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APO-GO PFS 5MG/ML SOLUTION FOR INFUSION IN PRE-FILLED SYRINGE

Active substance: APOMORPHINE HYDROCHLORIDE

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PFS PIL UK-IRL-MT XXXR_9245875 (5974-01) 28/08/2014 15:16 Page 1

mg/ml
Withdraw contents immediately after opening.
Take care not to splash any of the solution onto yourself,
or the carpet as it may stain green. At the end of use the
glass pre-filled syringe should be discarded in a Sharps
bin as well as any used plastic syringes and the adaptor.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose
of medicines no longer required. These measures will
help to protect the environment.

Manufacturers
Catalent Belgium S.A
Font Saint Landry 10, B-1120 Brussels
(Neder Over Heembeek), Belgium
Rovi Contract Manufacturing, S.L.,
Julián Camarillo, 35
Madrid 28037, Spain
STADA Arzneimittel AG,
Stadastraße 2 – 18, 61118 Bad Vilbel, Germany

6. Further information
What APO-go PFS contains
The active substance is apomorphine hydrochloride.
1ml solution contains 5mg apomorphine hydrochloride.
Each 10ml pre-filled syringe contains 50mg
apomorphine hydrochloride.
The other ingredients are:
– Sodium metabisulphite (E223)
– Hydrochloric acid, concentrated
– Water for Injections

This medicinal product is authorised in the Member
states of the EEA under the following names:

Iceland:

Apo-go Pumpfill 5 mg/ml
innrennslislyf, lausn í áfylltri sprautu

Ireland, UK,
Malta:

APO-go PFS 5mg/ml Solution
for Infusion in Pre-filled Syringe

Netherlands:

APO-go 5mg/ml oplossing voor
infusie in een voorgevulde spuit

Norway:

Britaject 5mg/ml infusjonsvæske,
oppløsning i ferdigfylt sprøyte

Bulgaria:

What APO-go PFS looks like and contents of
the pack
APO-go PFS is a solution for infusion, pre-filled syringe.
The solution is clear and colourless.
APO-go PFS is supplied in clear glass pre-filled
syringes. Each pack contains 5 syringes containing 10ml
solution, in an outer cardboard carton.
Bundle packs of 25 (5x5) and bundle packs of
50 (10x5) are available in some territories.

АПО-гo ® ПНС 5mg/ml
Инфузионен разтвор в
предварително напълнена
спринцовка

APO-go PFS, 5 mg/ml,
roztwór do infuzji

Portugal:
Austria, Germany, APO-go 5 mg/ml Infusionslösung
Switzerland:
in einer Fertigspritze

Poland:

Apo-go 5mg/ml Solução para
perfusão em seringa pré-cheia

Romania:

For use in adults

APO-go 5 mg/ml soluţie perfuzabilă
în seringă preumplută unidoză

Package Leaflet Information for the User

Slovak Republic: APO-go® 5 mg/ml infúzny roztok
naplený v injekčnej striekačke

Cyprus:

Slovenia:

APO-go 5 mg/ml raztopina za
infundiranje v napolnjeni
injekcijski brizgi

Denmark:

APO-go Pumpfill 5 mg/ml
infusionsvæske, opløsning i
fyldt injektionssprøjte

Spain:

APO-go PFS 5 mg/ml Solución para
Perfusión en Jeringa Precargada

Read all of this leaflet carefully before
you start using this medicine.

Sweden:

France,
Luxembourg:

APOGO 5mg/ml Solution pour
Perfusion en Seringue Préremplie

APO-go Pumpfill 5 mg/ml
infusionsvätska, lösning i
förfylld spruta

– Keep this leaflet. You may need to read
it again.

Greece:

Marketing Authorisation Holder and Manufacturer
Britannia Pharmaceuticals Ltd.
Park View House, 65 London Road, Newbury
Berkshire RG14 1JN, United Kingdom

APO-go® PFS 5mg/ml
∆ιάλυµα για Έγχυση σε
Προγεµισµένη Σύριγγα

APO-go® PFS 5mg/ml
∆ιάλυµα για Έγχυση σε
Προγεµισµένη Σύριγγα

Hungary:

– If you have any further questions,
ask your doctor or pharmacist.
This leaflet was last revised in 08/2014.

– 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.

BRITAJECT 5mg/ml oldatos
infúzió előretöltött fecskendőben

– If any of the side effects get serious,
or if you notice any side effects not
listed in this leaflet, please tell your
doctor or pharmacist.
XXXXXXX

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5

UK-IRL-MT XXX.R / 9245875 XXXX

PFS PIL UK-IRL-MT XXXR_9245875 (5974-01) 28/08/2014 15:16 Page 2

mg/ml
– if you feel sick or suffer from being sick
– if you have any mental disorders when
APO-go PFS is started
– if you are elderly or frail
– when driving or operating machinery since
apomorphine may cause sleepiness including sudden
sleep onset episodes (you must not drive or operate
machinery if APO-go PFS makes you sleepy)
– your doctor should check your blood regularly when
taking APO-go PFS with levodopa (another treatment
for Parkinson's disease).
Tell your doctor if you or your family/carer notices that
you are developing urges or cravings to behave in ways
that are unusual for you and you cannot resist the
impulse, drive or temptation to carry out certain activities
that could harm yourself or others. These are called
impulse control disorders and can include behaviours
such as addictive gambling, excessive eating or
spending, an abnormally high sex drive or an increase
in sexual thoughts or feelings. Your doctor may need to
adjust or stop your dose.

In this leaflet:
1. What APO-go PFS is and what it is used for
2. Before you use APO-go PFS
3. How to use APO-go PFS
4. Possible side effects
5. How to store APO-go PFS
6. Further information
1. What APO-go PFS is and what it is used for
Apomorphine hydrochloride 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 or nurse will help you to recognise the signs
of when to use your medicine.
2. Before you use APO-go PFS
Do not use APO-go PFS
– 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 to move) on account of the
treatment with levodopa
– if you are allergic to apomorphine or any of the other
ingredients of APO-go PFS (for other ingredients
see section 6)
– if you or someone in your family are known to have
an abnormality of electrocardiogram (ECG) called
"long QT syndrome". Tell your doctor.

If any of the above situations applies to you,
please inform your doctor or nurse.
Check with your doctor or pharmacist before
taking your medicine if: You are using medicines
that are known to affect the way your heart beats.
This includes medicines used for heart rhythm problems
(such as quinidine and amiodarone), for depression
(including tricyclic antidepressants such as amitriptyline
and imipramine) and for bacterial infections ('macrolide'
antibiotics such as erythromycin, azithromycin and
clarithromycin) and domperidone.
Taking other medicines
If you take apomorphine in combination with other
medicines (especially neuroleptica such as clozapine
or medicines to reduce your blood pressure or other
medicines for Parkinson’s disease) the effect of your
medicines may be altered. Your doctor will advise you
if you need to adjust the dose of your apomorphine or
any of your other medicines.

Take special care with APO-go PFS
– if you have kidney problems
– if you have lung problems
– if you have heart problems
– if you have low blood pressure or feel faint and
dizzy when you stand
– if you are taking any medicines to treat high
blood pressure
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Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.

APO-go PFS has been designed for continuous infusion
with a syringe driver. It is not to be used for intermittent
injection. Your doctor will decide which minipump and/or
syringe-driver and which dosage settings you should use.

Using APO-go PFS with food and drink
Food and drink do not affect APO-go PFS.

Both the amount of APO-go PFS that you should use
and the total amount of time you should receive your
medicine each day, will depend upon your personal
needs. Your doctor will discuss this with you and tell
you how much of your medicine you should administer.
The amount that will work best will have been
determined on your visit to the specialist clinic.
The average infusion dose per hour is between 1mg
and 4mg apomorphine hydrochloride.
Continuous infusion is usually given when you are awake
and generally stopped before sleeping. The amount of
apomorphine hydrochloride that you receive each day
should not exceed 100mg. Your doctor or nurse will
decide which dose is best for you.

Pregnancy and breast-feeding
APO-go PFS should not be used during pregnancy unless
clearly necessary. Check with your doctor or nurse before
using APO-go PFS if you are pregnant, think you may be
pregnant or you are planning to become pregnant.
It is not known whether APO-go PFS is transferred to
breast milk. Talk to your doctor if you are breast-feeding
or intend to breast-feed. Your doctor will explain to you,
whether you should continue/discontinue breast-feeding
or continue/discontinue taking this medicine.
Ask your doctor or pharmacist for advice before taking
any medicine.

A different site for your infusion should be used every
12 hours.

Driving and using machines
Do not drive if APO-go PFS makes you sleepy. Do not use
any tools or machines if APO-go PFS makes you sleepy.
This medicine can affect your ability to drive. Do not
drive whilst taking this medicine until you know how this
medicine affects you. It may be an offence to drive if
your ability to drive safely is affected. There is further
information for patients who are intending to drive in
Great Britain - go to https://www.gov.uk/drug-driving-law

This medicine should not be administered into a vein.
There is no need to dilute APO-go PFS before use.
In addition, it should not be mixed with other medicines.
If you use more APO-go PFS than you should
– tell your doctor or contact your nearest hospital
emergency department immediately.
– it is important to administer the correct dose of
APO-go PFS and not to use more than the amount
recommended by your doctor. Higher doses may
cause a slow heart rate, excessive sickness,
excessive sleepiness and/or difficulty breathing.
You may also feel faint or dizzy particularly when you
stand up, due to low blood pressure. Lying down and
raising your feet will help to treat low blood pressure.

Important information about some of the ingredients
of APO-go PFS
Rarely sodium metabisulphite may cause a severe
allergic reaction and difficulty breathing. This medicinal
product contains less than 1 mmol (23mg) of sodium
per 10ml, i.e. essentially sodium free.
3. How to use APO-go PFS
The infusion is given subcutaneously (i.e. into the area
under the skin).

If you forget to use APO-go PFS
– take it when you next require it.
− do not take a double dose to make up for
a forgotten dose.

Do not use a syringe if the solution has turned green.
Always use APO-go PFS exactly as your doctor has told
you. You should check with your doctor or pharmacist if
you are not sure.
2

Rare side effects (1 to 10 users in 10,000):
• an allergic reaction such as:
– difficulty breathing or tightness of the chest
– puffiness of the eyelids, face or lips
– swelling or redness of the tongue
• eosinophilia, an abnormally high amount of white
blood cells in the blood or in body tissues.

If you stop using APO-go PFS
– contact your doctor before stopping treatment and
discuss whether this is appropriate or not.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, APO-go PFS can cause side effects,
although not everybody gets them. Tell your doctor if you
think your medicine is making you feel unwell or if you
get any of the following:
Very common side effects (more than 1 user in 10):
• lumps under the skin at the site of injection which are
sore, troublesome and may be red and itchy. In order
to avoid getting these lumps, it is advisable to change
the site of injection every time you insert the needle.

Side effects with unknown frequency (frequency
cannot be estimated from the available data):
• Swelling of the legs, feet or fingers
• Inability to resist the impulse, drive or temptation to
perform an action that could be harmful to you or
others, which may include:
H Strong impulse to gamble excessively despite
serious personal or family consequences.
H Altered or increased sexual interest and
behaviour of significant concern to you or
to others, for example, an increased sexual drive.
H Uncontrollable excessive shopping or spending.
H Binge eating (eating large amounts of food in
a short time period) or compulsive eating
(eating more food than normal and more than
is needed to satisfy your hunger).
Tell your doctor if you experience any of these
behaviours; she or he will discuss ways of
managing or reducing the symptoms.
If any of the side effects get serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.

Common side effects (1 to 10 users in 100):
• feeling sick or being sick, particularly when starting
APO-go PFS. Domperidone should be started at least
2 days before APO-go PFS to stop you feeling or being
sick. If you are taking domperidone and still feel sick,
or if you are not taking domperidone and have
sickness, tell your doctor or nurse as soon as possible.
• feeling tired or extremely sleepy.
• confusion or hallucinations.
• yawning.
• feeling dizzy or light-headed when standing up.
Uncommon side effects (1 to 10 users in 1,000):
• increased involuntary movements or increased
shakiness during 'on' periods.
• haemolytic anaemia, an abnormal breakdown of red
blood cells in the blood vessels or elsewhere in the
body. This is an uncommon side effect that can occur
in patients also taking levodopa.
• suddenly falling asleep
• rashes
• breathing difficulties
• injection site ulceration
• reduction in red blood cells which can make the skin
pale yellow and cause weakness or breathlessness
• reduction in blood platelets, which increases the risk
of bleeding or bruising.

5. How to store APO-go PFS
Keep out of the reach and sight of children.
Do not use APO-go PFS after the expiry date which is
stated on the label/carton. The expiry date refers to the
last day of that month.
Keep the pre-filled syringe in the outer carton in order
to protect from light. Do not store above 25°C.
Once opened APO-go PFS should be used immediately
and any remaining solution discarded.
Single use only.
Do not use APO-go PFS if the solution has turned green.
It should only be used if the solution is clear, colourless
and free of any visible particles.
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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