Rispoval 3 BRSV Pi3 BVD Lyophilisate and Suspension for Suspension for Injection for Cattle

Страна: Велика Британія

мова: англійська

Джерело: VMD (Veterinary Medicines Directorate)

Активний інгредієнт:

Bovine parainfluenza virus 3, Bovine respiratory syncytial virus, Bovine viral diarrhoea virus

Доступна з:

Zoetis UK Limited

Код атс:

QI02AH

ІПН (Міжнародна Ім'я):

Bovine parainfluenza virus 3, Bovine respiratory syncytial virus, Bovine viral diarrhoea virus

Фармацевтична форма:

Suspension for injection

Тип рецепту:

POM-V - Prescription Only Medicine – Veterinarian

Терапевтична група:

Cattle

Терапевтична области:

Live and Inactivated Viral Vaccine

Статус Авторизація:

Authorized

Дата Авторизація:

2005-05-03

Характеристики продукта

Revised: January 2020
AN: 01190/2019
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Rispoval 3 BRSV Pi3 BVD
Lyophilisate and suspension for suspension for injection for cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (4 ml) contains:
ACTIVE SUBSTANCE(S):
_Lyophilised fraction_
Parainfluenza 3 virus, modified live strain RLB 103
10
5.0
to 10
8.6
CCID
50
Bovine Respiratory Syncytial Virus, modified live strain 375
10
5.0
to 10
7.2
CCID
50
_Liquid fraction_
Bovine Virus Diarrhoea Virus Type 1, inactivated strains 5960
(cytopathic) and 6309
(non-cytopathic), to induce a GMT seroneutralisation titre in guinea
pigs of at least 3.0 log
2
ADJUVANT:
Alhydrogel 2%
0.8 ml (equivalent to 24.36 mg of aluminium
hydroxide)
CCID
50 =
Cell Culture Infectious Dose 50%
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and suspension for suspension for injection.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of calves from 12 weeks of age to:
-
reduce virus excretion and the clinical signs caused by bovine Pi3
virus,
-
reduce virus excretion caused by BRSV infection,
-
reduce virus excretion and the severity of the leucopenia induced by
BVDV type 1
infection.
Onset of immunity:
3 weeks after vaccination
Revised: January 2020
AN: 01190/2019
Page 2 of 5
Duration of immunity:
6 months (demonstrated by challenge studies) after vaccination
for BRSV and BVDV Type 1. Duration of immunity has not
been established for bovine Pi3 virus.
Efficacy has not been demonstrated against BVDV Type 2 strains.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Not applicable.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
In case of accidental self-injection, seek medical advice immediately
and