Dacepton 5 mg/ml solution for infusion

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Apomorphine hydrochloride hemihydrate

Tersedia dari:

EVER Valinject GmbH

Kode ATC:

N04BC; N04BC07

INN (Nama Internasional):

Apomorphine hydrochloride hemihydrate

Dosis:

5 milligram(s)/millilitre

Bentuk farmasi:

Solution for infusion

Jenis Resep:

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

Area terapi:

Dopamine agonists; apomorphine

Status otorisasi:

Not marketed

Tanggal Otorisasi:

2014-05-09

Selebaran informasi

PACKAGE LEAFLET: INFORMATION FOR THE USER
DACEPTON 5 MG/ML
solution for infusion
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 5
mg/ml solution for infusion, which will be referred to as
Dacepton 5
mg/ml throughout this leaflet.
WHAT IS IN THIS LEAFLET
1.
What Dacepton 5 mg/ml is and what it is used for
2.
What you need to know before you use Dacepton 5 mg/ml
3.
How to use Dacepton 5 mg/ml
4.
Possible side effects
5.
How to store Dacepton 5 mg/ml
6.
Contents of the pack and other information
1.
WHAT DACEPTON 5 MG/ML IS AND WHAT IT IS USED FOR
Apomorphine hydrochloride hemihydrate belongs to a group of medicines
known as dopamine
agonists. Dacepton 5 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 or nurse will help you to recognise the signs of when to
use your medicine.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DACEPTON 5 MG/ML
DO NOT USE DACEPTON 5 MG/ML
-
if you are under 18 years of age
-
if you have breathing difficulties or suffer from asthma
-
if you have dementia or Alzheimer’s disease
-
if you suffer from confusion, hallucinations, or any other similar
problems
-
if you have liver problems
-
if you have severe dyskinesia (involuntary movements) or severe
dystonia (inability t

Karakteristik produk

Health Products Regulatory Authority
12 March 2024
CRN00DW7N
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dacepton 5 mg/ml solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 5 mg apomorphine hydrochloridehemihydrate
20 ml contain 100 mg apomorphine hydrochloride hemihydrate
_Excipient with known effect:_
Sodium metabisulphite (E223) 1 mg per ml
Sodium chloride 8 mg per ml
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion
Clear and colourless to slightly yellow solution, free from visible
particles pH of 3.3 – 4.0.
Osmolality: 290 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 5 MG/ML SOLUTION FOR
INFUSION:_
Patients selected for treatment with Dacepton 5 mg/ml solution for
infusion 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
treatment with Dacepton 5 m