CLOXASEAL 600

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

CLOXACILLIN AS THE BENZATHINE SALT; BISMUTH SUBNITRATE

Available from:

NORBROOK LABORATORIES AUSTRALIA PTY LIMITED

INN (International Name):

cloxacillin as benzathine(600mg/Sg)+bismuth subnitrate(2.6g/Sg)

Pharmaceutical form:

MISC. INTRA MAMMARY

Composition:

CLOXACILLIN AS THE BENZATHINE SALT ANTIBIOTIC Active 600.0 mg; BISMUTH SUBNITRATE MINERAL-BISMUTH Active 2.6 g

Units in package:

100x9.4g; 200x9.4g; 20x9.4g

Class:

VM - Veterinary Medicine

Therapeutic area:

ANTIBIOTIC & RELATED

Product summary:

Poison schedule: 4; Withholding period: MEAT: DO NOT USE less than 30 days befor e slaughter for human consumption. MILK : DO NOT USE in lactating cows or within 35 days of calving. After calving colos trum or milk from treated dry cows MUST NOT BE USED for human consumption or pro cessing for 96 hours (8 milkings). If pr emature or unscheduled calving occurs co nsult the prescribing veterinarian for advice on handling milk for bobby calve s.; Host/pest details: COW (TEAT/UDDER): [ARCANOBACTERIUM SPP., MASTITIS, STREPTOCOCCI, STREPTOCOCCUS DYSGALACTIAE]; Poison schedule: 4; Withholding period: MEAT: DO NOT USE less than 30 days be fore slaughter for human consumption. MILK: DO NOT USE in lactating cows or within 35 days of calving. After ca lving colostrum or milk from treated dry cows MUST NOT BE USED for human co nsumption or processing for 96 hours ( 8 milkings). If premature or unschedul ed calving occurs consult the prescri bing veterinarian for advice on handli ng milk for bobby calves.; Host/pest details: COW (TEAT/UDDER): [ARCANOBACTERIUM SPP., MASTITIS, STREPTOCOCCI, STREPTOCOCCUS DYSGALACTIAE]; Poison schedule: 4; Withholding period: ; Host/pest details: COW (TEAT/UDDER): [ARCANOBACTERIUM SPP., MASTITIS, STREPTOCOCCI, STREPTOCOCCUS DYSGALACTIAE]; For the control of mastitis caused by organisms sensitive to cloxacillin in dairy cows at drying off.DO NOT USE in lactating cows or within 35 days of calving. Contraindicated for use in cows that are allergic to penicillin

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

For Official Use Only
E-LABEL APPLICATION (DRAFT)
COMPANY NAME:
NORBROOK LABORATORIES AUSTRALIA PTY LIMITED
PRODUCT NAME:
CLOXASEAL 600
ELABEL APPLICATION NO:
DC10-8332696E14
APVMA APPROVAL NO:
80397/100774
VERSION NO:
6.0
APPLICATION STARTED:
2014-Sep-19 10:07:33
VERSION CREATED:
2015-Nov-27 13:53:19
STARTED BY:
Mohanraj Vj
PRINTED:
2015-Nov-27 13:59:25
LABEL NAME:
CloxaSeal 600
SIGNAL HEADINGS:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
CONSTITUENT
STATEMENTS:
Each 9.4 g injector contains: 600 mg CLOXACILLIN (as benzathine salt)
and 2.6g Bismuth
subnitrate
CLAIMS:
For the control of mastitis caused by organisms sensitive to
cloxacillin in dairy cows at
drying off
NET CONTENTS:
9.4 g NET
DIRECTIONS FOR USE:
CloxaSeal 600 is a stable product prepared under sterile conditions,
consisting of a
common injector applicator containing 2 existing products: ELACLOX DCX
DRY COW
INTRAMAMMARY SUSPENSION (the intramammary suspension of Cloxacillin
benzathine)
and SURESEAL (the intramammary teat sealant which contains bismuth
subnitrate).
Each single dose 9.4 g injector contains 1 dose of each of two
products: 600 mg
CLOXACILLIN (as the benzathine salt) in a long-acting base with 3%
aluminium stearate in
the front half near the nozzle, and 2.6g of bismuth subnitrate in the
rear half of the injector.
The injector presents a convenient applicator for single use thus
minimising the risk of
introduction of new infections during administration.
Cloxacillin is a semi-synthetic penicillin derived from
6-aminopenicillinic acid with
bactericidal activity, while the seal portion prevents from new
infections by forming a
physical barrier at the entry of the teat canal.
CloxaSeal 600 is packed to be administered as a single insertion
application of two
suspension products for dry cow therapy one after another. It is
formulated for the control
of mastitis caused by organisms sensitive to Cloxacillin in dairy cows
at drying off, and for
protection against further infections during the dry period.
The