PRID DELTA 1.55G VAGINAL DELIVERY SYSTEM
Country: Australia
Language: English
Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)
Patient Information leaflet
(PIL)
04-06-2021
Summary of Product characteristics
(SPC)
21-06-2017
Active ingredient:
PROGESTERONE
Available from:
CEVA ANIMAL HEALTH PTY LTD
INN (International Name):
progesterone(1.55g/Dv)
Pharmaceutical form:
PARENTERAL IMPLANT, DEVICE
Composition:
PROGESTERONE STEROID-PROGESTIN Active 1.55 g/Dv
Units in package:
1 sachet; 10 sachet
Class:
VM - Veterinary Medicine
Manufactured by:
CEVA ANIMAL HEALTH
Therapeutic group:
CATTLE | HEIFER (YOUNG FEMALE CATTLE) | BEEF | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK | CALF | COW | COW Y
Therapeutic area:
ENDOCRINE SYSTEM
Therapeutic indications:
CONTROL OF OESTRUS
Product summary:
Poison schedule: 5; Withholding period: WHP: Meat: Zero(0) days, Milk: Zero(0 ) days. Always remove the devices fr om animals before slaughter. Trade Advi ce EXPORT SLAUGHTER INTERVAL (ESI): Z ero(0) days.; Host/pest details: CATTLE: [CONTROL OF OESTRUS]; HEIFER (YOUNG FEMALE CATTLE): [CONTROL OF OESTRUS]; For the control of oestrus in cows and heifers.
Authorization status:
Registered
Authorization date:
2023-07-01
Patient Information leaflet
PRID DELTA 1.55G VAGINAL DELIVERY SYSTEM
64665/129090
Product Name:
APVMA Approval No:
Label Name:
PRID DELTA 1.55G VAGINAL DELIVERY SYSTEM
Signal Headings:
CAUTION
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
1.55 g per device PROGESTERONE
Claims:
For the control of the oestrus cycle in cows and heifers including:
a) Synchronisation of oestrus including fixed time artificial
insemination (FTAI) protocols.
b) Synchronisation of oestrus of donor and recipient animals for
embryo transfer.
To be used in combination with a prostaglandin (PGF2α or analogue)
c) Induction and synchronisation of oestrus in cycling and non cycling
cattle including fixed
time artificial insemination (FTAI) protocols.
• In cycling cattle. To be used in combination with prostaglandin
(PGF2α) or
analogue.
• In cycling and non-cycling cattle. To be used in combination with
gonadotropin
releasing hormone (GnRH) or analogue and PGF2α or analogue.
• In non-cycling cattle. To be used in combination with PGF2α or
analogue and
equine chorionic gonadotrophin (eCG).
Net Contents:
1 sachet
10 sachet
Directions for Use:
Restraints:
Contraindications:
This product is contraindicated for use in:
- sexually immature heifers.
- animals with genital infections or abnormal genital tracts, e.g,
freemartins.
- less than 35 days after calving RLP APPROVED
Precautions:
Animals in poor condition, whether from illness, inadequate nutrition,
under unnecessary
stress or other factors, may respond poorly to treatment.
It is recommended to wait a minimum of 35 days following parturition
before starting the
treatment with this product.
Side Effects:
During the course of the seven day treatment, the device may induce a
mild localised
inflammatory response of the vaginal wall. A clinical study carried
out with 319 cows and
heifers showed that this localised reaction resulted 25% of animals
showing ropy or cloudy
vaginal discharges from vulva at the time of device removal.
This local reaction disappeared rapidly without any trea
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Summary of Product characteristics
PRODUCT NAME: PRID DELTA 1.55G VAGINAL DELIVERY SYSTEM
PAGE: 1 OF 4
THIS REVISION ISSUED: NOVEMBER 2010
MATERIAL SAFETY DATA SHEET
Issued by: Ceva Delvet Pty Ltd
Phone: 1300 655 125
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
CEVA DELVET PTY LTD
PHONE: 1300 655 125
B4, 26 POWERS RD
SEVEN HILLS, NSW 2147
CHEMICAL NATURE:
Active ingredient, progesterone, is a sex hormone presented here in a
suitable
applicator/device.
TRADE NAME:
PRID DELTA 1.55G VAGINAL DELIVERY SYSTEM
APVMA CODE:
64665
PRODUCT USE:
For the control of oestrus in cows and heifers as stated on the label.
CREATION DATE:
NOVEMBER, 2010
THIS VERSION ISSUED:
NOVEMBER, 2010
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:
S24. Avoid contact with skin.
SUSMP CLASSIFICATION:
S5
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
EMERGENCY OVERVIEW
PHYSICAL DESCRIPTION & COLOUR
: A whitish triangular device with a double 50cm cord attached.
ODOUR:
No odour.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product.
POTENTIAL HEALTH EFFECTS
INHALATION:
SHORT TERM EXPOSURE:
Available data indicates that this product is not harmful. In addition
product is unlikely to
cause any discomfort or irritation.
LONG TERM EXPOSURE:
No data for health effects associated with long term inhalation.
SKIN CONTACT:
SHORT TERM EXPOSURE:
Available data indicates that this product is not harmful. It should
present no hazards in
normal use. In addition product is unlikely to cause any discomfort in
normal use.
LONG TERM EXPOSURE:
No data for health effects associated with long term skin exposure.
EYE CONTACT:
SH
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