BOVACLOX DC INTRAMAMMARY SUSPENSION
Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Súhrn charakteristických
(SPC)
02-05-2024
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Aktívna zložka:
AMPICILLIN TRIHYDRATE
Dostupné z:
Norbrook Laboratories Limited
ATC kód:
QJ51RC
INN (Medzinárodný Name):
AMPICILLIN TRIHYDRATE
Dávkovanie:
7
Forma lieku:
intramammary Suspension
Typ predpisu:
POM
Terapeutické skupiny:
Bovine
Terapeutické oblasti:
Beta-lactam antibacterials, penicillins, combinations with other antibacterials
Terapeutické indikácie:
Antibacterial
Stav Autorizácia:
Authorised
Dátum Autorizácia:
1987-10-01
Súhrn charakteristických
IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
(S.I. NO. 786 OF 2007)
VPA: 10999/003/001
Case No: 7003115
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:
NORBROOK LABORATORIES LIMITED
STATION WORKS, CAMLOUGH ROAD, CO. DOWN BT35 6JP
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:
BOVACLOX DC INTRAMAMMARY SUSPENSION
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 28/08/2008_
_CRN 7003115_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Bovaclox DC Intramammary Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 4.5 g syringe contains:
Cloxacillin (as Cloxacillin Benzathine) 500 mg and Ampicillin (as Ampicillin Trihydrate) 250 mg.
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Intramammary suspension. An off-white suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dairy cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET
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