Apo-go PEN 10mg/ml Solution for Injection

Negara: Malta

Bahasa: Inggris

Sumber: Medicines Authority

Bahan aktif:

APOMORPHINE HYDROCHLORIDE

Tersedia dari:

STADA Arzneimittel AG Stadastraße 2-18, 61118 Bad Vilbel, Germany

Kode ATC:

N04BC07

INN (Nama Internasional):

APOMORPHINE HYDROCHLORIDE 10 mg/ml

Bentuk farmasi:

SOLUTION FOR INJECTION IN A PRE-FILLED PEN

Komposisi:

APOMORPHINE HYDROCHLORIDE 10 mg/ml

Jenis Resep:

POM

Area terapi:

ANTI-PARKINSON DRUGS

Status otorisasi:

Authorised

Tanggal Otorisasi:

2011-11-29

Selebaran informasi

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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 do

Karakteristik produk

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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 the 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 = 2.5 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.
_ _
Posology
_Determination of the threshold dose _
The appropriate dose for each patient is established by increm