5 mg / ml solution for infusion in a pre-filled syringe of 
apomorphine hydrochloride. For use in adults

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

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. WHAT APO-go Pumpfill IS AND WHAT IT IS USED FOR  
2. BEFORE YOU USE APO-go Pumpfill 
3. HOW TO USE APO-go Pumpfill 
4. Possible side effects 
5. HOW APO-go Pumpfill TO BE STORED  
6. OTHER INFORMATION 

1. WHAT APO-go Pumpfill IS AND WHAT IT IS USED FOR 

APO-go Pumpfill contains apomorphine hydrochloride. Apomorphine hydrochloride belongs to a group of medicines called dopamine agonists, which are used to treat Parkinson’s disease. Apomorphine reduces the time with difficult Parkinson’s symptoms, so-called “off periods” 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 recognize the signs of when you need to use the medicine.

Despite the name, apomorphine does not contain morphine.

2. BEFORE USING APO-go Pumpfill

Before using the APO-go Pumpfill, your doctor will take an ECG ( electrocardiogram ) and ask for a list of all the medicines you are taking. The ECG examination will be repeated during the first days of treatment and at those times when the doctor deems it necessary. He or she will also ask if you have any other illnesses, especially with regard to the heart. Some questions and examinations may be repeated at each doctor’s visit. If you get symptoms that may come from the heart, e.g. palpitations, fainting, or fainting, tell your doctor immediately. You should also tell your doctor if you get diarrhea or start using new medicine.

Do not use APO-go Pumpfill if :

  • you are under 18 years old
  • you have difficulty breathing or asthma
  • you have dementia or Alzheimer’s disease
  • you suffer from confusion, hallucinations, or other similar problems
  • you have liver problems
  • you have severe hypermobility, so-called dyskinesia (strong involuntary movements), or abnormal muscle tension (so-called dystonia ) due to 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 has an abnormal electrocardiogram ( ECG ), which is called “long QT syndrome”.

Warnings and cautions

Talk to your doctor, pharmacist or nurse before using APO-go Pumpfill if:

  • you have kidney problems
  • you have lung problems
  • you have heart problems
  • you have low blood pressure or feel weak and dizzy when you get up
  • you are taking any medicine for high blood pressure
  • you suffer from nausea or vomiting
  • you have some mental problems when starting APO-go Pumpfill
  • you are older or weak

Tell your doctor if you or your family/carer notice that you develop a strong desire or desire to behave in ways that are unusual for you, or if you can not resist the impulse, drive, or temptation to perform certain activities. which may harm you or others. These behaviors are called disturbed impulse control and can include gambling addiction, compulsive eating, compulsive buying, an abnormally high sex drive, or an increase in sexual thoughts and feelings. Your doctor may need to adjust your dose or discontinue treatment.

Some patients experience addictive symptoms that lead to cravings for large doses of apomorphine and other medicines used to treat Parkinson’s disease.

Tell your doctor or nurse if any of the above conditions are true for you.

Children and young people

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

Other medicines and APO-go Pumpfill

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Talk to your doctor or pharmacist before using this medicine if:

  • you use drugs that are known to affect how your heartbeats. This includes drugs 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 are taking this medicine while taking other medicines, this may affect their effectiveness. This is especially true for:

  • drugs such as clozapine used in the treatment of certain mental illnesses
  • antihypertensive drugs
  • other medicines for Parkinson’s disease.

Your doctor will tell you if you need to adjust the dose of apomorphine or any of the other medicines.

If you are taking both levodopa (another medicine for Parkinson’s disease ) and apomorphine, your doctor should take regular blood tests.

Use of APO-go Pumpfill with food and drink 

Food and drink do not affect the effectiveness of this medicine.

Pregnancy, breastfeeding, and fertility

APO-go Pumpfill should not be used during pregnancy unless clearly necessary. Ask your doctor or pharmacist for advice before taking APO-go Pumpfill if you are pregnant, think you may be pregnant, or are planning to have a baby.

It is not known whether APO-go Pumpfill is excreted in human milk. Talk to your doctor if you are breast-feeding or planning to breast-feed. Your doctor will explain to you whether you should continue/discontinue breast-feeding or continue/discontinue the medication.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Do not drive if APO-go Pumpfill makes you sleepy. Do not use tools or machines if this medicine makes you drowsy.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Important information about some of the ingredients of APO-go Pumpfill

APO-go Pumpfill contains sodium metabisulphite which in rare cases can cause a severe allergic reaction with symptoms such as rash, itching, difficulty breathing, swelling of the eyelids, face or lips, swelling or red tongue. If you get any of these side effects, consult your nearest emergency department immediately.

APO-go Pumpfill contains less than 1 mmol sodium (23 mg) per 10 ml, ie essentially ‘sodium-free’. next to “sodium-free”.

3. HOW TO USE APO-go Pumpfill

Before using the APO-go Pumpfill, your doctor will make sure that you can tolerate this medicine as well as an anti-nausea medicine that you need to use at the same time.

This infusion is given subcutaneously (ie in the area under the skin).

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Do not use APO-go Pumpfill if:

  • the solution has turned green
  • APO-go Pumpfill has been designed for continuous infusion with a syringe pump. APO-go Pumpfill must not be used for intermittent injection. The doctor decides which mini-pump and/or syringe pump and dose setting you should use.

Dosage

Both the dose of an APO-go Pumpfill and the time required for the treatment each day are governed by your individual needs. Your doctor will tell you how much medicine to administer.

The dose that is most suitable for you has been determined at an initial assessment at a specialist clinic. The usual infusion dose per hour is 1 to 4 mg apomorphine hydrochloride. Continuous infusion is usually given while you are awake and ends before you go to sleep. The daily dose of apomorphine hydrochloride must not exceed 100 mg. Your doctor or nurse will decide which dose is best for you.

Another infusion site should be used every 12 hours.

The drug must not be injected into a vein.

APO-go Pumpfill does not need to be diluted before use. APO-go Pumpfill should not be mixed with other medicines.

If you use too much APO-go Pumpfill

  • It is important to use the correct dose of an APO-go Pumpfill and not to exceed the prescribed dose. Higher doses may cause a slow heart rate, severe nausea, drowsiness, and/or difficulty breathing. You may also feel weak or dizzy, especially when getting up, due to low blood pressure. Lying down with your legs raised helps with low blood pressure.

If you forget to use APO-go Pumpfill

  • administer the medicine the next time you need it.
  • Do not take a double dose to make up for a forgotten dose.

If you stop using APO-go Pumpfill

  • consult a doctor before stopping treatment to discuss whether a possible termination of treatment is appropriate for you.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor if you think the medicine makes you feel unwell or if you experience any of the following:

Very common (may affect more than 1 user in 10)

  • calluses and lumps under the skin at the injection site that are tender, painful, and maybe red and itchy. To avoid these knots, you should change the injection site each time you insert the needle.
  • hallucinations (seeing, hearing, or feeling things that are not real)

Common (may affect up to 1 in 10 people)

  • nausea or vomiting especially when you start using APO-go Pumpfill.
  • Treatment with domperidone should be started at least 2 days before APO-go Pumpfill treatment to prevent nausea or vomiting. If you are nauseous despite domperidone, or if you do not take domperidone and vomit, tell your doctor or nurse as soon as possible.
  • fatigue or heavy sleepiness
  • confusion or hallucinations
  • yawn
  • you feel dizzy or dizzy when you get up

Uncommon (may affect up to 1 in 100 people)

  • increased involuntary movements (so-called dyskinesias, hypermobility) or aggravated tremors during so-called “on” periods (ie when the drug has an effect)
  • anemia, abnormal breakdown of red blood cells in blood vessels or in other parts of the body. This is a less common side effect that may occur in patients who are also taking levodopa.
  • sudden sleep attacks
  • rash
  • breathing difficulties
  • ulceration at the injection site
  • decreased number of red blood cells, which can cause the skin to turn pale yellow and cause weakness and shortness of breath
  • decreased platelet count, which may increase the risk of bleeding and bruising.

Rare (may affect up to 1 in 1,000 people)

  • An allergic reaction such as:
    • difficulty breathing or pressure over the chest
    • swollen eyelids, face, or lips
    • swollen or reddish tongue
  • eosinophilia, an abnormally high number of white blood cells in the blood or in tissue one.

Has been reported (occurs in an unknown number of users):

You may experience the following side effects:

  • swelling of legs, feet, or fingers.
  • inability to resist an impulse to perform an action that may be harmful such as:
    • a strong impulse to excessive gambling despite serious consequences for you personally or for your family
    • altered or increased sexual interest or behavior that makes you or others noticeably concerned, e.g. an increased sexual drive
    • uncontrollable and excessive need to buy things and spend money
    • binge eating (eating large amounts of food in a short time) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger)
  • fainting
  • aggression, anxiety, restlessness.
  • headache

Tell your doctor if you experience any of these behaviors to discuss ways to manage or reduce the symptoms.

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information

5. HOW TO STORE APO-go Pumpfill 

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. The expiration date is the last day of the specified month.

Store the prefilled syringe in the original package. Sensitive to light.

Store below 25 ° C.

Opened APO-go Pumpfill should be used immediately and the remaining solution should be discarded. For single use only.

Do not use this medicine if the solution turns green. APO-go Pumpfill should only be used when the solution is clear, colorless, and free of visible particles.

Use the contents of a pre-filled syringe immediately after opening. Be careful not to splash the solution on yourself, or e.g. on a carpet as the solution may cause greening. The emptied pre-filled glass syringe with plastic syringe and adapter must be discarded in containers for sharp objects.

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.

6. FURTHER INFORMATION 

Content declaration

The active substance is apomorphine hydrochloride. 1 ml solution contains 5 mg apomorphine hydrochloride. Each 10 ml pre-filled syringe contains 50 mg of apomorphine hydrochloride.

Other ingredients are:

  • sodium metabisulfite (E223)
  • hydrochloric acid, concentrated
  • water for injections.

For information on sodium metabisulfite, see section 2, “APO-go Pumpfill contains sodium metabisulfite”.

What the medicine looks like and the contents of the pack

APO-go Pumpfill is a solution for infusion, pre-filled ice cream syringe. The solution is clear and colorless.

APO-go Pumpfill is supplied in a clear pre-filled glass syringe. Each pack contains 5 pre-filled syringes with 10 ml solution in a cardboard box. Multiple packs of 25 (5×5) and multiple packs of 50 (10×5) are available in some countries.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

STADA Arzneimittel AG

Stadastraße 2 – 18

61118 Bad Vilbel

Germany

Manufacturer

Catalent Belgium SA 
Font Saint Landry 10 
B-1120 Brussels (Neder Over Heembeek) 
Belgium

Or

Rovi Contract manufacturing, SL.

Julián Camarillo, 35

Madrid 28037

Spain

Or

STADA Arzneimittel AG

Stadastraße 2 – 18

61118 Bad Vilbel

Germany

Local representative

STADA Nordic ApS

Marielundvej 46A

DK-2730 Herlev

Denmark

Muhammad Nadeem

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