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

Active substance(s): APOMORPHINE HYDROCHLORIDE

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more food than normal and more than is needed
to satisfy your hunger).
• fainting
• aggression, agitation
• headache.
Tell your doctor if you experience any of these
behaviours; she or he will discuss ways of
managing or reducing the symptoms.

colourless and free of any visible particles.
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.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will
help protect the environment.

Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side
effects directly via:
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance, Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal
By reporting side effects you can help provide more
information on the safety of this medicine.

6. Contents of the pack and other information
What APO-go PFS contains
– The active substance is apomorphine hydrochloride.
1 ml solution contains 5 mg apomorphine
hydrochloride. Each 10 ml pre-filled syringe contains
50 mg apomorphine hydrochloride.
– The other ingredients are:
– sodium metabisulphite (E223)
– hydrochloric acid, concentrated
– water for injections.
Refer to ‘Section 2: APO-go PFS contains sodium
metabisulphite’ regarding sodium metabisulphite.

5. How to store APO-go PFS
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date which is
stated on the label and 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 this medicine if the solution has turned
green. It should only be used if the solution is clear,

Netherlands:


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

Norway:


Britaject 5 mg/ml infusjonsvæske,
oppløsning i ferdigfylt sprøyte

Portugal:


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

Romania:


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

Distributor in UK
Britannia Pharmaceuticals Ltd.
200 Longwater Avenue, Green Park, Reading
Berkshire RG2 6GP, UK

Slovenia:



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

Distributor in Ireland
Clonmel Healthcare Ltd.
Waterford Road, Clonmel, County Tipperary, Ireland

Spain:


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

Sweden:



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

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

Package Leaflet:
Information for the user
For use in adults

Austria, Germany: APO-go 5 mg/ml Infusionslösung in

einer Fertigspritze

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.

Bulgaria:




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

Contents of the pack
APO-go PFS is supplied in clear glass pre-filled
syringes. Each pack contains 5 syringes containing 10
ml solution, in an outer cardboard carton.
Bundle packs of 25 (5x5) and bundle packs of 50 (10x5)
are available in some territories.
Not all pack sizes may be marketed.

Cyprus:


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

Denmark:



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

Luxembourg:


APOGO 5 mg/ml Solution pour
Perfusion en Seringue Préremplie

Greece:


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

Marketing Authorisation Holder and Manufacturer
Britannia Pharmaceuticals Ltd.
200 Longwater Avenue, Green Park, Reading
Berkshire RG2 6GP, UK
Tel: +44 1189 209500
Email: bplwebmaster@britannia-pharm.com

Ireland, UK,
Malta:

If this leaflet is difficult to see or read and you would
like it in a different format, please contact Britannia
Pharmaceuticals Ltd.

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.

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

This leaflet was last revised in August 2017.
GXXXXXX

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PFS-ROV-PIL-UK66.indd 1

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

UK-IRL-MT 019.R / 9245875 XXXX

– 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.

*Abbreviated to APO-go PFS in the text

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16/08/2017 12:00

What is in this leaflet:
1. What APO-go PFS is and what it is used for
2. What you need to know 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. Contents of the pack and other information

or severe dystonia (inability to move) on account of the
treatment with levodopa
– you are allergic to apomorphine or any of the other
ingredients of this medicine (listed in section 6)
– you or someone in your family are known to have an
abnormality of electrocardiogram (ECG) called “long
QT syndrome”.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using
APO-go PFS if:
– you have kidney problems
– you have lung problems
– you have heart problems
– you have low blood pressure or feel faint and dizzy
when you stand
– you are taking any medicines to treat high blood
pressure
– you feel sick or suffer from being sick
– you have any mental disorders when APO-go PFS is
started
– you are elderly or frail.
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.
Some patients develop addiction-like symptoms leading
to craving for large doses of APO-go PFS and other
medicines used to treat Parkinson’s disease.
If any of the above situations applies to you, please
inform your doctor or nurse.

1. What APO-go PFS is and what it is used for
APO-go PFS contains apomorphine hydrochloride.
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.
Despite the name, apomorphine does not contain
morphine.
2. What you need to know before you use
APO-go PFS
Before you use APO-go PFS, 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 concerning
your heart. Some of the questions and investigations
may be repeated at each medical visit. If you experience
symptoms which may come from the heart, e.g.
palpitations, fainting, or near-fainting, you should report
this to your doctor immediately. Also if you experience
diarrhoea or start a new medication, this should be
reported to your doctor.

Children and adolescents
APO-go PFS should not be used in children and
adolescents under 18 years of age.

Do not use APO-go PFS if:
– you are under 18 years of age
– you have breathing difficulties or suffer from asthma
– you have dementia or Alzheimer’s disease
– you suffer from confusion, hallucinations or any other
similar problems
– you have liver problems
– you have severe dyskinesia (involuntary movements)

Other medicines and APO-go PFS
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Check with your doctor or pharmacist before taking your
medicine if:
1

PFS-ROV-PIL-UK66.indd 2

information for patients who are intending to drive in
Great Britain - go to https://www.gov.uk/drug-driving-law
APO-go PFS contains sodium metabisulphite
APO-go PFS contains sodium metabisulphite which rarely
can cause a severe allergic reaction with symptoms such
as rash or itchy skin, difficulty breathing, puffiness of the
eyelids, face or lips, swelling or redness of the tongue. If
you experience these side effects, immediately go to the
nearest hospital casualty department.
APO-go PFS contains less than 1 mmol (23 mg) of
sodium per 10 ml, i.e. essentially sodium free.

– 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.
If you use this medicine in combination with other
medicines the effect of your medicines may be altered.
This is particularly true for:
– medicines such as clozapine to treat mental disorders
– medicines to lower your blood pressure
– other medicines for Parkinson’s disease.
Your doctor will advise you if you need to adjust the dose
of your apomorphine or any of your other medicines.
If you are taking levodopa (another medicine for
Parkinson’s disease) as well as apomorphine your doctor
should check your blood regularly.

3. How to use APO-go PFS
Before you use APO-go PFS, your doctor will ensure that
you tolerate the medicine and an antiemetic medicine that
you need to use simultaneously.
The infusion is given subcutaneously (i.e. into the area
under the skin).
Always use this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Do not use APO-go PFS if:
– the solution has turned green.
– 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.
How much to use
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 1 mg and 4 mg 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 100 mg. Your doctor
or nurse will decide which dose is best for you.
A different site for your infusion should be used every
12 hours.

APO-go PFS with food and drink
Food and drink do not affect the way this medicine will
work.
Pregnancy and breast-feeding
APO-go PFS should not be used during pregnancy unless
clearly necessary. Check with your doctor or pharmacist
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.
Driving and using machines
Do not drive if APO-go PFS makes you sleepy. Do not use
any tools or machines if this medicine 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
2

This medicine must 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.

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: may affect up to 1 in 100 people
• 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.
Rare: may affect up to 1 in 1,000 people
• 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.
Not known: 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:
m strong impulse to gamble excessively despite
serious personal or family consequences
m altered or increased sexual interest and
behaviour of significant concern to you or
to others, for example, an increased sexual drive
m uncontrollable excessive shopping or spending
m binge eating (eating large amounts of food in a
short time period) or compulsive eating (eating

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.
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.
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
medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine 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: may affect more than 1 in
10 people
• 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.
• hallucinations (seeing, hearing or feeling things that
are not there).
Common: may affect up to 1 in 10 people
• 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
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16/08/2017 12:00

+ Expand Transcript

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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