DACEPTON 10 Mg/Ml Solution for Inj/Inf

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

APOMORPHINE HYDROCHLORIDE HEMIHYDRATE

Dostupné z:

EVER Neuro Pharma GmbH

ATC kód:

N04BC07

INN (Medzinárodný Name):

APOMORPHINE HYDROCHLORIDE HEMIHYDRATE

Dávkovanie:

10 Mg/Ml

Forma lieku:

Solution for Inj/Inf

Typ predpisu:

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

Terapeutické oblasti:

Dopamine agonists

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2012-12-18

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE USER 

DACEPTON 10 MG/ML SOLUTION FOR INJECTION OR INFUSION 
Apomorphine hydrochloride hemihydrate 

Read all of this leaflet carefully before you start using this
medicine.  
-  Keep this leaflet. You may need to read it again.  
-  If you have any further questions, ask your doctor or pharmacist.

-  This medicine has been prescribed for you. Do not pass it on to
others. It may 
harm them, even if their symptoms are the same as yours.  
-  If any of the side effects gets serious, or if you notice any
side effects not listed in 
this leaflet, please tell your doctor or pharmacist.  

The name of your medicine is Dacepton 10 mg/ml Solution for injection
or infusion, 
which will be referred to as Dacepton 10 mg/ml throughout this
leaflet. 

IN THIS LEAFLET:  
1.  What Dacepton 10 mg/ml is and what it is used for  
2.  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. Further 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). 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 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 or nurse will help you to recognise the signs of when to
use your 
medicine. 
Despite the name, apomorphine does not contain morphine. 

2. BEFORE YOU USE DACEPTON

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dacepton 10 mg/ml Solution for injection or infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 10 mg apomorphine hydrochloride hemihydrate.
5 ml contains 50 mg apomorphine hydrochloride hemihydrate.
Excipient:
Sodium metabisulphite (E223) 1 mg per ml
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection or infusion
The solution is clear and colourless or almost colourless to slightly yellow, practically free from visible particles
pH of 3.0 – 4.0.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The treatment of disabling motor fluctuations (“on-off” phenomena) in patients with Parkinson's disease which persist
despite individually titrated treatment with levodopa (with a peripheral decarboxylase inhibitor) and/or other dopamine
agonists.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_SELECTION OF PATIENTS SUITABLE FOR DACEPTON 10 MG/ML INJECTIONS:_
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.
It is essential that the patient is established on domperidone, usually 20 mg three times daily, for at least two days prior
to initiation of therapy.
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 10 mg/ml.
ADULTS
ADMINISTRATION
Dacepton 10 mg/ml is for subcutaneous use by intermittent bolus injection