Alamycin SA 100 Injection

Nazione: Australia

Lingua: inglese

Fonte: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Compra

Foglio illustrativo (PIL)

01-07-2013

Scheda tecnica (SPC)

01-07-2013

Principio attivo:

OXYTETRACYCLINE HYDROCHLORIDE

Commercializzato da:

NORBROOK LABORATORIES AUSTRALIA PTY LIMITED

INN (Nome Internazionale):

oxytetracycline as HCl(96mg/mL)

Forma farmaceutica:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composizione:

OXYTETRACYCLINE HYDROCHLORIDE ANTIBIOTIC Active 100.0 mg/ml

Confezione:

100 mL; 250 mL; 500 mL

Classe:

VM - Veterinary Medicine

Gruppo terapeutico:

Area terapeutica:

ANTIBIOTIC & RELATED

Indicazioni terapeutiche:

Dettagli prodotto:

Poison schedule: 4; Withholding period: WITHHOLDING PERIODS: MEAT: CATTLE: DO N OT USE less than 8 days before slaughter for human consumption. PIGS: DO NOT US E less than 9 days before slaughter for human consumption. SHEEP: DO NOT USE le ss than 9 days before slaughter for huma n consumption. MILK: Milk collected fro m cows or ewes within 96 hours (8 Milkin gs) following treatment MUST NOT BE USE D or processed for human consumption, or fed to bobby calves Export Slaughter I nterval (ESI): Cattle: DO NOT USE less than 11 days before slaughter for export . Pigs: DO NOT USE less than 15 days be fore slaughter for export. Sheep: DO NO T USE less than 9 days before slaughter for export. Before using this product, confirm the current ESI from Norbrook on 1800 665 866 or the APVMA website (www. apvma.gov.au/residues); Host/pest details: CATTLE: [ANTIBIOTICS - ORAL, PARENTERAL]; PIGS: [ANTIBIOTICS - ORAL, PARENTERAL]; SHEEP: [ANTIBIOTICS - ORAL, PARENTERAL]; Poison schedule: 4; Withholding period: WITHHOLDING PERIODS: MEAT: CATTLE: DO NOT USE less than 11 days before slaug hter for human consumption. PIGS: DO NO T USE less than 8 days before slaughter for human consumption. SHEEP: DO NOT U SE less than 15 days before slaughter f or human consumption. MILK: Milk colle cted from cows or ewes within 60 hours (5 milkings) following treatment MUST N OT BE USED for human consumption or pro cessing. This milk should not be fed to bobby calves. TRADE ADVICE: CATTL E: DO NOT USE less than 11 days before slaughter for export. PIGS: DO NOT USE less than 8 days before slaughter for e xport. SHEEP: This product does not hav e an ESI established.; Host/pest details: CATTLE: [ANTIBIOTICS - ORAL, PARENTERAL]; PIGS: [ANTIBIOTICS - ORAL, PARENTERAL]; SHEEP: [ANTIBIOTICS - ORAL, PARENTERAL]; Broad spectrum antibiotic injection for use in cattle, sheep and pigs.

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2023-07-01

Foglio illustrativo

DRAFT TEXT LABEL – ALAMYCIN 10 Injection
IMMEDIATE CONTAINER: MAIN PANEL
Text appearing above and below the header and footer lines is not
included in the label.
11 May 2010
Page 1 of 4
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
ALAMYCIN 10 INJECTION
96 mg/mL Oxytetracycline (as the hydrochloride)
Broad spectrum antibiotic injection for use in cattle, sheep and pigs
100 ML [250 ML]
[Norbrook Logo]

RLP
APPROVED

Info

PEST

Verified

DRAFT TEXT LABEL – ALAMYCIN 10 Injection
IMMEDIATE CONTAINER: ANCILLARY PANEL
Text appearing above and below the header and footer lines is not
included in the label.
11 May 2010
Page 2 of 4
DIRECTIONS FOR USE
DOSAGE AND ADMINISTRATION
When kept at recommended storage temperatures, the product remains
stable for 14 days
after first broaching of the container.
Intramuscular or slow intravenous injection.
If volume to be given is greater than 20 mL it should be divided and
injected into two sites.
CATTLE: 4 mg/kg (2 mL per 50 kg bodyweight) daily for 3-5 days.
SHEEP, PIGS: 4-9 mg/kg (2-4.5 mL per 50 kg bodyweight) daily
for 3-5 days.
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.
WITHHOLDING PERIODS:
MEAT: DO NOT USE LESS THAN 15 DAYS BEFORE SLAUGHTER FOR HUMAN
CONSUMPTION.
MILK: MILK COLLECTED FROM COWS OR EWES WITHIN 60 HOURS (5 MILKINGS)
FOLLOWING
TREATMENT MUST NOT BE USED FOR HUMAN CONSUMPTION OR PROCESSING. THIS
MILK
SHOULD NOT BE FED TO BOBBY CALVES.
TRADE ADVICE:
EXPORT SLAUGHTER INTERVAL (ESI): THIS PRODUCT DOES NOT HAVE AN ESI
ESTABLISHED. FOR ADVICE ON THE ESI, CONTACT THE MANUFACTURER ON 1800
665 866 BEFORE
USING THIS PRODUCT.
FIRST AID
If poisoning occurs, contact a doctor or Poisons Information Centre.
_Phone Australia 131 _
_126._
Manufactured by: Norbrook Laboratories Ltd, UK
Di

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Scheda tecnica

PRODUCT NAME: ALAMYCIN 10 INJECTION
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:
Water solution of antibiotic.

TRADE NAME:
ALAMYCIN 10 INJECTION
APVMA CODE: 51973
PRODUCT USE:
For the treatment of infections due to oxytetracycline susceptible
organisms in cattle,
sheep and pigs.

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: S36, S24/25. Wear suitable protective clothing.
Avoid contact with skin and eyes.
SUSDP CLASSIFICATION: S4
ADG CLASSIFICATION: None allocated. Not a Dangerous Good under the
ADG Code.
UN NUMBER: None allocated
EMERGENCY OVERVIEW
PHYSICAL DESCRIPTION & COLOUR: Amber coloured liquid.
ODOUR: No 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 also 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 EXPOSUR

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