Nobivac Tricat Trio, Lyophilisate and Solvent for Suspension for Injection for Cats

国: イギリス

言語: 英語

ソース: VMD (Veterinary Medicines Directorate)

有効成分:

Feline calicivirus, Feline panleukopenia virus, Feline viral rhinotracheitis virus

から入手可能:

MSD Animal Health UK Limited

ATCコード:

QI06AD04

INN（国際名）:

Feline calicivirus, Feline panleukopenia virus, Feline viral rhinotracheitis virus

医薬品形態:

Lyophilisate and solvent for suspension for injection

処方タイプ:

POM-V - Prescription Only Medicine – Veterinarian

治療群:

Cats

治療領域:

Live Viral Vaccine

認証ステータス:

Authorized

承認日:

2007-05-01

製品の特徴

Revised: August 2020
AN: 00299/2020
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobivac Tricat Trio, Lyophilisate and Solvent for Suspension for
Injection for
Cats
* The affix ‘Novum’ is added temporarily during transitional
period between old
and new product.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per dose of 1 ml:
Lyophilisate
ACTIVE SUBSTANCES:
live attenuated feline calicivirus, strain F9:

4.6 log
10
PFU
1
;
live attenuated feline herpes virus type 1, strain G2620A:

5.2 log
10
PFU
1
;
live attenuated feline panleucopenia virus, strain MW-1:

4.3 log
10
CCID
50
2
1
PFU: Plaque-Forming Units
2
CCID
50:
Cell Culture Infective Dose 50%
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
Off-white lyophilisate
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of cats:
−
to reduce the clinical signs caused by infection with feline
calicivirus (FCV)
and feline herpes virus type 1 (FHV),
−
to prevent the clinical signs, leucopenia and virus excretion caused
by
infection with feline panleucopenia virus (FPLV).
Onset of immunity: for FCV and FHV: 4 weeks; for FPLV: 3 weeks.
Duration of immunity for FCV and FHV: 1 year, for FPLV: 3 years.
Revised: August 2020
AN: 00299/2020
Page 2 of 5
4.3
CONTRAINDICATIONS
See point 4.7
4.4
SPECIAL WARNINGS
Maternal antibodies, which may persist up to the age of 9-12 weeks,
can have a
negative influence on the efficacy of vaccination. In the presence of
maternal
antibodies, vaccination may not completely prevent the clinical signs,
leucopenia and virus excretion following an FPLV infection. In such
cases
where a relatively high level of maternally derived antibodies is
expected, the
vaccination schedule should be planned accordingly.
4.5
SPECIAL PRECAUTIONS FOR USE
(i)
Special precautions for use in animals
Only healthy animals should be vaccinated.
(ii)
Speci