Revised: September 2014 AN: 00641/2014 SUMMARY OF

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Revised: September 2014
AN: 00641/2014
SUMMARY OF PRODUCTS CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Apometic 10mg/ml Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains
Active substance
Apomorphine hydrochloride
10 mg
Excipients
Sodium metabisulphite
1.0 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for Injection
Clear, colourless or almost colourless solution
4.
CLINICAL PARTICULARS
4.1
Target species
Dogs
4.2
Indications for use, specifying the target species
To induce emesis in dogs that have, or are suspected to have, ingested
substances that may be poisonous.
4.3
Contraindications
Do not use in cases of depression of the central nervous system.
Do not use in cats and other species.
Do not use in cases of caustic poisoning or where gastric foreign bodies may
be present.
Do not use in cases of poisoning due to pyrethroids
Do not use in animals known to be hypersensitive to apomorphine or any
other excipients.
4.4
Special warnings for each target species
Do not exceed the recommended dosage. Emesis occurs rapidly (within 10
minutes). If emesis is not induced following a single injection, repeated
injections will also prove ineffective and should not be given.
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Revised: September 2014
AN: 00641/2014
4.5
Special precautions for use
i. Special precautions for use in animals
Use of the product is not recommended if the poison was ingested, or
suspected to be ingested, more than 2 hours previously.
The use of the product in cases of known or suspected hepatic
impairment should be in accordance with a risk/benefit assessment by
the responsible veterinarian.
ii. Special precautions for the person administering the veterinary
medicinal product to animals
Avoid accidental self-injection. In case of accidental self-injection,
seek medical advice immediately and show the package leaflet or
label to the doctor.
Avoid contact with skin and eyes. In case of contact with skin or eyes,
rinse immediately with fresh water.
iii. Other precautions
None
4.6
Adverse reactions (frequency and seriousness)
Adverse effects include hypotension, drowsiness and/or sedation, dyskinesia
and protracted vomiting.
The decrease in blood pressure is dose-dependent. The maximum decrease
in blood pressure is normally reached after 5 minutes following i.v. dose and
the blood pressure returns to basal level after 10 to 30 minutes.
4.7
Use during pregnancy, lactation or lay
No data are available. Use only according to the benefit/risk assessment by
the responsible veterinarian.
4.8
Interaction with other medicinal products and other forms of interaction
Dopamine antagonists (e.g. phenothiazines) may negate the emetic effect of
apomorphine.
4.9
Amount(s) to be administered and administration route
Dogs: 0.2 mg per kg bodyweight (0.02 ml/kg bodyweight), by subcutaneous
injection.
Weigh animals before treatment.
Use a 1ml syringe graduated to 0.01ml to facilitate accurate dosing
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Revised: September 2014
AN: 00641/2014
4.10
Overdose (symptoms, emergency procedures, antidotes), if necessary
Overdose may result in respiratory and/or cardiac depression, CNS
stimulation or depression and protracted vomiting. Doses of 0.4 mg/kg - 1.6
mg/kg administered intravenously in dogs resulted in a short period of
sedation followed by incessant running lasting from ½ to 1 hour from which
the animals recovered. Naloxone may reverse the respiratory and CNS
effects of the product but not the emetic effects.
4.11
Withdrawal period(s)
Not applicable
5.
PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Dopamine agonists
ATC Vet Code: QN04BC07
5.1
Pharmacodynamic properties
Apomorphine is a synthetic derivative of morphine with no analgesic, opiate
or addictive properties. At low doses, apomorphine induces emesis by
stimulation of the dopamine receptors in the chemoreceptor trigger zone
(CTZ).
Higher doses of apomorphine, however, may suppress vomiting by
stimulating the µ receptors in the vomiting centre in the brain.
It may lower blood pressure and body temperature and increase heart rate
but these effects are transient. It may also increase cortisol levels, reduce
gastrin and insulin levels but these effects disappear within 30-60 minutes.
5.2
Pharmacokinetic properties
Absorption
After subcutaneous administration apomorphine is rapidly absorbed.
Concentrations sufficient to induce emesis in the dog are achieved during the
first 3-10 minutes and peak plasma concentrations are achieved in 20 to 25
minutes.
Distribution
Apomorphine is lipophilic and it penetrates tissues well. Diffusion across the
blood-brain barrier is rapid after injection.
Metabolism
Apomorphine is extensively metabolised by the liver into non-active
metabolites.
Excretion
The metabolites and very little unchanged apomorphine (<2%) are excreted
via the urine. The half-life of apomorphine in dogs is 30-64 minutes.
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Revised: September 2014
AN: 00641/2014
6.
PHARMACEUTICAL PARTICULARS
6.1
List of excipients
Sodium metabisulphite
Hydrochloric acid
Sodium hydroxide
Water for injections
6.2
Incompatibilities
In the absence of compatibility studies, apomorphine must not be mixed with
other veterinary medicinal products.
6.3
Shelf life
The shelf life of the veterinary medicinal product as packaged for sale: 3
years.
For single use only. Any unused solution should be discarded.
6.4
Special precautions for storage
Do not store above 25°C.
Store in the original package to protect from light.
The solution should be inspected visually prior to use. Only clear and
colourless solutions should be used.
6.5
Nature and composition of immediate packaging
Clear glass (Ph Eur Type I) ampoules containing 2 ml solution for injection, in
packs of 2 or 5 ampoules in a cardboard box.
Not all pack sizes may be marketed.
6.6
Special precautions for the disposal of unused veterinary medicinal
product or waste materials derived from the use of such products, if
appropriate
Any unused veterinary medicinal product or waste materials derived from
such veterinary medicinal products should be disposed of in accordance with
local requirements.
7.
MARKETING AUTHORISATION HOLDER
Forum Products Limited
Crown House
2-8 Gloucester Road
Redhill
Surrey
RH1 1FH
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Revised: September 2014
AN: 00641/2014
8.
MARKETING AUTHORISATION NUMBER
Vm 05928/4006
9.
DATE OF FIRST AUTHORISATION
Date: 26 April 2013
10.
DATE OF REVISION OF THE TEXT
Date: September 2014
Prohibition of sale, supply and/or use:
None
03 October 2014
Page 5 of 5
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