100 units/ml solution for injection in a vial
insulin aspart
1. What Fiasp is and what it is used for
Fiasp is mealtime insulin with fast-acting blood sugar lowering effect. Fiasp is an injection solution containing insulin aspart and is used to treat diabetes mellitus in adults, adolescents, and children from 1 year of age. Diabetes is a disease in which the body does not produce enough insulin to keep blood sugar levels under control. Treatment with Fiasp helps prevent complications of diabetes.
Fiasp should be injected shortly (0 to 2 minutes) before the start of the meal, with the option of injecting up to 20 minutes after the start of the meal.
This medicine has a maximum effect between 1 and 3 hours after injection one, and the effect lasts for 3 to 5 hours.
This medicine should normally be used in combination with medium-acting or long-acting insulin preparations.
This medicine can also be used for continuous infusion with a pump system.
2. What you need to know before using Fiasp
Do not use Fiasp
- if you are allergic to insulin aspart or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Fiasp. Pay special attention to the following:
- Low blood sugar (hypoglycemia) – If your blood sugar is too low, follow the advice for low blood sugar in section 4 “Possible side effects”. Fiasp begins to lower blood sugar faster than other mealtime insulins. If low blood sugar occurs, you may experience it earlier after an injection of Fiasp.
- High blood sugar ( hyperglycemia If your blood sugar is too high, follow the advice for high blood sugar in section 4 “Possible side effects”.
- Switching from other insulin preparations – The insulin dose may need to be changed if you switch from another insulin.
- Pioglitazone used with insulin – It may increase the risk of heart failure, see below under “Other medicines and Fiasp”.
- Eye Disease – Rapid improvement in blood sugar control may lead to a temporary worsening of diabetes-related eye disease.
- Pain due to nerve damage – If your blood sugar level improves very quickly, you may get nerve-related pain. This is usually temporary.
- Swelling around the joints – When you start treatment, too much fluid can accumulate in the body. It causes swelling around the ankles and other joints. This is usually short-lived.
Some conditions and activities can affect how much insulin you need. Talk to a doctor:
- if you have problems with your kidneys, liver, adrenal glands, pituitary gland, or thyroid gland.
- if you exercise more than usual or want to change your regular diet, as it can affect your blood sugar level.
- If you become ill, continue to take your insulin and talk to a doctor.
When using Fiasp, it is strongly recommended that the name of the medicinal product and the batch number of each package be documented to maintain a register of used batch numbers.
Skin changes at the injection site
To help prevent changes in the adipose tissue under the skin, e.g. skin thickening, skin shrinkage, or lumps under the skin, you should always change the injection site. It may be that insulin et not work as well if you inject in an area with nodules or in a thickened or shriveled area (see “How to use Fiasp”). Contact your doctor if you notice skin changes at the injection site and before changing the injection site if you are currently injecting in an affected area. Your doctor may advise you to check your blood sugar more often and to adjust your insulin dose or the dose of other diabetes medicines.
Children and young people
This medicine is not recommended for children under 1 year of age.
Other medicines and Fiasp
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Some medicines affect your blood sugar level and you may need to change your insulin dose.
Below is a list of the most common medicines that can affect your insulin therapy.
Your blood sugar level may drop (hypoglycemia) if you take:
- other medicines for diabetes (tablets or as an injection )
- sulfonamides – against infection s
- anabolic steroid is – eg testosterone
- beta-blockers – for example for high blood pressure or angina (angina). These medicines may make it harder to recognize the low blood sugar warning signals (see section 4 “Low blood sugar warning signals”)
- acetylsalicylic acid (and other salicylates) – for pain and mild fever
- MAO inhibitors – for depression
- ACE inhibitors – for certain heart problems or high blood pressure.
Your blood sugar level may rise (hyperglycemia) if you take:
- danazol – against endometriosis
- birth control pills
- thyroid hormones – against thyroid diseases
- growth hormone – against growth hormone deficiency
- glucocorticoid is, for example, cortisone – for inflammation
- sympathomimetics, eg epinephrine ( adrenaline ), salbutamol, or terbutaline – for asthma
- thiazides – for high blood pressure or if your body retains too much fluid (fluid retention).
Octreotide and lanreotide – used to treat a rare disease with the overproduction of growth hormone ( acromegaly ). These can either raise or lower your blood sugar level.
Pioglitazone – diabetes drug (tablets) for the treatment of type 2 diabetes. Some patients who have had type 2 diabetes and heart disease for many years or patients who have previously had a stroke have developed heart failure during treatment with pioglitazone and insulin. Tell your doctor immediately if you get signs of heart failure such as unexpected shortness of breath, rapid weight gain, or local swelling ( edema ).
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist.
Fiasp with alcohol
If you drink alcohol, your insulin needs may change, as your blood sugar level may rise or fall. You should therefore check your blood sugar level more often than usual.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. This medicine can be used during pregnancy but your insulin dose may need to be changed during pregnancy and after delivery. Careful monitoring of your diabetes during pregnancy is needed. Avoiding low blood sugar ( hypoglycemia ) is especially important for your baby’s health.
There are no restrictions on treatment with Fiasp during breast-feeding.
Driving and using machines
Low blood sugar can affect your ability to drive or use tools or machines. Low blood sugar can affect your ability to concentrate and react. It can be dangerous for yourself and others. Ask your doctor if it is appropriate for you to drive if:
- you often get low blood sugar
- you find it difficult to recognize signs of low blood sugar.
Important information about some of the ingredients of Fiasp
This medicine contains less than 1 mmol sodium (23 mg) per dose. This means that this medicine is almost “sodium-free”.
3. How to use Fiasp
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
When to use Fiasp
Fiasp is mealtime insulin.
Adults: Fiasp should be injected just before (0 to 2 minutes) the meal begins, with the option to inject up to 20 minutes after the meal has started.
Children: Fiasp should be injected just before (0 to 2 minutes) the meal begins, with the possibility of injecting up to 20 minutes after the meal has started in situations where it is uncertain how the child will eat. Consult a physician regarding these situations.
This medicine has a maximum effect between 1 and 3 hours after injection one, and the effect lasts for 3 to 5 hours.
Dos Fiasp
Dose for type 1 and type 2 diabetes
Doctors will decide with you:
- how much Fiasp you need at each meal
- when to check your blood sugar level and if you need a higher or lower dose.
If you want to change your diet, consult a doctor, pharmacist, or nurse first, as changing your diet may change your need for insulin.
When using other medicines, ask your doctor if your treatment needs to be adjusted.
Dose adjustment for type 2 diabetes
The daily dose should be based on the blood sugar levels at meals and bedtime the previous day.
- Before breakfast – dose one should be adjusted based on the blood sugar level before lunch the day before.
- Before lunch – dose one should be adjusted based on the blood sugar level before dinner the day before.
- Before dinner – dose one should be adjusted based on the blood sugar level at bedtime the previous day.
| Table 1 Dose adjustment | ||
| Blood sugar at mealtime or bedtime | Dose adjustment | |
| mmol / l | mg / dl | |
| below 4.0 | under 71 | Reduce dose one by 1 unit |
| 4.0–6.0 | 71–108 | No dose adjustment |
| more than 6.0 | more than 108 | Increase dose one by 1 unit |
Use in elderly patients (65 years or older)
This medicine can be used by elderly patients. Talk to your doctor about changes in your dose.
If you have kidney or liver problems
If you have kidney or liver problems, you may need to check your blood sugar level more often. Talk to your doctor about changes in your dose.
How to inject Fiasp
This medicine is for injection under the skin ( subcutaneous injection ) or continuous infusion with a pump. The use of the pump requires thorough instructions from healthcare professionals.
Where you inject
- The best places to inject are in the front of the waist (abdomen) or the upper arms.
- Do not inject into a blood vessel or muscle.
- Change the injection site every day, within the same area, to reduce the risk of developing changes under the skin (see section 4).
Do not use Fiasp
- if the protective cap on the vial has come loose or is missing. The vial is fitted with a plastic protective cap to obtain a tamper-proof container. If the vial is not in perfect condition when you receive it, return the vial to the pharmacy/place of purchase.
- if the vial has not been stored correctly (see section 5 “How to store Fiasp”).
- if insulin is not clear (eg cloudy) and colorless.
How to inject Fiasp
Before using Fiasp for the first time, your doctor or nurse will show you how to use it.
1. Check the name and strength of the vial label to make sure it is Fiasp.
2. Remove the protective cap from the vial.
3. Always use a new injection needle for each injection to avoid contamination. Needles and syringes must not be shared with others.
4. Inject the same amount of air into the syringe as the dose of insulin you are to inject. Inject this air into the vial.
5. Turn the vial and syringe upside down, and draw the correct dose of insulin into the syringe. Pull the needle out of the vial. Squeeze the air out of the syringe and check that the dose is correct.
Inject insulin under the skin. Use the injection technique shown to you by your doctor or nurse.
7. Discard the injection needle after each injection.
For use in an infusion pump system
Follow your doctor’s instructions and recommendations on how to use Fiasp in a pump. Before using Fiasp in the pump system, you must have received comprehensive instructions for use as well as information on what to do if you become ill, have high or low blood sugar, or if the pump system breaks down.
Filling the pump
- Fiasp should never be diluted or mixed with any other insulin.
- Before inserting the needle, wash your hands and the skin where the needle is to be inserted, with soap and water, to avoid infection at the infusion site.
- When filling a new reservoir, do not leave large air bubbles in either the syringe or the hose.
- The infusion set (tubing and needle) should be replaced according to the instructions in the product information provided with the infusion set.
To take advantage of the insulin infusion, and to detect any malfunction of the insulin pump, it is recommended that you measure your blood sugar level regularly.
What to do if the pump system malfunctions
You must always have an alternative method is available for the injection of insulin under the skin (such as a pen or syringes), should there be a failure of the pump system.
If you use too much Fiasp
If you use too much insulin, your blood sugar may become too low (hypoglycemia). See the advice in section 4 under “Low blood sugar”.
If you forget to use Fiasp
If you forget to use insulin, your blood sugar level may become too high (hyperglycemia). See section 4 under “High blood sugar”.
Three simple steps that can help avoid too low or high blood sugar are:
- Always have syringes and a vial of Fiasp in reserve.
- Always have something with you that shows that you have diabetes.
- Always carry products that contain sugar. See section 4 under “What to do if you get low blood sugar”.
If you stop using Fiasp
Do not stop taking insulin without talking to a doctor first. If you stop using insulin, it can lead to very high blood sugar (severe hyperglycemia) and ketoacidosis (a condition with too high acidity in the blood that can be potentially life-threatening). See symptoms and advice in section 4 under “High blood sugar”.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Low blood sugar (hypoglycemia) is very common with insulin therapy (may affect more than 1 user in 10). It can be very serious. If your blood sugar level drops too much, you may become unconscious. Severe hypoglycemia can cause brain damage and be life-threatening. If you have low blood sugar symptoms, get your blood sugar level raised immediately. See the advice below under “Low blood sugar”.
If you get a severe allergic reaction to insulin or any of the other ingredients of Fiasp, stop using this medicine and contact your healthcare provider immediately.
Signs of a severe allergic reaction may include:
- local reactions (eg rash, redness, and itching ) spread to other parts of the body
- you suddenly feel sick and sweaty
- you start vomiting
- you have difficulty breathing
- you get palpitations or feel dizzy.
Allergic reactions such as rash over large areas of the body and swelling of the face may occur. These are less common and may affect up to 1 in 100 people. Contact a doctor if the symptoms get worse or if you do not see any improvement within a few weeks.
Skin changes at the injection site: If you inject insulin at the same site, the adipose tissue may either shrink (lipoatrophy) or thicken (lipohypertrophy) ( may affect up to 1 in 100 people ). Nodules under the skin can also be caused by the accumulation of a protein called amyloid ( cutaneous amyloidosis. How often this occurs is not known). It may be that insulin et not work as well if you inject in an area with nodules or in a thickened or shriveled area. Change the injection site for each injection to prevent these skin changes.
Other side effects include:
Common (may affect up to 1 in 10 people)
The reaction at the site of administration: There may be local reactions at the site of injection. These can include the following symptoms: skin rash, redness, inflammation, bruising, irritation, pain, and itching. The reactions usually disappear after a few days.
Skin reactions: Signs of allergy to the skin, such as eczema, rash, itching, hives, and dermatitis may occur.
General effects of insulin therapy including Fiasp
- Low blood sugar (hypoglycemia) (very common)
You can get low blood sugar if you:
Drink alcohol, use too much insulin, exercise more than usual, eat too little or skip a meal.
Warning signals for low blood sugar – these can come on suddenly:
- headache
- slurred speech
- palpitation
- cold sweats
- cool and pale skin
- nausea
- a strong feeling of hunger
- tremors or nervousness/anxiety
- the feeling of unusual tiredness, weakness, and drowsiness
- confusion
- concentration difficulties
- short-term vision change.
This is what you do if you have low blood sugar
- If you are conscious, treat your low blood sugar immediately with 15-20 g fast-acting carbohydrates: eat glucose tablets or any other snack that contains a lot of sugar, such as fruit juice, sweets, or cakes (for safety’s sake, always carry glucose tablets or snacks with a lot of sugar i).
- It is recommended that you measure your blood glucose level again after 15-20 minutes and treat yourself again if your blood sugar level is still below 4 mmol / l.
- Wait until the signs of low blood sugar have passed or your blood sugar level has stabilized. Then continue with insulin treatment as usual.
This is what others should do if you lose consciousness
Tell everyone you hang out with that you have diabetes. Tell them what can happen if your blood sugar gets too low, for example, that you may lose consciousness.
- Tell them that if you lose consciousness, they must do the following:
- turn to the side to avoid suffocation
- Immediately make sure you get medical attention
- Do not give yourself anything to eat or drink as you may suffocate.
You can regain consciousness faster if you receive a glucagon injection. Such an injection should only be given by a person who knows how to do it.
- If you are given glucagon, you will need sugar or a sugar-containing snack as soon as you regain consciousness.
- If you do not respond to the glucagon injection, you must be treated in a hospital.
If severe low blood sugar is not treated, it can eventually cause brain damage. These can be short-term or long-term. Low blood sugar can even cause death.
Talk to a doctor about:
- you have had such low blood sugar that you have lost consciousness
- you have been given an injection of glucagon
- you have had too low blood sugar a few times recently.
Does one of the times of your insulin injections, your meals, or exercise habits may need to be changed.
- High blood sugar ( hyperglycemia ) not known (can not be estimated from available data)
You can get high blood sugar if you:
Eat more or exercise less than usual, drink alcohol, get infection or fever, have not used enough insulin, regularly use too little insulin, forget to use your insulin, or stop using insulin.
Warning signals for high blood sugar – these usually occur gradually:
- blushing skin
- dry skin
- drowsiness or fatigue
- dry mouth
- fruit-smelling (acetone-like) breath
- you need to urinate more often
- thirst
- loss of appetite
- nausea or vomiting.
These signs may indicate a very serious condition called ketoacidosis. This means too much acidity in the blood because the body breaks down fat instead of sugar. If left untreated, it can lead to diabetic coma and eventually death.
This is what you do if you get high blood sugar
- Test your blood sugar level.
- If you have been taught how to do this, take a correction dose of insulin.
- Do a ketone test on the urine.
- Seek medical attention immediately if you have ketones.
5. How to store Fiasp
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.
Before first use:
Store in a refrigerator (2 ° C – 8 ° C). Do not freeze. Do not store near the heat sink. The vial should be stored in the outer carton. Sensitive to light.
After first opening or if brought as a spare: You can take your vial with you and store it at room temperature (maximum 30 ° C) or in a refrigerator (2 ° C-8 ° C) for up to 4 weeks (including time in a pump reservoir ). The vial should always be stored in the carton. Sensitive to light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is insulin aspart. 1 ml solution contains 100 units of insulin as part. One vial contains 1,000 units of insulin aspart in a 10 ml solution.
- The other ingredients are phenol, metacresol, glycerol, zinc acetate, disodium phosphate dihydrate, arginine hydrochloride, nicotinamide ( vitamin B 3 ), hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) (see the end of section 2 under “Important information on some ingredients”). in Fiasp ”) and water for injections.
What the medicine looks like and the contents of the pack
Fiasp is a clear, colorless, watery solution for injection in a vial.
Each vial contains 10 ml.
Pack sizes: 1, 5 and a multiple pack of 5 x (1 x 10 ml) vials. Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Novo Nordisk A / S,
Novo Allé,
DK-2880 Bagsværd, Denmark