NOVORAPID PUMPCART 100 U/mL INJECTABLE SOLUTION IN CARTRIDGE

Introduction

Package Leaflet: Information for the User

NovoRapid PumpCart 100units/ml solution for injection in cartridge

insulin aspart

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, nurse or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is NovoRapid PumpCart and what is it used for
2. What you need to know before you use NovoRapid PumpCart
3. How to use NovoRapid PumpCart
4. Possible side effects
5. Storing NovoRapid PumpCart
6. Contents of the pack and other information

1. What is NovoRapid PumpCart and what is it used for

NovoRapid is a modern insulin (insulin analogue) with a fast action. Modern insulins are improved versions of human insulin.

NovoRapid is used to reduce high blood sugar levels in adults, adolescents and children from 1 year of age with diabetes mellitus (diabetes). Diabetes is a disease where the body does not produce enough insulin to control blood sugar levels. Treatment with NovoRapid helps to prevent complications of diabetes.

NovoRapid PumpCart must be used in a pump. It covers your total daily insulin needs: the insulin you need throughout the day (basal) and the insulin you need when you eat (bolus). Before using NovoRapid PumpCart in the pump, you must have received complete training from your doctor or nurse.

Need for basal insulin (throughout the day):when using NovoRapid PumpCart in a pump, the insulin is released constantly to cover your basal insulin needs. If you change the basal insulin setting, the change will start to take effect within 10-20 minutes. If you stop the pump, the effect of the insulin will last for 3 to 5 hours. Before setting or changing the basal dose, read the pump manual (user manual) carefully.

Need for bolus insulin (mealtime):NovoRapid will start to lower your blood sugar levels within 10-20 minutes of starting the bolus administration (see section 3, How to use NovoRapid PumpCart, for more information on how to adjust your bolus dose). The maximum effect occurs between 1 and 3 hours after bolus administration and the effect lasts for 3 to 5 hours.

2. What you need to know before you use NovoRapid PumpCart

Do not use NovoRapid PumpCart

? If you are allergic to insulin aspart or any of the other ingredients of this medicine (see section 6, Contents of the pack and other information).

? If you suspect you are going to have a hypoglycaemia (low blood sugar level) (see a) Summary of serious and frequent adverse reactions in section 4).

? If the cartridge or the device containing the cartridge has been dropped, damaged or broken.

? If it has not been stored correctly or if it has been frozen (see section 5, Storing NovoRapid PumpCart).

? If the insulin does not have a clear and colourless appearance.

If any of these circumstances apply to you, do not use NovoRapid PumpCart. Consult your doctor, nurse or pharmacist.

Before using NovoRapid PumpCart

? Check the label to ensure that the insulin is the type that has been prescribed for you.

? Always check the cartridge, including the rubber stopper at the end of the cartridge. Do not use it if it is damaged, if insulin is leaking or if the rubber stopper has moved above the white band at the end of the cartridge. This could be a sign that insulin has leaked out. If you suspect that the cartridge is damaged, return it to your supplier.

? Do not share infusion equipment (cannula and needle) or NovoRapid PumpCart.

? NovoRapid PumpCart is only intended for injection under the skin (subcutaneously) using a pump. Consult your doctor if you need to inject insulin by another method.

Warnings and precautions

Some conditions and activities may affect your insulin requirement. Consult your doctor:

? If you have kidney, liver, adrenal, pituitary or thyroid gland problems.

? If you do more physical exercise than usual or if you want to change your diet, as this may affect your blood sugar level.

? If you are ill, continue your insulin treatment and consult your doctor.

? If you plan to travel abroad, time differences between countries may affect your insulin requirements and administration schedule.

Skin changes at the injection site

The injection site should be rotated to help avoid changes in the fatty tissue, such as thickening of the skin, shrinking of the skin or lumps under the skin. Insulin may not work well if it is injected into a lumpy, shrunk or thickened area (see section 3, How to use NovoRapid PumpCart). Inform your doctor if you notice any changes at the injection site. Inform your doctor if you are currently injecting into these affected areas, before starting to inject into a different area. Your doctor may advise you to check your blood sugar levels more closely and adjust your insulin dose or the dose of your other anti-diabetic medications.

Children and adolescents

Do not give this medicine to children under 1 year of age, as clinical trials have not been conducted in children under 1 year of age.

Other medicines and NovoRapid

Tell your doctor, nurse or pharmacist if you are using, have recently used or might use any other medicines.

Some medicines affect your blood sugar level and this may mean that you need to adjust your insulin dose. The following are the main medicines that may affect your treatment with insulin.

Your blood sugar level may be lowered (hypoglycaemia) if you take:

• other medicines for the treatment of diabetes;
• monoamine oxidase inhibitors (MAOIs) (used to treat depression);
• beta-blockers (used to treat high blood pressure);
• angiotensin-converting enzyme (ACE) inhibitors (used to treat certain heart diseases or high blood pressure);
• salicylates (used to relieve pain and lower fever);
• anabolic steroids (such as testosterone);
• sulphonamides (used to treat infections).

Your blood sugar level may be raised (hyperglycaemia) if you take:

• oral contraceptives (birth control pills);
• thiazides (used to treat high blood pressure or excessive fluid retention);
• glucocorticoids (such as “cortisone” used to treat inflammation);
• thyroid hormones (used to treat thyroid gland disorders);
• sympathomimetics (such as adrenaline or salbutamol or terbutaline used to treat asthma);
• growth hormone (medicine to stimulate growth of the skeleton and body, which has a pronounced effect on metabolic processes);
• danazol (medicine that acts on ovulation).

Octreotide and lanreotide (used to treat acromegaly, a rare hormonal disorder that usually occurs in middle-aged adults, caused when the pituitary gland produces too much growth hormone) may increase or decrease your blood sugar levels.

Beta-blockers (used to treat high blood pressure) may weaken or completely suppress the first warning symptoms that could help you recognise when you have low blood sugar levels.

Pioglitazone (tablets used to treat type 2 diabetes)

Some patients with type 2 diabetes of long duration and previous heart disease or stroke who were treated with pioglitazone and insulin developed heart failure. Inform your doctor as soon as possible if you have signs of heart failure such as unusual shortness of breath, rapid weight gain or localised swelling (oedema).

If you have taken any of the medicines mentioned above, inform your doctor, nurse or pharmacist.

Alcoholic beverages and use of NovoRapid

? If you drink alcohol, it may alter your insulin requirement because your blood sugar level may increase or decrease. Careful monitoring is recommended.

Pregnancy and breast-feeding

? If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. NovoRapid can be used during pregnancy. You may need to adjust your insulin dose during pregnancy and after delivery. It is very important for the health of your baby to maintain good control of your diabetes, especially avoiding hypoglycaemia.

• There are no restrictions to the use of NovoRapid during breast-feeding.

Ask your doctor, nurse or pharmacist for advice before using this medicine while pregnant or breast-feeding.

Driving and using machines

? Please ask your doctor whether you can drive or use machines:

• If you have frequent hypoglycaemias.
• If you have difficulty recognising hypoglycaemias.

If your blood sugar levels are too low or too high, your concentration and reaction time may be affected, which can also affect your ability to drive or use machines. Be aware that you could put yourself or others at risk.

Important information about some of the ingredients of NovoRapid

NovoRapid contains less than 23 mg (1 mmol) of sodium per dose, so NovoRapid is essentially “sodium-free”.

3. How to use NovoRapid PumpCart

Dose and when to administer the insulin

Follow your doctor’s instructions for administering the insulin and adjusting the dose. If in doubt, consult your doctor, nurse or pharmacist. Your bolus dose (mealtime dose) should be adjusted based on your blood glucose measurement and food intake. Take some food within 10 minutes after the bolus dose to avoid hypoglycaemia. When necessary, the bolus insulin can be administered immediately after finishing a meal.

Do not change your insulin unless your doctor tells you to. If your doctor switches you from one type or brand of insulin to another, you may need to adjust your dose.

Use in children and adolescents

NovoRapid can be used in adolescents and children from 1 year of age.

Use in special patient groups

If you have kidney or liver problems, or if you are over 65 years old, you should monitor your blood sugar more frequently and consult your doctor about changes in your insulin dose.

How and where to inject

NovoRapid PumpCart is only intended for injection under the skin (subcutaneously) using a pump. Never inject directly into a vein (intravenously) or into a muscle (intramuscularly). Consult your doctor if you need to inject insulin by another method.

Before using NovoRapid PumpCart in a pump, you must have received thorough training in the use of the pump and the necessary information on the measures to be taken in case of illness, high or low blood sugar levels or pump failure. Follow your doctor’s instructions and advice on the use of NovoRapid PumpCart in a pump.

Insulin is normally injected into the abdominal area. Alternatively, if your doctor recommends it, you can use the thigh or the upper arm. When changing the infusion equipment (cannula and needle), make sure to change the insertion site of the needle (injection site). This may reduce the risk of developing lumps or depressions in the skin (see section 4, Possible side effects). The infusion equipment should be changed according to the instructions provided with the equipment.

When using an insulin pump

It is best to measure your blood sugar level regularly to get the maximum benefit from your insulin treatment and to ensure that the pump is working correctly. If you have any problems, consult your doctor.

? NovoRapid PumpCart should only be used with a pump designed to be used with this cartridge, such as the Accu-Chek Insight and YpsoPump insulin pumps.

? NovoRapid PumpCart is a pre-filled cartridge ready for use directly in the pump. Follow the pump manual (user manual).

? To ensure correct dosing, NovoRapid PumpCart must not be used in an insulin pen.

? NovoRapid must not be mixed with any other medicine, including other insulins, when used in a pump.

? Do not refill the cartridge. Once empty, it must be discarded.

? Always carry a spare NovoRapid PumpCart with you.

Read carefully the instructions for use on how to use NovoRapid PumpCart included in this package leaflet.

What to do in case of pump failure

Make sure you have an alternative method to inject insulin subcutaneously (e.g. an insulin pen) in case the pump fails.

If you use more insulin than you should

If you use too much insulin, your blood sugar level may become too low (hypoglycaemia). See a) Summary of serious and frequent adverse reactions in section 4.

If you forget to use your insulin

If you forget to inject your insulin, your blood sugar level may become too high (hyperglycaemia). See c) Effects of diabetes in section 4.

If you stop using your insulin

Do not stop using your insulin without consulting your doctor, he will tell you what to do. This could lead to very high blood sugar levels (severe hyperglycaemia) and ketoacidosis. See c) Effects of diabetes in section 4.

If you have any other questions about the use of this medicine, ask your doctor, nurse or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

• Summary of serious and very frequent adverse effects

Low blood sugar (hypoglycemia)is a very frequent adverse effect. It can affect more than 1 in 10 people.

Low blood sugar levels may appear if:

• too much insulin is injected;
• you eat very little or skip a meal;
• you do more exercise than usual;
• you drink alcohol (see Alcoholic Beverages and Use of NovoRapid in Section 2).

Warning signs of low blood sugar: cold sweat, cold and pale skin, headache, palpitations, nausea, excessive hunger, temporary changes in vision, drowsiness, unusual fatigue and weakness, nervousness or tremors, anxiety, confusion, and difficulty concentrating.

A severe drop in blood sugar can lead to loss of consciousness. If a severe and prolonged drop in blood sugar is not treated, it can cause brain damage (transient or permanent) and even death. You can recover consciousness more quickly if someone who knows how to do it administers a glucagon injection to you. If you are given glucagon, you should take glucose or a sugary product as soon as you regain consciousness. If you do not respond to glucagon treatment, you should be treated in a hospital.

What to do if your blood sugar level is low:

? If your blood sugar level is low, take glucose tablets or a sugary product (caramels, cookies, fruit juice) and adjust the insulin release or stop the pump. Measure your blood sugar level if possible and then rest. Always carry glucose tablets or sugary foods with you in case you need them.

? When the symptoms of hypoglycemia have disappeared or when blood sugar levels have stabilized, continue insulin treatment as usual.

? If you have had blood sugar levels so low that they have caused you to lose consciousness, if you have needed to be given a glucagon injection, or if you have had many drops in blood sugar levels, talk to your doctor. You may need to adjust the amount or administration schedule of insulin, food, or exercise.

Inform others that you have diabetes and what the consequences may be, including the risk of losing consciousness due to a drop in blood sugar levels. Inform them that if you become unconscious, they should lay you on your side and seek immediate medical attention. They should not give you anything to eat or drink as you could choke.

Severe allergic reactionsto NovoRapid or to any of its components (called a systemic allergic reaction) is a very rare but potentially fatal adverse effect. It can affect up to 1 in 10,000 people.

Consult your doctor immediately:

• if the signs of allergy spread to other parts of your body.
• if you suddenly feel sick and have sweats, vomiting, difficulty breathing, palpitations, feel dizzy.

? If you notice any of these symptoms, consult your doctor immediately.

Changes in the skin at the injection site: If insulin is injected in the same place, the fatty tissue can shrink (lipoatrophy) or become thicker (lipohypertrophy) (can affect up to 1 in 100 people). Lumps under the skin can also occur due to the accumulation of a protein called amyloid (cutaneous amyloidosis; the frequency of this is unknown). Insulin may not work very well if injected into a lumpy, shrunken, or thickened area. Change the injection site to help avoid these skin changes.

• List of other adverse effects

Uncommon adverse effects

Can affect up to 1 in 100 people.

Allergic reactions: local allergic reactions may appear at the injection site (pain, redness, hives, inflammation, bruising, swelling, and itching). These reactions usually disappear after a few weeks of treatment. If the symptoms do not disappear, or if they spread throughout your body, consult your doctor immediately. See also Severe Allergic Reactions above.

Visual problems: when starting insulin treatment, you may have problems with your vision, but this alteration is usually temporary.

Joint swelling: when starting insulin treatment, fluid accumulation can cause inflammation of the ankles and other joints. This effect usually disappears quickly. If it does not, consult your doctor.

Diabetic retinopathy (an eye disease related to diabetes that can lead to vision loss): if you have diabetic retinopathy and your blood sugar level improves very quickly, retinopathy may worsen. Consult your doctor.

Rare adverse effects

Can affect up to 1 in 1,000 people.

Painful neuropathy (pain due to nerve damage): if your blood sugar level improves very quickly, you may suffer from nerve-related pain. This is called acute painful neuropathy and is usually transient.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, nurse, or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

• Effects of diabetes

High blood sugar (hyperglycemia)

High blood sugar levels may appear if:

• you have not injected enough insulin;
• you forget to inject insulin or interrupt insulin treatment;
• you repeatedly inject less insulin than you need;
• you have an infection or fever;
• you eat more than usual;
• you do less physical exercise than usual.

Warning signs of high blood sugar:

the warning signs appear gradually. These include: increased need to urinate, thirst, loss of appetite, feeling of dizziness (nausea or vomiting), drowsiness or fatigue, dry and reddened skin, feeling of dryness in the mouth and fruity breath (acetone).

What to do if your blood sugar level is high:

? If you notice any of the described symptoms: check your blood sugar level, check the ketone level in your urine if possible, and consult your doctor immediately.

? These can be symptoms of a very serious disorder called diabetic ketoacidosis (acid builds up in the blood because the body breaks down fat instead of sugar). If left untreated, it could produce a diabetic coma and death.

5. Storage of NovoRapid PumpCart

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the cartridge label and on the packaging, after EXP. The expiration date is the last day of the month indicated.

Always keep the cartridge in the outer packaging when not in use to protect it from light. NovoRapid PumpCart must be protected from heat and excessive light during storage and use.

Before opening: the unused NovoRapid PumpCart must be stored in a refrigerator between 2°C and 8°C, away from the walls or the cooling component of the refrigerator. Do not freeze.

During use or when carried as a spare: the NovoRapid PumpCart in use must not be stored in a refrigerator. NovoRapid PumpCart carried as a spare can be kept for a maximum of 2 weeks below 30°C. After that, it can be used for a maximum of 7 days below 37°C in an insulin pump designed to be used with this cartridge, such as the Accu-Chek Insight and YpsoPump insulin pumps. Keep NovoRapid PumpCart in the packaging until you use it to protect it from damage. Always protect the cartridge from light during use.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of NovoRapid PumpCart

• The active substance is insulin aspart. Each ml contains 100 units of insulin aspart. Each cartridge contains 160 units of insulin aspart in 1.6 ml of injectable solution.
• The other components are glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide, and water for injectable preparations.

Appearance of the Product and Package Contents

NovoRapid PumpCart is presented as a solution for injection.

The packaging contains 5 cartridges and a multipack with 25 cartridges (5 packs of 5 cartridges) of 1.6 ml. Not all pack sizes may be marketed.

The solution is transparent and colorless.

Marketing Authorization Holder and Manufacturer

Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark

Please follow the instructions described in “Instructions for using NovoRapid PumpCart pre-filled cartridge”.

Date of the last revision of this leaflet:03/2023

Other Sources of Information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

Instructions for using NovoRapid PumpCart pre-filled cartridge

NovoRapid PumpCart can only be used with an insulin pump system designed to be used with this cartridge, such as the Accu-Chek Insight and YpsoPump insulin pumps. It must not be used with other devices not designed for NovoRapid PumpCart, as this may cause an incorrect dose of insulin to be administered and therefore hyper or hypoglycemia.

Read these instructions carefullybefore using your NovoRapid PumpCart.

Also, read the pump manual (user manual)that comes with the insulin pump.

Pay special attention to these notes as they are important for the safe use of NovoRapid PumpCart.

• Handle the pump and cartridge with care and follow the instructions carefully. Rough handling or misuse can cause incorrect dosing and can produce very high or very low blood sugar levels.

• NovoRapid PumpCart is ready to be used directly in the pump.

• NovoRapid PumpCart contains 1.6 ml of insulin aspart solution, equivalent to 160 units.

• This medicine must never be mixed with any other medicine.

• Do not refill NovoRapid PumpCart. Once empty, it must be discarded.

• Always make sure you have a spare NovoRapid PumpCart available.

• To ensure correct dosing, NovoRapid PumpCart must not be used in an insulin pen.

• NovoRapid PumpCart must be protected from heat and excessive light during storage and use.

• NovoRapid PumpCart must be kept out of the reach of other people, especially children.

1. Before inserting a NovoRapid PumpCart cartridge into your pump

• Bring NovoRapid PumpCart to room temperature.

• Remove NovoRapid PumpCart from its packaging.

• Check the label to ensure it is NovoRapid PumpCart.

• Check the expiration date that appears on the label and on the packaging.

Always check that NovoRapid PumpCart has the appearance it should. See Figure A.

You should only see the top of the plunger above the white label band. If you suspect that NovoRapid PumpCart is damaged, return it to your supplier.

Do not use itif it is damaged, or if it loses insulin or if the plunger has moved, making the bottom of the plunger visible above the white label band. This may mean that insulin has leaked out.

Check that the NovoRapid PumpCart insulin is transparent and colorless. If the insulin appears cloudy, do not use NovoRapid PumpCart. The cartridge may contain a small amount of air in the form of small bubbles.

1. Insertion of a new NovoRapid PumpCart cartridge into your pump

• Follow the instructions in the manual that comes with your pump to insert a new NovoRapid PumpCart cartridge into your pump.

• Insert NovoRapid PumpCart into the cartridge compartment of the pump. The plunger side is inserted first.

• Connect the infusion set to NovoRapid PumpCart by connecting the adapter to your pump.

Regularly check for damage to the pump and cartridge, such as cracks or leaks. If you smell insulin, it may indicate a leak. If you notice cracks or leaks, do not usethe cartridge. Follow the pump manual instructions to replace the cartridge and to clean the cartridge compartment in the pump. An insulin leak can cause incorrect dosing and can produce high blood sugar levels. See section 4 c) of the leaflet.

During the day and before going to bed, check that your pump is delivering insulin and that there are no leaks. You maynothave a pump alarm warning as a result of a failure in insulin delivery, and you may not realize there is a problem. You may need to check your blood sugar levels. Consult your doctor or diabetes care team if you suspect a problem with insulin delivery.

Make sure you always have an alternative method for administering insulin (e.g., an injection pen) in case the pump stops working. Seek medical attention if you think you have high blood sugar or diabetic ketoacidosis.

1. Removal of the empty NovoRapid PumpCart cartridge from your pump

• Follow the instructions in the pump manual to remove the empty NovoRapid PumpCart cartridge from your pump.

• Remove the adapter from the infusion set from the empty NovoRapid PumpCart cartridge.

• Discard the empty NovoRapid PumpCart cartridge and the used infusion set as instructed by your doctor or nurse.

• Follow the steps described in sections 1 and 2 to prepare and insert a new NovoRapid PumpCart cartridge into your pump.