PCL INTRAVAGINAL INSERT

Nazione: Australia

Lingua: inglese

Fonte: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Compra

Foglio illustrativo Foglio illustrativo (PIL)
20-06-2017

Principio attivo:

PROGESTERONE

Commercializzato da:

ZOETIS AUSTRALIA PTY LTD

INN (Nome Internazionale):

progesterone(1.38g/unit)

Forma farmaceutica:

MISC. INTRA VAGINAL/UTERINE PREP/DEVICE

Composizione:

PROGESTERONE STEROID-PROGESTIN Active 1.38 g/Ins

Confezione:

10 inserts

Classe:

VM - Veterinary Medicine

Prodotto da:

ZOETIS AUSTRALIA

Gruppo terapeutico:

COW | HEIFER (YOUNG FEMALE CATTLE) | BOVINE | COW YOUNG | FEMALE CATTLE

Area terapeutica:

ENDOCRINE SYSTEM

Indicazioni terapeutiche:

BOVINE OESTRUS CYCLE

Dettagli prodotto:

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.

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2023-07-01

Foglio illustrativo

                                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
                                
                                Leggi il documento completo