RECEPTAL

Main information

  • Trade name:
  • RECEPTAL SYNTHETIC GONADOTROPHIN RELEASING HORMONE
  • Pharmaceutical form:
  • PARENTERAL LIQUID/SOLUTION/SUSPENSION
  • Units in package:
  • 10mL, 50mL
  • Class:
  • Veterinary Medicine
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • INTERVET AUSTRALIA

Documents

Localization

  • Available in:
  • RECEPTAL SYNTHETIC GONADOTROPHIN RELEASING HORMONE
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • CATTLE | COW | FINFISH | HORSE MARE (FEMALE) | PIG GILT (YOUNG BREEDING FEMALE) | RABBIT | ANGORA | BEEF | BOS INDICUS | BOS TAU
  • Therapeutic area:
  • hormone
  • Therapeutic indications:
  • ANOESTRUS | DELAYED OVULATION | EGG BINDING | FERTILITY PROBLEMS | FOLLICLE STIMULATING HORMONE | IMPROVE PREGNANCY RATE | INDUCTION OF OVULATION | ANOESTRUS | OESTRUS CYCLE | OVARIAN CYSTS
  • Product summary:
  • For the treatment of infertility of ovarian origin and improvement of pregnancy rate in cows. For the treatment of anoestrus and to induce ovulation of a mature follicle in mares. For induction of ovulation in gilts & rabbits, Finfish - see label.see leaflet for details

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Registered and available
  • Authorization number:
  • 36019/59310
  • Authorization date:
  • 17-10-2014
  • Last update:
  • 15-06-2017

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

'

RECEPTAL SYNTHETIC GONADOTROPHIN RELEASING HORMONE 36019

29 Sept 2014

TEMPLATE

FOR

RELEVANT

LABEL

PARTICULARS

(RLPs)

(Veterinary

Products)

Select appropriate:

D

New Product (include all applicable RLPs) OR

ll'1l

Variation

(highlight instructions that are

being

varied).

Approval

label

being

varied:

[APVMA No. 36019/ATS No. 55480]

Signal

heading:

PRESCRIPTION

ANIMAL

REMEDY

KEEP

OUT

OF

REACH

OF

CHILDREN

FOR

ANIMAL

TREATMENT

ONLY

Product

name:

Receptal® Synthetic Gonadotrophin Releasing

Hormone

Active

ACTIVE

CONSTITUENT:

BUSERELIN

0.004

per mL

constituent/s:

Statement

For the treatment

infertility

ovarian origin

improvement

pregnancy rates

claims:

cows. For

treatment

anoestrus

induce ovulation

a mature follicle in

mares. For induction

ovulation in gilts

rabbits.

PRESENTATION

A ready-to-use colourless, aqueous injection solution

parenteral administration.

Buserelin

equivalent

the natural LH/FSH releasing hormone produced in the

hypothalamus.

causes

simultaneous release

lutein ising hormone (LH) and follicle

stimulating hormone

(FSH)

from the pituitary.

INDICATIONS

treatment

infertility

ovarian origin

improvement

pregnancy

rate

in

cows.

synchronisation

oestrus in dairy cows

reducing

calving

conception interval in these cows when

used

in conjunction

with

analogue

with

luteolytic activity

part

day fixed time insemination

regime.

Approved

For the treatment

anoestrus

mares.

induce ovulation

a mature follicle

thereby

synchronise ovulation

more closely

with

mating in mares.

For induction

ovulation after oestrus synchronization in

order

optimize

conception rate when

used

part

a single fixed time insemination program in

gilts.

induce ovulation

rabbits

For facilitate stripping

reduce mortality due

binding

Finfish.

contents:

10

mL, 50

mL

Directions

for

Use

DIRECTIONS

FOR

USE:

Heading:

READ

THE

ENCLOSED

LEAFLET

BEFORE

USING

THIS

PRODUCT.

Restraints:

Contraindications:

Precautions:

Pagelof2

RECEPTAL SYNTHETIC GONADOTROPHIN RELEASING HORMONE

36019

Sept

2014

Side

Effects:

Dosage

&

Use

contents

within 28 days

of

broaching

the

vial. Discard

the

unused

Administration:

portion.

Receptal

preferably given by intramuscular injection;

gilts

only

recommended route

administration. However, in

other

target species,

intravenous

subcutaneous routes

also

used

desired. Syringes and

needles should

from

gamma irradiated

packs.

alcohol

disinfectant should

used

this procedure.

Cattle:

Fertility disorders

ovarian origin

Cows:

- Follicular

cysts

with

without

prolonged

signs

Nymphomania; anoestrus

- Acyclia

(true

anoestrus)

5

ml

Delayed ovulation

- Improvement

pregnancy rate

cows

Horses:

Mares:

Cystic

changes

the ovaries

with

without

prolonged

permanent oestrus

induce ovulation

a mature follicle

thereby

Synchronise ovulation

more

closely with mating in mares.

-Anoestrus

twice,y

daily until

ovulation

Pigs:

Gilts:

- For ovulation induction after oestrus synchronisation

Rabbits:

- Induction

ovulation

post-partum insemination

- Improvement

conception rate

Finfish:

facilitate stripping

male

female fish

spawning

condition,

reduce mortality due

binding.

0.75-

1.0

ml

per kg

bodyweight

Special

Notes:

Cattle:

Follicular cysts

anoestrus

treatment

follicular cysts,

unnecessary

manually express

Cysts. A

corpus luteum

luteal cyst will usually

clearly detectable on either the affected

the normal ovary within about 8

days

after administration

Receptal®.

both

cases

Page

RECEPTAL SYNTHETIC GONADOTROPHIN RELEASING HORMONE 36019

29 Sept 2014

follow-up

treatment

with prostaglandin

induce luteinisation as indicated.

The response

treatment

should be checked after I 0-14 days, and

no corpus

luteum

present,

newly formed cysts

detected,

treatment

should be

repeated. Artificial insemination

service should take place during

first oestrus,

which occurs, on average, 20 days after treatment.

anoestrus cows

no oestrus occurs with I 0-12 days of treatment,

ovaries

should be examined.

oestrus does

occur within

three

weeks of

treatment

no functional structures can be detected then

treatment

should be repeated. The use

of progesterone

association with

Receptal® should be considered.

Acyclia

cattle (true anoestrus)

When

true

anoestrus occurs

ovaries are quiescent with

absence of cyclic

activity. The reason for

failure of normal activity

be due

insufficient release

production of gonadotrophins

cause folliculogenesis.

determine

that

truly acyclic,

rectal examinations should

carried

within

I I day interval between examinations. Alternatively, two samples of

milk

should be taken for

milk

progesterone assay with

day interval between

samples. Oestrus should occur 8-22 days after treatment.

oestrus

not been

observed

this stage, a further rectal examination should be carried out.

there

are no palpable structures on

ovaries, then

treatment

should be repeated.

however, a corpus luteum

palpated, then prostaglandin F2a

its analogue should

be administered, thus allowing

animal

return

oestrus 2-3 days later.

induce cyclicity post-partum,

treat

approximately 2

3 weeks post

calving.

Note:

cases of subinvolution,

ovulation occurs before the uterus

expelled

exudate and debris

corpus luteum

that

develops

be retained, the purulent

exudate

be increased

volume,

oestrous

cycle

be interrupted and

pyometra

perpetuated.

recommended that prostaglandin be injected 7

I 0 days after

treatment

with Receptal®

minimise the

risk

of pyometra development

cases of subinvolution.

Delayed Ovulation

These conditions

treated

time of artificial insemination when using fresh

semen

natural service,

6-8 hours prior

artificial insemination with

frozen/thawed semen. Ovulation

usually induced within 24 hours of treatment.

Improvement

pregnancy rate of cows

Receptal® should be injected

time of insemination with fresh semen

hours prior

artificial insemination with frozen/thawed semen. This helps

ensure

that ovulation occurs

correct

time after insemination.

Improvement

pregnancy rate

also be achieved

a single injection on

after insemination

helping

prevent luteolysis and consequently embryo

mortality.

synchronisation of oestrus

dairy cows

herds with pregnancy rates

first service above

50%,

first parity animals

(heifers), pregnancy rates

first insemination

be reduced

after use of a

fixed time insemination program.

Receptal®,

when used as part of a I 0

fixed time oestrous synchronisation and

insemination regime

will

increase submission rates and significantly reduce

calving

conception interval. The method comprises Receptal® used

conjunction with a

Page

RECEPTAL SYNTHETIC GONADOTROPHIN RELEASING HORMONE

36019

V3-29

Sept

2014

2a analogue

with

luteolytic activity.

Day 0

(eg.

Monday)

2.5 mL Receptal®

Day 7

(eg.

Monday)

Day 9

(eg.

Wednesday)

Day I 0

(eg.

Thursday)

Note

2a analogue at recommended luteolytic dose

2.5 mL Receptal®

Fixed time Artificial insemination 20-24 hours after final

Receptal® injection.

The induction

ovulation

possible

the presence

a functional corpus

luteum.

Mares:

induce ovulation

a mature follicle

thereby

synchronise ovulation

more

closely

with

mating.

Receptal® should

administered on the first day on which

follicle

reached its

maximum

size,

this being determined

previous clinical history

rectal

examinations.

Receptal®

best given approximately 6 hours

prior

service. This may

achieved

administering Receptal® in the morning

with

service in the afternoon

same

day,

alternatively

with

the injection given

the early afternoon

service in the

evening. The mare should

served

again

next

morning

still

oestrus. If

ovulation

occurred within 24 hours after treatment, then the injection should

repeated.

Note:

The ovulatory response

a single GnRH injection

variable. Once a 35 mm

follicle

been

detected,

alternative would

treat

twice daily with I 0 mL

Receptal® until ovulation

detected

palpation

ultrasonography.

Anoestrus

Receptal® should

injected twice daily until ovulation

detected by palpation

ultrasonography. Treatment

days

required.

Pigs:

Gilts:

induct ovulation in groups

gilts after oestrus synchronization.

well

managed

piggeries, ovulation

induced

groups

cycling gilts when

oestrus cycles

have

initially synchronized

with

a course

oral progestagen

such

'Regumate' (lntervet Australia Pty Limited)

days

followed

injection

Receptal at I 15-120 hours after

progestagen course.

Then gilts

served

with

single

fixed time insemination

30-33

hours after

Receptal® administration.

Administration

PMSG

in this fixed time insemination

protocol

recommended.

The presence

the boar at

time

artificial insemination

recommended.

Rabbits:

induce ovulation

post-partum insemination.

Administer Receptal®

subcutaneous injection 24 hours after parturition.

Insemination should

carried

immediately after treatment.

Page 4

RECEPTAL SYNTHETIC GONADOTROPHIN RELEASING HORMONE 36019

Sept 2014

Improvements

conception rates.

Inject Receptal® at the time

insemination

mating.

Finfish:

Inject Receptal® by intramuscular injection, 2

above

lateral line

posterior

the dorsal fin. Stripping should

performed 2-3

days

after treatment.

General

Directions:

When using fixed time insemination regimes,

recommended that cows showing

signs

oestrus after prostaglandin treatment should

inseminated when observed

in oestrus rather than completing

synchronisation program. Additionally, trials

have

shown

that

cows holding

their first service,

the fixed

time

insemination regime

improve

calving

conception interval

days when

compared

controls.

When

including

services, the calving

conception interval

shown

improved by 7

days.

Withholding

WITHHOLDING PERIOD:

days

Period/s:

Trade

Advice:

TRADE ADVICE:

EXPORT SLAUGHTER INTERVAL: 0 days

Safety

Directions:

applicable.

First

Aid:

poisoning

occurs,

contact

doctor

Poisons

Information

Centre.

Phone

Australia

Additional

User

ADDITIONAL

SAFETY

INFORMATION

Safety:

SPECIAL PRECAUTIONS

TAKEN

BY THE PERSON ADMINISTERING THE

VETERINARY MEDICINAL PRODUCT

ANIMALS

Because

the hormonal effects

buserelin during pregnancy, women who are

could

pregnant should

handle

product. Avoid contact

with

skin

eyes.

Accidental spillage on the

skin

should

washed

immediately with

soap

water.

the preparation should by accident enter

eyes,

rinse

eyes

with

water and

necessary contact a doctor.

case

accidental self injection,

seek

medical advice

immediately

show

package

insert

label

the physician.

Environmental

Statements:

applicable.

Disposal:

DISPOSE

empty containers by wrapping

with

paper

putting in the garbage.

Storage:

STORE

between

(Refrigerate, do

freeze). Product should

exposed

temperatures below freezing.

Use contents within

days

broaching

the vial.

Discard the unused portion.

Batch and Expiry

Batch No.

Expiry

Date:

REFER TO BATCH AND EXPIRY ON BOTTOM PANEL

Name

&

address:

.jMSD

Animal

Health

lntervet Australia Pty Limited

91-1

Harpin Street, Bendigo East VIC 3550

Page 5

RECEPTAL SYNTHETIC GONADOTROPHIN RELEASING HORMONE 36019

29 Sept 2014

The following

for APVMA use only:

~:VMA

approval

136019/59310

Page

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