APO-go PEN 30mg/3ml solution for injection

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Apomorphine hydrochloride

Dostupné z:

Britannia Pharmaceuticals Ltd

ATC kód:

N04BC07

INN (Medzinárodný Name):

Apomorphine hydrochloride

Dávkovanie:

10mg/1ml

Forma lieku:

Solution for injection

Spôsob podávania:

Subcutaneous

Trieda:

No Controlled Drug Status

Typ predpisu:

Caution - AMP level prescribing advised

Prehľad produktov:

BNF: 04090100; GTIN: 5055962500025

Príbalový leták

*
PACKAGE LEAFLET:
INFORMATION FOR THE USER
_* Abbreviated to _APO-go Pen_ in the text_
For use in adults
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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.
PEN PIL UK-IRL-MT61.indd 2
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blood pressure
– you feel sick or suffer from being sick
– your Parkinson’s disease causes certain
mental problems such as hallucinations
and confusion
– you are elderly or frail.
Tell your doctor if you or your family/carer
notices that you are developing urges or cra

Súhrn charakteristických

OBJECT 1
APO-GO PEN 10MG/ML SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 16-Mar-2018 | Britannia
Pharmaceuticals Limited
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 a 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 = 3.0 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