CUE-MATE INTRAVAGINAL PROGESTERONE DEVICE FOR CATTLE

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Patient Information leaflet (PIL)

20-06-2017

Summary of Product characteristics (SPC)

20-06-2017

Active ingredient:

PROGESTERONE

Available from:

VETOQUINOL AUSTRALIA PTY LTD

INN (International Name):

progesterone(1.56g/Dv)

Pharmaceutical form:

MISC. INTRA VAGINAL/UTERINE PREP/DEVICE

Composition:

PROGESTERONE STEROID-PROGESTIN Active 1.56 g/Dv

Units in package:

10 or50dev; 40 or 200; treat pods

Class:

VM - Veterinary Medicine

Therapeutic group:

Therapeutic area:

ENDOCRINE SYSTEM

Therapeutic indications:

ANOESTRUS | SYNCHRONISATION OF OESTRUS

Product summary:

Poison schedule: 5; Withholding period: MEAT: Zero (0) days. Remove any devices before slaughter. MILK: Zero (0) days. EXPORT SLAUGHTER INTERVAL (ESI): Zero (0) days. Before using the product, con firm the current ESI from Vetoquinol Aus tralia on 1800 032 355 or APVMA website (www.apvma.gov.au/residues).; Host/pest details: CATTLE: [ANOESTRUS, SYNCHRONISATION OF OESTRUS]; Poison schedule: 5; Withholding period: WITHHOLDING PERIODS: MEAT: Zero (0) da ys. Remove any devices before slaught er. MILK: Zero (0) days. EXPORT SLAU GHTER INTERVAL (ESI): Zero (0) days.; Host/pest details: CATTLE: [ANOESTRUS, SYNCHRONISATION OF OESTRUS]; The device is used in conjunction with oestradiol benzoate and/ or prostaglandin F2# (or its analogues) to: 1. prime anoestrous cows and induce cycling. 2. to inhibit follicle maturation for synchonising oestrus in normal cows.See Contraindications on label

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

VETOQUINOL AUSTRALIA PTY LTD
CUE-MATE INTRAVAGINAL PROGESTERONE DEVICE FOR CATTLE
52891/109135
COMPANY NAME:
PRODUCT NAME:
APVMA APPROVAL NO:
LABEL NAME:
CUE-MATE INTRAVAGINAL PROGESTERONE DEVICE FOR CATTLE
SIGNAL HEADINGS:
CAUTION
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
CONSTITUENT
STATEMENTS:
Each device contains 1.56 g PROGESTERONE in two treatment pods each
containing
0.78 g PROGESTERONE
CLAIMS:
Indications: The device is used in conjunction with oestradiol
benzoate and/or
prostaglandin F2# (or its analogues) to achieve therapeutic effects
for:-
1: A six day treatment of progesterone to prime anoestrous cows and
induce cycling.
2: A seven day treatment of progesterone in normal cows to inhibit
follicle maturation for
synchronising oestrus.
NET CONTENTS:
10 or 50 devices
40 or 200 replacement treatment pods (sufficient for 20/100
treatments)
DIRECTIONS FOR USE:
Refer to Page 3.
CONTRAINDICATIONS:
This product is contraindicated for use in animals that are in poor
condition or suffering ill
health or with abnormal vaginas.
This product is contraindicated for insertion into overly small
animals when application
discomfort is evident.
This product is contraindicated for treatment of anoestrous cows
within 21 days after
calving.
DOSAGE AND
ADMINISTRATION:
1: Anovulatory anoestrus in cattle: Using an approved applicator
insert 1.56 g progesterone
(2 pods) Cue-Mate® into the vagina. Leave for 6 days, remove, and 24
hours later (day
7), inject 1 mg of oestradiol benzoate. Most cows will respond within
2-4 days. Mate to
detected heat. Re-examine animals that do not respond and re-treat
those not cycling, if
necessary. RLP APPROVED
For Official Use Only
2: Synchronising cows: Insert 1.56 g progesterone (2 pods) Cue-Mate®
into the vagina
using an approved applicator. Inject the cow with 2 mg oestradiol
benzoate at insertion
time. Remove Cue-Mate® device on day 8 and inject the cow with PGF2#
(or analogue) at
manufacturer’s recommended dose. Following that, administer 1 mg of
oestradiol benzoate
at e

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Summary of Product characteristics

PRODUCT NAME: CUE-MATE INTRAVAGINAL PROGESTERONE TREATMENT FOR CATTLE
PAGE: 1 OF 4
THIS REVISION ISSUED: OCTOBER, 2015
SAFETY DATA SHEET
Issued by: Vetoquinol Australia Pty Ltd
Phone: 1800 032 355
(BUSINESS HOURS)
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER
VETOQUINOL AUSTRALIA PTY LTD
PHONE: 1800 032 355
(BUSINESS HOURS)
UNIT 302/2, 6-12 BORONIA ROAD, DA VINCI BUSINESS PARK,
FAX: 1800 648 460
BRISBANE AIRPORT, QLD 4008
CHEMICAL NATURE:
Intravaginal progesterone treatment for cattle
TRADE NAME:
Cue-Mate Intravaginal Progesterone Treatment For Cattle
APVMA CODE:
52891
PRODUCT USE:
For progesterone therapy of cattle to induce cycling and synchronise
oestrus.
CREATION DATE:
FEBRUARY, 2007
THIS VERSION ISSUED:
OCTOBER, 2015
and is valid for 5 years from this date.
POISONS INFORMATION CENTRE: PHONE 13 1126 FROM ANYWHERE IN AUSTRALIA
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Not classified as hazardous according to the criteria of SWA
Australia.
Not a Dangerous Good according to Australian Dangerous Goods (ADG)
Code, IATA and IMDG/IMSBC criteria.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
S45, S24/25. In case of accident or if you feel unwell, contact a
doctor or Poisons Information
Centre immediately (show the label where possible). Avoid contact with
skin and eyes.
SUSMP CLASSIFICATION:
S5
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good.
UN NUMBER:
None allocated
GHS SIGNAL WORD: NONE. NOT HAZARDOUS.
PREVENTION
P102: Keep out of reach of children.
P262: Do not get in eyes, on skin, or on clothing.
RESPONSE
P353: Rinse skin or shower with water.
P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P370+P378: Not combustible. Use extinguishing media suited to burning
materials.
STORAGE
P411: Store at temperatures not exceeding 30°C.
DISPOSAL
P501: Dispose of contents and containers as specified on the
registered labe

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