NOROCEF STERILE POWDER FOR INJECTION

Land: Australien

Språk: engelska

Källa: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Aktiva substanser:

CEFTIOFUR AS CEFTIOFUR SODIUM

Tillgänglig från:

NORBROOK LABORATORIES AUSTRALIA PTY LIMITED

INN (International namn):

ceftiofur as Na salt(50mg/mL)

Läkemedelsform:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Sammansättning:

CEFTIOFUR AS CEFTIOFUR SODIUM ANTIBIOTIC Active 50.0 mg/ml

Enheter i paketet:

1g; 4g

Klass:

VM - Veterinary Medicine

Terapeutisk grupp:

CATTLE | DOG | HORSE | BEEF | BITCH | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK | CALF | CASTRATE | COLT | CO

Terapiområde:

ANTIBIOTIC & RELATED

Terapeutiska indikationer:

INFECTIONS OF THE RESPIRATORY TRACT | INFECTIONS OF THE URINARY TRACTS | ACUTE RESPIRATORY INFECTIONS | BRONCHISEPTICA | BRONCHITIS | ESCHERICHIA COLI | GROUP D STREPTOCOCCUS | KLEBSIELLA SPP. | PHARYNGITIS | PNEUMONIA | PROTEUS SPP. | PSEUDOMONAS AERUGINOSA | STAPHYLOCOCCUS SPP. | TONSILLITIS

Produktsammanfattning:

Poison schedule: 4; Withholding period: WHP: CATTLE: MEAT: 24 hours MILK: NI L HORSES: MEAT: 28 days; Host/pest details: CATTLE: [INFECTIONS OF THE RESPIRATORY TRACT]; DOG: [INFECTIONS OF THE URINARY TRACTS]; HORSE: [INFECTIONS OF THE RESPIRATORY TRACT]; Poison schedule: 4; Withholding period: ; Host/pest details: CATTLE: [INFECTIONS OF THE RESPIRATORY TRACT]; DOG: [INFECTIONS OF THE URINARY TRACTS]; HORSE: [INFECTIONS OF THE RESPIRATORY TRACT]; For the treatment of respiratory infections in horses and cattle and urinary tract infections in dogs.Do not use for mass medication- for individual animal treatment only. Do not use by intramammary, topical or oral route in food producing animals. Do not use for the treatment of mastitis in dairy cattle

Bemyndigande status:

Stopped

Tillstånd datum:

2020-07-01

Bipacksedel

FINAL TEXT LABEL: NOROCEF STERILE POWDER FOR INJECTION
Immediate Container Label: Main Panel for Small containers
Text appearing above the Header and below the Footer lines is not
included in the label
10
th
June 2010
Page 1 of 9
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
NOROCEF STERILE POWDER FOR
INJECTION
ACTIVE CONSTITUENT: 50mg/mL CEFTIOFUR (as
CEFTIOFUR SODIUM) when reconstituted as directed
For the treatment of respiratory infections in horses and cattle and
urinary tract
infections in dogs
1g
[Norbrook logo] RLP APPROVED
Info
PEST


Verified
FINAL TEXT LABEL: NOROCEF STERILE POWDER FOR INJECTION
Immediate Container Label: Main Panel for Small containers
Text appearing above the Header and below the Footer lines is not
included in the label
__________________________________________________________________________________
6
th
August 2010 – 63555-45944
Page
2
of
9
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
DIRECTIONS FOR USE
RESTRAINTS:
DO NOT USE FOR MASS MEDICATION – FOR INDIVIDUAL ANIMAL TREATMENT
ONLY.
DO NOT USE BY INTRAMAMMARY, TOPICAL OR ORAL ROUTE IN FOOD PRODUCING
ANIMALS.
DO NOT USE FOR TREATMENT OF MASTITIS IN DAIRY CATTLE.
DOSE RATE: 2mg/kg ceftiofur for horses (IM) and dogs (SC) and 1mg/kg
for cattle (IM)
WITHHOLDING PERIODS:
CATTLE:
MEAT: 24 HOURS
MILK: NIL
HORSES:
MEAT: 28 DAYS
Norbrook Laboratories Australia Pty Ltd
STORAGE: See carton or leaflet.
APVMA 63555/45944
Batch No.:
Expiry Date
FINAL TEXT LABEL: NOROCEF STERILE POWDER FOR INJECTION
Immediate Container Label: Main Panel for Small containers
Text appearing above the Header and below the Footer lines is not
included in the label
__________________________________________________________________________________
6
th
August 2010 – 63555-45944
Page
3
of
9
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
NOROCEF STERILE POWDER FOR
INJECTION
ACTIVE CONSTITUENT: 50mg/mL CEFTIOFUR (as
CEFTIOFUR SODIUM) when reconstituted as directed
For the treatment of

Produktens egenskaper

PRODUCT NAME: NOROCEF STERILE POWDER FOR INJECTION
PAGE: 1 OF 4
THIS REVISION ISSUED: OCTOBER, 2010
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
CHEMICAL NATURE:
Ceftiofur is an antibiotic of the cephalosporin type. Presented here
as the sodium salt
for reconstitution prior to injection.
TRADE NAME:
NOROCEF STERILE POWDER FOR INJECTION
PRODUCT CODE:
63555
PRODUCT USE:
For the treatment of horses and cattle for diseases caused by
organisms susceptible
to Ceftiofur.
CREATION DATE:
OCTOBER, 2010
THIS VERSION ISSUED:
OCTOBER, 2010
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:
S22, S24/25. Do not breathe dust. Avoid contact with skin and eyes.
SUSMP 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 tan coloured powder or cake in a glass vial.
ODOUR:
No data re odour.
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 medication, as interactions can sometimes give
unexpected and undesired results.
POTENTIAL HEALTH EFFECTS
INHALATION:
SHORT TERM EXPOS