UTOZYME FOAMING PESSARIES

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Patient Information leaflet (PIL)

19-06-2017

Summary of Product characteristics (SPC)

19-06-2017

Safety Data Sheet (SDS)

05-08-1996

Active ingredient:

OXYTETRACYCLINE HYDROCHLORIDE

Available from:

JUROX PTY LIMITED

INN (International Name):

oxytetracycline as HCl(463.3mg/Ps)

Pharmaceutical form:

MISC. INTRA VAGINAL/UTERINE PREP/DEVICE

Composition:

OXYTETRACYCLINE HYDROCHLORIDE ANTIBIOTIC Active 500.0 mg/Pe

Units in package:

10 Pess; 20 Pess

Class:

VM - Veterinary Medicine

Therapeutic group:

Therapeutic area:

GENITOURINARY SYSTEM

Therapeutic indications:

Product summary:

Poison schedule: 4; Withholding period: WHP: Meat: DO NOT use later than 14 day s before slaughter for human consumptio n. Meat (Horses): DO NOT use less than 28 days before slaughter for human con sumption. Milk: Milk taken from animal s within 36 hours following a single tr eatment or 3 days following the last o f multiple treatments must not be used for human consumption or supplied for processing. TRADE ADVICE EXPORT SLAUG HTER INTERVAL (ESI): This product does not have an ESI established. For advice on the ESI contact Jurox Pty Ltd on 18 00 023 312 before using this product.; Host/pest details: CATTLE: [METRITIS, VAGINAL LOCAL REACTANT]; GOAT: [METRITIS, VAGINAL LOCAL REACTANT]; HORSE: [METRITIS, VAGINAL LOCAL REACTANT]; PIGS: [METRITIS, VAGINAL LOCAL REACTANT]; SHEEP: [METRITIS, VAGINAL LOCAL REACTANT]; Poison schedule: 4; Withholding period: ; Host/pest details: CATTLE: [METRITIS, VAGINAL LOCAL REACTANT]; GOAT: [METRITIS, VAGINAL LOCAL REACTANT]; HORSE: [METRITIS, VAGINAL LOCAL REACTANT]; PIGS: [METRITIS, VAGINAL LOCAL REACTANT]; SHEEP: [METRITIS, VAGINAL LOCAL REACTANT]; As an aid in the post-natal treatment of infections, cleaning of the uterus, retained placenta and metritis of cattle, sheep, goats, pigs and horses.Any variation by the prescribing vet to the approved dose, frequency, duration, route, disease or target species may result in the need to extend the approved withholding time.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

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PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATM ENT ONLY
UTOZYME
®
FOAMING PESSARIES
ACTIVE CONSTITUENT:
Each Pessary Contains:
500 mg OXYTETRACYCLINE
HYDROCHLORIDE
(Equivalent to 463.3 mg Oxytetracycline B.P.)
FOR INTRA-UTERINE USE
20 PESSARIES
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATM ENT ONLY
UTOZYME
®
FOAMING PESSARIES
ACTIVE CONSTITUENT:
Each Pessary Contains:
500 mg OXYTETRACYCLINE
HYDROCHLORIDE
(Equivalent to 463.3 mg Oxytetracycline B.P.)
FOR INTRA-UTERINE USE
20 PESSARIES
INDICATIONS:
As an aid in the post-natal treatment of infections, cleaning
of the uterus, retained placenta and metritis of cattle, sheep,
goats, pigs and horses.
DIRECTIONS FOR USE:
Insert 1 pessary high into the uterus followed by 200 mL of
water at body temperature by catheter.
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.
WITHHOLDING PERIODS:
MEAT: DO NOT USE LESS THAN 14 DAYS BEFORE SLAUGHTER
FOR HUMAN CONSUMPTION.
MEAT (HORSES): DO NOT USE LESS THAN 28 DAYS BEFORE
SLAUGHTER FOR HUMAN CONSUMPTION.
MILK: MILK TAKEN FROM ANIMALS WITHIN 36 HOURS FOLLOWING
A SINGLE TREATMENT, OR 3 DAYS FOLLOWING THE LAST OF
MULTIPLE TREATMENTS, MUST NOT BE USED FOR HUMAN
CONSUMPTION, OR SUPPLIED FOR PROCESSING.
TRADE ADVICE
EXPORT SLAUGHTER INTERVAL (ESI): THIS PRODUCT DOES
NOT HAVE AN ESI ESTABLISHED. FOR ADVICE ON THE ESI CONTACT
JUROX PTY LTD ON 1800 023 312 BEFORE USING THIS PRODUCT.
STORE BELOW 25° (Air Conditioning)
KEEP IN A DRY PLACE
B
EXP.
FIRST AID: If poisoning occurs, contact a
doctor or the Poisons Information Centre.
Phone Australia 131 126
DISPOSE of packaging by wrapping
in paper and putting in garbage.
® Jurox Pty Ltd Registered Trade Mark
Made in Australia
408971
APVMA Approval No. 36317/20Pes/0509
Pty Ltd
85 Gardiner Road
Rutherford NSW 2320
Infoline 1800 023 312
UTOZYME
®
FOAMING PESSARIES
376.25mm
262mm
Over

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Summary of Product characteristics

UTOZYME FOAMING PESSARIES
Page 1 of 6
continued
ISSUED:
13 AUGUST 2012
SAFETY DATA SHEET
SECTION 1: IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
PRODUCT NAME:
UTOZYME FOAMING PESSARIES
PRODUCT CODE:
503270 (20s)
RECOMMENDED USE:
Pessary for the post-natal treatment of infections, cleaning of the
uterus,
retained placenta and metritis of cattle, sheep, goats, pigs and
horses.
COMPANY IDENTIFICATION:
Jurox Pty Limited
ADDRESS:
85 Gardiner Street
Rutherford NSW 2320
Australia
CUSTOMER CENTRE:
1800 023 312
NATIONAL POISONS INFORMATION CENTRE:
131126 (Australia-wide)
EMERGENCY TELEPHONE NUMBER:
1800 023 312 (9a.m. – 5p.m.)
SECTION 2: HAZARDS IDENTIFICATION
GHS HAZARD CLASSIFICATIONS:
ACUTE TOXICITY CATEGORY 5
EYE IRRITATION CATEGORY 2B
LACTATION EFFECTS
REPRODUCTIVE TOXICITY CATEGORY 1B
SKIN CORROSION/IRRITATION CATEGORY 3
GHS PICTOGRAM:
HEALTH HAZARD
SIGNAL WORD:*
DANGER
HAZARD STATEMENTS:*
H303
May be harmful if swallowed.
H316
Causes mild skin irritation.
H320
Causes eye irritation.
H360
May damage fertility or the unborn child.
H362
May cause harm to breast-fed children.
PRECAUTIONARY STATEMENTS:*
PREVENTION
P201
Obtain special instructions before use.
P202
Do not handle until all safety precautions have been read and
understood.
P260
Do not breathe dust.
P263
Avoid contact during pregnancy/while nursing.
P264
Wash hands thoroughly after handling.
P270
Do not eat, drink or smoke when using this product.
P281
Use personal protective equipment as required.
RESPONSE
P305+P35
IF IN EYES: Rinse cautiously with water for several
+P338
minutes. Remove contact lenses, if present and easy to do.
Continue rinsing.
P308+P313
IF exposed or concerned: Get medical advice.
P312
Call a POISON CENTRE or doctor if you feel unwell.
P332+P313
If skin irritation occurs: Get medical advice.
UTOZYME FOAMING PESSARIES
Page 2 of 6
continued
P337+P313
If eye irritation persists: Get medical advice.
STORAGE
P405
Store locked up.
DISPOSAL
P501
Dispose of contents/container in accordance with local/national
regulations.
* N.B.: These stat

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Safety Data Sheet

WWW.JUROX.COM.AU
Customer Service 1800 023 312
® Registered Trademark of Jurox Pty Limited
TECHNICAL NOTES
ACTIVE CONSTITUENTS
Oxytetracycline hydrdochloride (500 mg)
(Equivalent to 463.3 mg Oxytetracycline)
INDICATIONS
An aid in the post-natal treatment of infections, cleaning of the
uterus, retained placenta and metritis of cattle, sheep, goats, pigs
and horses.
WITHHOLDING PERIODS
MEAT: (Cattle, sheep, goats, pigs) DO NOT USE less than 14 days before
slaughter for human consumption. (Horses) DO NOT USE less
than 28 days before slaughter for human consumption.
MILK: Milk taken from animals within 36 hours following a single
treatment or 3 days following the last of multiple treatments, MUST
NOT BE USED for human consumption, or supplied for processing.
TRADE ADVICE
EXPORT SLAUGHTER INTERVAL (ESI):
This product does not have an ESI established. For advice on the ESI
contact Jurox Pty Limited on 1800 023 312 before using this
product.
DOSAGE AND ADMINISTRATION
Insert 1 pessary high into the uterus followed by 200 mL of water at
body temperature by catheter.
STORAGE
Store below 25°C (air conditioning). Keep in a dry place.
UTOZYME
Foaming Pessaries
WWW.JUROX.COM.AU
Customer Service 1800 023 312
® Registered Trademark of Jurox Pty Limited
TECHNICAL NOTES
POISONS SCHEDULE
S4.
REGISTRATION NUMBERS
APVMA No. 36317
AU - Tech Note - Utozyme® / Jun 2018 / APPROVED

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