NOROCLOX 500 DRY COW INTRAMAMMARY SUSPENSION

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

CLOXACILLIN AS THE BENZATHINE SALT

Available from:

NORBROOK LABORATORIES AUSTRALIA PTY LIMITED

INN (International Name):

cloxacillin as benzathine(500mg/Sg)

Pharmaceutical form:

MISC. INTRA MAMMARY

Composition:

CLOXACILLIN AS THE BENZATHINE SALT ANTIBIOTIC Active 500.0 mg/4.5g

Units in package:

100 Syrs; 20 Syrs; 200 Syrs; 4.5g Syr

Class:

VM - Veterinary Medicine

Therapeutic group:

DAIRY CATTLE | BOVINE | BREEDERS | CALVES | DAIRY COW | GROWERS | LACTATING COW | MILKING COW

Therapeutic area:

ANTIBIOTIC & RELATED

Therapeutic indications:

MASTITIS | SUBCLINICAL MASTITIS

Product summary:

Poison schedule: 4; Withholding period: WHP: Milk: DO NOT USE in lactating cows or within 30 days of calving. After c alving colostrum or milk from treated dry cows MUST NOT BE USED for human con sumption or processing for 96 hours (8 milkings). If premature or unscheduled calving occurs consult the prescribing veterinarian for advice on handling mi lk for bobby calves. Meat: DO NOT USE l ess than 30 days before slaughter for h uman consumption.; Host/pest details: DAIRY CATTLE: [MASTITIS]; Poison schedule: 4; Withholding period: ; Host/pest details: DAIRY CATTLE: [MASTITIS]; For the treatment of subclinical mastitis caused by organisms sensitive to cloxacillin in dairy cows at drying off.DO NOT USE in lactating cows or within 30 days of calving. DO NOT USE in cows allergic to penicillin

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

APPROVED 
LABEL 

Info

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Verified

Draft Label Text:  NOROCLOX 500 Dry Cow Intramammary Suspension 
Bucket:  Main panel 
Text above the header line and below the footer line does not appear on the label 

PRESCRIPTION ANIMAL REMEDY 
KEEP OUT OF REACH OF CHILDREN 
FOR ANIMAL TREATMENT ONLY 

NOROCLOX 500 
DRY COW INTRAMAMMARY SUSPENSION 

Each 4.5 g syringe contains 500 mg CLOXACILLIN (as
benzathine salt) 

For the treatment of subclinical mastitis
caused by organisms  
sensitive to cloxacillin in dairy cows at drying off. 

CONTENTS: 100X 4.5 G SYRINGES 

APPROVED 
LABEL 
Draft Label Text:  NOROCLOX 500 Dry Cow Intramammary Suspension 
Bucket:  Main panel 
Text above the header line and below the footer line does not appear on the label 

PRESENTATION 
NOROCLOX 500 is a stable intramammary suspension prepared
under sterile conditions.  
Each single dose 4.5 g syringe contains 500 mg CLOXACILLIN (as
the benzathine salt) in a 
long-acting base with 3% aluminium stearate. 
Benzathine cloxacillin is a semi-synthetic penicillin
derived from 6-aminopenicillinic acid. 

USES 
NOROCLOX 500 is formulated for the treatment of subclinical mastitis
caused by organisms 
sensitive to cloxacillin
in dairy cows at drying off.  NOROCLOX 500 is active
against Gram 
positive organisms associated with mastitis and is effective
against _Streptococcus _
_dysgalactiae_ and
other streptococci and _Arcanobacterium pyogenes_.  As cloxacillin
is not 
destroyed by staphylococcal penicillinase, NOROCLOX 500 is active
against penicillin-
resistant staphylococci which are an important cause
of bovine mastitis.   
NOROCLOX 500 contains benzathine cloxacillin in a
long-acting aluminium stearate base. 
NOROCLOX 500 is bactericidal in action and is non-irritant in
the�

Summary of Product characteristics

PRODUCT NAME: NOROCLOX 500 DRY COW INTRAMAMMARY SUSPENSION 
PAGE: 1 OF 4 
THIS REVISION ISSUED: SEPTEMBER, 2009 
MATERIAL SAFETY DATA SHEET 
Issued by: Norbrook Laboratories Australia Pty Ltd 
Freecall: 1800 665 866
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)

SECTION 1 - IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY 
NORBROOK LABORATORIES AUSTRALIA PTY LTD 
FREECALL: 1800 665 866
UNIT 7/1 TRADE PARK DRIVE 
TULLAMARINE, VIC 3043 AUSTRALIA 

SUBSTANCE:  
Cloxacillin is  semi-synthetic penicillin derived from
6-amino-penicillanic acid.

TRADE NAME:  
NOROCLOX 500 DRY COW INTRAMAMMARY SUSPENSION 
APVMA CODE:  56978 
PRODUCT USE:  
An intramammary suspension containing cloxacillin (as the benzathine
salt) in a long 
acting base with aluminium stearate for the control of mastitis in
dairy cows.

CREATION DATE: 
SEPTEMBER, 2009 
THIS VERSION ISSUED: 
SEPTEMBER, 2009 and is valid for 5 years from this date. 
SECTION 2 - HAZARDS IDENTIFICATION 
STATEMENT OF HAZARDOUS NATURE  
This product is classified as: Not classified as hazardous
according to the criteria of SWA.  
Not a Dangerous Good according to the Australian Dangerous Goods
(ADG) Code.

RISK PHRASES: Not Hazardous - No criteria found. 
SAFETY PHRASES: Not Hazardous - No criteria found. 
SUSDP CLASSIFICATION: S4 
ADG CLASSIFICATION: None allocated. Not a Dangerous Good under the
ADG Code. 
UN NUMBER: None allocated 
EMERGENCY OVERVIEW 
PHYSICAL DESCRIPTION & COLOUR: Off-white to creamy liquid
suspension. 
ODOUR: Virtually odourless. 
MAJOR HEALTH HAZARDS: no significant risk factors have been found for
this product. This is an antibiotic preparation. 
Any person with a history of allergies to this class of
substances should avoid all contact with this product as it may 
cause sensitisation. This is a physiologically active product and
so contact should be minimised, especially if the user 
is taking a form of medi