HEPTAVAC

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CLOSTRIDIUM PERFRINGENS TYPE B STRAIN NO. 554 CLOSTRIDIUM PERFRINGENS TYPE C STRAIN NO.578 CLOSTRIDIUM PERFRINGENS TYPE D STRAIN NO. 603 CLOSTRIDIUM SEPTICUM STRAIN NO. 505 CLOSTRIDIUM TETANI STRAIN NO. S1123/91 CLOSTRIDIUM NOVYI STRAIN NO. 754 CLOSTRIDIUM CHAUVOEI STRAIN NO. 655 CLOSTRIDIUM CHAUVOEI STRAIN NO. 656 CLOSTRIDIUM CHAUVOEI STRAIN NO. 657 CLOSTRIDIUM CHAUVOEI STRAIN NO. 658 CLOSTRIDIUM CHAUVOEI STRAIN NO. 1048

Available from:

Intervet Ireland Limited

ATC code:

QI04AB01

Pharmaceutical form:

Suspension for Injection

Therapeutic group:

Immunological - Inactivated vaccine

Therapeutic area:

Ovine

Authorization date:

2003-08-27

Summary of Product characteristics

IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
(S.I. NO. 786 OF 2007)
VPA: 10996/145/001
Case No: 7005485
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:
INTERVET IRELAND LIMITED
MAGNA DRIVE, MAGNA BUSINESS PARK, DUBLIN 24, IRELAND
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:
HEPTAVAC
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 20/02/2009_
_CRN 7005485_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
HEPTAVAC
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Suspension for injection
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Sheep and pregnant sows.
Active substances:
per dose (2ml)
_Cl.perfringens _type B beta toxoid
60 - 120
TCP units
_Cl.perfringens _type C beta toxoid
60 - 120
TCP units
_Cl.perfringens _type D epsilon toxoid
160 - 320
TCP units
_Cl.septicum _toxoid
6 - 12
TCP units
_Cl.tetani _toxoid
12 - 24
TCP units
_Cl.