Duramune Pi

País: Reino Unido

Língua: inglês

Origem: VMD (Veterinary Medicines Directorate)

Ingredientes ativos:

Canine parainfluenza virus

Disponível em:

Zoetis UK Limited

Código ATC:

QI07AD08

DCI (Denominação Comum Internacional):

Canine parainfluenza virus

Forma farmacêutica:

Suspension for injection

Tipo de prescrição:

POM-V - Prescription Only Medicine – Veterinarian

Grupo terapêutico:

Dogs

Área terapêutica:

Live Viral Vaccine

Status de autorização:

Expired

Data de autorização:

2007-02-19

Características técnicas

Revised: 01 December 2014
AN: 00723/2014
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCT
Duramune Pi
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
QUALITATIVE COMPOSITION
Combined canine parainfluenza virus vaccine (live), freeze dried.
QUANTITATIVE COMPOSITION
1. FREEZE-DRIED 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 DILUENT FRACTION:
Water for injection
1
ml
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
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.
The onset of immunity is from two weeks after the second vaccination.
The duration
of immunity is one year.
Revised: 01 December 2014
AN: 00723/2014
Page 2 of 5
4.3
CONTRAINDICATIONS
See section 4.7.
4.4
SPECIAL WARNINGS
The live vaccine strain may spread to unvaccinated animals, but does
not cause
disease.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
None.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
In the case of accidental self-injection, seek medical advice
immediately and show the
package leaflet or the label to the physician.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Following the first vaccination, it is very common for puppies to
develop a small visible
swelling (<2 cm) lasting for generally only two days. Following the
second
vaccination, it is common for a small visible swelling (up to 5 cm) to
be seen at the
injection site, which may last for up to five days. The swelling may
be painful for 1 to 2
days.
In most cases, these small and transient injection site reactions
resolve with no nee