Apo-go PEN Solution for Injection 10mg/ml

Land: Malta

Språk: engelsk

Kilde: Medicines Authority

Aktiv ingrediens:

APOMORPHINE HYDROCHLORIDE

Tilgjengelig fra:

Britannia Pharmaceuticals Limited

ATC-kode:

N04BC07

INN (International Name):

APOMORPHINE HYDROCHLORIDE

Legemiddelform:

SOLUTION FOR INJECTION

Sammensetning:

APOMORPHINE HYDROCHLORIDE 10 mg/ml

Resept typen:

POM

Terapeutisk område:

ANTI-PARKINSON DRUGS

Autorisasjon status:

Authorised

Autorisasjon dato:

2011-11-29

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
APO-GO
® PEN 10 MG/ML SOLUTION FOR INJECTION *
Apomorphine hydrochloride
*
_Abbreviated to_
APO-go Pen
_in the text_
For use in adults
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What APO-go Pen is and what it is used for
2.
What you need to know before you use APO-go Pen
3.
How to use APO-go Pen
4.
Possible side effects
5.
How to store APO-go Pen
6.
Contents of the pack and other information
1.
WHAT APO-GO PEN IS AND WHAT IT IS USED FOR
APO-go Pen contains apomorphine solution for injection. It is injected
into the area under the skin
(subcutaneously). The active ingredient in APO-go Pen is apomorphine
hydrochloride. There is 10 mg
of apomorphine in each millilitre of solution.
Apomorphine hydrochloride belongs to a group of medicines known as
dopamine agonists. APO-go
Pen is used to treat Parkinson’s disease. Apomorphine helps to
reduce the amount of time spent in an
“off” or immobile state in people who have been previously treated
for Parkinson’s disease with
levodopa and/or other dopamine agonists. Your doctor or nurse will
help you to recognise the signs of
when to use your medicine.
Despite the name, apomorphine does not contain morphine.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE APO-GO PEN
Before you use APO-go Pen, your doctor will obtain an ECG
(electrocardiogram) and will ask for a
list of all other medicines you take. This ECG will be repeated in the
first days of your treatment and
at any point if your doctor thinks this is needed

Preparatomtale

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
APO-go PEN 10 mg/ml Solution for Injection*
_ _
_* ABBREVIATED TO _APO-GO _IN THE TEXT _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 10 mg apomorphine hydrochloride
Each 3 ml PEN contains 30 mg apomorphine hydrochloride
Excipient(s) with known effect
Sodium bisulphite 0.93 mg per ml
For a full list of excipients, see Section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection.
The solution is clear, practically colourless, odourless and free from
visible particles.
pH = 3.0 to 4.0
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The treatment of motor fluctuations (‘on-off’ phenomena) in
patients with Parkinson’s disease
which are not sufficiently controlled by oral anti-Parkinson
medication.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Selection of patients suitable for APO-go injections:
Patients selected for treatment with APO-go should be able to
recognise the onset of their
‘off’ symptoms and be capable of injecting themselves or else have
a responsible carer able to
inject for them when required.
Patients treated with apomorphine will usually need to start
domperidone at least two days
prior to initiation of therapy. The domperidone dose should be
titrated to the lowest effective
dose and discontinued as soon as possible. Before the decision to
initiate domperidone and
apomorphine treatment, risk factors for QT interval prolongation in
the individual patient
should be carefully assessed to ensure that the benefit outweighs the
risk (see section 4.4).
Apomorphine should be initiated in the controlled environment of a
specialist clinic. The
patient should be supervised by a physician experienced in the
treatment of Parkinson’s
disease (e.g. neurologist). The patient’s treatment with levodopa,
with or without dopamine
agonists, should be optimised before starting APO-go treatment.
_ _
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Posology
_Determination of the threshold dose _
The appropriate dose for each patient is established by i