ENZAPROST T INJECTION

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

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Active ingredient:
DINOPROST AS DINOPROST TROMETAMOL
Available from:
CEVA ANIMAL HEALTH PTY LTD
INN (International Name):
DINOPROST AS DINOPROST TROMETAMOL
Pharmaceutical form:
PARENTERAL LIQUID/SOLUTION/SUSPENSION
Composition:
DINOPROST AS DINOPROST TROMETAMOL PROSTAGLANDIN Active 5.0 mg/ml
Units in package:
10mL; 30mL; 50mL; 5mL
Class:
VM - Veterinary Medicine
Therapeutic area:
ENDOCRINE SYSTEM
Product summary:
Poison schedule: 4; Withholding period: WITHHOLDING PERIODS: Meat: Cattle: DO NOT USE less than 3 days before slaugh ter for human consumption. Pigs: DO NOT USE less than 1 day before slaughter f or human consumption. Milk: Cattle: Ze ro (0) days.; Host/pest details: CATTLE: [CONTROL OF OESTRUS, CONTROL OF REPRODUCTION, CORPUS LUTEUM -CONTROL OF REPRODUCTION, PROSTAGLANDIN]; PIG: [CONTROL OF OESTRUS, CONTROL OF REPRODUCTION, CORPUS LUTEUM -CONTROL OF REPRODUCTION, PROSTAGLANDIN]; Poison schedule: 4; Withholding period: ; Host/pest details: CATTLE: [CONTROL OF OESTRUS, CONTROL OF REPRODUCTION, CORPUS LUTEUM -CONTROL OF REPRODUCTION, PROSTAGLANDIN]; PIG: [CONTROL OF OESTRUS, CONTROL OF REPRODUCTION, CORPUS LUTEUM -CONTROL OF REPRODUCTION, PROSTAGLANDIN];
Authorization status:
Registered
Authorization number:
68155
Authorization date:
2021-07-01

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------------------------------------------------·---~0--~----~-

Australian

Government

A.

Australian Pesticides and

Veterinary

Medicines

Authority

TEMPLATE FOR RELEVANT LABEL PARTICULARS (RLPs)

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label being varied:

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Directions for Use

Heading:

Restraints:

Contraindications:

Precautions:

Side effects:

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

ENZAPROST T INJECTION

Dinoprost 5 mg/mL (as Dinoprost trometamol)

Prostaglandin for intramuscular use

cattle and pigs.

An aid

the control of reproduction

cattle and pigs.

For oestrus control and to aid

the control

reproduction dependent

a corpus

luteum.

mU

mU

mU

This product is contraindicated for use

Cattle

pigs suffering from acute or sub-acute disorders

the vascular or

respiratory systems, gastrointestinal tract or reproductive tract.

Pregnant animals unless induction of parturition or abortion

wanted.

Cases of known hypersensitivity to the active substance.

This product is contraindicated for intravenous administration.

Induction of parturition

sows earlier than 3 days before the predicted farrowing date

may result

reduced piglet viability and/or mortalities.

Cattle:

Transient increase

rectal temperature may be seen

cattle (usually at

overdose) which is not likely

be detrimental

the animal. Limited salivation may be

seen.

used

for induction

of parturition,

retained

foetal

membranes may occur more

frequently, depending

the time of use of the product.

Pigs:

Increased

body

temperature,

respiratory

rate,

salivation,

stimulation

defaecation and urination, flushing of the skin and restlessness (arching of back,

pawing and rubbing and gnawing the crate) may be seen

pregnant sows

gilts

after use of prostaglandins. These effects resemble the signs exhibited by sows prior

to normal parturition, except they appear

condensed

time.

The effects are

usually seen within

minutes of injection and disappear within one hour.

16

Wormald

Street,

Symonston

ACT 2609

PO

Box

6182,

Kingston

ACT 2604

Australia

Tel:

+61

2 6210 4700

Fax:

+61

2 6210 4674

www.apvma.gov.au

ABN

19 495 043 447

Dosage &

administration:

READ THE ENCLOSED LEAFLET BEFORE OPENING OR USING THIS PRODUCT

Use the contents within 28 days

first broaching

the vial.

Discard the unused

portion.

Use by intramuscular injection only.

Dose:

Cattle

(25 mg)

Pigs

(10mg)

Indications and Instructions for Use:

Cattle:

The luteolytic effect

ENZAPROST T may be utilised

follows:

1. Oestrus and Ovulation:

Use to more effectively control the time of oestrus and

ovulation in cycling cattle.

Treatment

individual cows or heifers during dioestrus will

normally return to oestrus and ovulate within 2 to 4 days

treatment.

This

be advantageously employed as an effective aid toward managing oestrus

and breeding in individual animals. (Note: Administration of ENZAPROST T to cattle

within 4 days after oestrus is unlikely to

result in luteolysis of the corpus luteum.

Administration within 48 hours before the onset

the next oestrus

not influence

the timing

the oestrus after treatment).

2.

Sub-Oestrus or Silent Heat:

Use to treat cattle which have a functional corpus

luteum but do not express normal behavioural oestrus.

Individual cows or heifers may

have normal cyclical ovarian activity without detectable behavioural oestrus; this

most

common

winter months, at

peak

lactation in high producing dairy cows and in

suckled beef cows.

If a corpus luteum

present and ovulation has not occurred

previous four days, administration

ENZAPROST

T

will result in regression

corpus luteum followed by return to oestrus and ovulation.

Breeding

cattle treated with ENZAPROST

T

for sub or silent heat may be by natural

service or artificial insemination at the usual time

relation to observed oestrus or by

fixed time insemination (at

hours

and 90 hours post-treatment).

3.

Abortion:

May be used to induce abortion in cattle from 5 to 150 days

gestation.

to day 70, the interval from treatment to abortion is usually less than 4 days and

between days 80 and 120 less than 7 days.

Note:

Beyond day 150, less than 60

percent may abort within three weeks even with doses

35 mg or greater. Death may

result from a ruptured uterus, especially

cervical dilation does not occur.

Following

abortion, foetal membranes may be retained.

4.

Parturition:

used to induce parturition on or after day 270

gestation. The

interval from administration to parturition is 1 to 8 days (average 3 days).

Induction

parturition is indicated where there is risk

oversize calves or where early parturition

desired,

including

expulsion

dead

foetus

where

pregnancies

complicated by miscellaneous conditions such

mummified or macerated foetuses,

hydrops amnii, hydroallantois, etc.

5.

Controlled Breeding:

The luteolytlc effect

ENZAPROST

T

cattle can be

utilised to control the timing

oestrus

cycling cattle that have a corpus luteum. This

luteolytic activity allows a wide range

oestrus control programmes for normally

cycling animals (at least 35 days after calving).

Program 1

1.

Inject 5

ENZAPROST

T

intramuscularly;

Repeat the injection

(1

0 to 12) days; then

Inseminate at 78 (75 to 80) hours after the second ENZAPROST T injection. Oestrus

detection or observation is not required if animals were cycling normally when injected.

This programme

recommended for most herds with successful AI experience and

where females are known to be cycling.

Program 2

1.

Inject 5

ENZAPROST T intramuscularly;

18

Wormald

Street.

Symonston

ACT 2609

PO

Box

6182.

Kingston

ACT 2604

Australia

Tel:

2 6210 4700

Fax:

2 6210 4874

www.apvma.gov.au

ABN 19 495 043 447

Repeat the injection at

(10 to 12) days; then

Inseminate at

7·1

72) and

(88 to 96) hours after the second ENZAPROST

T injection.

Oestrus detection or observation is not required if animals are cycling

normally when injected.

Double insemination may increase pregnancy rates

some herds.

Program 3*

Inject 5

ENZAPROST

T

intramuscularly;

Repeat the injection at

(10 to 12) days; then

Inseminate upon detection of oestrus.

Program 4*

Inject 5

ENZAPROST T intramuscularly;

Inseminate upon detection of oestrus.

If it

unknown whether most animals to

treated are cycling, use programs 3 and

4 with

oestrus

detection

rather

than

programs

1 and

which

fixed

time

insemination.

A "clean-up" bull may be used following any ENZAPROST T program, or insemination

repeated at the next detected oestrus, one cycle later for any animals that did

not conceive at first service.

Many factors may affect the practical application of these programs

many cases

these programs may

altered

meet the requirements of a specific operation. For

instance, some veterinarians may wish to design their own

programs for specific

situations

schedules. Whilst the activity of ENZAPROST T may be easily adapted

for individualised programs, these changes should

carefully evaluated to ensure

that the success of the breeding program is not detrimentally affected.

Management Considerations

in

Cows and Heifers

ENZAPROST T

only effective

normally cycling animals which have a functional

corpus luteum.

Some ENZAPROST T programs require two injections

(10 to 12)

days apart. This avoids the need to consider the animal's precise day of oestrus cycle

at the time of first injection.

Fixed time insemination should

reserved for groups

where all or nearly all animals are known

cycling normally.

Selection

appropriate program would be dependent

a number of factors such

ease and

capability of oestrus detection, the goal

AI program, cost

semen and the

number

times cattle could

handled, The success or failure of reproduction

management is

affected

by many factors which

are also

important when

using

ENZAPROST T

regulate the time of breeding.

Some of these factors are:

Cattle must

ready

breed-

they must have a corpus luteum

the ovary of at

least 5 days of age and

healthy.

Nutrition must

adequate prior to

during the breeding season

this has a

direct effect

conception and the initiation of oestrus

heifers or return of oestrus

cycles

cows following calving.

Facilities must

adequate

allow cattle handling without being detrimental to the

animal.

Oestrus must

detected accurately if timed

is not employed.

Semen of high fertility must

used.

Semen must

inseminated properly.

Note: Following unsuccessful treatment

insemination, abnormal cycling may

experienced.

A successful

AI

program can employ ENZAPROST T effectively, but a poor

program will continue

to

be

poor unless other management deficiencies are

remedied.

18

Wormald

Street,

Symonston

ACT 2609

PO

Box

6182,

Kingston

ACT

2604

Australia

Tel:

+612

6210 4700 Fax:

2 6210 4874

www.apvma.gov.au

ABN

19495

043 447

General

directions:

Withholding

Period/s:

Trade Advice:

Safety Directions:

First Aid:

Pigs:

The luteolytic effect of ENZAPROST

T

utilised as follows:

Induction

of

Parturition

ENZAPROST

T

(2mL) may

used

induce parturition

pigs within three (3) days

the normal predicted farrowing date.

Response to treatment varies by individual

animals with a mean interval from treatment

parturition

approximately 33 hours.

This can

advantageously employed to control the time of farrowing

sows and gilts

late gestation. Treatment earlier than three days before the predicted farrowing date

may produce weak piglets and reduced survival.

Management Considerations

in

Sows

and Gilts

Successful use of ENZAPROST T for induction of parturition depends

a number of

important factors.

Since treatment must be given at a relatively specific interval

during late gestation, it

important that adequate records been maintained on:

1.

The average length of the gestation period for the animals on specific premises,

The breeding date and predicted farrowing date for each animal.

This information is essential

determine the appropriate time for treatment.

Since the objectives and potential benefits may vary by location, the development of

specific programs will

important to successful use of ENZAPROST

T.

Such

programs should

designed to meet individual needs to function as

aid to

reproductive management.

Cattle and Pigs:

Practise aseptic techniques: Use a sterile needle

syringe and

when withdrawing each dose adequately clean and disinfect the vial closure before

use. Thoroughly clean and disinfect the site of injection before injection. Take care

avoid post-injection bacterial infections, which have the potential

result

death due

to fulminant anaerobic infections.

At the first sign of infection at the injection site

employ aggressive, relevant antibiotic therapy.

WITHHOLDING

PERIODS:

Meat:

Cattle:

DO

NOT

USE less than 3 days before slaughter

for

human

consumption.

Pigs:

DO

NOT

USE less than 1

day

before slaughter

for

human

consumption.1 day

Milk:

Cattle: Zero (0) days.

EXPORT SLAUGHTER INTERVAL: (ESI): An

has not been established for this

product.

Note-

observing the meat withholding period may not be sufficient

mitigate

potential risks

export trade. Trade advice should be sought from Ceva Animal Health

Pty Ltd

(02) 9652 7000 before using this product.

FIRST AID: If poisoning occurs, contact a doctor or Poisons Information Centre.

Phone Australia 131126.

18

Wormald

Street,

Symonston

ACT

2609

PO

Box

6182,

Kingston

ACT 2604

Australia

Tel:

2 6210 4700

Fax:

2 6210 4874

WINW.apvma.gov.au

ABN 19 495 043 447

Additional user

ADDITIONAL SAFETY INFORMATION:

not allow pregnant women, asthmatics

safety:

persons with bronchial or other respiratory problems to administer this product.

Spills

of ENZAPROST

the skin should

washed off immediately with soap

water.

Instruction

Doctor -

Should

respiratory embarrassment result from

accidental

inhalation or injection

Enzaprost

humans, a rapid-action bronchodilator such

isoprenaline or salbutamol by inhalation

indicated.

Environmental

statements:

Disposal:

Dispose

of empty container by wrapping with paper and putting

garbage.

Storage:

Store

below 25°C (Air conditioning).

not freeze.

Protect from light.

Once the vial is broached, store the contents below 25°C (Air conditioning) and use

contents within 28 days.

Discard the unused portion.

Name

&

address:

Ceva Animal Health Pty

Moores

Glenorie NSW 2157 Australia

Phone: (02) 9652 7000

The following

for APVMA

only:

~=VMA

approval

APVMA No: 68155/61438

18 Wormald

Street,

Symonston

ACT 2609

PO

Box

6182,

Kingston

ACT 2604

Australia

Tel;

+61

2 6210 4700

Fax:

+61

2 6210 4874

www.apvma.gov.au

ABN

19

495 043 447

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