TRIVACTON 6
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
27-04-2024
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
INACTIVATED BOVINE CORONAVIRUS STRAIN F15, INACTIVATED BOVINE ROTAVIRUS STRAIN RO1, INACTIVATED E.COLI K99 STRAIN SEROTYPE O101, INACTIVATED E.COLI Y STRAIN SEROTYPE O117, INACTIVATED E.COLI F41 STRAIN SEROTYPE O101, E.COLI 31A ANTIGEN
Available from:
Merial Animal Health Limited
ATC code:
QI02AL01
INN (International Name):
INACTIVATED BOVINE CORONAVIRUS STRAIN F15, INACTIVATED BOVINE ROTAVIRUS STRAIN RO1, INACTIVATED E.COLI K99 STRAIN SEROTYPE O101,
Dosage:
Unknown
Pharmaceutical form:
Suspension for Injection
Prescription type:
LM-Licensed Merchant
Therapeutic group:
Bovine
Therapeutic area:
Inactivated Bovine rotavirus vaccine + inactivated Bovine coronavirus vaccine + inactivated Escheri
Therapeutic indications:
Immunological - Inactivated vaccine
Authorization status:
Authorised
Authorization date:
2003-08-06
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
(S.I. NO. 786 OF 2007)
VPA: 10857/032/001
Case No: 7004880
The Irish Medicines Board in exercise of the powers conferred on it by Animal Remedies (No. 2) Regulations (S.I. No. 786 of 2007) hereby
grants to:
MERIAL ANIMAL HEALTH LIMITED
SANDRINGHAM HOUSE, SANDRINGHAM AVENUE, HARLOW BUSINESS PARK, HARLOW, ESSEX CM19 5TG, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations and the general conditions of the attached authorisation, in respect of the
Veterinary Medicinal Product:
TRIVACTON 6
The particulars of which are set out in Part 1 and Part 2 of the said Schedule. The authorisation is also subject to any special conditions as may
be specified in the said Schedule.
The authorisation,unless revoked, shall continue in force from 30/01/2009.
Signed on behalf of the Irish Medicines Board
________________
A person authorised in that behalf by the said Board.
(NOTE: This authorisation replaces any previous authorisation in respect of this product which is now null and void.)
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 31/01/2009_
_CRN 7004880_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
TRIVACTON 6.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
* 1SA.U = q.s. to obtain to obtain a seroagglutinating antibody titre of 1 log
10
in mice after one administration of
vaccine.
** 1SN.U = q.s. to obtain a seroneutralising antibody titre of 1 log
10
in guinea-pigs after two administrations of
vaccine.
For a full list of excipients, see section 6.1
Each 5 ml of vaccine contains:
Active substance(s):
Inactivated E. coli (ant
Read the complete document
