015
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE IMMUNOLOGICAL VETERINARY MEDICINAL
PRODUCT
Duramune Pi + LC
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
QUALITATIVE 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 1 ml dose
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
Adjuvants
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.
**
RP = Relative Potency
Revised: October 2015
AN. 00644/2015
Page 2 of 6
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
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 _Leptospira interrogans_, serovars _canicola_ and
_icterohaemorrhagiae_;
and to reduce infection at the intestinal level caused by canine
coronavirus.
The onset of immunity is from two weeks after the second vaccination.
The duration of immunity is one year; after one ye