Dacepton 10 mg/ml solution for injection in cartridge

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Apomorphine hydrochloride hemihydrate

Boleh didapati daripada:

EVER Valinject GmbH

Kod ATC:

N04BC; N04BC07

INN (Nama Antarabangsa):

Apomorphine hydrochloride hemihydrate

Dos:

10 milligram(s)/millilitre

Borang farmaseutikal:

Solution for injection in cartridge

Jenis preskripsi:

Product subject to prescription which may not be renewed (A)

Kawasan terapeutik:

Dopamine agonists; apomorphine

Status kebenaran:

Not marketed

Tarikh kebenaran:

2017-06-16

Risalah maklumat

PACKAGE LEAFLET: INFORMATION FOR THE USER
DACEPTON 10 MG/ML SOLUTION FOR INJECTION IN CARTRIDGE
Apomorphine hydrochloride hemihydrate
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<, nurse> or
pharmacist.
-
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<, nurse> or
pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
The name of your medicine is Dacepton 10 mg/ml solution for injection
in cartridge, which will
be referred to as Dacepton 10 mg/ml throughout this leaflet.
WHAT IS IN THIS LEAFLET
1.
What Dacepton 10 mg/ml is and what it is used for
2.
What you need to know before you use Dacepton 10 mg/ml
3.
How to use Dacepton 10 mg/ml
4.
Possible side effects
5.
How to store Dacepton 10 mg/ml
6.
Contents of the pack and other information
1.
WHAT DACEPTON 10 MG/ML IS AND WHAT IT IS USED FOR
Dacepton 10 mg/ml contains apomorphine solution for injection. It is
injected into the area
under the skin (subcutaneously) by using only the dedicated
D-mine-Pen. The active
ingredient in Dacepton 10 mg/ml is apomorphine hydrochloride
hemihydrate. There is 10 mg
of apomorphine hydrochloride hemihydrate in each millilitre of
solution.
Apomorphine hydrochloride hemihydrate belongs to a group of medicines
known as
dopamine agonists. Dacepton 10 mg/ml 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
previously been treated for Parkinson’s disease with levodopa
(another treatment for
Parkinson‘s disease) and/or other dopamine agonists.
Your doctor will help you to recognise the signs of when to
use your medicine.
Despite the name, apomorphine does not co

Ciri produk

Health Products Regulatory Authority
12 March 2024
CRN00DW7N
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dacepton 10 mg/ml solution for injection in cartridge
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 10 mg apomorphine hydrochloridehemihydrate.
Each 3 ml cartridge contains 30 mg apomorphine hydrochloride
hemihydrate.
Excipients with known effect:
Sodium metabisulphite (E223) 1 mg per ml
Sodium less than 2.3 mg per ml
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection in cartridge
The solution is clear, colourless to slightly yellow and free of
particles.
pH of 3.0 – 4.0.
Osmolality: 62,5 mOsm/kg
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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 DACEPTON 10 MG/ML SOLUTION FOR
INJECTION IN CARTRIDGE:_
Patients selected for treatment with Dacepton 10 mg/ml 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 be