MOVAPO PEN apomorphine hydrochloride hemihydrate 30 mg/3 mL Solution for Injection, Cartridge

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

apomorphine hydrochloride hemihydrate, Quantity: 30 mg

Available from:

Stada Pharmaceuticals Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Subcutaneous

Units in package:

5 x 3 mL pens

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

MOVAPO PEN 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.

Product summary:

Visual Identification: A clear, colourless solution and practically free from visible particles; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 16 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2017-11-03

Patient Information leaflet

MOVAPO PEN
®
1
MOVAPO
® PEN
_apomorphine (a-poe-MOR-feen) hydrochloride hemihydrate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about MOVAPO PEN. 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 MOVAPO
PEN 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 WITH THE MEDICINE.
You may need to read it again.
For further information on
MOVAPO PEN please refer to “A
guide to the use of apomorphine in
the treatment of Parkinson’s Disease
for patients and carers” which is
available from STADA
Pharmaceuticals Australia Pty Ltd.
WHAT MOVAPO PEN IS
USED FOR
MOVAPO PEN 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.
BEFORE YOU USE
MOVAPO PEN
_WHEN YOU MUST NOT USE IT _
DO NOT USE MOVAPO PEN IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
apomorphine or sodium
metabisulfite
•
any of the ingredients listed at the
end of this leaflet
•
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, tongue
or other parts of the body
•
rash, itching or hives on the skin
DO NOT USE THIS MEDICINE IF YOU
HA

Summary of Product characteristics

MOVAPO PEN 12 May 2020
_ _
Page 1 of 17
_ _
AUSTRALIAN PRODUCT INFORMATION – MOVAPO
® PEN
(APOMORPHINE HYDROCHLORIDE HEMIHYDRATE) SOLUTION
FOR INJECTION
1
NAME OF THE MEDICINE
Apomorphine hydrochloride hemihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 3 mL injection cartridge contains 30 mg apomorphine hydrochloride
hemihydrate, hence
1 mL of solution contains 10 mg apomorphine hydrochloride hemihydrate
(10 mg/mL).
Sodium metabisulfite 1.37 mg/mL is included in the formulation as an
antioxidant.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Solution for injection.
MOVAPO PEN is a sterile clear, colourless solution and practically
free from visible particles.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MOVAPO PEN 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
The optimal dosage of MOVAPO PEN has to 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.
If incremental dose adjustments smaller than 1 mg are required another
product containing
apomorphine should be used.
MOVAPO PEN 12 May 2020
_ _
Page 2 of 17
_ _
PATIENT SELECTION
For patients in whom conventional therapy has failed, MOVAPO PEN is
only considered to be
suitable for Parkinson’s disease patients capable of recognising and
anticipating ‘off’ phases in
motor performance. Patients must be capable and motivated for MOVAPO
PEN to be used
effectively. Adult patients through all age ranges have been
succe