APOMINE Intermittent apomorphine hydrochloride hemihydrate 30mg/3mL injection cartridge

Ország: Ausztrália

Nyelv: angol

Forrás: Department of Health (Therapeutic Goods Administration)

Aktív összetevők:

apomorphine hydrochloride hemihydrate, Quantity: 10 mg

Beszerezhető a:

Interpharma Pty Ltd

Gyógyszerészeti forma:

Injection, solution

Összetétel:

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

Az alkalmazás módja:

Subcutaneous

db csomag:

5 x 3mL

Recept típusa:

(S4) Prescription Only Medicine

Terápiás javallatok:

Apomorphine Injection 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.

Termék összefoglaló:

Visual Identification: A clear colourless or almost colourless solution.; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Engedélyezési státusz:

Registered

Engedély dátuma:

2018-06-07

Betegtájékoztató

APOMINE
® INTERMITTENT
_Apomorphine hydrochloride hemihydrate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about APOMINE
Intermittent. 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
Intermittent 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 Intermitent please
contact your health care professional.
WHAT APOMINE
INTERMITTENT IS USED
FOR
APOMINE Intermittent 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 INTERMITTENT
_WHEN YOU MUST NOT USE IT_
DO NOT USE APOMINE INTERMITTENT
IF YOU HAVE AN ALLERGY TO:
•
apomorphine
•
sodium metabisulfite (E223)
•
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
HAVE OR HAVE HAD ANY OF THE
FOLLOWING MEDICAL CONDITIONS:
•
certain forms of dementia eg.
Alzheim

Termékjellemzők

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AUSTRALIAN
PRODUCT
INFORMATION
–
APOMINE
®
INTERMITTENT
(APOMORPHINE
HYDROCHLORIDE HEMIHYDRATE) INJECTION CARTRIDGE
1.
NAME OF THE MEDICINE
Apomorphine hydrochloride hemihydrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Apomine
®
Intermittent is a sterile solution for injection containing 10 mg/mL
of apomorphine
hydrochloride hemihydrate in Water for Injections BP. Each 3 mL
cartridge contains 30 mg
apomorphine hydrochloride hemihydrate. Sodium metabisulfite 1 mg/mL is
included in the
formulation as an antioxidant.
Excipient(s) with known effect:
Sodium metabisulfite
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Apomine
®
Intermittent is a clear, colourless to slightly yellow sterile
solution for subcutaneous
injection, free from visible particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Apomine
®
Intermittent 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 Apomine
®
Intermittent 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
DOSAGE
The optimal dosage of Apomine
®
Intermittent 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.
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METHOD OF ADMINISTRATION
PATIENT
SELECTION:
For
patients
in
whom
conventional
therapy
has
failed,
Apomine
®
Intermittent
injections are only considered to be suitable for Parkinson’s
disease patients
capable of recognising
and anticipating ‘off’ phases in mo