ALAMYCIN LA 300 OXYTETRACYCLINE INJECTABLE SOLUTION

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

OXYTETRACYCLINE AS THE DIHYDRATE

Available from:

NORBROOK LABORATORIES AUSTRALIA PTY LIMITED

INN (International Name):

oxytetracycline as dihydrate(300mg/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

OXYTETRACYCLINE AS THE DIHYDRATE ANTIBIOTIC Active 300.0 mg/ml

Units in package:

100mL; 250mL; 500mL

Class:

VM - Veterinary Medicine

Therapeutic group:

CATTLE | PIGS | SHEEP | BEEF | BOAR | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK | CALF | COW | DAIRY COW | EW

Therapeutic area:

ANTIBIOTIC & RELATED

Therapeutic indications:

ACTINOMYCES PYOGENES | ANTIBIOTICS - ORAL, PARENTERAL | ATROPHIC RHINITIS | BACTERIAL INFECTION | BACTERIAL KERATO CONJUNCTIVITIS | BORDETELLA BRONCHISEPTICA | CHLAMYDIA SPP. | ENZOOTIC ABORTION | ERYSIPELAS INFECTION | FOOTROT - DICHELOBACTER NODOSUS | INFECTIONS OF THE RESPIRATORY TRACT | INFECTIONS OF THE URINARY TRACTS | MASTITIS | MYCOPLASMA SPP. | ORGANISMS SENSITIVE TO OXYTETRACYCLINE | PASTEURELLA SPP. | PNEUMONIA | PROTOZOA | RICKETTSIAE | STAPHYLOCOCCUS SPP. | STREPTOCOCCI | ACUTE RESPIRATORY INFECTIONS | AIRSACCULITIS | AMOXYCILLIN SENSITIVE BACTERIA | ANAEROBIC BACTERIAL INFECTION | ASSOCIATED WITH VIRAL DISEASE | AVIAN MYCOPLASMAS | BACTERIAL PNEUMONIA | BRONCHISEPTICA | BRONCHITIS | CANINE COUGH SYNDROME | CLAVULANIC ACID SENSITIVE | COCCIDIOSIS | CORYZA | CRD | DERMATOSES | DIARRHOEA | ENDOMETRITIS | ENTERIC BACTERIAL INFECTION | ENTERITIS | ENZOOTIC PNEUMONIA | ESCHERICHIA COLI | EUROPEAN BROOD DISEASE | GENTAMICIN SENSITIVE | GRAM NEGATIVE ORGANISMS | GRAM POSITIVE ORGANISMS | GROUP D STREPTO

Product summary:

Poison schedule: 4; Withholding period: WHP: Cattle: Do not use less than 35 d ays before slaughter for human consumpt ion. Sheep and pigs: Do not use less th an 28 days before slaughter for human consumption. Milk: Milk collected from cows within 7 days (14 milkings) or ewe s within 8 days (16 milkings) following treatment must not be used for human c onsumption or processing. This milk sh ould not be fed to bobby calves. ESI: Cattle: DO NOT USE less than 35 days b efore slaughter for export. Sheep and P igs: DO NOT USE less than 28 days befor e slaughter for export.; Host/pest details: CATTLE: [ACTINOMYCES PYOGENES, ANTIBIOTICS - ORAL, PARENTERAL, ATROPHIC RHINITIS, BACTERIAL INFECTION, BORDETELLA BRONCHISEPTICA, CHLAMYDIA SPP., ERYSIPELAS INFECTION, INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE URINARY TRACTS, MASTITIS, MYCOPLASMA SPP., ORGANISMS SENSITIVE TO OXYTETRACYCLINE, PASTEURELLA SPP., PNEUMONIA, PROTOZOA, RICKETTSIAE, STAPHYLOCOCCUS SPP., STREPTOCOCCI]; PIGS: [ACTINOMYCES PYOGENES, ANTIBIOTICS - ORAL, PARENTERAL, BACTERIAL INFECTION, BORDETELLA BRONCHISEPTICA, CHLAMYDIA SPP., ERYSIPELAS INFECTION, INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE URINARY TRACTS, MYCOPLASMA SPP., ORGANISMS SENSITIVE TO OXYTETRACYCLINE, PASTEURELLA SPP., PROTOZOA, RICKETTSIAE, STAPHYLOCOCCUS SPP., STREPTOCOCCI]; SHEEP: [ACTINOMYCES PYOGENES, ANTIBIOTICS - ORAL, PARENTERAL, BACTERIAL INFECTION, BACTERIAL KERATO CONJUNCTIVITIS, BORDETELLA BRONCHISEPTICA, CHLAMYDIA SPP., ENZOOTIC ABORTION, ERYSIPELAS INFECTION, FOOTROT - DICHELOBACTER NODOSUS, INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE URINARY TRACTS, MYCOPLASMA SPP., ORGANISMS SENSITIVE TO OXYTETRACYCLINE, PASTEURELLA SPP., PROTOZOA, RICKETTSIAE, STAPHYLOCOCCUS SPP., STREPTOCOCCI]; Poison schedule: 4; Withholding period: ; Host/pest details: CATTLE: [ACTINOMYCES PYOGENES, ANTIBIOTICS - ORAL, PARENTERAL, ATROPHIC RHINITIS, BACTERIAL INFECTION, BORDETELLA BRONCHISEPTICA, CHLAMYDIA SPP., ERYSIPELAS INFECTION, INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE URINARY TRACTS, MASTITIS, MYCOPLASMA SPP., ORGANISMS SENSITIVE TO OXYTETRACYCLINE, PASTEURELLA SPP., PNEUMONIA, PROTOZOA, RICKETTSIAE, STAPHYLOCOCCUS SPP., STREPTOCOCCI]; PIGS: [ACTINOMYCES PYOGENES, ANTIBIOTICS - ORAL, PARENTERAL, BACTERIAL INFECTION, BORDETELLA BRONCHISEPTICA, CHLAMYDIA SPP., ERYSIPELAS INFECTION, INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE URINARY TRACTS, MYCOPLASMA SPP., ORGANISMS SENSITIVE TO OXYTETRACYCLINE, PASTEURELLA SPP., PROTOZOA, RICKETTSIAE, STAPHYLOCOCCUS SPP., STREPTOCOCCI]; SHEEP: [ACTINOMYCES PYOGENES, ANTIBIOTICS - ORAL, PARENTERAL, BACTERIAL INFECTION, BACTERIAL KERATO CONJUNCTIVITIS, BORDETELLA BRONCHISEPTICA, CHLAMYDIA SPP., ENZOOTIC ABORTION, ERYSIPELAS INFECTION, FOOTROT - DICHELOBACTER NODOSUS, INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE URINARY TRACTS, MYCOPLASMA SPP., ORGANISMS SENSITIVE TO OXYTETRACYCLINE, PASTEURELLA SPP., PROTOZOA, RICKETTSIAE, STAPHYLOCOCCUS SPP., STREPTOCOCCI]; Broad spectrum antibiotic injection for use in cattle, sheep, and pigs.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.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

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Summary of Product characteristics

PRODUCT NAME: ALAMYCIN LA 300 OXYTETRACYCLINE INJECTABLE SOLUTION
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 LA 300 OXYTETRACYCLINE INJECTABLE SOLUTION
APVMA CODE:
53087
PRODUCT USE:
Broad spectrum antibiotic injection for use 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
: Clear, dark 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 EXPOSURE:
Available data indicates that this product is not harmful. In addition
product is unlikely to
cause any