MOVAPO PFS apomorphine hydrochloride hemihydrate 50mg/10mL solution for subcutaneous infusion pre-filled syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

apomorphine hydrochloride hemihydrate, Quantity: 50 mg

Available from:

Stada Pharmaceuticals Australia Pty Ltd

INN (International Name):

apomorphine hydrochloride hemihydrate

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Subcutaneous

Units in package:

5 x 10mL pre-filled syringe

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

MOVAPO PFS 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 Injection should be undertaken by a specialist unit in a hospital setting. Conventional therapy should be continued during "on" phases.

Product summary:

Visual Identification: Clear solution, practically colourless, odourless and practically free from visible particles.; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2008-08-08

Patient Information leaflet

MOVAPO
®
AND MOVAPO
®
PFS
1
MOVAPO
® AND
MOVAPO
® PFS
_apomorphine (a-poe-MOR-feen) hydrochloride hemihydrate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about MOVAPO and
MOVAPO Pre-Filled Syringe (PFS).
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 or
MOVAPO PFS 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 or MOVAPO PFS 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 AND
MOVAPO PFS ARE
USED FOR
MOVAPO and MOVAPO PFS
contain 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 OR MOVAPO
PFS
_WHEN YOU MUST NOT USE IT _
DO NOT USE MOVAPO INJECTION OR
MOVAPO PFS 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
•
sw

Summary of Product characteristics

MOVAPO PFS 6 January 2021
_ _
Page 1 of 12
AUSTRALIAN PRODUCT INFORMATION – MOVAPO
® PFS
(APOMORPHINE HYDROCHLORIDE HEMIHYDRATE) SOLUTION
FOR INJECTION IN PRE-FILLED SYRINGE
1
NAME OF THE MEDICINE
Apomorphine hydrochloride hemihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 mL pre-filled syringe contains 50 mg apomorphine hydrochloride
hemihydrate.
Sodium metabisulfite 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 in pre-filled syringe.
MOVAPO Pre-Filled Syringe (PFS) is a clear solution, practically
colourless, odourless and
practically free from visible particles.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MOVAPO PFS 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 PFS 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.
MOVAPO PFS is a pre-diluted pre-filled syringe intended for use as a
continuous
subcutaneous infusion with suitable pumps/syringe drivers.
There is no need to dilute MOVAPO PFS prior to use.
MOVAPO PFS 6 January 2021
_ _
Page 2 of 12
MOVAPO PFS is for single use in one patient only. Contains no
antimicrobial agent. For
microbial reasons, once opened the contents of the pre-filled syringe
should be used for
infusion immediately. The infusion site should be changed every 12
hours. Any unused
solution should be discarded. Do not use if the s