Produodopa

Package leaflet: Information for the patient

Produodopa, 240 mg/ml + 12 mg/ml, infusion solution
Foslevodopa + Foscarbidopa
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, as 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 a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Produodopa is and what it is used for
2. Important information before using Produodopa
3. How to use Produodopa
4. Possible side effects
5. How to store Produodopa
6. Contents of the pack and other information
7. Instructions for using Produodopa infusion with the Vyafuser pump

1. What Produodopa is and what it is used for

Produodopa contains two active substances, foslevodopa and foscarbidopa, and is used in the treatment of Parkinson's disease.
How Produodopa works

• In the body, foslevodopa is converted into a substance called dopamine, thereby replenishing dopamine levels in the brain and spinal cord. Dopamine facilitates the transmission of nerve impulses between nerve cells.
• Insufficient dopamine levels lead to symptoms of Parkinson's disease, such as tremor, feelings of stiffness, slowness of movement, and problems with balance.
• Treatment with foslevodopa increases dopamine levels in the body and thus reduces the severity of symptoms.
• Foscarbidopa enhances the therapeutic effect of foslevodopa and also reduces its side effects.

2. Important information before using Produodopa

When not to use Produodopa

• if the patient is allergic to foslevodopa, foscarbidopa, or any of the other ingredients of this medicine (listed in section 6)
• if the patient has a condition of the eye called narrow-angle glaucoma
• if the patient has severe heart problems
• if the patient has an irregular heartbeat (severe arrhythmia)
• if the patient has experienced the acute phase of a stroke
• if the patient is taking medicines called non-selective MAO inhibitors or selective MAO-A inhibitors, such as moclobemide or phenelzine. These medicines must be discontinued at least two weeks before starting treatment with Produodopa.
• if the patient has a tumour of the adrenal gland (pheochromocytoma)
• if the patient has hormonal disorders, such as excessive cortisol production (Cushing's syndrome) or overproduction of thyroid hormones (hyperthyroidism)
• if the patient has ever had skin cancer or has atypical moles ("spots") or skin lesions that have not been examined by a doctor.

Do not use Produodopa if any of the above apply to the patient. If in doubt, consult a doctor before starting treatment with Produodopa.

Warnings and precautions

Before starting treatment with Produodopa and during therapy, discuss with a doctor, pharmacist, or nurse if:

• the patient has ever had a heart attack, blocked blood vessels in the heart, or other heart diseases, including heart rhythm disorders (arrhythmias)
• the patient has a lung disease such as asthma
• the patient has ever had a hormonal disorder
• the patient has ever had depression with suicidal thoughts or any other psychiatric disorders
• the patient has been diagnosed with a condition of the eye called open-angle glaucoma
• the patient has ever had a stomach ulcer
• the patient has ever experienced seizures (convulsions)
• the patient has kidney or liver disease
• the patient is on a diet with controlled sodium intake (see "Produodopa contains sodium")
• the patient develops skin changes at the infusion site, such as redness, warmth, swelling, pain, or discolouration upon pressure
• the patient experiences increasing weakness, pain, numbness, or loss of sensation in the fingers or feet (polyneuropathy). Before starting treatment with Produodopa, the doctor will assess whether the patient has symptoms of neuropathy and will perform periodic examinations. Consult a doctor if the patient already has neuropathy or conditions associated with neuropathy.

If any of the above apply to the patient or if the patient is unsure, inform the doctor before starting treatment with Produodopa.

Inform the doctor if involuntary and uncontrolled movements of the limbs, back, neck, or jaw (dyskinesias) occur, or if stiffness or slowness of movements worsens. The daily dose may need adjustment, or the cause may be device blockage.

Malignant neuroleptic syndrome

Do not stop or reduce the dose of Produodopa unless instructed by a doctor. Abrupt discontinuation or rapid dose reduction of Produodopa may cause a serious condition called "malignant neuroleptic syndrome." Symptoms may include:

• rapid heartbeat, changes in blood pressure, and sweating, followed by fever
• rapid breathing, muscle rigidity, decreased level of consciousness, and coma
• increased levels of proteins in the blood (an enzyme called "creatine kinase"). This level is measured by the doctor.

Impulse control disorders – changes in patient behaviour

Inform the doctor if the patient, family members, or caregivers notice the emergence of impulses or irresistible urges to engage in behaviours that are not typical for the patient, or if the patient is unable to resist impulsive desires, urges, or temptations to perform certain actions that may be harmful to themselves or others. These behaviours are called impulse control disorders and include:

• gambling addiction
• excessive eating or spending
• increased sexual drive or intensified sexual thoughts or feelings.

The doctor may need to re-evaluate the current treatment. The doctor will discuss with the patient ways to manage or reduce the severity of these symptoms (see section 4 "Impulse control disorders – changes in patient behaviour").

Dopaminergic dysregulation syndrome

If the patient or their family (caregiver) notices symptoms resembling addiction, leading to a desire to take high doses of Produodopa and other medicines used in the treatment of Parkinson's disease, inform the doctor.

Infections at the infusion site

Inform the doctor if the patient develops skin changes at the infusion site, such as redness, warmth, swelling, pain, or discolouration upon pressure. Always use aseptic (sterile) techniques when administering this medicine and change the infusion site regularly (at least every third day), using a new infusion set. Ensure that a new infusion site is at least 2.5 cm away from any site used within the last 12 days. More frequent changes of the infusion site may be necessary if any of the above skin changes occur.

Produodopa and cancer

In the body, foscarbidopa (a component of Produodopa) breaks down into a substance called hydrazine. Hydrazine may potentially damage genetic material, which could lead to the development of cancer. However, it is not known whether the amount of hydrazine produced during the administration of a normal dose of Produodopa could cause this effect.

Children and adolescents

Produodopa must not be used in children and adolescents under 18 years of age. The medicine has not been studied in this age group.

Produodopa and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. This includes over-the-counter medicines and herbal products.

Before starting treatment with Produodopa, inform the doctor or pharmacist if the patient is taking medicines for:

• tuberculosis – such as isoniazid
• anxiety – such as benzodiazepine derivatives
• nausea or vomiting – such as metoclopramide
• high blood pressure – such as antihypertensive medicines
• blood vessel spasms – such as papaverine
• seizures (convulsions) or epilepsy – such as phenytoin
• psychiatric disorders – such as antipsychotic medicines, including phenothiazine derivatives, butyrophenone derivatives, and risperidone
• Parkinson's disease – such as tolcapone, entacapone, opicapone, and amantadine
• depression – such as tricyclic antidepressants, including amoxapine and trimipramine.

Inform the doctor or pharmacist if the patient is taking a COMT (catechol-O-methyltransferase) inhibitor, as it may increase levodopa levels in the blood. The doctor may need to adjust the dose of these medicines.

Inform the doctor or pharmacist if the patient is taking sympathomimetics, such as salbutamol, phenylephrine, isoprenaline, or dobutamine, used to treat low blood pressure. Sympathomimetics and levodopa may increase the risk of high blood pressure (hypertension) or irregular heart rhythm (arrhythmia).

Inform the doctor or pharmacist if the patient is taking medicines known to be eliminated by an enzyme called "CYP1A2." Examples of such medicines include:

• caffeine (helps with concentration)
• melatonin (helps with sleep)
• fluvoxamine, duloxetine (antidepressant that improves mood)
• clozapine (helps control schizophrenia)
• theophylline (helps with asthma)

Some medicines (such as selegiline) taken by the patient may lower blood pressure, causing dizziness upon standing from a chair or bed (orthostatic hypotension). Produodopa may worsen dizziness. Slowly rising from a lying to a standing position may reduce dizziness.

Do not use Produodopa if the patient is taking:

• medicines used for depression called selective MAO-A inhibitors or non-selective MAO inhibitors, such as moclobemide or phenelzine.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to have a baby, she should consult a doctor before using this medicine.

Produodopa is not recommended during pregnancy or in women of childbearing potential who are not using effective contraception, unless the benefits to the mother outweigh the potential risks to the unborn child.

It is not known whether Produodopa passes into human milk. Breastfeeding must be discontinued during treatment with Produodopa.

Driving and using machines

Do not drive, use tools, or operate machinery until the patient knows how Produodopa affects them.

• Produodopa may cause marked drowsiness or, occasionally, sudden episodes of falling asleep (sleep attacks).
• Produodopa may lower blood pressure, which may cause a feeling of lightheadedness or dizziness. Do not drive, use tools, or operate machinery until fully awake or until lightheadedness or dizziness has completely subsided.

Produodopa contains sodium

Talk to your doctor or pharmacist if the patient requires 9 ml or more of Produodopa per day for a prolonged period, especially if a low-salt (low-sodium) diet has been recommended.

3. How to use Produodopa

This medicine should always be used exactly as instructed by your doctor, nurse, or pharmacist.
If you have any doubts, consult your doctor, nurse, or pharmacist.
How to use Produodopa

• Before starting treatment, the patient or caregiver will be trained in the use of the product and the infusion pump.
• Produodopa is a solution administered under the skin (called subcutaneous infusion), usually into the abdominal area using an infusion pump. A five-centimeter area around the navel should be avoided.
• Your doctor or nurse will adjust the pump settings to deliver a dose appropriate to the patient's individual needs.
• The pump delivers the medicine continuously over 24 hours. It may be necessary to reload the pump with a new syringe within 24 hours to ensure sufficient medicine levels in the blood to control symptoms.

How much medicine to use

• This medicine should always be used exactly as prescribed by your doctor.
• Your doctor determines the dose of Produodopa and duration of treatment. Usually, a continuous maintenance dose is administered.
• If needed, the patient may receive additional doses (available as a pump option) to manage sudden OFF symptoms during continuous infusion, as decided by the doctor.
• If the infusion is interrupted for more than 3 hours, a self-administered loading dose (available as a pump option) may be required before resuming continuous infusion, to rapidly restore symptom control.

Before using Produodopa, read section 7 "Instructions for use of Produodopa for infusion using the Vyafuser pump".
Use of a higher than recommended dose of Produodopa
If a higher than recommended dose of Produodopa is used, contact your doctor immediately or go to the hospital without delay. Bring the medicine packaging with you. The following symptoms may occur:

• abnormally fast, slow, or irregular heartbeat (arrhythmia),
• low blood pressure (hypotension).

Missing a dose or interrupting the use of Produodopa
If the patient forgets to administer Produodopa, infusion should be restarted via the pump at the usual dose as soon as possible.
The use of Produodopa may be temporarily interrupted, for example, during showering.
If the infusion is interrupted for longer than one hour, the infusion set (infusion line and cannula) must be replaced and the infusion site changed.
If the interruption lasts longer than 3 hours, a self-administered loading dose may be necessary to rapidly restore symptom control. The loading dose option is available in the pump, which must be set according to the doctor’s or nurse’s instructions.
If you have any further doubts about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You must stop using Produodopa and contact your doctor immediately if any of the following serious adverse reactions occur.
Urgent medical attention may be required.

• Acute angle-closure glaucoma (sudden eye pain, headache, blurred vision, nausea and vomiting).
• Swelling of the face, tongue or throat, which may make swallowing or breathing difficult, or skin rash (urticaria). These may be signs of a severe allergic reaction (anaphylactic reaction). Frequency cannot be estimated from the available data.

Your doctor will decide whether you may continue treatment with Produodopa.
Other adverse reactions
If any of the following adverse reactions occur, contact your doctor, pharmacist or nurse immediately.
Very common: may affect more than 1 in 10 patients

• Infection at the infusion site (inflammation of connective tissue at the infusion site) (see section 2)
• Anxiety
• Seeing, hearing or sensing things or events that are not real (hallucinations)
• Depression
• Reactions at the infusion site (redness, lump, swelling, pain)
• Falling
• Urinary tract infections

Common: may affect up to 1 in 10 patients

• Reactions at the infusion site (bruising, peeling of thin layers of skin, leakage of medicine, bleeding, inflammation, irritation, nodule, lump, itching, rash)
• Abscess at the infusion site
• Decreased appetite
• Confusion
• False beliefs (delusions)
• Paranoia
• Thoughts of suicide (suicidal thoughts)
• Problems with thinking, learning and memory (cognitive dysfunction)
• Involuntary movements (dyskinesia)
• Involuntary muscle contractions of the eyes, head, neck or body (dystonia)
• Headaches
• Reduced sense of touch, tingling or numbness, burning or prickling sensations in the hands, arms, legs or feet (hypoesthesia, paraesthesia)
• Progressive weakness or pain, or numbness, or loss of sensation in fingers or feet (polyneuropathy)
• Sudden or unpredictable return of Parkinson's disease symptoms – known as the "ON/OFF phenomenon"
• Sudden sleep attacks, excessive daytime sleepiness, sleep disorders
• High or low blood pressure
• Dizziness
• Dizziness upon standing or changing position (orthostatic hypotension, orthostatic dizziness) – caused by low blood pressure. Always change body position slowly – do not stand up too quickly.
• Fainting
• Abdominal pain (lower abdominal pain)
• Constipation
• Dry mouth
• Nausea, diarrhoea or vomiting
• Inability to control urination (urinary incontinence)
• Difficulty passing urine (urinary retention)
• Lack of energy, weakness (fatigue)
• Swelling of the lower limbs or hands due to excess fluid (peripheral oedema)
• Psychotic disorder
• Vitamin B deficiency
• Vitamin B deficiency
• Increased levels of amino acids, small particles that make up proteins in the body
• Increased blood homocysteine levels; this is an amino acid that helps build proteins in the body
• Sore throat
• Weight gain
• Weight loss
• Difficulty sleeping (insomnia)
• Skin rashes, itching, excessive sweating
• Muscle cramps
• Feeling of breathlessness
• General malaise
• Anaemia
• Unusual dreams
• Restlessness
• Abdominal distension (bloating), flatulence, indigestion (dyspeptic symptoms)
• Pain
• Neck pain
• Difficulty swallowing or taste disturbances (bitter taste)
• Irregular heartbeat

Impulse control disorders – changes in patient behaviour . Common: may affect up to 1 in 10 patients.
Some individuals are unable to resist an impulse to perform actions that may be harmful to themselves or others. These include:

• Strong impulse to gamble compulsively, despite serious consequences for the patient or their family,
• Change or increase in sexual thoughts and behaviours, which may be very distressing for the patient or others, for example increased libido,
• Uncontrollable excessive shopping or spending,
• Binge eating – consuming large amounts of food in a short time or compulsive overeating – eating more food than normal and more than the body needs.

Inform your doctor if you, your family or caregiver notice any of these behaviours. It may be necessary for the doctor to re-evaluate the current treatment. The doctor will discuss with you ways to manage or reduce the severity of symptoms.
Uncommon: may affect up to 1 in 100 patients

• Desire to take high doses of Produodopa, higher than necessary to control motor symptoms, known as dopamine dysregulation syndrome
• Dark discoloration of urine
• Hoarseness, chest pain
• Hair loss, skin redness, urticaria
• Increased salivation
• Change in gait
• Attempted or completed suicide, suicide
• Low white blood cell count or changes in blood cell counts that may lead to bleeding
• Elevated mood (euphoria), increased interest in sexual activity, dementia, feeling of anxiety
• Difficulty controlling movements and making sudden movements that the patient cannot control
• Difficulty opening the eyes, double vision, blurred vision, optic nerve damage (ischaemic optic neuropathy)
• Palpitations (awareness of irregular heartbeat)
• Confusion
• Nightmares
• Venous congestion

Rare: may affect up to 1 in 1000 patients

• Teeth grinding
• Painful erection that does not subside
• Appearance of new or worsening skin changes or moles ("spots") or development of skin cancer (malignant melanoma)
• Dark discoloration of saliva or sweat, burning sensation of the tongue, hiccups
• Unusual thoughts
• Abnormal breathing

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Produodopa

Keep the medicine out of the sight and reach of children.
Store the vials in their outer packaging to protect them from breakage.
Do not use this medicine after the expiry date stated on the vial label and the carton. The expiry date refers to the last day of the specified month.

• Do not freeze.
• Store and transport in a refrigerated condition (2°C - 8°C).
• Vials may be stored at room temperature not exceeding 30°C for a single period of up to 28 days.
• The carton includes a space for recording the date the medicine was removed from the refrigerator.
• Once stored at room temperature, the medicine must not be returned to the refrigerator.
• Discard the medicine if not used within the 28-day period of room temperature storage.
• The entire contents of the vial must be transferred completely into a syringe for administration.
• Do not reuse previously opened vials; they are intended for single use only.
• After opening: use immediately. The shelf life after transferring the medicine from the vial into the syringe is 24 hours.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
• Discard the vial after transferring the medicine into the sy游戏副本

6. Contents of the package and other information

What Produodopa contains

• The active substances in this medicine are foslevodopa and foscarbidopa. 1 ml contains 240 mg of foslevodopa and 12 mg of foscarbidopa.
• 1 vial of 10 ml contains 2400 mg of foslevodopa and 120 mg of foscarbidopa.
• Other ingredients are: sodium hydroxide 10N (for pH adjustment), concentrated hydrochloric acid (for pH adjustment), and water for injections.

What Produodopa looks like and contents of the pack
Produodopa is a clear to slightly opalescent, particle-free solution. It is contained in a clear, colourless glass vial sealed with a grey bromobutyl rubber stopper, an aluminium cap, and a turquoise plastic flip-off cap. The solution may be colourless, yellow, brown, or may have a purple or red tint. Differences in colour are expected and do not affect the quality of the medicine. The solution may become darker after piercing the vial stopper or when in a syringe.
Each pack contains 7 vials of 10 ml each, in a cardboard box.
Sterile, single-use infusion components (syringe, infusion set, and vial adapter), which have been qualified for use, are supplied separately by the physician or pharmacy. The Vyafuser pump is supplied separately.
Marketing Authorisation Holder
AbbVie Sp. z o.o.
ul. Postępu 21B
02-676 Warsaw
Tel.: + 48 22 372 78 00
Manufacturer/Importer
AbbVie S.r.l.
S.R. 148 Pontina Km 52 snc
04011 Campoverde di Aprilla (LT)
Italy
or
AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany
Other sources of information
Detailed information on this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products http://urpl.gov.pl
This medicinal product is authorised in the Member States of the European Economic Area under the following names:

7. Instructions for using Produodopa infusion with the Vyafuser pump

Before administering Produodopa, please read the following section carefully.
Important information
Read the instructions below carefully – these instructions explain how to prepare and use the medicine Produodopa.

• Produodopa is administered as a subcutaneous infusion using the Vyafuser pump and its components (syringe, infusion set, and vial adapter).
• The components of the infusion set can be obtained from your doctor or pharmacy.
• Before using Produodopa, you must also read carefully the full instructions for the vial adapter, the infusion set, and the patient instructions for the Vyafuser pump.
• Your doctor or nurse will prepare the pump for you to ensure you always receive the correct dose.
• Before starting treatment, your doctor or nurse will instruct you on how to use the medicine and operate the pump.
• If anything is unclear, ask your doctor or nurse.

How to prepare the medicine

• Do not dilute the Produodopa solution or fill the syringe with any other solution.
• Before infusion, the medicine should be at room temperature. If stored in the refrigerator, remove the vial from the fridge and leave it for 30 minutes at room temperature, away from direct sunlight. If the medicine has been refrigerated, do not heat it (in vial or syringe) by any method other than allowing it to warm to room temperature. For example, do not heat it in a microwave or hot water.

1. Preparation
Always follow the recommendations below in the order listed when you need to refill the pump with Produodopa.

• Wash your hands with soap and water and dry them thoroughly.
• Ensure you have a clean, flat surface available. This helps prevent contamination during syringe preparation.
• On the flat surface, place:
  • the syringe (in its packaging)
  • the vial of Produodopa solution
  • the vial adapter (in its packaging). A new vial adapter must be used with each new vial of Produodopa solution.
  • alcohol-impregnated swabs (not included in the medicine pack)
• Check the vial, vial adapter, and syringe for expiration date and any signs of damage to the packaging.
• Do not use the vial, vial adapter, or syringe if the sterile packaging is damaged.
• Do not use Produodopa solution, vial adapter, or syringe after the expiration date.
• Do not use if the Produodopa solution is cloudy or contains lumps or particles.

2. Preparing the vial of solution

1. Prepare the vial of solution.

a. Remove the plastic cap from the vial of solution.

b. Wipe the top of the vial with an alcohol-impregnated swab and allow it to air dry.
2) Attach the vial adapter to the vial of solution.
The vial adapter may look different from the one shown in this section.
a. Remove the paper cover from the vial adapter packaging. Keep the adapter in its plastic packaging until step 3.
b. Using the packaging, firmly press the vial adapter straight down onto the vial of solution until it clicks into place.
c. Remove the packaging straight from the vial adapter.
More detailed information can be found in the vial adapter user manual.
3) While holding the vial adapter firmly, attach the syringe to the vial adapter by pushing and then screwing it in (clockwise). Do not over-tighten.
4) Hold the syringe vertically with the vial of solution above the syringe.

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5) It is important to keep the syringe pointing straight upwards.
6) While holding the syringe firmly in one hand, use the other hand to pull the plunger down to draw the entire contents of the vial of solution into the syringe, up to a volume of approximately 12 ml or until air appears at the tip of the syringe.

a. Ensure that the entire contents of the vial of solution have been drawn into the syringe.
b. Air (an empty space) will be visible at the tip of the syringe.
7) Check for air bubbles.

a. Small air bubbles are acceptable, and air at the tip of the syringe is expected. If only small air bubbles are visible or no bubbles are present, skip the next section and proceed to step 9: Removing air from the syringe.
b. If large air bubbles are present, they must be removed. If large air bubbles are visible, proceed to the next section, step 8: Manual removal of air bubbles.
8) Manual removal of air bubbles.

a. Slowly and gently rotate the syringe and tilt it back and forth to coalesce the bubbles into one. Do not shake or tap the syringe to remove air bubbles.
b. If air bubbles persist, collect them by gently rotating the syringe up and down.

c. When the large air bubbles have combined into one, proceed to the next step.
9) Remove air from the syringe.
a. With the vial of solution still attached, point the syringe upwards.

b. Slowly push the air from the syringe back into the vial. You will feel resistance as the air is pushed back into the vial of solution.
c. Continue pushing until all air has been expelled from the syringe into the vial of solution and solution is visible at the tip of the syringe.

d. A small air bubble may appear in the corner if the syringe is tilted. This is acceptable.
10) Turn the syringe and vial of solution upside down so that the vial of solution stands vertically on a flat surface.

11. Disconnect the syringe from the vial adapter.

a. Hold the vial adapter firmly with one hand and the syringe barrel with the other.
b. Unscrew the syringe from the vial adapter. Do not press the plunger while disconnecting, otherwise the solution may leak.
c. Place the syringe on a clean surface, ensuring the tip does not touch any non-sterile surface.
12) The syringe is now ready for use.
3. Preparing the Produodopa infusion

• Connect the infusion set to the new syringe.
  • While holding the syringe firmly, connect the infusion set to the syringe and screw it tightly into place.
  • Detailed instructions are provided in the infusion set instructions.
• Insert the syringe into the pump.
  • Detailed instructions are provided in the Vyafuser pump patient instructions.
• Prime the infusion set. Priming means the pump pushes medicine from the syringe through the infusion set to remove air from the set.
  • Detailed instructions are provided in the Vyafuser pump patient instructions.

4. Choosing and preparing the infusion site

Select the area shown (on the abdomen), at least 5 cm from the navel.

• Avoid areas with scars, hardened tissue, stretch marks, skin folds, or natural body creases, or areas where clothing may cause irritation (e.g., near the waistband).
• Open an alcohol-impregnated swab and clean the selected infusion site with it. Allow it to air dry for at least 1 minute.

Detailed instructions are provided in the infusion set instructions and Vyafuser pump patient instructions.

• Insert the cannula into the body and connect the infusion set to the cannula.
  • Insert the cannula into the body.
  • Connect the infusion set to the cannula.
  • Detailed instructions are provided in the infusion set instructions.

5. Starting the Produodopa infusion

• Turn on the pump. Detailed instructions are provided

in the Vyafuser pump patient instructions.

• Options for drug delivery via the pump

• The pump has alternative administration options available, which the doctor may set if necessary.

6. After use

• Used vials of solution with the vial adapter still attached should be disposed of according to local regulations or as advised by the doctor, pharmacist, or nurse.