TETRAVET FLEXI-DOSE OXYTETRACYCLINE PVP INJECTION

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

oxytetracycline as HCl(92.7mg/mL)

Available from:

PHARM TECH

INN (International Name):

oxytetracycline as HCl(92.7mg/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Units in package:

100mL,250mL

Class:

Veterinary Medicine

Manufactured by:

BAYER AUSTRALIA

Therapeutic group:

CAT | CATTLE | DOG | HORSE | PIGS | SHEEP | BEEF | BITCH | BOAR | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK |

Therapeutic area:

antibiotic

Therapeutic indications:

ORGANISMS SENSITIVE TO OXYTETRACYCLINE | ENTERIC BACTERIAL INFECTION | RESPIRATORY INFECTION

Product summary:

For the treatment of organisms sensitive to oxytetracycline in horses, cattle, sheep, pigs, dogs and cats.This product may cause anaphylaxis in young cattle. See also CONTRA-INDICATIONS & WARNINGS sections on label.

Authorization status:

Registered but not available

Authorization date:

2002-08-26

Patient Information leaflet

Pharm Tech Pty Limited -
Draft
Label -
Version Controlled
_TETRA_
_VET_
_FLEX/-DOSE OXYTETRACYCLINE PVP_
_INJECTION_
Printed on
8/13/2002
2:02 PM
Page 1
of?
Vial
Label
PRESCRIPTION ANIMAL RE
KEEP OUT OF REACH OF CHI
FOR ANIMAL TREATMENT
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TETRA
VET FLEXI-DOSE
OXYTETRACYCLINE PVP INJECTION
100 mglrnL Oxytetracycline Hydrochloride (equivalent to 92.7 mg/mL
Oxytetracyline,
free base)
For treatment
of
organisms sensitive to Oxytetracycline in horses,
cattle,
sheep,
pigs,
dogs,&c~s.
;~
100 mL [250 ml.,
500 mL
1
DIRECTIONS
FOR
USE:
READ THE ATTACHED LEAFLET BEFORE USING THIS PRODtJCT.
This product containing PVP (Povidone) may cause anaphylaxis in
youngjcattle.
Antihistamine or adrenaline treatment
may be a suitable antidote.
WITHHOLDING
PERIOD:
.
.
MEAT:
CATTLE:
DO NOT USE LESS
THAN
14
DAYS
BEFORE
SLAUGHTER FOR
HUMAN
CONSUMPTION.
MEAT:
SHEEP
&
PIGS: DO NOT USE LESS
THAN
10
DAY$ BEFORE
SLAUGHTER FOR
HUMAN
CONSUMPTION.
MILK:
MILK
COLLECTED
FROM
COWS
WITHIN
72
HOURS
FOLLOWING
TREATMENT
MUST NOT BE USED
FOR
HUMAN
CONSUMPTION
OR
PROCESSING
MEAT
WITHHOLDING
PERIOD HORSES:
28
DAYS
Pharm Tech
Pty
Limited -
Draft Label -
Version Controlled
_TETRA VET_
FLEXI~DOSE
_OXYTETRACYCLINE PVP INJECTION_
Printed on
8/13/2002
2:02 PM
Page 2 o£1
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 time.
Dispose
of
empty containers by wrapping in paper and putting in garbage.
Store below 25°C (Air conditioning).
Protect from light.
Do not freeze.
Batch No:
Expiry Date:
NRA Approval No.
5bi!>~~
/01';02.
Pharm
Tech
Pty Limited
ABN 77
_084_
248
_206_
8 Apollo
Ave
West Pymble
NSW
_2073_
AUSTRALIA
ORDERS
&
PRODUCT
INFORMATION:
_0500_
886 668
www.pharmtech.com.au
Package Insert
PRESCRIPTION
ANIMAL
REMEDY
KEEP
OUT

Summary of Product characteristics

Date of Issue: June 2009
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1. IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
PRODUCT NAME
Tetravet Flexidose
OTHER NAMES
None allocated
APPEARANCE
Clear light to yellowish solution.
USE:
FOR ANIMAL TREATMENT ONLY
For treatment of infections caused by sensitive to Oxytetracycline in
horses, cattle, sheep, pigs, dogs and
cats.
SUPPLIER COMPANY DETAILS:
Bomac Pty Ltd
ADDRESS
15/36 Leighton Place
Hornsby NSW 2077
Australia
TELEPHONE NUMBER
61 (0)2 9987 4922
EMERGENCY NUMBER (FOR GENERAL INFORMATION)
For general information:
61 (0)2 9987 4922 (Business hours only)
Australian Poisons Information Centre: 13 11 26 (24 hour service)
Police, Fire Brigade or Ambulance:
000
FACSIMILE NUMBER
61 (0)2 9987 4188
2. HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE:
NON-HAZARDOUS SUBSTANCE, NON-DANGEROUS GOODS according to criteria of
NOHSC* Australia.
POISON SCHEDULE
S4.
*NOHSC = National Occupational Health and Safety Commission.
3. COMPOSITION
INGREDIENTS
Date of Issue: June 2009
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CHEMICAL NAME
CAS NO.
CONTENT (%W/V)
Oxytetracycline
79-57-2
10%
4. FIRST AID MEASURES
SWALLOWED:
Thoroughly wash mouth with water, and then give some water to drink.
Further measures should not be
necessary unless significant quantities have been ingested. If in
doubt, or if allergic to penicillin, consult
medical advice. Seek immediate medical advice or contact a Poisons
Information Centre 13 1126.
EYE:
Immediately flush out with a gentle stream of clean water for 15
minutes. Seek medical advice.
SKIN:
Wash contact areas with soap and water. Remove contaminated clothing
and laundry before re-use. If skin
contact occurs, immediately remove all contaminated clothing,
including footwear. Flush skin with running
water and soap