ESTRUMATE

Main information

  • Trade name:
  • ESTRUMATE SYNTHETIC PROSTAGLANDIN FOR CATTLE AND HORSES
  • Pharmaceutical form:
  • PARENTERAL LIQUID/SOLUTION/SUSPENSION
  • Units in package:
  • 10x20mL, 20mL, 100mL
  • Class:
  • Veterinary Medicine
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • INTERVET AUSTRALIA

Documents

Localization

  • Available in:
  • ESTRUMATE SYNTHETIC PROSTAGLANDIN FOR CATTLE AND HORSES
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • CATTLE | HORSE | BEEF | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK | CALF | COLT | COW | DAIRY COW | DONKEY |
  • Therapeutic area:
  • prostaglandin
  • Therapeutic indications:
  • BOVINE OESTRUS CYCLE | EQUINE OESTRUS CYCLE | CTRL OF OESTRUS REL.BEHAVIOUR
  • Product summary:
  • A luteolytic agent for clinical use and the control of the bovine and equine oestrus cycles.Should not be administered to pregnant animals where the foetus is not to be aborted. Care should be taken when handling this product especially by women of child bearing age and also by asthmatics.

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Registered and available
  • Authorization number:
  • 36076/107149
  • Authorization date:
  • 15-03-2017
  • Last update:
  • 15-06-2017

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

ESTRUMATE SYNTHETIC PROSTAGLANDIN FOR CATTLE AND HORSES

36076/107149

Product Name:

APVMA Approval No:

Label Name:

ESTRUMATE SYNTHETIC PROSTAGLANDIN FOR CATTLE AND HORSES

Signal Headings:

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

Constituent

Statements:

250 ug/ml CLOPROSTENOL AS THE SODIUM SALT

Claims:

A luteolytic agent for clinical use and the control of the bovine and equine oestrous cycles.

ESTRUMATE a synthetic prostaglandin analogue for use in cattle and horses, is

structurally related to Prostaglandin F2a (PGF2a). Each mL of the colourless aqueous

solution contains 263ug of cloprostenol sodium equivalent to 250ug cloprostenol. The

solution also contains 2% benzyl alcohol Ph. Eur. as a bactericide.

Action: ESTRUMATE is a potent luteolytic agent, i.e. it causes functional and morphological

regression of the corpus luteum (luteolysis) in a variety of circumstances. Luteolysis is

usually followed by return to oestrus two to four days after treatment, and normal ovulation.

Net Contents:

10 x 20mL

100mL

20mL

Directions for Use:

For use by or under direction of a registered veterinarian

DIRECTIONS FOR USE

Contraindications:

ESTRUMATE should not be administered to pregnant animals where the foetus is not to be

aborted, since luteolysis at some stages of gestation will result in the loss of the foetus.

ESTRUMATE should not be administered by intravenous injection.

Side Effects:

Note: There is a refractory period of four to five days after ovulation when cattle are

insensitive to the luteolytic effect of prostaglandins. ESTRUMATE has a good safety margin

and does not impair fertility. No deleterious effects have been reported on the progeny

conceived at the oestrus following treatment.

RLP

APPROVED

In cattle adverse reactions have not been seen at up to 80 times the effective

recommended dose (500μg). The only clinically apparent effect was mild and transient

diarrhoea.

In horses adverse reactions including sweating (occurring within about 20 minutes of

treatment), increased respiratory and cardiac rates, signs of abdominal discomfort,

watery diarrhoea and depression may occur when exceptionally high doses are given.

However adverse reactions are usually mild and transient. ESTRUMATE should NOT be

administered to:

Mares suffering from acute or sub-acute disorders of the gastrointestinal tract.

Mares suffering from acute or sub-acute respiratory disease. (This is a precautionary

measure because in some species of animals, dosing with prostaglandins can result in

acute respiratory distress.)

Pregnant mares, since luteolysis at some stages of gestation will result in the loss of the

foetus.

Dosage and

Administration:

Use the contents within 28 days after first broaching the vial. Discard unused portion.

This section contains file attachment.

Withholding Periods:

WITHHOLDING PERIODS:

MEAT (CATTLE, HORSES): DO NOT USE less than one day before slaughter for human

consumption.

MILK: Zero (0) days.

Trade Advice:

TRADE ADVICE:

EXPORT SLAUGHTER INTERVAL (ESI): An ESI has not been established for this product.

Note-observing the meat withholding period may not be sufficient to mitigate potential risks

to export trade. Trade advice should be sought from Intervet/MSD Animal Health on 1800

033 461 before using this product.

First Aid Instructions:

If poisoning occurs, contact a doctor or Poisons Information Centre. Phone Australia 13 11

First Aid Warnings:

Additional User

Safety:

ESTRUMATE can be absorbed through the skin and therefore, care should be taken when

handling this product, especially by women of child bearing age and also by asthmatics. In

case of accidental spillage on skin, wash immediately with water.

Prostaglandins of the F2a type may cause broncho-spasm in man, although the

possible incidence of this effect with ESTRUMATE is not known. Should respiratory

embarrassment result from accidental inhalation or injection, a rapid acting broncho-dilator,

e.g. isoprenaline or salbutamol by inhalation is indicated.

Disposal:

Dispose of empty container by wrapping in paper and putting in garbage.

Storage:

Store below 30°C (Room Temperature). PROTECT from light.

CATTLE

I.

Therapeutic:

A single intramuscular dose of ESTRUMATE is likely to be highly effective in the following clinical

conditions of the cow.

Suboestrus (or non-detected oestrus - NDO):

This condition occurs in heavy yielding cows, usually at peak lactation, which have normal ovarian

cyclicity but in which behavioural manifestations of oestrus are either very mild, transient or absent.

Such animals can be treated with ESTRUMATE following

diagnosis

a corpus

luteum

rectal

palpation and then closely observed for oestrus. Those showing heat should be inseminated. Some

animals may have been treated during the refractory period of the cycle and therefore will not

respond. Animals not showing heat should receive a further single injection 11 days after the first and

be inseminated 72 and 96 hours later.

Termination of Normal but Unwanted Pregnancies:

Pregnancy can be terminated from one week after conception until the 150th day of gestation. Before

100 days gestation, abortion can be induced rapidly and efficiently. Between 100 and 150 days of

gestation results are less reliable, probably because a proportion of cattle may become progressively

less dependent upon the corpus luteum for the maintenance of pregnancy. Abortion should not be

induced after day 150 of gestation. Treated animals should be kept under supervision until expulsion

of the foetus and the placental membranes is complete, as an occasional animal may develop metritis

following abortion. Most cows will abort in 3-5 days; if an animal has not aborted by the eighth day, a

second injection should be given.

Termination of Abnormal Pregnancy

Removal of mummified foetus:

Death of the conceptus may be followed by its dehydration and degeneration. Induction of luteolysis

at any stage of pregnancy will result in the expulsion of this mummified foetus from the uterus into the

vagina. Manual removal from the vagina may be necessary. Normal cyclical activity should then

follow.

Hydrops of the Foetal Membranes:

Pathological accumulation of placental fluids - hydramnios or hydrallantois - can cause severe

physiological complications and death. Surgical drainage is not usually successful in alleviating the

condition. A single dose of ESTRUMATE may be used to induce parturition in such cases, success

has been achieved as early as the sixth month of pregnancy.

Chronic endometritis (Pyometra):

Damage to the reproductive tract at calving or post-partum retention of the placenta, frequently lead to

infection and inflammation of the uterus. Acute or sub-acute endometritis occurring shortly after

parturition may require both local and systemic antibiotic treatment and this often results in resolution

of the condition. However, under certain circumstances the endometritis may progress until, at a few

weeks post-partum the uterus is very swollen, of a soft doughy consistency and full of purulent

discharge. This is characterised by a lack of cyclical oestrus behaviour and the presence of a

persistent corpus luteum. This condition can be successfully treated by induction of luteal regression.

Where necessary, treatment may be repeated at 10 to 14 day intervals.

Induction of Parturition:

Induction of parturition should take place as close to the predicted calving date as possible and not

more than 10 days before. Induction should not be attempted before day 270 of gestation measured

from the confirmed day of conception. All treated animals must receive adequate supervision. In

common with all other methods of shortening the gestation period a higher than usual incidence of

retention of the foetal membranes is to be expected. It is now recognised that there may be a

reduced survival rate in calves born as a result of early induction. Any increased mortality is due to

lack of viability as a result of prematurity rather than any effect from the prostaglandins.

Ovarian Luteal Cysts:

Where cystic ovaries associated with persistent luteal tissue and absence of oestrus are diagnosed,

ESTRUMATE has proved effective in correcting the condition and bring about a return of cycling.

Accurate diagnosis is essential if completely satisfactory results are to be achieved.

II.

Controlled Breeding Programmes in Cattle.

The luteolytic activity of ESTRUMATE can be harnessed to control the breeding patterns of cattle. A

variety of treatment regimes exists from which it is possible to choose the most appropriate for the

characteristics and objectives of each particular individual, group or herd. ESTRUMATE can be used

to complement oestrus detection input or animals may be bred “on schedule” during critical times of

the breeding season, without reference to oestrus detection. Use one of the following programs:

Day 1:

ESTRUMATE

injection.

Day 11:

ESTRUMATE

injection.

BREED:

At the usual time, relative

to detected heat OR

At about 72 hours and 96

Hours post-injection OR

Mass AI at 72 hours, with

re-insemination of those in

Oestrus over the next 2 to 3

days.

Palpate

All animals with

corpus luteum

ESTRUMATE

injection.

Day 1:

ESTRUMATE

injection.

Detect heat and

breed.

Day 11: All animals

not bred

ESTRUMATE

injection.

Detect heat for 6

days and breed.

Day 6: All animals

not bred

ESTRUMATE

injection.

NOTE:

Best results obtained where heat detection is utilised. This is generally assisted by the use of

tail paint.

Identification of animals is important.

Conception rate may be about 20% less if insemination is carried out en masse 72 hours after

injection with no following insemination.

ESTRUMATE can also be used in systems which include other treatment regimes. e.g. CIDR.

III.

Dairy Herd

To control oestrus in the individual animal giving better control of the calving index by allowing

artificial insemination without oestrus detection. The number of cows culled as barren is consequently

reduced.

To synchronise oestrus in groups of cows to promote management of the herd in groups of

suitable size for feeding, A.I. and ‘drying off’. The chances of maintaining a strictly seasonal calving

herd are improved and the number of barren cows at the end of the breeding programme is reduced.

To permit the use of A.I. in dairy heifers which, in turn, allows the speeding up of the breeding

programme, the use of a bull known to produce few dystocia problems, better control of heifer

management, and steaming up prior to calving.

IV.

Beef Herd

To facilitate the use of A.I. improving the progeny through the use of genetically superior bulls. The

problems of oestrus detection are avoided and the labour involved in carrying out an A.I. programme

is reduced by allowing groups of cattle to be presented instead of single animals.

To permit better management at conception and calving: The calving pattern is altered, resulting

in greater average age and weight of calves at weaning. The peak calving period can be forecast

more accurately in relation to other events in the farm calendar and there is an improved potential for

‘flushing’ the cows prior to A.I.

Dosage and Administration

Single or repeat doses of 2 mL (500

g cloprostenol) by intramuscular injection.

HORSES

ESTRUMATE as a potent luteolytic agent causes regression of the corpus luteum in MARES, in a

variety of circumstances. Luteolysis is usually followed by oestrus, appearing 2 to 4 days after

treatment, with ovulation during the induced oestrus. This sequence of events is seen, for example,

in mares treated with ESTRUMATE during dioestrus (the progestational) phase of the oestrus cycle,

but it should be noted that there is a refractory period of 4 to 5 days after ovulation when mares are

not responsive to the luteolytic action of prostaglandins.

ESTRUMATE has a wide margin of safety and has no deleterious effect on foals conceived and born

as a result of mares being covered at the induced oestrus. This property of shortening the life-span of

the corpus luteum makes ESTRUMATE of clinical value in:-

Induction of Luteolysis following early foetal death and resorption: About 8 to 10 per cent of all

mares which conceive lose the conceptus during the first 100 days of pregnancy. Persistence of

luteal function in the ovary precludes an early return of oestrus. Treatment before day 45 is

recommended. After that time no response may be obtained due to the presence of circulating

P.M.S.G.

Termination of Pseudopregnancy: Some mares covered at normal oestrus and subsequently

found to be empty (but not having lost or resorbed a conceptus) display clinical signs of pregnancy.

These animals are said to be ‘pseudopregnant’.

Treatment of Lactation anoestrus: Failure of lactating mares to cycle again for several months after

exhibiting an early ‘foal heat’ can be avoided in most cases. Some variability does however occur.

Barren and maiden mares: Some of these animals will be found, on examination, to have a

functional corpus luteum and are either suffering from abnormal persistence of luteal function or are

simply failing to exhibit normal oestrus behaviour (‘silent heat’) while ovarian cyclicity continues.

Synchronisation of oestrus: Under some circumstances this may be a desirable objective in stud

management. Treatment during dioestrus usually induces oestrus after 2 to 4 days, with ovulation

occurring 8 to 12 days after treatment.

Nomination of the time of service: Mares may be brought into oestrus at will, simply as an aid to

successful and economic management of stallions during the breeding season.

Dosage and Administration

A single intramuscular injection of 0.5 to 1.0 mL for animals up to 400 kg bodyweight. 1.0 to 2.0 mL

for horses weighing 400 kg and above.

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EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3801 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/020/11/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3799 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/019/11/T/03

Europe -DG Health and Food Safety