MOVAPO apomorphine hydrochloride hemihydrate 50 mg/5 mL injection ampoule

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; sodium hydroxide; hydrochloric acid

Administration route:

Subcutaneous

Units in package:

5 x 5 mL ampoules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

Visual Identification: A clear, colourless or almost colourless solution, practically free from visible particles.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2008-01-30

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 6 January 2021
_ _
Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION – MOVAPO
®
(APOMORPHINE HYDROCHLORIDE HEMIHYDRATE) SOLUTION
FOR INJECTION
1
NAME OF THE MEDICINE
Apomorphine hydrochloride hemihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2 mL ampoule contains 20 mg apomorphine hydrochloride
hemihydrate.
Each 5 mL ampoule 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.
MOVAPO
is a clear, colourless or almost colourless solution practically free
from visible
particles.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MOVAPO 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 MOVAPO 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 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 6 January 2021
_ _
Page 2 of 14
PATIENT SELECTION
For patients in whom conventional therapy has failed, MOVAPO
injections are 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 to be used effectively. Adult patients through all age ranges
have been successfully
managed with apomorphine injections. MOVAPO is contraindicated in
children and
adolescents up to 18 years of age (see Section 4.3 Contraindications).
The elderly are w