Randlab Oxytetracycline Injection 100 mg/mL

Šalis: Australija

kalba: anglų

Šaltinis: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Veiklioji medžiaga:

OXYTETRACYCLINE AS OXYTETRACYCLINE HYDROCHLORIDE

Prieinama:

RANDLAB AUSTRALIA PTY LTD

Vaisto forma:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Sudėtis:

OXYTETRACYCLINE AS OXYTETRACYCLINE HYDROCHLORIDE ANTIBIOTIC Active 100.0 mg/ml

Vienetai pakuotėje:

100 mL; 250 mL

Klasė:

VM - Veterinary Medicine

Gydymo sritis:

ANTIBIOTIC & RELATED

Produkto santrauka:

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 WITHHO LDING PERIOD (HORSES): DO NOT USE less t han 28 days before slaughter for human c onsumption. MILK: Milk collected from a nimals within 72 hours (6 milkings) foll owing treatment MUST NOT BE USED or pro cessed for human consumption or processi ng, or fed to bobby calves. Any varia tion by the prescribing veterinarian to the approved dose, frequency, duration r oute, disease or target species may resu lt in the need to extend the approved wi thholding period. EXPORT SLAUGHTER INTE RVAL (ESI): This product does not have a n ESI established. For advice on the ES I, contact Randlab Australia Pty Ltd on (61-2) 9728 3505 before using this produ ct.; Host/pest details: CALF: [BACTERIA]; CAT: [BACTERIA]; CATTLE: [BACTERIA]; DOG: [BACTERIA]; HORSE: [BACTERIA]; LAMB: [BACTERIA]; PIG - PIGLET: [BACTERIA]; PIGS: [BACTERIA]; SHEEP: [BACTERIA]

Autorizacija statusas:

Registered

Leidimo data:

2023-07-01

Pakuotės lapelis

Randlab Oxytetracycline Injection 100 mg/mL
90134/127718
Product Name:
APVMA Approval No:
Label Name:
Randlab Oxytetracycline Injection 100 mg/mL
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
100 mg/mL OXYTETRACYCLINE (as the hydrochloride)
Claims:
For treatment of organisms sensitive to oxytetracycline in horses,
cattle, sheep, pigs, dogs
and cats
Resistance may develop to any chemical
Net Contents:
100 mL, 250 mL
Directions for Use:
Restraints:
DO NOT exceed 25 mL injection site volume.
For long acting mode of action: Injections should be given in the neck
region.
Contraindications:
This product is contraindicated in horses during concomitant therapy
with corticosteroids.
Precautions:
Use this product with caution during the period of tooth development,
including late
pregnancy as it may lead to tooth discolouration.
Side Effects:
Use of this product may cause anaphylaxis in cattle. Prompt treatment
with adrenaline or
antihistamine is indicated.
Dosage and
Administration: RLP APPROVED
General Directions:
Withholding Periods:
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 before slaughter
for human
consumption.
MEAT WITHHOLDING PERIOD (HORSES): DO NOT USE less than 28 days before
slaughter for human consumption.
MILK: Milk collected from animals within 72 hours (6 milkings)
following treatment MUST
NOT BE USED or processed for human consumption or processing, or fed
to bobby calves.
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.
Trade Advice:
EXPORT SLAUGHTER INTERVAL (ESI): This product does not have an ESI
established.
For advice on the ESI, contact Randlab Australia Pty Ltd on (61-2)
9728 3505 before using
this product.
Safety Directions:
First Aid Instructions:
If poisoning occurs, contact a doct

Prekės savybės

Product Name: Randlab Oxytetracycline Injection 100mg/mL
Page: 1 of 5
This version issued: February, 2021
SAFETY DATA SHEET
Issued by: Randlab Australia Pty Ltd
Phone: [phone]
Section 1 - Identification of The Material and Supplier
Randlab Australia Pty Ltd
Phone: [phone]
7/85 Alfred Road
Fax: [phone]
Chipping Norton NSW 1270
AUSTRALIA
Trade Name:
Randlab Oxytetracycline Injection 100mg/mL
Chemical nature:
Injection containing Oxytetracycline hydrochloride.
Product Use:
Veterinary product. For the treatment of organisms sensitive to
oxytetracycline in horses,
cattle, sheep, pigs, dogs and cats.
This version issued:
February, 2021 and is valid for 5 years from this date.
Poisons Information Centre: Phone 13 1126 from anywhere in Australia
National Poisons Centre: Phone 0800 POISON (0800 764 766) from
anywhere in New Zealand
Section 2 - Hazards Identification
Prevention:
P102:
Keep out of reach of children.
P103:
Read label before use.
P264:
Wash contacted areas thoroughly after handling.
P270
Do not eat, drink or smoke when using this product.
P273:
Avoid release to the environment.
Response:
P101:
If medical advice is needed, have product container or label at hand.
P301 + P312
IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel
unwell.
P330:
Rinse mouth.
Disposal:
P501:
Dispose of contents and containers as specified on the registered
label.
Section 3 - Composition/Information on Ingredients
I
ngredients
CAS No
Concentration
Oxytetracycline (as hydrochloride)
2058-46-0
10.0%
Other ingredients
secret
to 100
GHS Class
GHS Category
Hazard Code
Hazard Statement
Acute toxicity: oral
Category 4
H302
Harmful if swallowed.
Aquatic toxicity (chronic)
Category 4
H401
Toxic to aquatic life.
Signal word:
Warning
GHS Pictogram:
Product Name: Randlab Oxytetracycline Injection 100mg/mL
Page: 2 of 5
This version issued: February, 2021
SAFETY DATA SHEET
Issued by: Randlab Australia Pty Ltd
Phone: [phone]
Section 4 - First Aid Measures
General Information:
If you feel that you ma