PEN V 10% INTERVET PREMIX FOR MEDICATED FEEDINGSTU
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
01-05-2024
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Active ingredient:
PHENOXYMETHYLPENICILLIN POTASSIUM
Available from:
Intervet Ireland Limited
ATC code:
QJ01CE02
Dosage:
10 %w/w
Pharmaceutical form:
Premix for Med.Feedstuffs
Therapeutic group:
Antibacterial
Therapeutic area:
Porcine
Authorization date:
1997-02-21
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
(S.I. NO. 786 OF 2007)
VPA: 10996/050/001
Case No: 7005189
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:
PEN V 10% INTERVET PREMIX FOR MEDICATED FEEDINGSTUFF
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 07/05/2009.
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 08/05/2009_
_CRN 7005189_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Pen V 10% Intervet premix for medicated feedingstuff
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance
Phenoxymethylpenicillin potassium 10% w/w in an inert base
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Premix for medicated feedingstuff
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The product is indicated for the treatment of penicillin sensitive in
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