BOVISEAL PLUS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
03-05-2024
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Active ingredient:
CLOXACILLIN BISMUTH SUBNITRATE
Available from:
Cross Vetpharm Group Ltd.
ATC code:
QJ51CF02
Dosage:
600 Milligram
Pharmaceutical form:
Intramammary suspension and intramammary ointment
Therapeutic group:
Antibacterial
Therapeutic area:
Bovine
Authorization date:
2004-11-19
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Boviseal Plus
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Boviseal Plus 1:
Intramammary Suspension
ACTIVE SUBSTANCE
MG PER 3.6 G UNIT DOSE
Cloxacillin
600
(as Cloxacillin benzathine)
Boviseal Plus 2:
Intramammary Ointment
ACTIVE SUBSTANCES
PER 4 G UNIT DOSE
Bismuth subnitrate
2.6 g
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Boviseal Plus 1: Intramammary suspension.
White to off-white suspension
Boviseal Plus 2: Intramammary ointment.
Greyish-white ointment
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cows
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For routine use in cows at drying off, to treat existing infection of the udder caused by organisms sensitive to
Cloxacillin and to assist in preventing further infection during the dry cow period. This results in a reduction in the
incidence of subclinical mastitis in cows at calving and of clinical mastitis in the dry period and the subsequent
lactation (for at least 60 day after calving).
4.3 CONTRAINDICATIONS
Do not use in the lactating cow.
Do not use within 28 days of the expected calving date.
Do not use within 3 days of the administration of any other intramammary preparations.
Do not use in known cases of hypersensitivity to the active ingredients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Not applicable.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 22/11/2011_
_CRN 7011483_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Care should be taken to avoid the contamination of the injector nozzle when the cap has been removed.
Therapy should be based on local (regional, farm level) epidemiolog
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