PEN-STREP 20/20 SUSPENSION FOR INJECTION

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PROCAINE PENICILLIN G, STREPTOMYCIN SULFATE, PROCAINE HYDROCHLORIDE

Available from:

Alfasan Nederland B.V

ATC code:

QJ01RA01

INN (International Name):

PROCAINE PENICILLIN G, STREPTOMYCIN SULFATE, PROCAINE HYDROCHLORIDE

Dosage:

200/200/20 Milligram

Pharmaceutical form:

Suspension for Injection

Prescription type:

POM

Therapeutic group:

Bovine

Therapeutic area:

Penicillins, combinations with other antibacterials

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

1987-10-01

Summary of Product characteristics

IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
(S.I. NO. 786 OF 2007)
VPA: 10980/009/001
Case No: 7005141
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:
ALFASAN INTERNATIONAL B.V.
KUIPERSWEG 9, 3449 JA WOERDEN, WOERDEN 3440AB, NETHERLANDS
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-STREP 20/20 SUSPENSION FOR INJECTION
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 previously revoked, shall continue in force from 30/09/2007.
Signed on behalf of the Irish Medicines Board
________________
A person authorised in that behalf by the said Board.
(NOTE: From this date of effect, this authorisation replaces any previous authorisation in respect of this product which is now null and void.)
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 25/08/2009_
_CRN 7005141_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Pen-Strep 20/20 Suspension for Injection
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
Cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Infections caused by or associated with penicillin and streptomycin susceptible organisms.
4.3 CONTRAINDICATIONS
Do not use in anim