TETANUS TOXOID CONCENTRATED
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
07-05-2024
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:
TETANUS TOXOID
Available from:
Intervet Ireland Limited
ATC code:
QI02AB
Pharmaceutical form:
Suspension for Injection
Therapeutic group:
Immunological - Inactivated vaccine
Therapeutic area:
Bovine
Authorization date:
2004-05-19
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
(S.I. NO. 786 OF 2007)
VPA: 10996/151/001
Case No: 7006085
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:
TETANUS TOXOID CONCENTRATED
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 23/11/2009.
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 27/11/2009_
_CRN 7006085_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Tetanus Toxoid Concentrated
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
1 DOSE (1 ML)
Purified, concentrated tetanus toxoid
27 Lf units*
* 27 Lf units resulting in a minimum potency of 30 IU/ml when tested in guinea pigs according to Ph.Eur.
ADJUVANT:
Aluminium hydroxide
3.0 mg
EXCIPIENTS:
For a full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Suspension for injection
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horses, cattle, sheep, pigs, c
Read the complete document
