PCL INTRAVAGINAL INSERT
Country: Australia
Language: English
Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)
Patient Information leaflet
(PIL)
20-06-2017
Send request.
Active ingredient:
PROGESTERONE
Available from:
ZOETIS AUSTRALIA PTY LTD
INN (International Name):
progesterone(1.38g/unit)
Pharmaceutical form:
MISC. INTRA VAGINAL/UTERINE PREP/DEVICE
Composition:
PROGESTERONE STEROID-PROGESTIN Active 1.38 g/Ins
Units in package:
10 inserts
Class:
VM - Veterinary Medicine
Manufactured by:
ZOETIS AUSTRALIA
Therapeutic group:
COW | HEIFER (YOUNG FEMALE CATTLE) | BOVINE | COW YOUNG | FEMALE CATTLE
Therapeutic area:
ENDOCRINE SYSTEM
Therapeutic indications:
BOVINE OESTRUS CYCLE
Product summary:
Poison schedule: 5; Withholding period: WHP: MEAT: NIL, MILK: NIL Inserts sh ould always be removed before slaughter .; Host/pest details: COW: [BOVINE OESTRUS CYCLE]; HEIFER (YOUNG FEMALE CATTLE): [BOVINE OESTRUS CYCLE]; Poison schedule: 5; Withholding period: ; Host/pest details: COW: [BOVINE OESTRUS CYCLE]; HEIFER (YOUNG FEMALE CATTLE): [BOVINE OESTRUS CYCLE]; Progesterone intravaginal insert for controlled breeding in cattle.
Authorization status:
Registered
Authorization date:
2023-07-01
Patient Information leaflet
Draft text label:
PCl
Intravaginal
Insert
IMMEDIATE LABEL (front
panel)
Text above the header
line and below the footer
line is not included in the label
CAUTION
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
PEL
INTRAVAGINAL
INSERT
Active constituent:
PROGESTERONE 1.38 9 per insert
PROGESTERONE INTRAVAGINAL INSERT FOR CONTROLLED BREEDING IN CATTLE.
CONTENTS:
10 INSERTS.
II
January
_2005_
Page 1
of3
Draft
text
label:
PCl
Inlravaginallnsert
IMMEDIATE LABEL (back panel)
Text
above lhe header line and below the footer line is not
included in
the label
INDICATIONS
Control
of the oestrous cycle in maiden heifers and parous cows to synchronise
oestrus for:
(a)
concentrated artificial
insemination (AI) programs;
(b)
concentrated AI programs for re-insemination (re-synchronisation);
(c)
embryo transfer (ET) programs.
Treatment
of anoestrus during early lactation in dairy cows or suckled beef
cows.
DIRECTIONS FOR USE
THIS PRODUCT IS CONTRAINDICATED FOR USE IN ANIMALS WITH ABNORMAL
VAGINAS.
DOSAGE AND ADMINISTRATION
FOR SYNCHRONISATION OF OESTRUS:
Step 1 (Day 0):
Administer a
PCl
Intravaginal
Insert and concurrently inject either
oestradiol
benzoate
(1
mg with heifers, 2 mg with cows), or gonadotrophin
releasing hormone (GnRH;
100
/-lg
native GnRH or equivalent);
Step 2 (Day 8):
Remove
PCl
Intravaginal
Insert and concurrently inject
a recommended
luteolytic dose of a prostaglandin
F
2
",
(PGF);
Step 3 (Day 9):
Inject either oestradiol
benzoate (0.75 mg with heifers,
1 mg with cows) at
24 hours after Step 2; or GnRH (as in Step 1) at 36 hours after Step
2;
Step 4 (Day 10):
(a)
Fixed-time AI from 24 hours after oestradiol
benzoate is possible
with dairy or beef heifers and beef cows.
Insemination following
observed behavioural
oestrus on Days 10, 11 and 12 is preferable
with dairy cows.
(b)
Fixed-time AI is essential
from 12 to 16 hours after GnRH.
FOR RE-SYNCHRONISATION FOR RE-INSEMINATION:
Step 1:
Administer a
PCl
Intravaginal
Insert from 12 to 14 days after first
insemination.
A concurrent
injection of 0.5 mg oes
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