Dacepton solution for injection

দেশ: আর্মেনিয়া

ভাষা: ইংরেজি

সূত্র: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

সক্রিয় উপাদান:

apomorphine hydrochloride hemihydrate

থেকে পাওয়া:

EVER Pharma Jena GmbH

এটিসি কোড:

N04BC07

INN (আন্তর্জাতিক নাম):

apomorphine hydrochloride hemihydrate

ডোজ:

10mg/ml

ফার্মাসিউটিকাল ফর্ম:

solution for injection

প্যাকেজ ইউনিট:

(5) cartridges 3ml in plastic tray

প্রেসক্রিপশন টাইপ:

Prescription

অনুমোদন অবস্থা:

Registered

অনুমোদন তারিখ:

2020-04-06

তথ্য লিফলেট

The name of your medicine is Dacepton 10 mg/ml solution for injection
in
cartridge, which will be referred to as Dacepton throughout this
leaflet.
WHAT IS IN THIS LEAFLET
1. What Dacepton is and what it is used for
2. What you need to know before you use Dacepton
3. How to use Dacepton
4. Possible side effects
5. How to store Dacepton
6. Contents of the pack and other information
1. WHAT DACEPTON IS AND WHAT IT IS USED FOR
Dacepton 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
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 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
DO NOT USE DACEPTON
-
if you are allergic to apomorphine or any of the other ingredients of
this medicine (listed in section 6).
-
if you are under 18 years of age
-
if you have breathing difficulties
-
if you have dementia or Alzheimer’s disease
-
if
you
suffer
from
a
mental
illness
with
symptoms
such
as
hallucinations, delusions, disordered thoughts, loss of contact with
reality
-
if you have liver problems
-
if you have severe dyskinesia (involuntary movements) or severe
dystonia (inability to move) despite taking levodopa
-
if you or someone in your family are known to have an abnormality
of electrocardiogram (ECG) called “long QT syndrome”. Tell your
doctor.
-
if you use the antiemetic ondansetrone
WARNINGS AND PRECAUTIONS
Before
you
use
Dacepton:
y

পণ্য বৈশিষ্ট্য

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 hydrochloride
hemihydrate.
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 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.
_Adults _
Method of administration
Da