APOMINE apomorphine hydrochloride hemihydrate 100 mg/20 mL solution for infusion vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

apomorphine hydrochloride hemihydrate, Quantity: 5 mg/mL

Available from:

Interpharma Pty Ltd

INN (International Name):

apomorphine hydrochloride hemihydrate

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium metabisulfite; sodium chloride; hydrochloric acid; water for injections

Administration route:

Subcutaneous

Units in package:

5 vials per pack, 1 vial per pack, 10 vials per pack

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Indicated to reduce the number and severity of ?off? phases in patients with Parkinson?s disease severely disabled by motor fluctuations refractory to conventional therapy. Initiation of therapy with apomorphine should be undertaken in a specialist unit in a hospital setting. Conventional therapy should be continued during ?on? phases.

Product summary:

Visual Identification: Clear and colourless to slightly yellow solution free from visible particles in a Type I glass vial with bromobutyl rubber closure and aluminium flip-off cap; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2016-08-16

Patient Information leaflet

Apomine (Apomorphine hydrochloride hemihydrate) Solution for Infusion
Page 1
APOMINE
®
_ _SOLUTION FOR INFUSION
Apomorphine _(a-poe-MOR-feen) _hydrochloride hemihydrate_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about APOMINE
®
_ _
Solution for Infusion. It does not
contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits
.
Your doctor has weighed
the risks of you using APOMINE
®
Solution for Infusion against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET IN A SAFE PLACE.
You may need to read it again.
For further information on
APOMINE
®
Solution for Infusion
please contact your health care
professional.
WHAT APOMINE
®
SOLUTION FOR INFUSION IS
USED FOR
APOMINE
_®_
Solution for Infusion
contains apomorphine which
belongs to a group of medicines
called dopaminergic compounds.
Apomorphine is used in the
treatment of Parkinson’s disease to
reduce the number and severity of
bouts of freezing and stiffness (or
“off” periods).
This medicine works by acting on
dopamine receptors. These
receptors help control movement
by the body.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
This medicine is available only with
a doctor’s prescription.
There is not enough information to
recommend the use of this
medicine in children under 18
years.
BEFORE YOU USE
APOMINE
® SOLUTION FOR
INFUSION
_WHEN YOU MUST NOT USE IT _
DO NOT USE APOMINE
® SOLUTION
FOR INFUSION IF YOU HAVE AN
ALLERGY TO:
•
apomorphine
•
sodium metabisulfite
•
certain types of pain killers
such as morphine or other
opioid analgesics.
Some of the symptoms of an
allergic reaction may include
shortness of breath, wheezing or
difficulty breathing; swelling of the
face, lips,

Summary of Product characteristics

Version:pfpapovi11020
Supercedes: pfpapovi10519
Page 1 of 10
AUSTRALIAN PRODUCT INFORMATION – APOMINE
® (APOMORPHINE
HYDROCHLORIDE HEMIHYDRATE) SOLUTION FOR INFUSION VIAL
1 NAME OF THE MEDICINE
Apomorphine hydrochloride hemihydrate
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 20 mL vial contains 100 mg apomorphine hydrochloride hemihydrate,
hence 1 mL of solution
contains 5 mg apomorphine hydrochloride hemihydrate (5 mg/mL).
Excipients with known effect:
sodium metabisulfite
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Apomine
®
Solution for Infusion is a clear and colourless to slightly yellow
sterile solution, free from
visible
particles and containing apomorphine hydrochloride hemihydrate in
Water for Injections.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Apomine
®
Solution for Infusion is indicated to reduce the number and severity
of ‘off’ phases in
patients
with Parkinson’s disease severely disabled by motor fluctuations
refractory to conventional therapy.
Initiation of therapy with apomorphine should be undertaken in a
specialist unit in a hospital setting.
Conventional therapy should be continued during ‘on’ phases.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
The optimal dosage of Apomine
®
Solution for Infusion must be determined on an individual patient
basis.
Hospital admission under appropriate specialist supervision is advised
when establishing a patient’s
therapeutic regime.
It is essential that the patient is established on the antiemetic
domperidone for at least 48 - 72 hours
prior to initiation of therapy.
PATIENT SELECTION:
For patients in whom conventional therapy
has failed, Apomine
®
Solution for Infusion is only
considered to be suitable for Parkinson’s disease patients capable
of recognising and anticipating ‘off’
phases in motor performance. Apomine
®
Solution for Infusion is not recommended in children and
adolescents up to 18 years of age.
The elderly are well represented in the population of patients with