Novorapid: Uses, Side Effects and Dosage

Serious warnings and precautions box

What NOVORAPID® is used for:

• The treatment of patients with diabetes mellitus who require insulin for the control of hyperglycemia.

How NOVORAPID® works:

NOVORAPID^® is an insulin analogue used to treat diabetes.

NOVORAPID^® will start to lower your blood sugar 10-20 minutes after you take it, it has a maximum effect between 1 and 3 hours and the effects last for 3-5 hours. Due to this short action NOVORAPID^® should normally be taken in combination with intermediate-acting or long-acting insulin preparations.

The ingredients in NOVORAPID® are:

Medicinal ingredients: The active ingredient in NOVORAPID^® is insulin aspart.

Non-medicinal ingredients: Glycerol; phenol; metacresol; zinc chloride; sodium chloride; disodium phosphate dihydrate; sodium hydroxide; hydrochloric acid and water for injection.

• Hypoglycemia is the most common adverse effect of insulin, including NOVORAPID^®.
• If hypoglycemia or hypoglycemic reactions are not treated they can result in the loss of consciousness, coma or death.
• Glucose monitoring is recommended for all patients with diabetes.
• Any change of insulin should be made cautiously and only under medical supervision. This may result in dosage adjustment.

• NOVORAPID^® should be given immediately before a meal because of the fast onset of action (start of the meal should be not more than 5-10 minutes after injection) (see ’How to take NOVORAPID^®’).

• Never inject your insulin directly into a vein.
• NOVORAPID^® should not be used if it is not water-clear and colourless.

NOVORAPID® comes in the following dosage form(s):

NOVORAPID^® is available from Novo Nordisk Canada in the following format:

• NOVORAPID^® 10 mL vial
• NOVORAPID^® Penfill^® 3 mL cartridge (designed for use with Novo Nordisk Insulin Delivery Devices)

NOVORAPID^® Penfill^® in use with Novo Nordisk Insulin Delivery Systems is designed for use with NovoFine^® and/or NovoFine^® Plus needles. Novo Nordisk cannot be held responsible for malfunctions occurring as a consequence of using NOVORAPID^® with products that do not meet the same specifications or quality standards as NovoFine^® and/or NovoFine^® Plus needles.

Do not use NOVORAPID® if:

• You feel a hypoglycemic reaction (low blood sugar) coming on. (see “What are possible side effects from NOVORAPID^®?” for more about hypoglycemia).
• You are allergic (hypersensitive) to insulin aspart, metacresol or any of the other ingredients in this insulin. Look out for the signs of an allergic reaction. (see “What are possible side effects from NOVORAPID^®?”)
• The Penfill^® or Novo Nordisk Insulin Delivery Device containing the cartridge is dropped, damaged or crushed; there is a risk of leakage of insulin.
• The protective cap is loose or missing. Each vial has a protective, tamper proof plastic cap. If the cap is not in perfect condition when you get the vial, return the vial to your supplier.
• The insulin has not been stored correctly or if it has been frozen. (see “How to store NOVORAPID^®”)
• The insulin does not appear water-clear and colourless.

Do not refill a NOVORAPID^® Penfill^® cartridge.

NOVORAPID^® Penfill^® cartridges are designed to be used with Novo Nordisk Insulin Delivery Devices, NovoFine^® and NovoFine^® Plus needles as part of The All In-One System^®.

If you are treated with NOVORAPID^® Penfill^® and another insulin in Penfill^® cartridge, you should use two Novo Nordisk Insulin Delivery Devices, one for each type of insulin.

As a precautionary measure, you should carry a spare syringe and extra insulin in case the insulin delivery device is lost or damaged.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take NOVORAPID®. Talk about any health conditions or problems you may have, including if you:

• Have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands, your doctor may decide to alter your insulin dose.
• Drink alcohol (including wine and beer) your need for insulin may change as your blood sugar level may either rise or fall.
• Have an infection, fever or have had an operation you may need more insulin than usual.
• Suffer from diarrhea, vomiting or eat less than usual you may need less insulin than usual.
• Exercise more than usual or if you want to change your usual diet.
• Are ill: continue taking your insulin. Your need for insulin may change.
• Go abroad: travelling over time zones may affect your insulin needs and the timing of your injections. Consult your doctor if you are planning such travel.

• Are pregnant, or planning a pregnancy or are breastfeeding please contact your doctor for advice.

• Drive or use tools or machines: watch for signs of a hypoglycemia. Your ability to concentrate or to react will be less during a hypoglycemic reaction. Please keep this in mind in all situations where you might put yourself and others at risk (e.g. driving a car or operating machinery). Never drive or use machinery if you feel a hypoglycemic reaction coming on.

Discuss with your doctor whether you should drive or use machines at all, if you have a lot of hypoglycemic reactions or if you find it hard to recognize hypoglycemia.

Before you travel, check with your doctor or pharmacist on the availability of NOVORAPID^® in other countries. If possible, bring enough NOVORAPID^® with you on your trip.

Thiazolidinediones (class of oral antidiabetic drugs) used together with insulin may increase risk of oedema and heart failure. Inform your doctor as soon as possible if you experience localised swelling (oedema) or signs of heart failure such as unusual shortness of breath.

Hypokalemia (low potassium) is a possible side effect with all insulins. You might be more at risk if you are on potassium lowering drugs or losing potassium (e.g. diarrhea).

NOVORAPID^® has a rapid onset of effect therefore if hypoglycemia occurs, you may experience it earlier after an injection when compared to soluble human insulin.

Other warnings you should know about:

• You may have a very rare serious allergic reaction to NOVORAPID^® or one of its ingredients (called a generalized allergic reaction). See also the warning in ‘Do not use NOVORAPID^® if’.
• Skin changes at the injection site: The injection site should be rotated to help prevent changes to the fatty tissue under the skin, such as skin thickening, skin shrinking or lumps under the skin. The insulin may not work very well if you inject into a lumpy, pitted, or thickened area. Tell your healthcare professional if you notice any skin changes at the injection site. Tell your healthcare professional if you are currently injecting into these affected areas before you start injecting in a different area. A sudden change of site may result in hypoglycemia. Your healthcare professional may tell you to check your blood sugar more closely, and to adjust your insulin or your other antidiabetic medications dose.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with NOVORAPID®:

Some medicines affect the way glucose works in your body and this may influence your insulin dose. Listed below are the most common medicines, which may affect your insulin treatment. Tell your doctor, Diabetes Nurse Educator or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. In particular, you should tell your doctor if you are using any medicine as mentioned below that affects your blood sugar level.

If you take any of the medicines below, your blood sugar level may fall (hypoglycemia)

• Other medicines for the treatment of diabetes
• Monoamine oxidase inhibitors (MAOI) (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 lower fever)
• Anabolic steroids (such as testosterone)
• Sulfonamides (used to treat infections)

If you take any of the medicines below, your blood sugar level may rise (hyperglycemia)

• 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], or salbutamol, terbutaline used to treat asthma)
• Growth hormone (medicine for stimulation of skeletal and somatic growth and pronounced influence on the body’s metabolic processes)
• Danazol (medicine acting on ovulation)

Octreotide and lanreotide (used for treatment of acromegaly, a rare hormonal disorder that usually occurs in middle-aged adults, caused by the pituitary gland producing excess growth hormone) may either increase or decrease your blood sugar level.

Beta-blockers (used to treat high blood pressure) may weaken or suppress entirely the first warning symptoms which help you to recognise a hypoglycemia.

How to take NOVORAPID®:

NOVORAPID^® is for injection under the skin (subcutaneously).

NOVORAPID^® 10 mL vial is also for continuous infusion in a pump system. NOVORAPID^® may also be given intravenously by healthcare professionals under close supervision by a doctor.

Always vary the site you inject within the same region, to avoid lumps (see ‘What are possible side effects from using NOVORAPID^®?’). The best places to give yourself an injection are: the front of your thighs, the front of your waist (abdomen), the upper arm, or the buttocks. Your insulin will work more quickly if you inject into the front of your waist.

You should always measure your blood glucose regularly.

Talk about your insulin needs with your doctor and Diabetes Nurse Educator. Do not change your insulin unless your doctor tells you to. Follow their advice carefully. This leaflet is a general guide only.

If your doctor has switched you from one type or brand of insulin to another, your dose may have to be adjusted by your doctor.

Due to the faster onset of action, NOVORAPID^® should be given close to a meal (start of the meal should be no more than 5-10 minutes after the injection). When necessary, NOVORAPID^® can be given soon after a meal, instead of before the meal.

Before using NOVORAPID®

• Check the label to make sure you have the right type of insulin.
• Remove the protective cap [vial].
• Always check the Penfill^® cartridge, including the plunger. Don't use it if any damage is seen or if there is a gap between the plunger and the white barcode label. Take it back to your supplier or call Novo Nordisk Canada at 1-800-465-4334 for assistance. See your Novo Nordisk Insulin Delivery Device manual for further instructions.
• Always use a new needle for each injection to prevent contamination [Penfill^®].
• Do not share your NOVORAPID^® Penfill^® in a Novo Nordisk Insulin Delivery Device with another person, even if the needle is changed. Do not reuse or share needles with another person including family members. You may give another person an infection or get an infection from them.

If you use only one type of insulin [vial]

• Draw into the syringe the same amount of air as the dose of insulin you are going to inject. Inject the air into the vial.
• Turn the vial and syringe upside down and draw the correct insulin dose into the syringe. Pull the needle out of the vial. Then expel the air from the syringe and check that the dose is correct.

If you have to mix two types of insulin [vial]

• NPH (Neutral Protamine Hagedorn) insulin is the only type of insulin that can be mixed with NOVORAPID^® and the mixture must be injected immediately under your skin (subcutaneously). NOVORAPID^® should be drawn into the syringe before you draw your NPH insulin.
• Just before use, roll the NPH insulin between your hands until the liquid is uniformly white and cloudy.
• Draw into the syringe the same amount of air as the dose of the NPH insulin. Inject the air into the vial containing the NPH insulin and pull out the needle.
• Draw into the syringe the same amount of air as the dose of NOVORAPID^®. Inject the air into the vial containing NOVORAPID^®. Turn the vial and syringe upside down and draw up the prescribed dose of NOVORAPID^®. Expel any air from the syringe and check that the dose is correct.
• Push the needle into the vial of the NPH insulin, turn the vial and syringe upside down and draw out the dose you have been prescribed. Expel any air from the syringe and check the dose. Inject the mixture immediately.
• Always mix NOVORAPID^® and the NPH insulin in the same order.

How to inject this insulin [vial]

• Pinch your skin between two fingers, push the needle into the skin fold and inject the insulin under the skin.
• Keep the needle under your skin for at least 6 seconds to make sure you have injected all the insulin.

For use in an infusion pump system [vial]:

NOVORAPID^® should never be mixed with any other insulin when used in a pump.

Follow the instructions and recommendations from your doctor regarding the use of NOVORAPID^® in a pump. Before using NOVORAPID^® in a pump system you must receive comprehensive instructions in its use and information about any actions to be taken in case of illness; too high or too low blood sugar; or failure of the pump system.

• Before inserting the needle, use soap and water to wash your hands and the skin around the area where the needle is inserted so as to avoid any infection at the infusion site.
• When you fill a new reservoir, be certain not to leave large air bubbles in either the syringe or the tubing.
• Changing the infusion set (tubing and needle) must be done according to the instructions in the product information supplied with the infusion set.

To get the benefit of insulin infusion, and to detect a possible malfunction of the insulin pump, you should measure your blood sugar level regularly.

What to do in case of pump system failure

You should always have alternative insulin available for injection under the skin in case of pump system failure.

How to inject this insulin [Penfill^®]

• Inject the insulin under the skin. Use the injection technique advised by your doctor or Diabetes Nurse Educator and described in your Novo Nordisk Insulin Delivery Device Manual.
• Keep the needle under your skin for at least six seconds. Keep the push button fully depressed until the needle has been withdrawn. This will ensure correct delivery and limit possible flow of blood into the needle or insulin reservoir.
• After each injection be sure to discard the needle. Otherwise, the liquid may leak out when the temperature changes.

Overdose:

Causes of a hypoglycemia:

You get a hypoglycemia if your blood sugar gets too low.

This might happen:

• If you take too much insulin.
• If you eat too little or miss a meal.
• If you exercise more than usual.

The warning signs of a hypoglycemia may come on suddenly and can include: cold sweat; cool pale skin; headache; rapid heartbeat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; and difficulty concentrating.

If you get any of these signs: eat glucose tablets or a high sugar snack (sweets, biscuits, fruit juice), then rest. Don't take any insulin if you feel a hypoglycemia coming on. Carry glucose tablets, sweets, biscuits or fruit juice with you, just in case.

Tell your relatives, friends and close colleagues that if you pass out (become unconscious), they must turn you on your side and get medical help right away. They must not give you anything to eat or drink as it could choke you.

• If severe hypoglycemia is not treated, it can cause brain damage (temporary or permanent) and even death.
• If you have a hypoglycemia that makes you pass out, or if you get a lot of hypoglycemias, talk to your doctor. The amount or timing of your insulin dose, the amount of food you eat or the amount of exercise you do, may need to be adjusted.

Using glucagon

You may recover more quickly from unconsciousness with an injection of the hormone glucagon given by someone who knows how to use it. If you are given glucagon, you will need to eat glucose or a sugary snack as soon as you are conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital. Contact your doctor or hospital emergency after an injection of glucagon: you need to find the reason for your hypoglycemia in order to avoid getting more.

Causes of a hyperglycemia:

You get a hyperglycemia if your blood sugar gets too high.

This might happen:

• If you forget to take insulin.
• If you repeatedly take less insulin than you need.
• If you eat more than usual.
• If you exercise less than usual.

The warning signs appear gradually. They include: increased urination; feeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed dry skin; a dry mouth and a fruity (acetone) smelling breath.

These may be signs of a very serious condition called diabetic ketoacidosis. If you don't treat it, this could lead to diabetic coma and death.

If you get any of these signs: test your blood sugar level; test your urine for ketones if you can; then seek medical advice right away.

Possible side effects from using NOVORAPID®:

These are not all the possible side effects you may have when taking NOVORAPID^®. If you experience any side effects not listed here, tell your healthcare professional. The most common side effect is low blood sugar (hypoglycemia). See the advice in ‘How to take NOVORAPID^®?’

Serious side effects and what to do about them

If you think you, or a person you are caring for, have taken too much NOVORAPID^®, contact a healthcare professional, hospital emergency department, or regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no symptoms.

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Keep out of the reach and sight of children.

NOVORAPID^® [vial] that is not being used is to be stored in the refrigerator between 2°C-8°C, in the original package, not in or too near the freezer section or cooling element. Do not freeze.

Always keep the vial in the outer carton when you're not using it in order to protect it from light.

NOVORAPID^® [Penfill^®] that is not being used is to be stored in the refrigerator between 2°C to 8°C, away from the cooling element. Do not freeze.

NOVORAPID^® [vial/Penfill^®] that is being used or is about to be used is not to be kept in the refrigerator. You can carry it with you and keep it at room temperature (not above 30°C). Use within 4 weeks.

Always keep the Penfill^® cartridge in the outer carton when not using it, in order to protect it from light.

NOVORAPID^® should be protected from excessive heat and sunlight.

Do not use NOVORAPID^® after the expiry date printed on the label and carton.

NOVORAPID^® should not be disposed of in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

What NOVORAPID^® looks like and package content

NOVORAPID^® comes as a water-clear, colourless, aqueous solution in packages of one 10 mL vial per carton.

NOVORAPID^® Penfill^® comes as a water-clear, colourless, aqueous solution in packages of 5 cartridges of 3 mL per carton.

1 mL contains 100 U (units) of insulin aspart.

1 vial contains 10 mL of insulin aspart equivalent to 1000 U.

1 Penfill^® cartridge contains 3 mL of insulin aspart equivalent to 300 U.

If you want more information about NOVORAPID®:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada Drug Product Database website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website www.novonordisk.ca, or by calling 1-800-465-4334.

Last Revised 2026-05-12

© 2026 Novo Nordisk A/S

Manufactured by: For more information contact: Novo Nordisk Canada Inc. Mississauga, Ontario, Canada, L5N 6M1 1 • 800 • 465 • 4334 www.novonordisk.ca

Novo Nordisk^®, NOVORAPID^®, Penfill^®, NovoFine^®, NovoFine^® Plus, NovoPen^® 4, NovoPen Echo^®, The All In-One System^® and Devices Matter^® are trademarks owned by Novo Nordisk A/S and used by Novo Nordisk Canada Inc. under licence.