COOPERS ENGEMYCIN 100 OXYTETRACYCLINE HYDROCHLORIDE 100MG/ML INJECTION

Land: Australia

Språk: engelsk

Kilde: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Preparatomtale Preparatomtale (SPC)
19-06-2017

Aktiv ingrediens:

OXYTETRACYCLINE HYDROCHLORIDE

Tilgjengelig fra:

INTERVET AUSTRALIA PTY LIMITED

INN (International Name):

oxytetracycline as HCl(100mg/mL)

Legemiddelform:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Sammensetning:

OXYTETRACYCLINE HYDROCHLORIDE ANTIBIOTIC Active 100.0 mg/ml

Enheter i pakken:

100mL; 250mL

Klasse:

VM - Veterinary Medicine

Produsert av:

INTERVET AUSTRALIA

Terapeutisk gruppe:

CALF | CAT | CATTLE | DOG | HORSE | LAMB | PIG - PIGLET | PIGS | SHEEP | BEEF | BEEF CALF | BITCH | BOAR | BOS INDICUS | BOS TAU

Terapeutisk område:

ANTIBIOTIC & RELATED

Indikasjoner:

BACTERIA

Produkt oppsummering:

Poison schedule: 4; Withholding period: MEAT (CATTLE AND CALVES): DO NOT USE les s than 14 days before slaughter for huma n consumption. MEAT (SHEEP AND PIGS): D O NOT USE less than 10 days before slaug hter for human consumption. MEAT WHP (H ORSES): DO NOT USE less than 28 days bef ore slaughter for human consumption. MI LK: Milk collected from animals within 7 2 hours (6 milkings) following treatment MUST NOT BE USED for human consumption or processing or fed to bobby calves. TRADE ADVICE: (ESI): This product does not have an ESI established. For advice on the ESI, contact the manufacturer on 1800 225 511 before using this product.; Host/pest details: CALF: [BACTERIA]; CAT: [BACTERIA]; CATTLE: [BACTERIA]; DOG: [BACTERIA]; HORSE: [BACTERIA]; LAMB: [BACTERIA]; PIG - PIGLET: [BACTERIA]; PIGS: [BACTERIA]; SHEEP: [BACTERIA]; Poison schedule: 4; Withholding period: WHP: MEAT (CATTLE AND CALVES): DO NOT USE less than 14 days before slaughter for human consumption. MEAT (SHEEP AND PIGS): DO NOT USE less than 10 days be fore slaughter for human consumption. MEAT WHP (HORSES): DO NOT USE less than 28 days before slaughter for human con sumption. MILK: Milk collected from ani mals within 72 hours (6 milkings) follo wing treatment MUST NOT BE USED for hum an consumption or processing or fed to bobby calves. TRADE ADVICE: (ESI): T his product does not have an ESI establ ished. For advice on the ESI, contact t he manufacturer on 1800 225 511 before using this product.; Host/pest details: CALF: [BACTERIA]; CAT: [BACTERIA]; CATTLE: [BACTERIA]; DOG: [BACTERIA]; HORSE: [BACTERIA]; LAMB: [BACTERIA]; PIG - PIGLET: [BACTERIA]; PIGS: [BACTERIA]; SHEEP: [BACTERIA]; Poison schedule: 4; Withholding period: ; Host/pest details: CALF: [BACTERIA]; CAT: [BACTERIA]; CATTLE: [BACTERIA]; DOG: [BACTERIA]; HORSE: [BACTERIA]; LAMB: [BACTERIA]; PIG - PIGLET: [BACTERIA]; PIGS: [BACTERIA]; SHEEP: [BACTERIA]; For the treatment of organisms sensitive to oxytetracycline in horses, cattle, sheep, pigs, dogs and cats.Milk from treated animals should not be fed to bobby calves. See Restraints & PRECAUTIONS on product leaflet also.

Autorisasjon status:

Registered

Autorisasjon dato:

2023-07-01

Informasjon til brukeren

                                REGISTERED PRODUCT NAME:
ENGEMYCIN 100 OXYTETRACYCLINE
HYDROCHLORIDE 100MG/ML INJECTION
PAGE 1 OF 10
PACK SIZES: 100 ML, 250 ML
DATE (VERSION CONTROL):21/01/2011 V5
DESCRIPTION: CARTON
APVMA: 37256/51450
PANEL LABELS, TEXT ABOVE THE HEADER AND BELOW THE FOOTER ARE NOT
INCLUDED IN THIS LABEL TEXT.
_MAIN PANEL _
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
COOPERS
®
ENGEMYCIN
® 100
OXYTETRACYCLINE HYDROCHLORIDE 100 MG/ML INJECTION
ACTIVE INGREDIENTS:
OXYTETRACYCLINE (as the hydrochloride) 100 mg/mL
For treatment of organisms sensitive to oxytetracycline in horses,
cattle, sheep, pigs,
dogs and cats.
100mL/250mL
[Coopers logo] RLP APPROVED
Info
PEST

Verified
REGISTERED PRODUCT NAME:
ENGEMYCIN 100 OXYTETRACYCLINE
HYDROCHLORIDE 100MG/ML INJECTION
PAGE 2 OF 10
PACK SIZES: 100 ML, 250 ML
DATE (VERSION CONTROL):21/01/2011 V5
DESCRIPTION: CARTON
APVMA: 37256/51450
PANEL LABELS, TEXT ABOVE THE HEADER AND BELOW THE FOOTER ARE NOT
INCLUDED IN THIS LABEL TEXT.
_ _
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT.
DIRECTIONS FOR USE:
RESTRAINTS:
DO NOT EXCEED 25ML INJECTION SITE VOLUME.
DOSAGE & ADMINISTRATION:
USE ALL PRODUCT WITHIN 4 WEEKS OF OPENING.
For long acting mode of action: INJECTIONS SHOULD BE GIVEN IN THE NECK
REGION.
Use of this product may cause anaphylaxis in cattle. Prompt treatment
with
adrenaline or antihistamine is indicated.
ANY VARIATION BY THE PRESCRIBING VETERINARIAN TO THE APPROVED DOSE,
FREQUENCY,
DURATION, ROUTE, DISEASE OR TARGET SPECIES MAY RESULT IN THE NEED TO
EXTEND THE
APPROVED WITHHOLDING PERIOD.
24 HOURS DOSAGE REGIMEN - give once daily by injection by the route
recommended for the species as per the dosing table on the product
leaflet.
LONG ACTING DOSAGE REGIMEN (cattle, sheep and pigs only) – give by
intramuscular injection in the neck only, repeat after 2 days, if
required.
WITHHOLDING PERIOD:
MEAT (CATTLE AND CALVES): DO NOT USE LESS THAN 14 DAYS BEFORE
SLAUGHTER FOR HUMAN CONSUMPTION.
MEAT (SHEEP AND PIGS): DO NOT USE LESS THAN 10 DAYS BEFOR
                                
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Preparatomtale

                                PRODUCT NAME: ENGEMYCIN 100 OXYTETRACYCLINE HYDROCHLORIDE
100MG/ML INJECTION
MATERIAL SAFETY DATA SHEET
THIS REVISION ISSUED: JULY, 2014
PAGE: 1 OF 6
MATERIAL SAFETY DATA SHEET
Issued by: Intervet Australia Pty Limited (known as MSD Animal Health)
Phone: 1 800 033 461 (Business Hours)
Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800
764 766 in New Zealand)
SUBSTANCE:
Oxytetracycline Hydrochloride Sterile Injection.
TRADE NAME:
ENGEMYCIN 100 OXYTETRACYCLINE HYDROCHLORIDE 100MG/ML INJECTION
RECOMMENDED USE:
Broad spectrum antibiotic injection for use in horses, cattle, sheep,
pigs, dogs and cats.
APVMA NO:
37256
THIS VERSION ISSUED:
Is valid for 5 years from this date.
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:
S25, S45. Avoid contact with eyes. In case of accident or if you feel
unwell, contact a doctor or
Poisons Information Centre immediately (show the label where
possible).
SUSDP CLASSIFICATION:
S4
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
PHYSICAL DESCRIPTION & COLOUR:
Clear yellow solution.
ODOUR:
No odour.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product. A
significant ingredient is an
antibiotic. 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 an antibiotic preparation, and has mild acute effects.
However, if taken in large quantities, or under non medical
supervision, may cause adverse health effects. Unlikely to cause
problems in normal use.
INHALATION:
SHORT TERM EXPOSURE:
Available data indicates that this product is not harmful. In addition
product is unlikely to
cause any discomfort or irritation.
LONG TERM EXPOSURE:
No data for health effects associated with long term
                                
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