APO-go POD 5 mg/ml solution for infusion in cartridge

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Apomorphine hydrochloride hemihydrate

Available from:

Stada Arzneimittel AG

ATC code:

N04BC07

INN (International Name):

Apomorphine hydrochloride hemihydrate

Dosage:

5 milligram(s)/millilitre

Pharmaceutical form:

Solution for infusion in cartridge

Therapeutic area:

apomorphine

Authorization status:

Not marketed

Authorization date:

2020-11-13

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
APO-GO
® POD 5 MG/ML SOLUTION FOR INFUSION 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, 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 possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What APO-go POD is and what it is used for
2.
What you need to know before you use APO-go POD
3.
How to use APO-go
POD
4.
Possible side effects
5.
How to store APO-go POD
6.
Contents of the pack and other information
1.
WHAT APO-GO POD IS AND WHAT IT IS USED FOR
APO-go POD contains apomorphine hydrochloride hemihydrate (further
referred to as
‘apomorphine’).
There is 5 mg apomorphine in each millilitre of solution.
Apomorphine belongs to a group of medicines known as dopamine agonists
which are used to treat
Parkinson’s disease. It 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 and/or other dopamine
agonists. Your doctor, pharmacist or nurse will help you to recognise
the signs of when to use your
medicine. This medicine is for use in adults only.
Despite the name, apomorphine does not contain morphine.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE APO-GO POD
Before you use APO-go POD, your doctor will obtain an ECG
(electrocardiogram) and will ask for a
list of all other medicines you take. This ECG will be repeated in the
first days of your treatment and
at any point if your doctor thinks this is needed. He or she will also
ask you about other diseases you
may have, in particular concern

Summary of Product characteristics

Health Products Regulatory Authority
07 September 2023
CRN00D5XR
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
APO-go POD 5 mg/ml solution for infusion in cartridge
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains 5 mg apomorphine hydrochloride hemihydrate
Each 20 ml cartridge contains 100 mg apomorphine hydrochloride
hemihydrate
Excipients with known effect:
Sodium metabisulfite (E223), 0.5 mg per ml
For the full list of excipients, see Section 6.1
3 PHARMACEUTICAL FORM
Solution for infusion in cartridge.
Clear solution, colourless and practically free from visible particles
pH 3.0-4.0
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
APO-go POD is indicated in adults.
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 POD:
Patients who have shown a good 'on' period response during the
initiation stage of apomorphine therapy, but whose overall
control remains unsatisfactory using intermittent injections, or who
require many and frequent injections, may be transferred to
continuous subcutaneous infusion by minipump. Patients who have
frequent 'off' periods not controlled by oral/transdermal
medication may also be commenced on continuous subcutaneous infusion
by minipump without prior use of intermittent
injections.
Patients selected for treatment with APO-go POD should be capable of
setting up an infusion system themselves or else have a
responsible carer able to set up an infusion system 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 whenever possible. Before the decision to
initiate domperidone and apomorphine treatment, risk factors for QT
interval prolongation in the individual pa