Duramune Pi

Country: United Kingdom

Bahasa: Inggeris

Sumber: VMD (Veterinary Medicines Directorate)

Bahan aktif:

Canine parainfluenza virus

Boleh didapati daripada:

Zoetis UK Limited

Kod ATC:

QI07AD08

INN (Nama Antarabangsa):

Canine parainfluenza virus

Borang farmaseutikal:

Suspension for injection

Jenis preskripsi:

POM-V - Prescription Only Medicine – Veterinarian

Kumpulan terapeutik:

Dogs

Kawasan terapeutik:

Live Viral Vaccine

Status kebenaran:

Expired

Tarikh kebenaran:

2007-02-19

Ciri produk

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