5 mg / ml Infusion solution
apomorfinhydrokloridhemihydrat
What Apomorphine PharmSwed is and what it is used for
Apomorphine hydrochloride belongs to a group of medicines called dopamine agonists, which are used to treat Parkinson’s disease. Apomorphine reduces the time of “off” or immobile status in people previously 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.
Apomorphine hydrochloride contained in Apomorphine PharmSwed may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions,
and always follow their instructions.
What you need to know before you use Apomorphine PharmSwed
Do not use Apomorphine PharmSwed
- if you are allergic to apomorphine or any of the other ingredients of this medicine (listed in section 6)
- if you are under 18 years of age
- if you have difficulty breathing or asthma
- if you have dementia or Alzheimer’s disease
- if you suffer from confusion, hallucinations, or other similar problems
- if you have any liver disease
- if you have severe hypermobility, so-called dyskinesia (strong involuntary movements), or abnormal muscle tension (so-called dystonia ) due to treatment with levodopa
Warnings and cautions
Talk to your doctor before using Apomorphine PharmSwed
- if you or someone in your family has an abnormal electrocardiogram ( ECG ), which is called “long QT syndrome”.
- if you have kidney problems
- if you have any lung disease
- if you have any heart disease
- if you have low blood pressure or feel weak and dizzy when you get up
- if you are taking any medicine for high blood pressure
- if you suffer from nausea or vomiting
- if you are older or weak
- if you have any mental health problems when starting Apomorphine PharmSwed
- If you are taking both levodopa (another medicine for Parkinson’s disease ) and apomorphine, your doctor should check your blood counts regularly.
Before using Apomorphine PharmSwed, 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.
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 PharmSwed and other medicines used to treat Parkinson’s disease.
Tell your doctor or nurse if any of the above conditions are true for you.
Other medicines and Apomorphine PharmSwed
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The treatment effect may be affected if Apomorphine PharmSwed is taken at the same time as certain other medicines (such as clozapine or antihypertensive medicines or medicines for Parkinson’s disease ). Your doctor will tell you if the dose of Apomorphine PharmSwed or any of the other medicines needs to be adjusted.
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.
Apomorphine PharmSwed with food and drink
Apomorphine PharmSwed is not affected by food and drink.
Pregnancy and breastfeeding
Pregnancy
Apomorphine PharmSwed should not be used during pregnancy unless clearly necessary. Talk to your doctor or nurse before using Apomorphine PharmSwed if you are pregnant, think you may be pregnant, or are planning to have a baby.
Breast-feeding
It is not known whether Apomorphine PharmSwed 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.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Take special care when driving or performing work that requires increased alertness as apomorphine may cause drowsiness including sudden sleep attacks (do not drive or perform work that requires increased alertness if Apomorphine PharmSwed makes you sleepy).
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.
Apomorphine PharmSwed contains sodium metabisulfite
Sodium metabisulfite can in rare cases cause severe hypersensitivity reactions and convulsions in the trachea.
This medicine contains 3.3 mg sodium per ml. This should be considered by patients on a low-salt diet.
3. How to use Apomorphine PharmSwed
Before you take Apomorphine PharmSwed, your doctor will make sure that you are taking this medicine and anti-nausea medicine that you need to take at the same time.
This infusion is given subcutaneously (ie in the area under the skin).
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. Apomorphine PharmSwed has been designed for continuous infusion using an infusion pump. Your doctor will decide which infusion pump and dose setting you should use. Follow your doctor’s instructions and advice on how to use Apomorphine PharmSwed in an infusion pump. Read the instructions for use that come with the infusion pump and follow it carefully.
Both the dose of Apomorphine PharmSwed and the time required for 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. It is usually given while you are awake and ends before you start sleeping. 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 should not be injected into a vein. Apomorphine PharmSwed does not need to be diluted before use. Apomorphine PharmSwed should not be mixed with other medicines.
Instructions on how to use Apomorphine PharmSwed
- Wash the rubber stopper clean with a disinfectant wipe.
- Insert the syringe needle into the center of the rubber stopper.
- Turn the bottle and syringe upside down.
- Pull up the desired volume into the syringe.
- Pull the injection needle out of the vial.
- Then carefully follow the instructions that come with the infusion pump.
The treatment will be started by your doctor who will inform you care about the use of the infusion pump, infusion technique, and handling when administering the medicine.
If you forget to use Apomorphine PharmSwed
- 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 Apomorphine PharmSwed
- 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:
Serious side effects:
An allergic reaction that can be severe is rare, with symptoms such as:
- difficulty breathing or pressure over the chest
- swollen eyelids, face, or lips
- swollen or reddish tongue
Other side effects:
Very common (may affect more than 1 user in 10)
- hallucinations (seeing, hearing, or feeling things that are not real)
- 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.
Common (may affect up to 1 in 10 people)
- nausea or vomiting especially when you start using. Apomorphine PharmSwed. Treatment with domperidone should be started at least 2 days before Apomorphine PharmSwed 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.
- transient fatigue at the start of treatment, after each dose of Apomorphine PharmSwed. This usually passes after a few weeks of treatment.
- fatigue or heavy sleepiness
- dizziness, fraud
- confusion or hallucinations
- yawn
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, which can cause the skin to turn pale yellow and cause weakness and shortness of breath, may occur in patients who are also taking levodopa.
- rash
- breathing difficulties
- drop in blood pressure when getting up, which can cause dizziness, dizziness or fainting
- ulceration at the injection site
- decreased platelet count, which may increase the risk of bleeding and bruising.
- The use of levodopa and apomorphine may affect the results of a specific laboratory test, called the Coombs test.
Rare (may affect up to 1 in 1,000 people)
- 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)
- fainting
- 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)
- aggression
- anxiety, restlessness
- headache
Tell your doctor if you experience any of these behaviors, so you can talk about a way 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 Apomorphine PharmSwed
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 carton and vial label after EXP. The expiration date is the last day of the specified month.
Store in the outer carton. Sensitive to light.
Do not store above 25 ° C.
Opened vials are stored in the outer carton and should be used immediately. For single use only.
The drug can be stored in a mini pump and/or syringe pump and administered during/up to 24 hours without limitation of storage temperature. Other storage times and storage conditions are the responsibility of the user.
Discard unused solution.
The solution should be inspected visually before use. Do not use Apomorphine PharmSwed if the solution turns green. Apomorphine PharmSwed should only be used when the solution is clear and free of visible particles.
Be careful not to splash the solution on yourself, or e.g. on textiles or household surfaces as the solution may cause green staining. Used needles and vials should 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. Contents of the packaging and other information
Content declaration
- The active substance is apomorphine hydrochloride hemihydrate. 1 ml contains 5 mg of apomorphine hydrochloride hemihydrate. One vial of 20 ml solution contains 100 mg apomorphine hydrochloride hemihydrate.
- The other ingredients are:
sodium chloride sodium metabisulfite (E223)
hydrochloric acid for pH adjustment
water for injections
What the medicine looks like and the contents of the pack
Apomorphine PharmSwed is a solution for infusion. The solution is clear and practically colorless.
Apomorphine PharmSwed is supplied in glass vials with bromobutyl rubber stoppers and aluminum lids. Each pack contains 5 vials of 20 ml (5×20).
Marketing Authorisation Holder:
Evolan Pharma AB
Box 120
182 12 Danderyd
Manufacturer:
Apotek Produktion och Laboratorier AB (APL)
Box 3076
903 03 Umeå
This medicinal product is authorized under the European Economic Area under the names:
| Denmark | Apomorphine PharmSwed |
| Norway | Apomorphine PharmSwed |
| Iceland | Apomorphine PharmSwed |
| Netherlands | Apomorphine hydrochloride PharmSwed 5mg / ml, solution for infusion |
| Germany | Apomorphine hydrochloride PharmSwed 5 mg/ml infusion solution |
| Great Britain | Apomorphine hydrochloride 5 mg / ml solution for infusion |
| Ireland | Apomorphine hydrochloride 5 mg / ml solution for infusion |