ESTROPLAN FLEXI

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Active ingredient:
CLOPROSTENOL AS SODIUM
Available from:
PARNELL TECHNOLOGIES PTY LTD
INN (International Name):
cloprostenol as Na salt(250ug/mL)
Pharmaceutical form:
PARENTERAL LIQUID/SOLUTION/SUSPENSION
Composition:
CLOPROSTENOL AS SODIUM PROSTAGLANDIN Active 250.0 ug/ml
Units in package:
100mL
Class:
VM - Veterinary Medicine
Manufactured by:
PARNELL TECHNOLOGIES
Therapeutic group:
COW | BOVINE | FEMALE CATTLE
Therapeutic area:
ENDOCRINE SYSTEM
Therapeutic indications:
CYSTIC OVARIES | INDUCE ABORTION | INDUCTION OF PARTURITION | PYOMETRA | SUB OESTRUS | SYNCHRONISATION OF OESTRUS | INDUCTION OF CALVING | SILENT HEAT
Product summary:
Poison schedule: 4; Withholding period: WHP:MEAT:DO NOT use less than 1 day be fore slaughter for human consumption. M ILK:NIL; Host/pest details: COW: [CYSTIC OVARIES, INDUCE ABORTION, INDUCTION OF PARTURITION, PYOMETRA, SUB OESTRUS, SYNCHRONISATION OF OESTRUS]; Poison schedule: 4; Withholding period: ; Host/pest details: COW: [CYSTIC OVARIES, INDUCE ABORTION, INDUCTION OF PARTURITION, PYOMETRA, SUB OESTRUS, SYNCHRONISATION OF OESTRUS]; For luteolysis of functional corpora lutea in cows.Do not use in pregnant animals when abortion or induced parturition is not the objective. Do not administer intravenously.
Authorization status:
Registered
Authorization number:
49746
Authorization date:
2020-07-01

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Company:

PARNELL Laboratories (Aust) Pty Ltd

File Name:

49746_47366_Leaflet_MPL_V01.pdf

Dimensions:

450mm x 95mm

Scale:

90% (if printed on A3 sheet)

Date:

20/05/2009

Colours:

BLACK

50247b-01

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

ACTIVE CONSTITUENT

CLOPROSTENOL (as the sodium salt) 250

g/mL

For luteolysis of functional corpora lutea in cows.

PHARMACOLOGY

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

PGF2

dinoprost.

Actions

reproductive

system

play

role

ovulation, luteolysis, gamete transport, uterine motility,

expulsion of foetal membranes, and sperm transport in

both the male and female tracts.

employed

reproductive

therapeutics

primarily

their

potent

luteolytic

effects.

PGF2

causes rapid regression of functional corpora lutea,

with

resultant

rapid

decline

progesterone

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

ovarian

response to circulating gonadotrophin, or stimulation

catalytic

enzymes.

PGF2

also

direct

stimulatory effect on uterine smooth muscle causing

contraction, and a relaxant effect on the cervix.

Pharmacokinetics

Cloprostenol is rapidly distributed in the body following

intramuscular administration. In cattle maximum tissue

levels

reached

within

minutes

dosing.

Cloprostenol

eliminated

approximately

equal

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

form.

cattle

cloprostenol

biological

half-life

hours.

Within

hours

concentration

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.

CLINICAL APPLICATION

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

induced

subsequent

oestrus

periods

normal, and there are no detrimental effects on calves

conceived following PG treatment.

estroPLAN can

used

following

clinical

situations:

1.

Synchronisation of the oestrous cycle for

controlled breeding

estroPLAN alone

used

number

treatment regimens to synchronise the oestrous cycle

of groups of cows. Some of these are described

below:

Double

Prostaglandin

Program:

injections

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.

Why-Wait

Program:

Heat

detection

during

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.

Modified

Why-Wait

Program:

Heat

detection

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.

d) PGF2

+ GnRH Programs: Injection of estroPLAN

combination

with

Gonadotrophin

Releasing

Hormone

(GnRH)

(GONAbreed

Injection,

APVMA

no. 53601, ACVM no. 8149) followed by fixed-time

insemination. One such program is OVsynch, which

may be summarized as follows:

Day 0

GnRH administration

Day 7

PGF2

administration

Day 9

GnRH administration

(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

protocol

degree

precision

that

allows

fixed-time

insemination,

which

provides

numerous

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

eliminated,

calving

conception

interval

reduced and a tighter calving pattern is achieved.

Protocols

such

OVsynch

have

measured

favourably against standard prostaglandin programs in

terms of reproductive parameters such as pregnancy

rate and calving to conception interval.

GnRH/PGF2

oestrus

synchronisation

protocols

are intended for lactating dairy cattle. Variable results

are reported in the literature for the application of

GnRH/PGF2

in heifers.

2.

Unobserved oestrus in cows with normal

corpora lutea

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

corpus

luteum

prior

estroPLAN administration.

Oestrus

should

commence

days

following

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

estroPLAN

flexi

of the corpus luteum and will necessitate a further

injection 14 days after the first.

3.

Termination of unwanted normal pregnancies

(eg. following mismating)

Pregnancy

terminated

treatment

with

estroPLAN from days 7 - 150 following conception.

Between days 7 and 100 abortion is rapidly and

reliably

induced

within

days

treatment.

Between days 100 - 150 results may be less reliable due

to the decreasing role of luteal progesterone and

increasing

role

placental

progesterone

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

membranes

complete.

Abortion

should

be induced with estroPLAN alone after day 150 of

gestation.

4.

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

necessary.

Pathological

accumulation

placental

fluids

(hydramniosis

hydrallantois)

life

threatening

condition,

rarely

resolved

surgical

drainage.

Termination

pregnancy

estroPLAN is often the preferred treatment option.

5.

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

attempted

prior

gestation.

Parturition usually occurs between 36 and 48 hours

following

treatment

with

estroPLAN.

cows

induced should be closely supervised. As with all other

methods used to induce parturition there may be a

higher

than

usual

incidence

retained

foetal

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.

6.

Retained foetal membranes, pyometra or

chronic endometritis

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

treatment

post-partum

uterine

infections

regression of the corpus luteum and stimulation of

myometrial

contractions.

rapid

decline

progesterone and increase in oestrogen which occur

result

luteolysis

stimulate

uterine

defence

mechanisms and further aid in resolution of infection.

7.

Luteal cysts

Cystic ovaries may be associated with persistent luteal

tissue, and treatment with estroPLAN may effectively

resolve such conditions and allow a return to normal

cyclical activity.

DIRECTIONS FOR USE

Do not use in pregnant animals when abortion or

induced parturition is not the objective.

Do not administer intravenously.

Cows:

Single

repeat

doses

mL (500

Cloprostenol)

intramuscular

injection

anterior half of the neck.

OVsynch Oestrus Synchronisation Protocol:

Day 0

1mL GONAbreed Injection*

Day 7

2mL estroPLAN Injection

Day 9

1mL GONAbreed Injection*

Insemination 8 - 24 hours after 2nd GONAbreed

Injection

*GONAbreed

Injection

contains

Gonadorelin

acetate) 100

g/mL.

Parnell Laboratories (Aust) Pty Ltd, APVMA no. 53601.

Parnell Laboratories New Zealand Limited, ACVM no.

8149.

WITHHOLDING PERIODS

MEAT WITHHOLDING PERIOD: DO NOT USE LESS

THAN 1 DAY BEFORE SLAUGHTER FOR HUMAN

CONSUMPTION.

MILK WITHHOLDING PERIOD: NIL.

TRADE ADVICE

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).

CAUTION

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

drug.

Cloprostenol is readily absorbed through the skin:

any cloprostenol contacting skin must be washed

off immediately using soap and water.

ADVERSE EFFECTS

Occasional side effects have been observed following

intramuscular administration of PG. Such effects are

generally transient and have little detrimental effect on

the animal.

cattle,

increased

body

temperature

salivary

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

adverse effects.

STORAGE & DISPOSAL

Store below 25°C (Air Conditioning).

Protect from light.

Following

withdrawal

first

dose,

remainder of the pack within 28 days or discard the

unused portion.

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

conditions.'

PARNELL LABORATORIES (AUST) PTY. LTD.

4/476 Gardeners Road, Alexandria NSW 2015

Registered to:

PARNELL LABORATORIES NEW ZEALAND LIMITED

PO Box 73160, Auckland International Airport,

Auckland 2150

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

Address

Address

Unit 4, Century Estate

PO Box 73160

476 Gardeners Road

Auckland International Airport

Alexandria, NSW 2015

Manukau 2150

Australia

New Zealand

Telephone Number

Telephone Number

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)

Facsimile Number

Facsimile Number

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

Chemical Entity

CAS Number

Proportion

Buffering Agents

<1% w/v

Cloprostenol (as sodium)

55028-72-3

0.025% w/v

Preservative

<1% w/v

Water

7732-18-5

to 100%

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

Personal Protection:

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.

Boiling Point

Melting Point

Not determined

Not determined

Vapour Pressure

Specific Gravity

Not determined

1.00 - 1.05

Flash Point

Flammability Limits

Not determined

Not determined

Solubility in Water

Other Properties

Aqueous solution

Not applicable

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.

Cloprostenol Toxicity

IV >5mg/kg

SC >5mg/kg

IM >5mg/kg

oral >310mg/kg

The most likely route of accidental exposure to cloprostenol in Estroplan Injection is by spillage on unprotected

skin.

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

th

February 2009

Replaces MSDS dated 16 September 2008

Replaces MSDS dated 10 July 2003

Replaces MSDS dated 20 July 2001

End of MSDS

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