Canixin DHPPi Lyophilisate and Solvent for Suspension for Injection for Dogs

Država: Velika Britanija

Jezik: angleščina

Source: VMD (Veterinary Medicines Directorate)

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Lastnosti izdelka Lastnosti izdelka (SPC)
07-12-2023

Aktivna sestavina:

Canine adenovirus, Canine distemper virus, Canine parainfluenza virus, Canine parvovirus

Dostopno od:

Virbac

Koda artikla:

QI07AD04

INN (mednarodno ime):

Canine adenovirus, Canine distemper virus, Canine parainfluenza virus, Canine parvovirus

Farmacevtska oblika:

Lyophilisate and solvent for suspension for injection

Tip zastaranja:

POM-V - Prescription Only Medicine – Veterinarian

Terapevtska skupina:

Dogs

Terapevtsko območje:

Live Viral Vaccine

Status dovoljenje:

Authorized

Datum dovoljenje:

2016-09-08

Lastnosti izdelka

                                Revised: December 2023
AN: 03634/2022 & 03635/2022
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
CANIXIN DHPPi lyophilisate and solvent for suspension for injection
for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 1 ml contains:
ACTIVE SUBSTANCES:
Lyophilisate
Live attenuated canine distemper virus (CDV) - Lederle
strain
10
3.0 -
10
4.9
CCID
50
*
Live attenuated canine adenovirus type 2 (CAV-2) -
Manhattan strain
10
4.0
-
10
6.0
CCID
50
*
Live attenuated canine parvovirus (CPV) - CPV780916
strain
10
5.0
-
10
6.8
CCID
50
*
Live attenuated canine parainfluenza virus (CPIV) -
Manhattan strain
10
5.0
-
10
6.9
CCID
50
*
*
Cell culture infectious dose 50%
Solvent
Water for injections
1 ml
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
Lyophilisate: White lyophilisate.
Solvent: Colourless liquid.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dog
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of dogs from 8 weeks of age to:
-
prevent mortality and clinical signs caused by canine distemper virus;
-
prevent mortality and clinical signs caused by canine adenovirus type
1;
Revised: December 2023
AN: 03634/2022 & 03635/2022
Page 2 of 6
-
prevent
clinical
signs
and
mortality
and
reduce
excretion
caused
by
canine
parvovirus in challenge studies performed with a CPV-2b strain;
-
prevent
clinical
signs
and
reduce
excretion
caused
by
canine
parvovirus
in
a
challenge study performed with a CPV-2c strain
-
reduce respiratory clinical signs and viral excretion caused by canine
parainfluenza
virus and canine adenovirus type 2;
Onset of immunity:
The onset of immunity has been demonstrated:
•
From 3 weeks after the primary vaccination for CDV, CAV2 and CPV
•
From 4 weeks after the primary vaccination for CPiV and CAV-1
Duration of immunity:
After the primary vaccination course, the duration of immunity lasts
for one year for all
components.
In the dur
                                
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