CHORULON CHORIONIC GONADOTROPHIN 10000 I.U.

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

Buy It Now

Active ingredient:
GONADOTROPHIN-CHORIONIC
Available from:
Intervet Australia Pty Limited
INN (International Name):
gonadotrophin-chorionic(2000IU/mL)
Pharmaceutical form:
PARENTERAL LIQUID/SOLUTION/SUSPENSION
Composition:
GONADOTROPHIN-CHORIONIC HORMONE-GONADOTROPHIN Active 2000.0 IU/ml
Units in package:
#5 x 5mL; #diluent; *5x10000IU; *vial/bot
Class:
VM - Veterinary Medicine
Manufactured by:
INTERVET AUSTRALIA
Therapeutic group:
DOG | FISH - COMMERCIAL | HEIFER (YOUNG FEMALE CATTLE) | HORSE MARE (FEMALE) | BITCH | BOVINE | CASTRATE | COW YOUNG | FEMALE HO
Therapeutic area:
ENDOCRINE SYSTEM
Therapeutic indications:
HORMONAL MANIPULATION
Product summary:
Poison schedule: 4; Withholding period: WITHHOLDING PERIOD: Zero (0) days. EXPORT SLAUGHTER INTERVAL (ESI): Zero ( 0) days.; Host/pest details: DOG: [HORMONAL MANIPULATION]; FISH - COMMERCIAL: [HORMONAL MANIPULATION]; HEIFER (YOUNG FEMALE CATTLE): [HORMONAL MANIPULATION]; HORSE MARE (FEMALE): [HORMONAL MANIPULATION]; Poison schedule: 4; Withholding period: ; Host/pest details: DOG: [HORMONAL MANIPULATION]; FISH - COMMERCIAL: [HORMONAL MANIPULATION]; HEIFER (YOUNG FEMALE CATTLE): [HORMONAL MANIPULATION]; HORSE MARE (FEMALE): [HORMONAL MANIPULATION]; For hormonal manipulation in cattle, horses, dogs, and fish.
Authorization status:
Registered
Authorization number:
53659
Authorization date:
2020-07-01

CHORULON®

Chorionic

Gonadotrophin

10000

53659

TEMPLATE

RELEVANT

LABEL

PARTICULARS

(RLPs)

(Veterinary

Products)

Select appropriate:

New Product (include all applicable RLPs) OR

li1l

Variation

(highlight instructions that are

being

varied).

Approval

of label

being

varied:

[APVMA

53659/1 OIU/0409

Signal heading:

PRESCRIPTION

ANIMAL

REMEDY

KEEP

REACH

CHILDREN

ANIMAL

TREATMENT

ONLY

Product name:

CHORULON®

Chorionic

Gonadotrophin

10000 IU

CHORULON®

Chorionic

Gonadotrophin

0000

Phosphate

Buffered

Saline

Diluent

Active

Chorionic gonadotrophin

2000

IU/mL

constituent/s:

Chorionic gonadotrophin

2000

IU/mL

(when

reconstituted 10000

When reconstituted with CHORULON® 10000

freeze dried powder

will

contain 2000

IU/ml

HCG.

Statement of

hormonal manipulation

cattle, horses, dogs

fish.

claims:

MODE

ACTION:

CHORULON®

presented

a white freeze-dried crystalline plug containing CHORIONIC

GONADOTROPHIN,

together

with

diluent

pack.

CHORULON® (chorionic gonadotrophin) is a complex glycoprotein capable of supplementing

and being substituted for the lutein ising hormone secreted by the anterior pituitary gland

both

the male and female. In the female, CHORULON®promotes maturation of the follicle, ovulation

and the formation of the corpus luteum.

the male, CHORULON®stimulates the production of

testosterone and thus influences the development and maintenance of primary and secondary

Approved

male sex characteristics. CHORULON®is also suitable for hormonal control

offish

reproduction.

These properties make CHORULON® suitable for the treatment of several fertility problems in

domestic animals

it regulates and re-establishes the normal oestrus cycle.

Net contents:

10000

bottles

with

5 mL

diluent

Directions for Use

READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT.

Heading:

DIRECTIONS FOR USE:

DIRECTIONS

USE:

(FISH)

CHORULON® should

used under the guidance of a veterinarian. experienced with the

breeding of intended recipient fish species. The doses and general breeding advice provided in

table below are intended as a general guide only and specific advice from the prescribing

veterinarian should

followed. Broodstock should have fully developed gonads with eggs and

milt present, prior

injection. Give by intraperitoneal injection. This route involves the risk of

damaging or infecting the intestines

the fish.

Anaesthesia is often needed to avoid stress and

reduce backflow of fluid after withdrawal

syrinoe.

Restraints:

Contraindications:

Precautions:

In rare cases,

with all protein preparations, anaphylactoid incidents may occur shortly after

injection. Adrenaline injection

000) given

when symptoms appear is the standard

treatment. The administration

corticosteroid may also be indicated.

Extensive safety testing has not been conducted on

ev~cies

of fish.

Side

Effects:

Page

CHORULON®

Chorionic

Gonadotrophin

I 0000

53659

Dosage

&

Withdraw 5

diluent and reconstitute

CHORULON®

vial. Transfer reconstituted material to

Administration:

remainder

diluent and mix

gentle inversion. Repeat this process

thoroughly flush out

CHORULON®

vial. Use immediately. Give by intramuscular

subcutaneous injection.

Animal Species

Indications

Dosage

Administration

Cow,

heifer

Improvement

conception rate

1500

SCat

Cystic ovary syndrome, anoestrus,

3000

prolonged oestrus and/or

nymphomania due

cystic follicle

degeneration

Anoestrus (silent heat with small

1500-3000

or5C

follicles)

Mare

Anoestrus (follicles?. 2 em diameter)

1500

3000

Repeat

necessary after

days.

Induction

ovulation

improve

1500

5000

mating

conception rate

Bitch

Anoestrus

After

pre-(reatment

with

PMSG

(FOLLIGON®) 500

first

oestrus

Delayed ovulation, prolonged

oestrus

Repeat

treatment

until

vaginal discharge disappears

Male Dog

Cryptorchidism

Twice weekly

weeks

Deficiency

libido

hours before

mating

Fish

Reproduction

Refer

reverse side

leaflet.

Anoestrus

is often

caused

inadequate

management

(feeding

housing).

Therefore

improvement

management

is a

pre-requisite

successful

treatment.

product

does

contain

preservative.

Following reconstitution

recommended

preparation

immediately

discard

unused

portion.

sinale

only.

Fish

Species

Dose

(IU/kg

General

breeding

guidance

Silver perch

(Bidyanus

bidyanus)

150-200

Season:

October

February

Oocyte

diameter: 0.7-1.0 mm

Salinity: 0

° /

Water

temperature:

15°C.

Golden Perch

(Macquaria

ambigua)

Season:

October

February

Oocyte

diameter: >0.9

Salinity: 0

Water

temperature: 23-25°C.

Trout

(Maccullachel/a

macquariensis)

000-3000

Season: August-September

500-1500

Oocyte

diameter: 2.3-3.4 mm

Salinity: 0

Water

temperature: 14-20°C

Australian

Bass

(Macquaria

novemacuieata)

500-1

Season:

Mid-May

August

Salinity: 15-35 o

Water

temperature: I B-20°C.

Murray Cod

(Maccul/achel/a

pee/i~

000-1000

Season: September to November

Salinity: 0

Water

temperature: 20-21

Macquarie Perch

(Macquoria

australasica)

Season:

October

December

Salinity: 0

Water

temperature: I B-20oC

Black

Bream

(Acanthopagrus

butcher!)

Season:

October-December

Inject immediately after capture

from wild.

Water

temperature: 18-20°C

Snapper

(Pagrus

aurotus)

'"d

Season:

October

January

Oocyte

diameter: >0.9mm

Salinity: 35

° /

Water

temperature: 20°C

Goldfish

(Carassius

auratus

auratus

Season: August-September

Page 2

CHORULON®

Chorionic

Gonadotrophin

10000 IU

53659

Salinity: 0

Water

temperature: 20·22°C

IU/kg

International units per kilogram

bodyweight

male; F

female

General Direction-s:

Withholding

Periodls:

WITHHOLDING PERIOD:

Zero

days.

Trade Advice:

EXPORT

SLAUGHTER INTERVAL (ESI): Zero

days.

Safety Directions:

First

Aid:

If poisoning occurs, contact a

doctor

or Poisons Information Centre.

Phone Australia 13

Additional

User

Safety:

Environmental

Statements:

Disposal:

Dispose

of empty containers

outer packaging by wrapping with paper and putting in garbage.

Storage:

Store

below 25°C (Air conditioning).

Protect from light.

Batch and Expiry

Batch

Expiry Date

Name

&

address:

The following is for

APVMA

use only:

:VMA

approval

153659/56011

Page 3

Product Name: Chorulon Chorionic Gonadotrophin

MATERIAL SAFETY DATA SHEET

This revision issued: July, 2009

Page: 1 of 5

MATERIAL SAFETY DATA SHEET

Issued by: Intervet Australia Pty Limited Phone: 1 800 033 461 (Business Hours)

Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800 764 766 in New Zealand)

Substance:

Gonadotrophin is a hormone. Other ingredients include a caking agent and a buffer

system.

Trade Name:

Chorulon Chorionic Gonadotrophin

Other names:

This MSDS is intended for three variants of a basic product, differing only in the quantity

of Gonadotrophin in the vial.

Recommended Use:

Source of luteinizing hormone for gonadogenesis by injection in horses, cattle, dogs and

fish.

APVMA No:

37225, 37226, 53659

Creation Date:

November, 2006

This version issued:

July, 2009

and is valid for 5 years from this date.

Statement of Hazardous Nature:

This product is classified as:

Not classified as hazardous according to the criteria of SWA.

Not a Dangerous Good according to the Australian Dangerous Goods (ADG) Code.

Risk Phrases:

Not Hazardous - No criteria found.

Safety Phrases:

S45. In case of accident or if you feel unwell, contact a doctor or Poisons Information Centre

immediately (show the label where possible).

SUSDP Classification:

ADG Classification:

None allocated. Not a Dangerous Good under the ADG Code.

UN Number:

None allocated

Physical Description & Colour:

This product comprises a white to off-white freeze dried powder or plug, and

clear aqueous solution for reconstitution prior to use.

Odour:

No odour.

Major Health Hazards:

no significant risk factors have been found for this product.

Gonadotrophin mimics the action of the pituitary hormone luteinising hormone which controls the release of eggs from the

ovary in women, and controls production of the male hormone, testosterone in men. It stimulates egg release (ovulation)in

some infertile women after follicle development has been stimulated with follicle stimulating hormone (FSH). In men it is

used in the management of delayed puberty, undescended testes and oligospermia (low sperm count).

Gonadotrophin given parenterally can profoundly influence human fertility so care must be taken to avoid accidental self

injection. The effect however is strongly dose dependent. HCG is a glycoprotein and is inactive if taken orally, however

with glycoproteins there is always the risk of an anaphylactoid reaction from parenteral use.

In addition, side effects in humans from Gonadotrophin injection include headache, tiredness, moods, oedema and pain

at injection site.

Inhalation:

Potential Health Effects

Emergency Overview

Section 2 - Hazards Identification

Section 1 - Identification of Chemical Product and Company

Intervet Australia Pty Limited

91-105 Harpin Street

Tel: 1 800 033 461

Bendigo East, Vic 3550, AUSTRALIA

Fax: 1 800 817 414

Company ABN: 79 008 467 034

Product Name: Chorulon Chorionic Gonadotrophin

MATERIAL SAFETY DATA SHEET

This revision issued: July, 2009

Page: 2 of 5

MATERIAL SAFETY DATA SHEET

Issued by: Intervet Australia Pty Limited Phone: 1 800 033 461 (Business Hours)

Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800 764 766 in New Zealand)

Short Term Exposure:

Available data indicates that this product is not harmful. In addition product is unlikely to

cause any discomfort or irritation.

Long Term Exposure:

No data for health effects associated with long term inhalation.

Skin Contact:

Short Term Exposure:

Available data indicates that this product is not harmful. It should present no hazards in

normal use. In addition product is unlikely to cause any discomfort in normal use.

Long Term Exposure:

No data for health effects associated with long term skin exposure.

Eye Contact:

Short Term Exposure

: This product is believed to be not irritating to eyes.

Long Term Exposure

: No data for health effects associated with long term eye exposure.

Ingestion:

Short Term Exposure

: Significant oral exposure is considered to be unlikely. This product is unlikely to cause any

irritation problems in the short or long term.

Long Term Exposure

: No data for health effects associated with long term ingestion.

Carcinogen Status:

SWA:

No significant ingredient is classified as carcinogenic by SWA.

NTP:

No significant ingredient is classified as carcinogenic by NTP.

IARC:

No significant ingredient is classified as carcinogenic by IARC.

Ingredients

CAS No

Conc,%

TWA (mg/m

3

)

STEL (mg/m

3

)

Gonadotropin, chorionic

9002-61-3

not set

not set

Other non hazardous ingredients

various

<5

not set

not set

Water

7732-18-5

to 100

not set

not set

** There are three variations of this product, containing 1500, 5000 and 10000iu gonadotrophin/vial.

This is a commercial product whose exact ratio of components may vary slightly. Minor quantities of other non hazardous

ingredients are also possible.

The SWA TWA exposure value is the average airborne concentration of a particular substance when calculated over a normal 8 hour working day for a

5 day working week. The STEL (Short Term Exposure Limit) is an exposure value that may be equalled (but should not be exceeded) for no longer than

15 minutes and should not be repeated more than 4 times per day. There should be at least 60 minutes between successive exposures at the STEL.

The term "peak "is used when the TWA limit, because of the rapid action of the substance, should never be exceeded, even briefly.

General Information:

You should call The Poisons Information Centre if you feel that you may have been poisoned, burned or irritated

by this product. The number is 13 11 26 from anywhere in Australia (0800 764 766 in New Zealand) and is

available at all times. Have this MSDS with you when you call.

Self Injection: Accidental self injection may lead to an inflammatory response. Medical advice should be sought on the

management of deep injections, particularly those near a joint or associated with bruising. If possible the application of

gentle squeezing pressure with absorbent material (e.g. facial tissues) at the injection site will swab up unabsorbed

vaccine. Strong squeezing of the site should be avoided. The damaged area should be thoroughly cleansed and a topical

antiseptic applied.

Contact or Poisoning:

From the available evidence, this product would appear to offer no significant health

hazard by any exposure route except by injection. Consequently, First Aid is not generally required. If in doubt, contact a

Poisons Information Centre or a doctor.

Section 3 - Composition/Information on Ingredients

Section 4 - First Aid Measures

Section 5 - Fire Fighting Measures

Product Name: Chorulon Chorionic Gonadotrophin

MATERIAL SAFETY DATA SHEET

This revision issued: July, 2009

Page: 3 of 5

MATERIAL SAFETY DATA SHEET

Issued by: Intervet Australia Pty Limited Phone: 1 800 033 461 (Business Hours)

Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800 764 766 in New Zealand)

Fire and Explosion Hazards:

There is no risk of an explosion from this product under normal circumstances if it is

involved in a fire.

Only small quantities of decomposition products are expected from this products at temperatures normally achieved in a

fire. This will only occur after heating to dryness.

Fire decomposition products from this product are not expected to be hazardous or harmful.

Extinguishing Media

: Not Combustible. Use extinguishing media suited to burning materials.

Fire Fighting

: If a significant quantity of this product is involved in a fire, call the fire brigade.

Flash point

:

Does not burn.

Upper Flammability Limit:

Does not burn.

Lower Flammability Limit:

Does not burn.

Autoignition temperature:

Not applicable - does not burn.

Flammability Class:

Does not burn.

Accidental release

: This product is sold in small packages, and the accidental release from one of these is not

usually a cause for concern. For minor spills, refer to product label for specific instructions. No special protective clothing

is normally necessary because of this product. However it is good practice to wear latex gloves when handling vaccines.

In the event of a major spill, prevent spillage from entering drains or water courses and call emergency services.

Handling

: Keep exposure to this product to a minimum, and minimise the quantities kept in work areas. Check Section

8 of this MSDS for details of personal protective measures, and make sure that those measures are followed. The

measures detailed below under "Storage" should be followed during handling in order to minimise risks to persons using

the product in the workplace. Also, avoid contact or contamination of product with incompatible materials listed in Section

10.

Storage

: This product is a Scheduled Poison. Observe all relevant regulations regarding sale, transport and storage of

this schedule of poison. Store in the closed original container in a dry, cool (8°C before reconstitution and 2-8°C after

reconstitution), well-ventilated area out of direct sunlight. Make sure that the product does not come into contact with

substances listed under "Incompatibilities" in Section 10. Some liquid preparations settle or separate on standing and may

require stirring before use. Check packaging - there may be further storage instructions on the label.

The following Australian Standards will provide general advice regarding safety clothing and equipment:

Respiratory equipment: AS/NZS 1715, Protective Gloves: AS 2161, Industrial Clothing: AS2919, Industrial Eye

Protection: AS1336 and AS/NZS 1337, Occupational Protective Footwear: AS/NZS2210.

SWA Exposure Limits

TWA (mg/m

3

)

STEL (mg/m

3

)

Exposure limits have not been established by SWA for any of the significant ingredients in this product.

No special equipment is usually needed when occasionally handling small quantities. The following instructions are for

bulk handling or where regular exposure in an occupational setting occurs without proper containment systems.

Ventilation:

No special ventilation requirements are normally necessary for this product. However make sure that the

work environment remains clean and that vapours and mists are minimised.

Eye Protection:

Eye protection is not normally necessary when this product is being used. However, if in doubt, wear

suitable protective glasses or goggles.

Skin Protection:

The information at hand indicates that this product is not harmful and that normally no special skin

protection is necessary. However, we suggest that you routinely avoid contact with all chemical products and that you

wear suitable gloves (preferably elbow-length) when skin contact is likely.

Protective Material Types:

There is no specific recommendation for any particular protective material type.

Section 8 - Exposure Controls and Personal Protection

Section 7 - Handling and Storage

Section 6 - Accidental Release Measures

Product Name: Chorulon Chorionic Gonadotrophin

MATERIAL SAFETY DATA SHEET

This revision issued: July, 2009

Page: 4 of 5

MATERIAL SAFETY DATA SHEET

Issued by: Intervet Australia Pty Limited Phone: 1 800 033 461 (Business Hours)

Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800 764 766 in New Zealand)

Respirator:

Usually, no respirator is necessary when using this product. However, if you have any doubts consult the

Australian Standard mentioned above.

Physical Description & Colour

This product comprises a white to off-white freeze dried powder or plug, and

clear aqueous solution for reconstitution prior to use.

Odour:

No odour.

Boiling Point:

Approximately 100°C at 100kPa (liquid only).

Freezing/Melting Point:

Approximately 0°C (liquid); decomposes (solid).

Volatiles:

Water component.

Vapour Pressure:

2.37 kPa at 20°C (water vapour pressure).

Vapour Density:

No data.

Specific Gravity:

No data.

Water Solubility:

Completely soluble in water.

pH:

6.5-7.2

Volatility:

No data.

Odour Threshold:

No data.

Evaporation Rate:

No data.

Coeff Oil/water Distribution

No data

Autoignition temp:

Not applicable - does not burn.

Reactivity:

This product is unlikely to react or decompose under normal storage conditions. However, if you have any

doubts, contact the supplier for advice on shelf life properties.

Conditions to Avoid:

Store in the closed original container in a dry, cool, well-ventilated area out of direct sunlight.

Incompatibilities:

acids, bases, oxidising agents, reducing agents.

Fire Decomposition:

Only small quantities of decomposition products are expected from this products at

temperatures normally achieved in a fire. This will only occur after heating to dryness. Carbon dioxide, and if combustion

is incomplete, carbon monoxide and smoke. Water. Carbon monoxide poisoning produces headache, weakness, nausea,

dizziness, confusion, dimness of vision, disturbance of judgment, and unconsciousness followed by coma and death.

Polymerisation:

This product will not undergo polymerisation reactions.

Local Effects:

Target Organs:

Ingredient

Risk Phrases

No ingredient mentioned in the HSIS Database is present in this product at hazardous concentrations.

This product is biodegradable. It will not accumulate in the soil or water or cause long term problems.

Classification of Hazardous Ingredients

Section 9 - Physical and Chemical Properties

Section 10 - Stability and Reactivity

Section 11 - Toxicological Information

Section 12 - Ecological Information

Section 13 - Disposal Considerations

Product Name: Chorulon Chorionic Gonadotrophin

MATERIAL SAFETY DATA SHEET

This revision issued: July, 2009

Page: 5 of 5

MATERIAL SAFETY DATA SHEET

Issued by: Intervet Australia Pty Limited Phone: 1 800 033 461 (Business Hours)

Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800 764 766 in New Zealand)

Disposal:

There are many pieces of legislation covering waste disposal and they differ in each state and territory, so

each user must refer to laws operating in their area. In some areas, certain wastes must be tracked. The Hierarchy of

Controls seems to be common - the user should investigate: Reduce, Reuse, and Recycle and only if all else fails should

disposal be considered. Note that properties of a product may change in use, so that the following suggestions may not

always be appropriate. The following may help you in properly addressing this matter for this product. This product may

be recycled if unused, or if it has not been contaminated so as to make it unsuitable for its intended use. If it has been

contaminated, it may be possible to reclaim the product by filtration, distillation or some other means. If neither of these

options is suitable, consider controlled incineration, or landfill.

ADG Code:

This product is not classified as a Dangerous Good. No special transport conditions are necessary unless

required by other regulations.

AICS:

All of the significant ingredients in this formulation are compliant with NICNAS regulations.

The following ingredients: Gonadotropin, chorionic, are mentioned in the SUSDP.

This MSDS contains only safety-related information. For other data see product literature.

Acronyms:

ADG Code

Australian Code for the Transport of Dangerous Goods by Road and Rail, 7th Edition

AICS

Australian Inventory of Chemical Substances

SWA

Safe Work Australia, formerly ASCC and NOHSC

CAS Number

Chemical Abstracts Service Registry Number

Hazchem Code

Emergency action code of numbers and letters that provide information to emergency

services especially firefighters

IARC

International Agency for Research on Cancer

NOS

Not otherwise specified

NTP

National Toxicology Program (USA)

R-Phrase

Risk Phrase

SUSDP

Standard for the Uniform Scheduling of Drugs & Poisons

UN Number

United Nations Number

THIS MSDS SUMMARISES OUR BEST KNOWLEDGE OF THE HEALTH AND SAFETY HAZARD INFORMATION OF THE PRODUCT AND HOW TO

SAFELY HANDLE AND USE THE PRODUCT IN THE WORKPLACE. EACH USER MUST REVIEW THIS MSDS IN THE CONTEXT OF HOW THE

PRODUCT WILL BE HANDLED AND USED IN THE WORKPLACE.

IF CLARIFICATION OR FURTHER INFORMATION IS NEEDED TO ENSURE THAT AN APPROPRIATE RISK ASSESSMENT CAN BE MADE, THE

USER SHOULD CONTACT THIS COMPANY SO WE CAN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION FROM OUR SUPPLIERS

OUR RESPONSIBILITY FOR PRODUCTS SOLD IS SUBJECT TO OUR STANDARD TERMS AND CONDITIONS, A COPY OF WHICH IS SENT TO

OUR CUSTOMERS AND IS ALSO AVAILABLE ON REQUEST.

Please read all labels carefully before using product.

This MSDS is prepared in accord with the SWA document “National Code of Practice for the

Preparation of Material Safety Data Sheets” 2nd Edition [NOHSC:2001(2003)]

Section 14 - Transport Information

Section 15 - Regulatory Information

Section 16 - Other Information

Similar products

Search alerts related to this product

View documents history

Share this information