APOMORPHINE EMETIC TABLETS
Country: Australia
Language: English
Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)
Patient Information leaflet
(PIL)
25-01-2021
Summary of Product characteristics
(SPC)
19-06-2017
Safety Data Sheet
(SDS)
25-01-2021
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 date:
2023-07-01
Patient Information leaflet
JUROX APOMORPHINE EMETIC TABLETS
48380/12
3719
Product Name:
APVMA Approval No:
Label Name:
JUROX APOMORPHINE EMETIC TABLETS
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
Each tablet contains 6.5 mg APOMORPHINE HYDROCHLORIDE
Claims:
Label: An emetic for use in dogs.
Leaflet: 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.
Net Contents:
20 tablets
Directions for Use:
Restraints:
Contraindications:
DO NOT USE in cats, rodents or rabbits.
DO NOT USE in dogs hypersensitive to morphine.
DO NOT USE in dogs which have ingested sharp objects, strong acids,
alkalis or caustic
agents because of the risk for additional oral, oesophageal or gastric
injury with emesis.
DO NOT USE in dogs which are hypoxic, dyspnoeic, in shock, seizuring,
comatose,
severely depressed, lacking normal pharyngeal reflexes, or which have
displayed
protracted vomiting, due to increased risk of aspiration.
DO NOT USE in dogs which have ingested petroleum distillates due to
risks associated
with aspiration.
Precautions:
Apomorphine administration following poisoning with strychnine or
other CNS stimulants
may precipitate seizures.
Care should be used when treating poisoning cases caused by CNS
depressants due to
the possible summation of effects.
The safety of this drug has not been established during pregnancy and
lactation in dogs. RLP APPROVED
Side Effects:
Sedation and tachycardia are common following apomorphine
administration in dogs.
Hypersalivation and protracted vomiting can occur in dogs, which may
be treated with
maropitant or metoclopramide.
Eye redness / irritation after ophthalmic administration is possible;
flushing the conjunctiva
with sterile saline after emesis is recommended.
Overdose may result in respiratory and / or cardiac depression,
hypotension, CNS
stimulation (excitement, seizures) or depression. Naloxone may reverse
the CNS and
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Summary of Product characteristics
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 hydroch
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Safety Data Sheet
WWW.JUROX.COM.AU
Customer Service 1800 023 312
® Registered Trademark of Jurox Pty Ltd
TECHNICAL
ACTIVE CONSTITUENTS
Apomorphine hydrochloride 6.5 mg / tablet
PROPERTIES
Apomorphine Tablets are an emetic for use in dogs. Apomorphine is an
agonist of D1 and D2 receptors in the central nervous system.
Vomiting usually occurs within 5 minutes after administration and can
last for up to 25 minutes.
INDICATIONS
Induction of emesis.
PRECAUTIONS
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, dyspnoeic, 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.
Due to the possible summation of effects, care must be taken when
treating poisoning cases caused by CNS depressants.
Overdosage is characterised by rapid respiration, running in circles
or tetanic convulsions and can be treated by a phenothiazine
derivative such as chlorpromazine.¹
Haloperidol is a known potent antagonist to apomorphine.²
APOMORPHINE
Emetic Tablets
WWW.JUROX.COM.AU
Customer Service 1800 023 312
® Registered Trademark of Jurox Pty Ltd
TECHNICAL
DIRECTIONS FOR USE
FOR CONJUNCTIVAL OR ORAL ADMINISTRATION
0.25 mg/kg (1 tablet/26 kg)
Place the tablet under the conjunctiva or give orally
FOR SUBCUTANEOUS ADMINISTRATION
Dissolve the tablet in 20 mL Water for Injections or sterile saline or
equivalent (0.325 mg/mL)
Dose at 0.08 mg/kg (0.246 mL/kg)
FOR INTRAVENOUS ADMINISTRATION
Dissolve the tablet in 20mL Water for Injections or sterile saline or
equivalent (0.325 mg/mL)
Dose at 0.04 mg/kg (0.123 mL/kg)
PRESENTATION
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.
POISONS
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