NovoRapid PumpCart 100 U/ml solution for injection in cartridge

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

NovoRapid PumpCart 100 units/ml solution for injection in cartridge

insulin aspart

Read this entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, nurse or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, nurse or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

NovoRapid is used to lower high blood glucose levels in adults, adolescents, and children from 1 year of age onwards who have diabetes mellitus (diabetes). Diabetes is a condition in which the body does not produce enough insulin to control blood glucose levels. Treatment with NovoRapid helps prevent diabetes-related complications.

NovoRapid PumpCart must be used in an insulin pump. It covers your total daily insulin requirements: both the insulin needed throughout the day (basal) and the insulin needed at meal times (bolus). Before using NovoRapid PumpCart in a pump, you must have received complete training from your doctor or nurse.

Basal insulin requirement (throughout the day): When using NovoRapid PumpCart in a pump, insulin is continuously released to meet your basal insulin needs. If you change your basal insulin setting, the change will begin to affect you within the next 10–20 minutes. If you stop the pump, the insulin effect will last for 3 to 5 hours. Before setting or adjusting your basal dose, carefully read the pump manual (user manual).

Bolus insulin requirement (at meal times): NovoRapid will begin to lower your blood glucose within 10–20 minutes after starting the bolus administration (see section 3, How to use NovoRapid PumpCart, for more information on adjusting 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 using 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 further information).

? If you suspect you are about to experience hypoglycaemia (low blood sugar levels) (see a) Summary of serious and very common adverse effects in section 4).

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

? If it has not been stored properly or if it has been frozen (see section 5, Storage of NovoRapid PumpCart).

? If the insulin does not appear clear and colourless.

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

Before using NovoRapid PumpCart

? Check the label and make sure the insulin is the type prescribed for you.

? Always inspect the cartridge, including the rubber stopper at the end of the cartridge. Do not use 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 indicate that insulin has leaked out. If you suspect the cartridge is damaged, return it to your supplier.

? Perfusion sets (cannula and needle) and NovoRapid PumpCart must not be shared.

? NovoRapid PumpCart is intended only for subcutaneous (under the skin) administration using an infusion pump. Consult your doctor if you need to administer insulin by another method.

Warnings and precautions

Certain conditions and activities may affect your insulin requirements. Consult your doctor:

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

? If you are doing more physical exercise than usual or if you plan to change your diet, as this may affect your blood sugar levels.

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

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

Skin changes at the injection site

Injection sites should be rotated to help prevent changes in fatty tissue, such as skin thickening, skin shrinking, or lumps under the skin. Insulin may not work well if injected into an area that is lumpy, shrunken, or thickened (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 such affected areas before switching to a different injection site. Your doctor may advise you to monitor your blood sugar levels more closely and may adjust your insulin dose or the dose of your other antidiabetic medications.

Children and adolescents

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

Other medicines and NovoRapid

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

Some medicines affect your blood sugar levels and may require adjustment of your insulin dose. The main medicines that may affect your insulin treatment are listed below.

Your blood sugar level may decrease (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 conditions or high blood pressure);
• salicylates (used to relieve pain and reduce fever);
• anabolic steroids (such as testosterone);
• sulfonamides (used to treat infections).

Your blood sugar level may increase (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 epinephrine [adrenaline], salbutamol, or terbutaline used to treat asthma);
• growth hormone (a medicine used to stimulate somatic and skeletal growth, which strongly influences metabolic processes);
• danazol (a medicine that affects ovulation).

Octreotide and lanreotide (used to treat acromegaly, a rare hormonal disorder usually occurring in middle-aged adults, caused by the pituitary gland producing excess growth hormone) may increase or decrease your blood sugar levels.

Beta-blockers (used to treat high blood pressure) may weaken or completely suppress the early warning symptoms that help you recognize when your blood sugar levels are low.

Pioglitazone (tablets used to treat type 2 diabetes)

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

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

Alcohol and use of NovoRapid

? If you drink alcohol, it may alter your insulin requirements, as your blood sugar levels may increase or decrease. Careful monitoring is recommended.

Pregnancy and breastfeeding

? If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. NovoRapid can be used during pregnancy. Your insulin dose may need to be adjusted during pregnancy and after delivery. Careful diabetes control is important for your baby’s health, especially to prevent hypoglycaemia.

• There are no restrictions on treatment with NovoRapid during breastfeeding.

Consult your doctor, nurse, or pharmacist before using this medicine if you are pregnant or breastfeeding.

Driving and use of machines

? Please ask your doctor whether you may drive or operate machinery:

• If you frequently experience hypoglycaemia.
• If you have difficulty recognizing hypoglycaemia.

If your blood sugar levels are low or high, your concentration and reaction ability may be impaired, and therefore your ability to drive or operate machinery may also be affected. Be aware that this could endanger your life or the lives of others.

Important information about some of the ingredients of NovoRapid

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

3. How to use NovoRapid PumpCart

Dosage and when to administer insulin

Follow exactly the insulin administration and dose adjustment instructions given by your doctor. If in doubt, consult your doctor, nurse, or pharmacist. Your bolus insulin dose (at mealtime) should be adjusted based on your blood glucose measurement and food intake. Eat a meal within 10 minutes after taking the bolus dose to avoid hypoglycaemia. When necessary, the insulin bolus may be administered immediately after finishing the meal.

Do not switch insulin unless your doctor tells you to. If your doctor changes you from one type or brand of insulin to another, you may need a dose adjustment.

Use in children and adolescents

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

Use in special patient groups

If you have impaired kidney or liver function, or if you are over 65 years of age, you should monitor your blood sugar more frequently and consult your doctor regarding any changes in your insulin dose.

How and where to inject

NovoRapid PumpCart is intended only for subcutaneous (under the skin) injection using an insulin pump. It must never be injected directly into a vein (intravenous route) or into muscle (intramuscular route). Consult your doctor if you need to administer insulin by another method.

Before using NovoRapid PumpCart in a pump, you must receive thorough training in pump use and information on the measures to take in case of illness, blood sugar levels that are too high or too low, or pump failure. Follow your doctor's instructions and advice on using NovoRapid PumpCart with an insulin pump.

Insulin is usually injected into the abdominal area. Alternatively, if recommended by your doctor, you may use the thigh or upper arm. When changing the infusion set (cannula and needle), be sure to change the insertion site (injection site). This may reduce the risk of developing lumps or depressions in the skin (see section 4, Possible side effects). Change the infusion set according to the instructions provided in the infusion set manual.

When using an insulin pump

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

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

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

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

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

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

? Always keep a spare NovoRapid PumpCart available.

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

What to do in case of pump failure

Ensure you have an alternative method available to administer insulin subcutaneously (e.g., an insulin pen) in case the pump stops working.

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 very common adverse effects in section 4.

If you forget to use your insulin

If you forget to inject 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 treatment with your insulin without consulting your doctor; he or she will advise 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 further 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 everyone will experience them.

a) Summary of serious and very common adverse effects

Low blood sugar (hypoglycaemia) is a very common adverse effect. It may affect more than 1 in 10 people.

Low blood sugar levels may occur if:

• too much insulin is injected;
• you eat very little or skip a meal;
• you exercise more than usual;
• you drink alcohol (see Alcohol 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 tiredness and weakness, nervousness or trembling, anxiety, confusion, and difficulty concentrating.

Severe low blood sugar can lead to loss of consciousness. If a severe and prolonged low blood sugar is not treated, it may cause brain damage (transient or permanent) and even death. Recovery of consciousness may be faster if someone trained administers a glucagon injection. If glucagon is given, you must take glucose or a sugary product as soon as you regain consciousness. If there is no response to glucagon treatment, you must 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 (candies, biscuits, fruit juice) and adjust or stop the insulin delivery from your pump. Check your blood sugar level if possible, then rest. Always carry glucose tablets or sugary foods in case you need them.

? Once the symptoms of hypoglycaemia have disappeared or blood sugar levels have stabilized, continue insulin treatment as usual.

? If your blood sugar has dropped so low that you became unconscious, if you required a glucagon injection, or if you have had frequent episodes of low blood sugar, speak to your doctor. You may need to adjust your insulin dose or regimen, diet, or exercise routine.

Inform others that you have diabetes and explain the possible consequences, including the risk of losing consciousness due to low blood sugar. Let them know that if you become unconscious, they should place you in the recovery position and seek immediate medical help. Do not allow them to give you food or drink, as you could choke.

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

Contact your doctor immediately:

• if signs of allergy spread to other parts of your body.
• if you suddenly feel unwell and have sweating, vomiting, difficulty breathing, palpitations, or dizziness.

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

Skin changes at the injection site: If you inject insulin in the same place repeatedly, fatty tissue may shrink (lipoatrophy) or thicken (lipohypertrophy) (may affect up to 1 in 100 people). Lumps under the skin may also occur due to accumulation of a protein called amyloid (cutaneous amyloidosis; frequency unknown). Insulin may not work effectively if injected into a lumpy, shrunken, or thickened area. Rotate injection sites to help prevent these skin changes.

b) List of other adverse effects

Uncommon adverse effects

May affect up to 1 in 100 people.

Signs of allergy: local allergic reactions may occur at the injection site (pain, redness, rash, swelling, bruising, oedema, and itching). These reactions usually resolve after a few weeks of treatment. If symptoms do not resolve, or if they spread throughout your body, consult your doctor immediately. See also Severe allergic reactions above.

Vision problems: when starting insulin treatment, you may experience vision disturbances, but this is usually temporary.

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

Diabetic retinopathy (a diabetes-related eye disease that may lead to vision loss): if you have diabetic retinopathy and your blood sugar level improves rapidly, the condition may worsen. Consult your doctor.

Rare adverse effects

May affect up to 1 in 1,000 people.

Painful neuropathy (pain due to nerve damage): if your blood sugar level improves rapidly, you may experience nerve-related pain. This is known as acute painful neuropathy and is usually temporary.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, nurse, or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

c) Effects of diabetes

High blood sugar (hyperglycaemia)

High blood sugar levels may occur if:

• insufficient insulin has been injected;
• 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 exercise less than usual.

Warning signs of high blood sugar:

warning signs appear gradually. These include: increased need to urinate, thirst, loss of appetite, feeling unwell (nausea or vomiting), drowsiness or tiredness, dry and flushed skin, dry mouth, and fruity breath odour (acetone).

What to do if your blood sugar level is high:

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

? These may be symptoms of a very serious condition called diabetic ketoacidosis (acid builds up in the blood because the body breaks down fat instead of sugar). If left untreated, it could lead to 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 expiry date stated on the label of the cartridge and on the outer packaging, indicated after CAD. The expiry date refers to the last day of the month indicated.

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

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

During use or when carried as a spare: NovoRapid PumpCart in use must not be stored in the refrigerator. A spare NovoRapid PumpCart may be kept for up to 2 weeks below 30°C. After this, it may be used for up to 7 days below 37°C in an insulin pump designed for use with this cartridge, such as the Accu-Chek Insight and YpsoPump insulin pumps. Keep NovoRapid PumpCart in its packaging until use 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 medicines and packaging that you no longer need. This helps protect the environment.

6. Contents of the pack and other 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 injections.

Appearance of the product and contents of the pack

NovoRapid PumpCart is a solution for injection.

The pack contains 5 cartridges and a multiple pack with 25 cartridges (5 packs of 5 cartridges) of 1.6 ml. Only certain pack sizes may be marketed.

The solution is clear and colourless.

Marketing Authorisation Holder and Manufacturer

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

Please follow the information described in “Instructions on how to use the NovoRapid PumpCart prefilled cartridge”.

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

Other sources of information

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

Instructions for using the NovoRapid PumpCart prefilled cartridge

NovoRapid PumpCart can only be used with an insulin pump infusion 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 result in incorrect insulin dosing and consequently hyper- or hypoglycaemia.

Read these instructions carefully before using your NovoRapid PumpCart.

Also read the pump manual (user manual) provided 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 carefully and follow the instructions closely. Rough handling or misuse may lead to incorrect dosing and may cause very high or very low blood sugar levels.

• NovoRapid PumpCart is ready for direct use 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 substance.

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

• Always ensure 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 others, 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 expiry date shown on the label and packaging.

Always check that NovoRapid PumpCart appears as it should. See Figure A.

Only the top part of the plunger should be visible above the white label band. If you suspect that NovoRapid PumpCart is damaged, return it to your supplier.

Do not use if it is damaged, leaking insulin, or if the plunger has moved, making the lower part of the plunger visible above the white label band. This may indicate insulin loss.

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

2. Inserting a new NovoRapid PumpCart cartridge into your pump

• Follow the instructions in the manual provided with your pump for inserting a new NovoRapid PumpCart cartridge into your pump.

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

• Connect the infusion set by attaching the adapter to your pump.

Check regularly for damage to the pump and cartridge, such as cracks or leaks. If you smell insulin, this may indicate a leak. If you observe cracks or leaks, do not use the cartridge. Follow the pump manual instructions to replace the cartridge and clean the cartridge compartment in the pump. An insulin leak may lead to incorrect dosing and may cause high blood sugar levels. See section 4 c) of the leaflet.

During the day and before going to sleep, check that your pump is delivering insulin and that there are no leaks. There may be no pump alert in the event of insulin delivery failure, and you may not notice 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.

Ensure you always have an alternative method of insulin administration available (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.

3. Removing 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 infusion set adapter from the empty NovoRapid PumpCart cartridge.

• Dispose of the used empty NovoRapid PumpCart cartridge and 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.