JUROX APOMORPHINE EMETIC TABLETS

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

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Active ingredient:
APOMORPHINE HYDROCHLORIDE
Available from:
Jurox Pty Limited
INN (International Name):
apomorphine HCl(6.5mg/Tb)
Pharmaceutical form:
ORAL TABLET
Composition:
APOMORPHINE HYDROCHLORIDE ALKALOID Active 6.5 mg/Tb
Units in package:
20 Tablets
Class:
VM - Veterinary Medicine
Therapeutic group:
DOG | BITCH | CASTRATE | PUPPY
Therapeutic area:
CENTRAL NERVOUS SYSTEM
Therapeutic indications:
EMETIC | INDUCE VOMITING
Product summary:
Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG: [EMETIC]; An emetic for use in dogs.
Authorization status:
Registered
Authorization number:
48380
Authorization date:
2020-07-01

Apomorphine Emetic Tablets

page 1/2

Labelling

APR12

Vial label

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

APOMORPHINE EMETIC TABLETS

Each tablet contains

6.5 mg APOMORPHINE HYDROCHLORIDE

An emetic for use in dogs

20 Tablets

READ THE ATTACHED LEAFLET

BEFORE USING THIS PRODUCT

Jurox Pty Limited

85 Gardiner Street

Rutherford NSW 2320 Australia

STORE below 30

C (Room Temperature).

Protect from light, moisture and air.

EXP.

APVMA 48380/56499

RLP

APPROVED

Infopest

Verified

Apomorphine Emetic Tablets

page 2/2

Labelling

APR12

Leaflet

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

APOMORPHINE EMETIC TABLETS

ACTIVE CONSTITUENT: Each tablet contains 6.5 mg Apomorphine Hydrochloride

DESCRIPTION:

An emetic for use in dogs, working directly on the CNS vomiting centre.

Vomiting usually occurs within 5 minutes after administration and can last for 20

to 25 minutes.

DIRECTIONS FOR USE:

Do not use in cats.

Do not use in dogs which have ingested strong acids, alkalis or caustic

agents.

Do not use in dogs which are hypoxic, dysnopeic, in shock, seizuring,

comatose or severely depressed.

Do not use in dogs which lack normal pharyngeal reflexes, or which have

displayed protracted vomiting.

Apomorphine administration following poisoning with strychnine or other

CNS stimulants may precipitate seizures.

Do not administer a second dose if the first dose fails to produce emesis.

Care should be used when treating poisoning cases caused by CNS depressants,

due to the possible summation of effects.

Overdosage, characterised by rapid respiration, running in circles or tetanic

convulsions, can be treated by a phenothiazone derivative such as

chlorpromazine.

Haloperidol is a known potent antagonist to Apomorphine.

Administration may be either by placing a tablet under the conjunctiva, by giving

orally, or by subcutaneous or intravenous injection.

Dose rates:

Ocular or oral administration: 0.25mg/kg (1 tablet per 26 kg bodyweight).

For subcutaneous or intravenous administration, dissolve the tablet in 20mL

Water for Injections, or sterile saline or equivalent, and inject as follows:

Subcutaneous: 0.08mg/kg (0.246mL/kg when tablet dissolved in 20mL water).

Intravenous: 0.04mg/kg (0.123mL/kg when tablet dissolved in 20mL water).

FIRST AID:

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

Phone Australia 131126.

PACK:

20 tablets in plastic vial, with label containing a light protective coating.

STORAGE:

Store below 30

C (Room Temperature). Protect from light, moisture and air.

DISPOSAL

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

Made in Australia by:

JUROX Pty. Limited

85 Gardiner Street

Rutherford NSW 2320

Infoline 1800 023 312

APVMA Approval No. 48380/56499

Barragry, Thomas B (1994). Veterinary Drug Therapy, p134.

Booth NH and McDonald LE (1982). Veterinary Pharmacology and Therapeutics (5th Edition), p597.

APOMORPHINE EMETIC TABLETS

Page 1 of 5

continued

ISSUED:

15 August 2012

SAFETY DATA SHEET

Section 1: IDENTIFICATION of CHEMICAL PRODUCT and COMPANY

Product Name:

Apomorphine Emetic Tablets

Product Code:

500490 (20 tablets)

Recommended Use:

An emetic for use in dogs

Company Identification:

Jurox Pty Limited

Address:

85 Gardiner Street

Rutherford NSW 2320

Australia

Customer Centre:

1800 023 312

National Poisons Information Centre:

131126 (Australia-wide)

Emergency Telephone Number:

1800 023 312 (9a.m. – 5p.m.)

Section 2: HAZARDS IDENTIFICATION

GHS Hazard Classifications:

Respiratory Sensitiser Category 1

Skin sensitiser Category 1

GHS Pictogram:

Exclamation mark

Health hazard

Signal Word:*

Danger

Hazard Statements:*

H317

May cause an allergic skin reaction.

H334

May cause allergy or asthma symptoms or breathing difficulties if inhaled.

Precautionary Statements:*

Prevention

P261

Avoid breathing dust.

P272

Contaminated work clothing should not be allowed out of the workplace.

P280

Wear protective gloves e.g. PVC or vinyl and protective eyewear e.g. Safety

glasses with eye side shields or chemical goggles.

P285

In case of inadequate ventilation wear respiratory protection.

Response

P302+P352

IF ON SKIN: Wash with plenty of soap and water.

P304+P341

IF INHALED: If breathing is difficult, remove victim to fresh air and

keep at rest in a position comfortable for breathing.

P333+P313

If skin irritation or rash occurs: Get medical advice/attention.

P342+P311

If experiencing respiratory symptoms: Call a POISON CENTRE or

doctor.

P363

Wash contaminated clothing before reuse.

Disposal

P501

Dispose of contents/container in accordance with local/national

regulations.

* N.B.: These statements are determined by Work Health and Safety regulations and may not reflect Signal Headings and

First Aid and Safety statements on product labelling, which are determined by a competent authority.

APOMORPHINE EMETIC TABLETS

Page 2 of 5

continued

Section 3: COMPOSITION / INFORMATION on INGREDIENTS

INGREDIENT

CAS No.

CONTENT

Apomorphine hydrochloride

314-19-2

20 - 25 %

Lactose

63-42-3

75 - 80%

Section 4: FIRST AID MEASURES

First Aid Measures:

Consult the National Poisons Centre on 131126 or a doctor immediately in every case of

suspected chemical poisoning. Never give fluids or induce vomiting if a patient is unconscious

or convulsing regardless of cause of injury. If medical advice/attention is needed, have product

container or label at hand.

Inhalation:

Remove patient to fresh air. Lay patient down and keep warm and rested. If breathing is

shallow or has stopped, ensure airway is clear and apply resuscitation. If breathing is difficult,

give oxygen. Seek medical assistance immediately.

Ingestion:

If swallowed, immediately give a glass of water. First aid is not generally required. If in doubt,

contact the National Poisons Centre on 131126.

Skin:

If skin contact occurs, wash affected area thoroughly with plenty of soap and water. If skin

irritation or rash occurs, get medical advice/attention. Remove and wash / dispose of

contaminated clothing promptly.

Eye:

If eye contact occurs, rinse cautiously with water for at least 20 minutes. If eye irritation

persists, get medical advice/attention.

Advice to Doctor:

Apomorphine is a morphine derivative with structural similarities to dopamine. It is a powerful

emetic by the subcutaneous route, and an expectorant by the oral route.

Flash Point:

Not flammable.

Hazardous Combustion

If involved in a fire, may emit noxious fumes. Non-combustible – not considered to be a

Products:

significant fire risk.

Extinguishing Media:

There is no restriction on the type of extinguisher which may be used. Use extinguishing media

suitable for surrounding area.

Protective Equipment:

Gas-tight chemical resistant suit, protective gloves and breathing apparatus

Spills and Disposal:

Wear appropriate protective clothing. Exclude non-essential people from the area. Contain

spill and sweep up / absorb with inert material such as soil, sand or absorbent granules and

place in a sealable waste container. Ventilate area and wash spill site after pick-up complete.

Dispose of waste safely in an approved landfill.

Protective Clothing:

For appropriate personal protective equipment see section 8.

Environmental

Prevent from entering drains, waterways or sewers. If spill does enter waterways contact

Precautions:

local authority.

Section 5: FIRE FIGHTING MEASURES

Section 6: ACCIDENTAL RELEASE MEASURES

APOMORPHINE EMETIC TABLETS

Page 3 of 5

continued

Handling:

This is a Schedule 4 (Prescription Animal Remedy) product, available only to or through a

veterinarian. Avoid contact with skin and eyes. Use personal protective equipment as required.

Storage:

Keep out of reach of children Store below 30ºC (room temperature), under secure conditions

appropriate to local requirements for this class of drug.

Other Information:

Always read the label before use. See label for further information on handling and storage.

This MSDS describes personal protective measures relating to long term industrial and manufacturing exposure

and emergency situations, such as accidents and spills. See product label for personal protective measures

during normal use of the marketed product.

Exposure Limits:

No exposure limits have been assigned for this product. Do not handle until all safety

precautions have been read and understood.

Protective Equipment:

Safety glasses with eye side shields or chemical goggles. Chemical protective gloves, e.g.

PVC. Safety footwear or safety gumboots, e.g. rubber.

Engineering Controls:

Handle in a well-ventilated area.

Hygiene Precautions:

Do not drink, eat or smoke when handling this product. Wash hands after use.

Appearance:

Off-white to light grey tablet.

Odour:

No data.

Odour threshold:

No data.

pH:

Not applicable.

Melting Point:

No data.

Boiling Point:

Not applicable.

Flash Point:

Not flammable.

Evaporation Rate:

Not applicable.

Flammability:

Not applicable.

Upper flammability

limits:

Not applicable.

Lower flammability

limits:

Not applicable.

Vapour Pressure:

Not applicable.

Vapour density:

Not applicable.

Relative density:

No data.

Specific Gravity:

Not applicable.

Solubility in Water:

Partly soluble (disintegrates).

Partition coefficient:

Not applicable.

Auto-ignition

temperature:

No data.

Decomposition

temperature:

Not applicable.

Viscosity:

Not applicable

Stability:

When stored appropriately this product should show no significant degradation for at least 36 months

from the date of manufacture

Hazardous

Not known to occur

Polymerisation:

Materials to Avoid:

Not applicable

Section 7: HANDLING AND STORAGE

Section 8: EXPOSURE CONTROLS/PERSONAL PROTECTION

Section 9: PHYSICAL AND CHEMICAL PROPERTIES

Section 10: STABILITY AND REACTIVITY

APOMORPHINE EMETIC TABLETS

Page 4 of 5

continued

Inhalation:

Unlikely to present an inhalation hazard under normal conditions of use, but breathing of dust

from tablets may cause respiratory irritation and allergy, and therefore should be avoided.

Ingestion:

Potentially harmful if swallowed. May cause nausea, sweating and salivation.

Apomorphine hydrochloride: Oral LD

; 300 mg/kg (mouse)

Skin:

Classified as a skin sensitiser. Skin contact may cause sensitisation in certain individuals.

Eye:

Not classified as an eye irritant, but may cause transient discomfort and redness following eye

contact.

Chronic Effects:

Persistent inhalation of dust or skin contact with this product may cause allergic reactions in

some individuals.

Reproductive Toxicity:

Not considered to affect reproduction, based on the results of animal studies.

Mutagenicity:

Based on laboratory and animal testing, exposure to apomorphine may result in irreversible

effects on cellular DNA.

Carcinogenicity:

Not considered to be carcinogenic, based on the results of animal studies.

Ecotoxicity:

Not ecotoxic

Ingredient

Persistence:

Water/Soil

Persistence:

Air

Bioaccumulation

Mobility

Apomorphine

hydrochloride

HIGH

No data

available

Lactose

No data

available

Product Disposal:

Dispose of product only by using according to label or by approved waste collection.

Container Disposal:

Wrap with paper and place in garbage.

Dangerous Goods

Not classed as a Dangerous Good according to the criteria of the Australian Dangerous

Classification:

Goods (ADG) Code.

HAZCHEM Code:

None.

Poisons Schedule:

APVMA Registration No:

48380

Section 11: TOXICOLOGICAL INFORMATION

Section 12: ECOLOGICAL INFORMATION

Section 13: DISPOSAL INFORMATION

Section 14: TRANSPORT INFORMATION

Section 15: REGULATORY INFORMATION

APOMORPHINE EMETIC TABLETS

Page 5 of 5

This information is based on data believed by Jurox Pty Limited to be accurate at the time of writing but is subject to change without notice. It is given

in good faith, but no warranty expressed or implied is made as to its accuracy, completeness otherwise and no assumption of liability from howsoever

arising is made by Jurox Pty Limited by reason of the provision of this information. Every person dealing with the materials referred to herein does so

at his/her own risk absolutely and must make independent determinations of suitability and completeness of information from all sources to ensure

their proper use.

This SDS supercedes the version created on 14 January 2008 and updates the format as per the Code of Practice on

Preparation of Safety Data Sheets for Hazardous Chemicals, December 2011, published by Safe Work Australia. This

SDS also changes the name from “VR Apomorphine Hydrochloride Tablets” to “Apomorphine Emetic Tablets”.

Legend

CAS No. means a unique number assigned to a chemical by the Chemical Abstracts Service.

GHS means the ‘Globally Harmonized System of Classification and Labelling of Chemicals, 3

rd

Revised Edition’,

published by the United Nations.

LD

50

means the median lethal dose, which represents the single dose of a substance that can be expected to cause death

in 50% of animals.

PVC means Polyvinyl chloride.

References

ChemID PlusLite, http://chem.sis.nlm.nih.gov/chemidplus/chemidlite.jsp, entry for Apomorphine hydrochloride anhydrous

(RN: 314-19-2).

Hazardous Substances Data Bank (HSDB), http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?HSDB entry for APOMORPHINE

(CASRN: 58-00-4).

END OF SDS

Section 16: OTHER INFORMATION

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