INGELVAC PRRS KV EMULSION FOR INJECTION FOR PIGS (SOWS AND GILTS)
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
PORCINE REPRODUCTIVE AND RESPIRATORY SYNDROME VIRUS INACTIVATED
Available from:
Boehringer Ingelheim Ltd
ATC code:
QI09AA05
Pharmaceutical form:
Emulsion for Injection
Therapeutic group:
Immunological - Inactivated vaccine
Therapeutic area:
Porcine
Authorization date:
2003-06-06
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
VPA: 10007/037/001
Case No: 7006775
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:
BOEHRINGER INGELHEIM LTD
ELLESFIELD AVENUE, BRACKNELL, BERKSHIRE RG12 8YS, ENGLAND
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:
INGELVAC PRRS KV EMULSION FOR INJECTION FOR PIGS (SOWS AND GILTS).
The particulars of which are set out in the attached Schedule. The authorisation is also subject to any special conditions as may be specified in
the Schedule.
The authorisation,unless revoked, shall continue in force from 11/05/2010.
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 04/09/2010_
_CRN 7006775_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Ingelvac PRRS KV emulsion for injection for pigs (sows and gilts).
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Inactivated Porcine Reproductive and Respiratory Syndrome (PRRS) virus, P120 strain:
2.5 log10 IF* Units.
*IF Units: ImmunoFluorescence antibody titre obtained after two injections in pigs under specific laboratory
conditions.
ADJUVANT:
O/w oily excipient (containing hydrogenated polyisobutene as adjuvant):
q.s. 1 dose of 2 ml.
EXCIPIENTS:
For a full lis
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