Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)
PARNELL Laboratories (Aust) Pty Ltd
450mm x 95mm
90% (if printed on A3 sheet)
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
CLOPROSTENOL (as the sodium salt) 250
For luteolysis of functional corpora lutea in cows.
Prostaglandins (PGs) are 20-carbon unsaturated fatty
acids which consist of a cyclopentane ring with two
aliphatic side chains. They are synthesised from free
arachidonic acid in most major tissues in the body and
serve as local hormones, acting on tissues near their
site of synthesis.
PGs are structurally classified into nine major groups,
A to I, each containing subgroups denoted by
subscripts 1, 2 and 3. In domestic animals the most
important PG appears to be PGF2
. Cloprostenol is a
functional synthetic analogue of the naturally occurring
ovulation, luteolysis, gamete transport, uterine motility,
expulsion of foetal membranes, and sperm transport in
both the male and female tracts.
causes rapid regression of functional corpora lutea,
production. Luteolysis is usually followed by ovarian
follicular development and a return to oestrus with
normal ovulation. In cattle oestrus occurs 2 - 4 days
after luteolysis. The early corpus luteum is insensitive
to the effects of PG; this refractory period spans the first
4 - 5 days post ovulation in cows.
The precise mechanism of PG-induced luteolysis is
uncertain but may relate to blood flow changes in the
uteroovarian vessels, inhibition of the normal
response to circulating gonadotrophin, or stimulation
stimulatory effect on uterine smooth muscle causing
contraction, and a relaxant effect on the cervix.
Cloprostenol is rapidly distributed in the body following
intramuscular administration. In cattle maximum tissue
amounts via the kidney and in bile. Excretion in urine
is partly as unchanged cloprostenol, and partly as its
tetranor acid both in conjugated and unconjugated
cloprostenol at the injection site falls below the limits of
detection. Cloprostenol does not accumulate in the
mammary gland, with less than 0.75% of a given dose
eliminated in the milk.
Cloprostenol induces luteolysis of functional corpora
lutea, with return to oestrus in most cows in 2 - 4 days.
The corpus luteum is refractory to the effects of PG in
the first 4 - 5 days post ovulation. Conception rates at
normal, and there are no detrimental effects on calves
conceived following PG treatment.
Synchronisation of the oestrous cycle for
treatment regimens to synchronise the oestrous cycle
of groups of cows. Some of these are described
of estroPLAN 14 days apart. Artificial insemination or
natural mating at the induced oestrus which should be
detected 2 - 4 days after the second injection.
first 5 - 7 days of the mating period and artificial
insemination or natural joining of cows observed in
oestrus. Injection of cows not observed in oestrus with
estroPLAN at the end of the 5 - 7 day period and
artificial or natural mating at the induced oestrus which
should be detected 2 - 4 days after the injection.
during the 6 days prior to the start of mating. Cows not
observed in oestrus are given a single injection of
estroPLAN on mating start date. Cows observed in
oestrus are given a single injection of estroPLAN on
day 5 of the mating period. In both groups artificial or
natural mating at the induced oestrus which would be
detected 2 - 4 days after the injection.
+ GnRH Programs: Injection of estroPLAN
no. 53601, ACVM no. 8149) followed by fixed-time
insemination. One such program is OVsynch, which
may be summarized as follows:
(48 hours after PGF2
Insemination 8 - 24 hours after 2nd GnRH
Insemination is performed at a fixed time 8 to 24 hours
after the 2nd GnRH dose, regardless of the presence
or absence of visible oestrus.
Synchronisation of ovulation achieved by the OVsynch
management and economic benefits, particularly in
situations where the level of oestrus detection is low.
Large groups of cows may be inseminated together,
the need for oestrus detection in the first round is
reduced and a tighter calving pattern is achieved.
favourably against standard prostaglandin programs in
terms of reproductive parameters such as pregnancy
rate and calving to conception interval.
are intended for lactating dairy cattle. Variable results
are reported in the literature for the application of
Unobserved oestrus in cows with normal
Cows may be cycling normally, but either fail to display
behavioural oestrus or display only very subtle signs.
This condition occurs most commonly in high yielding
dairy cows at peak lactation. Normal ovarian cyclical
activity should be determined by rectal palpation of a
treatment, with artificial insemination or joining at the
detected heat. Failure of oestrus induction may result
if the treatment is given during the refractory period
of the corpus luteum and will necessitate a further
injection 14 days after the first.
Termination of unwanted normal pregnancies
(eg. following mismating)
estroPLAN from days 7 - 150 following conception.
Between days 7 and 100 abortion is rapidly and
Between days 100 - 150 results may be less reliable due
to the decreasing role of luteal progesterone and
maintenance of pregnancy. If abortion has not occurred
by the eighth day following treatment, a repeat injection
should be given. Treated animals should be closely
observed until expulsion of the foetus and placental
be induced with estroPLAN alone after day 150 of
Termination of abnormal pregnancy
(eg. expulsion of mummified foetuses)
Foetal death may result in the mummification of the
foetus in utero. Treatment with estroPLAN at any
stage of gestation will result in luteolysis and expulsion
of the mummified foetus from the uterus. Occasionally
manual removal of the foetus from the vagina is
estroPLAN is often the preferred treatment option.
Induction of parturition
Parturition may be induced using estroPLAN alone but
to optimise calf viability should be carried out as close
to the predicted calving date as possible and should
Parturition usually occurs between 36 and 48 hours
induced should be closely supervised. As with all other
methods used to induce parturition there may be a
membranes. Any reduction in survival rates of calves
born as a result of parturition induction is considered
to be a result of prematurity rather than an effect
attributable to PG treatment.
Retained foetal membranes, pyometra or
Cloprostenol has a stimulatory effect on the myometrium,
causing uterine contraction. This action can aid in
the expulsion of retained foetal membranes. In the
absence of septicaemia estroPLAN may aid in the
regression of the corpus luteum and stimulation of
progesterone and increase in oestrogen which occur
mechanisms and further aid in resolution of infection.
Cystic ovaries may be associated with persistent luteal
tissue, and treatment with estroPLAN may effectively
resolve such conditions and allow a return to normal
DIRECTIONS FOR USE
Do not use in pregnant animals when abortion or
induced parturition is not the objective.
Do not administer intravenously.
anterior half of the neck.
OVsynch Oestrus Synchronisation Protocol:
1mL GONAbreed Injection*
2mL estroPLAN Injection
1mL GONAbreed Injection*
Insemination 8 - 24 hours after 2nd GONAbreed
Parnell Laboratories (Aust) Pty Ltd, APVMA no. 53601.
Parnell Laboratories New Zealand Limited, ACVM no.
MEAT WITHHOLDING PERIOD: DO NOT USE LESS
THAN 1 DAY BEFORE SLAUGHTER FOR HUMAN
MILK WITHHOLDING PERIOD: NIL.
EXPORT SLAUGHTER INTERVAL (ESI): This product
does not have an ESI established. For advice on the
ESI, contact the manufacturer on (02) 9667 4411
before using this product.
FIRST AID: If poisoning occurs, contact a doctor or
Poisons Information Centre. Phone Australia 131126,
New Zealand 0800 POISON (0800 764766).
Women of child-bearing age, asthmatics or other
people with bronchial disease should use extreme
caution when handling cloprostenol as the drug
may induce abortion or acute bronchoconstriction.
Gloves should be worn when administering the
Cloprostenol is readily absorbed through the skin:
any cloprostenol contacting skin must be washed
off immediately using soap and water.
Occasional side effects have been observed following
intramuscular administration of PG. Such effects are
generally transient and have little detrimental effect on
secretion have been reported, usually associated with
the administration of 5 - 10 times the recommended
dose. Experimental administration of 50 - 100 times
the recommended dose to cattle resulted in signs of
uneasiness, salivation and milk let-down, but no other
STORAGE & DISPOSAL
Store below 25°C (Air Conditioning).
Protect from light.
remainder of the pack within 28 days or discard the
Dispose of empty container by wrapping with paper
and putting in garbage.
APVMA Approval Number: 49746/0509
NEW ZEALAND ONLY INFORMATION
Prescription Animal Remedy (P.A.R) Class 1. For use
only under the authority or prescription of a veterinari-
an. Registered pursuant to the ACVM Act 1997, No.
A7673. See www.nzfsa.govt.nz/acvm for registration
PARNELL LABORATORIES (AUST) PTY. LTD.
4/476 Gardeners Road, Alexandria NSW 2015
PARNELL LABORATORIES NEW ZEALAND LIMITED
PO Box 73160, Auckland International Airport,
Page 1 of 2
Material Safety Data Sheet:
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE COMPANY/UNDERTAKING
Product name : Estroplan flexi
Other names : Estroplan, Cloprostenol Injection
Recommended use: FOR ANIMAL TREATMENT ONLY. Luteolysis of functional corpora lutea in cows.
MANUFACTURER COMPANY DETAILS:
LICENSEE (NEW ZEALAND) DETAILS:
Parnell Manufacturing Pty Ltd
Parnell NZ Co
Unit 4, Century Estate
PO Box 73160
476 Gardeners Road
Auckland International Airport
Alexandria, NSW 2015
61 (0)2-9667 4411
0800 446 282 (Toll free within NZ)
Emergency Telephone Number
Emergency Telephone Number
61 (0)2-9667 4411 (Business Hours)
0800 446 282 (Business Hours)
61 (0)2-9667 4139
0800 727 533 (Toll free within NZ)
2. HAZARDS IDENTIFICATION
Hazardous substance according to criteria of Worksafe Australia.
3. COMPOSITION/INFORMATION ON INGREDIENTS
Cloprostenol (as sodium)
4. FIRST AID MEASURES
Wash off any Estroplan contacting skin immediately using soap and water. Seek medical assistance if required.
Swallowed: Seek medical assistance if required.
Eye: If in eyes, hold eyes open, flood with water for at least 15 minutes. Seek medical assistance if required.
Skin: If skin contact occurs remove contaminated clothing and wash skin thoroughly with soap and water. Seek
medical assistance if required.
Inhaled: Seek medical assistance if required.
First Aid Facilities: No specific first aid facilities required.
ADVICE TO DOCTOR: Treat symptomatically as required.
5. FIRE-FIGHTING MEASURES
This material is not considered a fire hazard. Use standard fire fighting techniques to extinguish fires involving
this material. Use water spray, dry chemical, carbon dioxide or foam.
6. ACCIDENTAL RELEASE MEASURES
Clear immediate area of unprotected personnel. Clean up spilled material with absorbent ensuring no contact
with skin during operation. Flush contaminated area with water and detergent.
Dispose of waste in accordance with local, state or federal laws.
7. HANDLING AND STORAGE
Handling: Avoid contact with eyes, skin and clothing.
Storage: Store below 25
C (Air conditioning). Protect from light.
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Exposure Standards: No exposure standard allocated
Engineering Controls:Not applicable
Wear gloves when handling product.
Avoid spraying or splashing of the preparation.
Avoid inhalation of aerosol spray or vapour of the preparation.
Page 2 of 2
Material Safety Data Sheet:
Avoid eating, drinking or smoking in area of product or during handling of product.
Avoid contamination of work area.
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance and Odour
Clear, colourless solution free from particulate matter with a mild amine odor.
1.00 - 1.05
Solubility in Water
10. STABILITY AND REACTIVITY
Chemical stability: Stable
Conditions to avoid: No data available
Incompatible materials: No data available
Hazardous decomposition products: No data available
Hazardous reactions: No data available
11. TOXICOLOGICAL INFORMATION
Acute Exposure: Women of child bearing age, asthmatics or other people with bronchial disease
should use extreme caution when handling Estroplan Injection as cloprostenol has the potential to
induce abortion or acute bronchoconstriction.
In vitro studies using human luteal tissue have determined that cloprostenol may not be luteolytic in humans.
The most likely route of accidental exposure to cloprostenol in Estroplan Injection is by spillage on unprotected
Swallowed: Cloprostenol may be absorbed via oral mucous membranes and from the gastrointestinal tract.
Eye: Cloprostenol may be absorbed via mucous membranes, including the conjunctiva.
Skin: Cloprostenol may be absorbed via intact skin and skin abrasions. Mild diarrhoea has been reported
following absorption of cloprostenol through skin.
Inhaled: Cloprostenol may be absorbed via respiratory mucous membranes.
Chronic Exposure: Not applicable
12. ECOLOGICAL INFORMATION
No data available
13. DISPOSAL CONSIDERATIONS
Product: Observe all federal, state, and local environmental regulations.
Contaminated packaging: Dispose of as unused product.
14. TRANSPORT INFORMATION
Dangerous Goods Class and Subsidiary Risk:No class and subsidiary risk allocated
Hazchem Code:No Hazchem code allocated
Store below 30
C (Room temperature). Protect from light.
15. REGULATORY INFORMATION
Poisons Schedule: Schedule 4 (Australia), Prescription Animal Remedy (P.A.R) Class I (New Zealand)
16. OTHER INFORMATION
Issue Date: 28 January 2011
Replaces MSDS dated 19 January 2010
Replaces MSDS dated 9
Replaces MSDS dated 16 September 2008
Replaces MSDS dated 10 July 2003
Replaces MSDS dated 20 July 2001
End of MSDS