FIASP 100 U/ML Инъекционный раствор

Анна Бирюкова

Анна Бирюкова – врач-терапевт с клиническим опытом в кардиологии, эндокринологии и гастроэнтерологии. Проводит онлайн-консультации для взрослых, сочетая системный подход с профессиональной поддержкой на всех этапах диагностики и лечения.

Кардиология – диагностика и лечение:

Артериальная гипертензия, скачки давления, профилактика сердечно-сосудистых осложнений.
Боль в груди, одышка, аритмии (тахикардия, брадикардия, перебои в сердце).
Отёки конечностей, хроническая усталость, снижение физической выносливости.
Расшифровка ЭКГ, анализ липидного профиля, оценка риска инфаркта и инсульта.
Кардиологическое наблюдение после COVID-19.

Эндокринология – сахарный диабет, щитовидная железа, метаболизм:

Раннее выявление и лечение сахарного диабета 1 и 2 типа, преддиабет.
Индивидуальный подбор терапии: пероральные препараты, инсулинотерапия.
Терапия GLP-1 – современные препараты для контроля веса и сахара: подбор схемы, контроль эффективности и безопасности.
Заболевания щитовидной железы – гипотиреоз, гипертиреоз, аутоиммунные процессы (Хашимото, Базедова болезнь).
Метаболический синдром: ожирение, нарушение липидного обмена, инсулинорезистентность.

Гастроэнтерология – ЖКТ:

Боли в животе, тошнота, изжога, гастроэзофагеальный рефлюкс (ГЭРБ).
Гастрит, синдром раздражённого кишечника (СРК), диспепсия.
Контроль хронических заболеваний ЖКТ, расшифровка анализов, интерпретация УЗИ и гастроскопии.

Общетерапевтическая помощь и профилактика:

ОРВИ, кашель, бронхит, сезонные инфекции.
Анализ результатов лабораторных исследований, коррекция лечения.
Вакцинация взрослых – составление плана, проверка противопоказаний.
Профилактика онкозаболеваний – планирование скринингов, оценка рисков.
Комплексный подход – от облегчения симптомов до повышения качества жизни.

Анна Бирюкова сочетает терапевтическую экспертизу с четким объяснением медицинских вопросов. Помогает пациентам принимать обоснованные решения, адаптировать лечение под образ жизни и достигать устойчивых результатов в управлении здоровьем.

Записаться на онлайн-консультацию

zł280

Больше времени

Материал предназначен для общего ознакомления. Для индивидуальных рекомендаций обратитесь к врачу. При тяжелых или быстро ухудшающихся симптомах обратитесь за неотложной медицинской помощью.

Инструкция по применению FIASP

Содержание инструкции

Fiasp 100 units/mL FlexTouch prefilled pen solution for injection
Fiasp 100 units/mL Penfill injectable solution in cartridge
Fiasp 100 units/mL injectable solution in a vial
Fiasp 100 units/mL PumpCart injectable solution in cartridge

Fiasp 100 units/mL FlexTouch prefilled pen solution for injection

insulin aspart

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What is Fiasp and what is it used for

Fiasp is a prandial insulin with a rapid effect of reducing blood sugar. Fiasp is an
injectable solution containing insulin aspart and is used to treat diabetes mellitus in adults,
adolescents and children aged 1 year and over. Diabetes is a disease in which the body does not
produce enough insulin to control blood sugar levels. Treatment with Fiasp
helps to prevent complications of diabetes.
Fiasp should be injected up to 2 minutes before the start of a meal, with the possibility of injecting it
up to 20 minutes after the start of a meal.
The maximum effect of the medicine will be achieved between 1 and 3 hours after the injection and the effect will last for 3-5 hours.
This medicine should normally be used in combination with intermediate or long-acting insulin preparations.

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 precautions
Talk to your doctor, pharmacist or nurse before using Fiasp. Pay particular attention
to:

Low blood sugar (hypoglycemia) - if your blood sugar is too low, follow the instructions for low blood sugar in section 4 ‘Possible side effects’. Fiasp starts to lower blood sugar faster than other prandial insulins. Hypoglycemia may occur earlier after an injection of Fiasp.
High blood sugar (hyperglycemia) - if your blood sugar is too high, follow the instructions for high blood sugar in section 4 ‘Possible side effects’.
Transferring from other insulin medicines - your doctor may need to advise you on the dose of insulin.
If your insulin treatment is in combination with pioglitazone (oral antidiabetic medicine used to treat type 2 diabetes) - Tell your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid weight gain or localized swelling caused by fluid retention (edema).
Eye problems - rapid improvement in blood sugar control can lead to a temporary worsening of eye problems such as diabetic retinopathy.
Pain due to nerve damage - if your blood sugar improves very rapidly, you may experience nerve-related pain, which is usually temporary.
Swelling around the joints - at the beginning of using the medicine, the body may retain more water than it should. This effect causes swelling around the ankles and other joints. It usually lasts only a short time.
Make sure you use the correct type of insulin: always check the insulin label before each injection to avoid accidental exchange between insulin products.
Treatment with insulin can induce the body to produce antibodies against insulin (substances that act against insulin). However, only very rarely will this require a change in the dose of insulin.

If you have vision problems, see section 3 ‘How to use Fiasp’.
Some conditions and activities can affect your insulin needs. Talk to your doctor:

if you have problems with your kidneys, liver, or adrenal, pituitary or thyroid glands
if you do more physical activity than usual or if you want to change your usual diet, as this can affect your blood sugar level
if you become ill, continue to use insulin and see your doctor.
If you are going abroad, traveling through different time zones can affect your insulin needs and the timing of injections.

When using Fiasp, it is strongly recommended to record the name and batch number of
each pack in order to keep a record of the batches used.
Skin changes at the injection site
The injection site must be rotated to help prevent changes in the fatty tissue under the
skin, such as thickening of the skin, thinning of the skin or the appearance of nodules under the skin.
Insulin may not work as well if you inject into an area with nodules, in an area
thinned or in an area thickened (see section 3 ‘How to use Fiasp’). Tell your doctor if you notice
skin changes at the injection site. If you are currently injecting into one of these affected areas
, see your doctor before starting to inject into another area. Your doctor
may advise you to check your blood sugar more carefully and adjust the dose of insulin or other
antidiabetic medicines.

Children and adolescents
This medicine is not recommended for use in 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 blood sugar levels; this may mean the
need for a change in your insulin dose.
The most common medicines that can affect insulin treatment are listed below.
Blood sugar levels may be lowered (hypoglycemia) if you use:

other medicines for diabetes (oral and injectable)
sulfonamide antibiotics (used to treat infections)
anabolic steroids (e.g. testosterone)
beta-blockers (used to treat high blood pressure or angina)
salicylates (used to relieve pain and lower fever)
monoamine oxidase inhibitors (MAOIs) (used to treat depression)
angiotensin converting enzyme (ACE) inhibitors (for some heart conditions or high blood pressure)

Blood sugar levels may be increased (hyperglycemia) if you use:

danazol (medicine that acts on ovulation)
oral contraceptives (birth control pills)
thyroid hormones (for thyroid problems)
growth hormone (for growth hormone deficiency)
glucocorticoids (such as ‘cortisone’ - for inflammation)
sympathomimetics (such as epinephrine (adrenaline), salbutamol, terbutaline - for asthma)
thiazides (for high blood pressure or excessive fluid retention).

Octreotide and lanreotide - used for the treatment of a rare disease characterized by excessive
production of growth hormone (acromegaly). They may increase or decrease your blood
sugar level.
If any of these situations apply to you (or if 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 more frequently than usual.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor for advice before using this medicine. This medicine can be
used during pregnancy, although it may be necessary to adjust your insulin dose during
pregnancy and after delivery. The amount of insulin you need usually decreases during
the first 3 months of pregnancy and increases for the remaining 6 months.
During pregnancy, you need to carefully control your diabetes and it is particularly
important to prevent low blood sugar (hypoglycemia) for the health of the baby. After having the baby, your insulin needs will probably return to what
you needed before pregnancy.
There are no restrictions on the use of Fiasp during breastfeeding.

Driving and using machines
Blood sugar that is too low can affect your ability to drive or use
tools or machines. If your blood sugar is too low, your ability to concentrate
or react may be impaired. This can put yourself and others in danger. Ask your
doctor if you can drive if:

your blood sugar becomes too low frequently
you have difficulty recognizing the signs of low blood sugar.

Important information about some ingredients of Fiasp
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. it is essentially ‘sodium-free’.

3. How to use Fiasp

Use this medicine following exactly the instructions of your doctor. If you have doubts consult your
doctor or pharmacist.
If you are blind or have severe vision problems and cannot read the dose counter, do not use
this pen without help. Get help from a person with good eyesight, who is trained to
use the FlexTouch prefilled pen.
The prefilled pen can deliver in one injection a dose from 1 to 80 units with increments of 1 unit.

When to use Fiasp
Fiasp is a prandial insulin.
Adults: Fiasp must be injected immediately before (0-2 minutes) the start of the meal, with the possibility of
injecting it up to 20 minutes after the start of the meal.
Children: Fiasp must be injected immediately before (0-2 minutes) the start of the meal, with the possibility of
injecting up to 20 minutes after the start of the meal, when there is uncertainty that the child will eat.
Ask your doctor for advice in these situations.
The maximum effect of the medicine will be achieved between 1 and 3 hours after the injection and the effect will last for 3-5 hours.

Dose of Fiasp
Dose for type 1 and type 2 diabetes
The doctor will decide together with you:

how much Fiasp you will need at each meal
when to check your blood sugar level and whether a higher or lower dose is needed.

If you want to change your usual diet, ask your doctor, pharmacist or
nurse for advice first because a change in diet can alter the insulin requirement.
When using Fiasp with other medicines, ask your doctor if the treatment needs to be modified.
Dose adjustment for type 2 diabetes
The daily dose should be based on the blood sugar level at meals and at bedtime the day before.

Before breakfast - the dose should be adjusted based on the blood sugar level before lunch the day before.
Before lunch - the dose should be adjusted based on the blood sugar level before dinner the day before.
Before dinner - the dose should be adjusted based on the blood sugar level at bedtime the day before.

Use in elderly patients (65 years or older)
This medicine can be used in elderly patients. Talk to your doctor about dose changes.
If you have kidney or liver problems
If you have kidney or liver problems you may need to check your blood sugar level more frequently. Talk to your doctor about dose changes.

Table 1 Dose adjustment
a Blood sugar level at meals or at bedtime		Dose adjustment
i mmol/L	mg/dL	Dose adjustment
z less than 4	less than 71	Reduce the dose by 1 unit
n 4-6	71-108	No dose adjustment
più di 6	more than 108	Increase the dose by 1 unit

Injection of Fiasp
This medicine is only suitable for injection under the skin (subcutaneous injection).
Before using Fiasp for the first time, your doctor or nurse must show you how to use the
prefilled pen. Talk to your doctor if you need to inject insulin in another way.

Where to inject

The best areas to inject are the front of the abdomen or the upper arms.
Do not inject the medicine into a vein or muscle.
Vary the injection site within the area where you inject each day to reduce the risk of developing changes under the skin (see section 4).

Do not use Fiasp

if the pen is damaged or has not been stored correctly (see section 5 ‘How to store Fiasp’).
if the insulin does not appear clear (e.g. cloudy) and colorless.

Detailed instructions on how to use the FlexTouch pen are on the back of this leaflet.

If you use more Fiasp than you should
If you use too much insulin your blood sugar level may drop too low (hypoglycemia), see the
advice in section 4 in ‘Blood sugar level too low’.

If you forget to use Fiasp
If you forget to use insulin, your blood sugar level may rise too high (hyperglycemia).
See section 4 in ‘Blood sugar level too high’.

Three simple precautions that can help prevent your blood sugar level from being
too low or too high are:

Always carry a spare pen with you in case the pen is lost or damaged.
Always carry something that shows you have diabetes.
Always carry products containing sugar. See section 4 in ‘What to do if your blood sugar level is too low’.

If you stop using Fiasp
Do not stop treatment with insulin without talking to your doctor. If you stop using
insulin, a very high blood sugar level (severe hyperglycemia) and
ketoacidosis (a condition characterized by too much acid in the blood, which can be life-threatening) may develop. See symptoms and advice in section 4 in ‘Blood sugar level too high’.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
A blood sugar level that is too low (hypoglycemia)is very common with insulin treatment (may affect more than 1 in 10 people). It can become very serious. If your blood sugar level gets very low, you may lose consciousness. Severe hypoglycemia can cause damage to the brain and be life-threatening. If you feel the symptoms of a low blood sugar level, act immediatelyto raise it. See the advice in the ‘Blood sugar level too low’ section below.

If you experience a severe allergic reaction(including anaphylactic shock) to insulin or any of the ingredients of Fiasp (the frequency with which this occurs is not known), stop using this medicine and seek immediate medical attention at the emergency room.
Signs of a severe allergic reaction may include:

localized reactions (skin rashes, redness and itching) spread to other parts of the body
you suddenly feel unwell and start sweating
you begin to feel sick (vomiting)
you have difficulty breathing
your heartbeat is fast or you feel dizzy.

Allergic reactionssuch as a widespread skin rash and swelling of the face may occur. These are uncommon and may affect up to 1 in 100 people. Contact a doctor if your symptoms worsen or do not improve within a few weeks.

Changes in the skin at the injection site:If you inject insulin into the same place, the fatty tissue may become thinner (lipoatrophy) or thicker (lipohypertrophy) (these are uncommon effects and may affect less than 1 in 100 people). Lumps under the skin can also be caused by the build-up of a protein called amyloid (cutaneous amyloidosis; the frequency with which this occurs is not known). Insulin may not work as well if you inject into an area with lumps, an area that is thinned, or an area that is thickened. Change the injection site with each injection to prevent these skin changes.

Other side effects include:
Common(may affect up to 1 in 10 people)
Reaction at the injection site: Local reactions can occur at the injection site. Signs may include: rash, redness, inflammation, bruising, irritation, pain and itching. Reactions usually disappear within a few days.
Skin reactions: Signs of allergy on the skin, such as eczema, rash, itching, hives and dermatitis may appear.

General effects of insulin treatment including Fiasp

Blood sugar level too low (hypoglycemia)(very common)

Your blood sugar level may become too low if:
You drink alcohol; you use too much insulin; you do more physical activity than usual; you eat too little or skip a meal.

Warning signs of a blood sugar level that is too low, which can occur suddenly:
headache; confused thinking; fast heartbeat; cold sweat; cold and pale skin; feeling unwell; very hungry; trembling or feeling nervous or anxious; unusual tiredness, weakness and sleepiness; confusion; difficulty concentrating; temporary visual disturbances.

What to do if your blood sugar level is too low

If you are conscious, treat the low blood sugar immediately with 15-20 g of fast-acting carbohydrates: eat glucose tablets or a sugary snack, such as fruit juice, sweets or biscuits (always carry glucose tablets or a sugary snack with you).
It is recommended to measure your blood sugar after 15-20 minutes and treat again if your blood sugar levels are still less than 4 mmol/L.
Wait until the signs of low blood sugar have disappeared or your blood sugar level has stabilized, then continue your insulin treatment as usual.

What others should do if you faint
Tell all the people you spend time with that you have diabetes and what the consequences may be, including the risk of fainting due to a blood sugar level that is too low.
Explain to them that, if you should faint, they must:

turn you onto your side to prevent choking
seek immediate medical help
do notgive you food or drink as this could cause you to choke.

You may regain consciousness more quickly with a glucagon injection, which should only be given by someone who knows how to use it.

If you are given glucagon, you will need sugar or a sweet snack as soon as you regain consciousness.
If you do not respond to the glucagon injection, you will need to be taken to hospital.

If severe hypoglycemia is not treated in time, it can cause brain damage, temporary or permanent, and can also cause death.

Contact your doctor if:

your blood sugar level has become so low that you have fainted
you have been given a glucagon injection
you have recently had more episodes of low blood sugar. You may need to adjust your insulin dose or injection times, your diet or your exercise.
Blood sugar level too high (hyperglycemia)Your blood sugar level may become too high if:You eat more or exercise less than usual; you drink alcohol; you get an infection or a fever; you do not use enough insulin; you continue to use less insulin than you need; you forget to use your insulin or stop using insulin.

Warning signs of a blood sugar level that is too high, which usually develop gradually:
red skin; dry skin; feeling sleepy or tired; dry mouth; fruity-smelling breath (acetone); passing urine more often; thirst; loss of appetite; feeling unwell (nausea or vomiting).
These can be signs of a very serious condition called diabetic ketoacidosis. This is a build-up of acid in the blood because the body is metabolizing fat instead of sugar. If not treated, it can lead to diabetic coma and eventually death.

What to do if your blood sugar level is too high

Measure your blood sugar level.
Use a corrective dose of insulin, if you have been taught how to do so.
Check for ketones in your urine.
If ketones are present, contact a doctor immediately.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

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 the packaging box after
‘Exp.’. The expiry date refers to the last day of that month.
Before first use:
Store in a refrigerator (2°C–8°C). Do not freeze. Keep away from refrigerating elements.
Keep the cap on the pen to protect the medicine from light.
After first opening or carried with you as a supply
You can carry with you as a supply the prefilled pen (FlexTouch) and keep it at room temperature (at
temperature below 30°C) or in a refrigerator (2°C–8°C) for up to 4 weeks. When not in use,
keep the cap on the pen to protect the medicine from light.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What Fiasp contains

The active substance is insulin aspart. 1 mL of the solution contains 100 units of insulin aspart. Each pre-filled pen contains 300 units of insulin aspart in 3 mL of solution.
The other components are phenol, metacresol, glycerol, zinc acetate, disodium phosphate dihydrate, arginine hydrochloride, nicotinamide (vitamin B3), hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) (see at the end of paragraph 2 in ‘Important information about some ingredients of Fiasp’) and water for injections.

Description of the appearance of Fiasp and content of the pack
Fiasp is presented as a clear and colourless aqueous injectable solution contained in a pre-filled pen.
Pack of 1, 5 or a multi-pack with 2 x 5 pre-filled pens of 3 mL. Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Novo Nordisk A/S,
Novo Allé,
DK-2880 Bagsværd, Denmark

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines
Agency, http://www.ema.europa.eu .

Instructions on how to use Fiasp FlexTouch
Read these instructions carefullybefore using the FlexTouch pre-filled pen. If you do not follow
the instructions carefully, you may inject too much or too little insulin, which can lead to a blood
sugar level that is too high or too low.

Do not use the pen without receiving adequate instructionfrom your doctor or nurse.
Start by checking the pen to make sure it contains Fiasp 100 units/mL,then look at the
illustrations below to learn about the different parts of the pen and the needle.

If you are blind or have severe visual impairment and cannot read the dose counter, do not use
this pen without help.Ask someone with good vision, who is trained to
use the FlexTouch pre-filled pen, to help you.
The pen is a pre-filled insulin pen with a selectable dose, containing 300 units of insulin.
You can select a maximum dose of 80 units per dose, in 1-unit increments.The pen is
designed to be used with single-use needles with a length between 4 mm and 8 mm
and a gauge between 30G and 32G. Needles are not included in the pack.

Important information
Pay particular attention to these notes because they are important for correct use of the pen.

Orange triangle with a white exclamation mark in the center, a symbol of warning or danger

Disassembled insulin pen with separate components: blue body, orange cartridge, transparent cap, needle and dosage window

1 Preparing the pen with a new needle

Check the name and dosage on the pen labelto make sure the pen contains Fiasp 100 units/mL. This is particularly important if you use more than one type of insulin. If you administer the wrong type of insulin, your blood sugar level may become too high or too low.
Remove the cap from the pen.

Injectable pen with black protective needle cap and orange part visible between fingers

Check that the insulin in the pen is clearand colourless. Look through the insulin window. If the insulin appears cloudy, do not use the pen.

Blue and orange injectable pen held in hand with needle visible

Take a new needleand remove the protective seal.

Hand holding a medical device with a cylinder and a plunger, white arrow indicates the direction of pushing

Make sure you attach the needle correctly.

Push the needle onto the pen.
Rotate it until it is secure.

Hand gripping an injection pen device with a curved arrow indicating rotation of the protective cap

The needle is covered by two caps. You must remove both of them.If you forget to remove
both caps, you will notinject any insulin.

Remove the outer cap of the needle and keep it for later.You will need it after the injection to safely remove the needle from the pen.

Injectable pen with orange protective needle inserting into a grey cylindrical adapter

Remove the inner cap of the needle and throw it away.If you try to put it back on, you may accidentally prick or injure yourself with the needle.

A drop of insulin may appear on the tip of the needle. This is normal, but you should still
check the insulin flow.

Do not attach a new needleto the pen until you are ready to give the injection.

Hand holding an injection device with a protective cap being removed

Always use a new needle for each injection
This reduces the risk of contamination, infection, insulin leakage, needle blockage and
incorrect dosage.

Never use a bent or damaged needle.
2 Checking the insulin flow

Always check the insulin flow before starting.This helps ensure that the entire dose of insulin is delivered.
Rotate the dose selector and select 2 units. Make sure the dose counter shows

Injectable pen held with two hands with arrow indicating pressure on the button and numeric display at the bottom

Hold the pen with the needle pointing upwards. Gently tap the tip of the penseveral times so that air bubbles collect at the top.

Hand holding an auto-injector device orange with needle and pressing the activation button

Press and hold the injection buttonuntil the dose counter returns to zero. The 0 must align with the dose indicator. A drop of insulin should appear on the tip of the needle.

Blue pen held in hand with arrow pointing to the left

A small air bubble may remain on the tip of the needle, but it will not be injected.

If the drop does not appear,repeat steps 2 Ato 2 Cup to 6 times. If the drop still does not
appear, change the needle and repeat steps 2 Ato 2 Cagain.
If the drop of insulin still does not appear, discard the pen and use a new one.

Always make sure a drop appearson the tip of the needle before the injection. This
ensures the correct flow of insulin.

If this does not happen, insulin is not injected, even if the dose counter may move.
This situation may indicate a blocked or damaged needle.

Always check the flow before the injection.If you do not check the flow, you may not inject
any insulin at all or you may inject too little. This can cause a high blood sugar level.

3 Selecting the dose

Before starting, check that the dose counter is at 0.The 0 must align with the dose indicator.
Rotate the dose selector to select the required dose,as instructed by your doctor or nurse. If you select the wrong dose, you can correct it by rotating the dose selector forwards or backwards.

A maximum of 80 units can be selected on the pen.

Blue injection pen held by two fingers with white arrow indicating dose adjustment and numbers 4-6-24 indicated on the side buttons

The dose selector changes the number of units. Only the dose counter and the dose indicator show how many units have been selected for each dose.
You can select up to 80 units per dose. When the pen contains less than 80 units, the
dose counter displays the number of units remaining.

Always use the dose counter and the dose indicator to
see how many units you are injecting before injecting the insulin.
Donot count the clicks of the pen to set the dose. If you select and inject the wrong dose, the
blood sugar level may rise or fall too much.
Do not use the insulin scale, which only shows approximately how much insulin is left
in the pen.
The dose selector makes a different click when rotated forwards, backwards or when it exceeds
the number of remaining units.

4 Injecting the dose

Insert the needle into the skinas shown by your doctor or nurse.
Make sure you can see the dose counter.Do not touch the dose counter with your fingers, otherwise the injection may stop.

Press and hold the injection button. Observe how the dose counter returns to 0.The 0 must align with the dose indicator. You may feel or hear a click.
Continue to press the injection button while keeping the needle in the skin.
Count slowly to 6 while continuing to press the injection button.
If the needle is pulled out too early, you may notice insulin leaking from the tip of the needle. In this case, the full dose will not have been delivered and you should increase the frequency of blood sugar monitoring.
Remove the needle from the skin.You can now release the injection button
If blood appears at the injection site, press lightly on the skin for a few minutes to
stop the bleeding, without rubbing the area.
After the injection, you may see a drop of insulin on the tip of the needle. This phenomenon
is normal and does not affect the dose just administered.
Always look at the dose counter to know how many units you are injecting.Keep
pressing the injection button until the dose counter shows 0. If the
dose counter does not return to 0, the full dose has not been delivered, which can
cause a high blood sugar level.
How to identify a blocked or damaged needle.
If the dose counter does not show a 0 after continuously pressing the delivery button, it is possible that a blocked or damaged needle has been used.
In this case nomedicine will have been delivered, even if the dose counter has moved from the originally set dose.
How to manage a blocked needle.
Remove the needle as described in paragraph 5 and repeat all steps starting from 1: Preparing
the pen with a new needle. Make sure you select the entire dose needed.
Never touch the dose counter during the injection.
This can interrupt the injection.
5 After the injection
Always dispose of the needle after each injection.
This reduces the risk of contamination, infection, insulin leakage, needle blockage and
incorrect dosage. If the needle is blocked, you will notbe able to inject the insulin.
Insert the needle tip into the outer capresting it on a flat surface, without touching either the needle or the outer needle cap.
When the needle is covered, completely press the outer cap with caution.
Unscrew the needleand dispose of it carefully according to the instructions of your doctor, nurse, pharmacist or local authorities.
Replace the pen capon the pen after each use to protect the insulin from light.
When the pen is empty, dispose of it withoutthe needle attached as instructed by your doctor,
nurse, pharmacist or local authorities.
Never try to replace the inner needle cap.You could prick or injure yourself with the needle.
Always remove the needle from the pen after each injectionand store the pen without the needle
attached. This reduces the risk of contamination, infection, insulin leakage, needle blockage and incorrect dosage.
6 How much insulin is left?
The insulin scaleshows approximatelyhow much insulin remains in the pen.
To see precisely how much insulin is left,use the dose counter: Rotate the dose selector until the dose counter stops. If it shows 80, there are at least 80units remaining in the pen. If it shows less than 80,the number shown is the number of units remaining in the pen.
Rotate the dose selector back until the dose counter shows 0.
If you need more insulin than is left in the pen, divide the dose between two pens.
If you divide the dose, be very careful to calculate the correct number.
If you are unsure, inject the full dose using a new pen. If you divide the dose incorrectly, you will inject too low or too high a dose of insulin, which can lead to blood sugar levels that are too high or too low.
Other important information
Always carry the pen with you.
Always carry an extra pen and new needles,in case you lose or damage the pen or needles.
Always keep the pen and needles out of sight and reach of others,especially children.
Never share the penand needles with other people. This can lead to cross-infection.
Never sharethe pen with other people. The medicine may be dangerous to their health.
You must be very careful when handling used needles to reduce the risk of needle stick injuries and cross-infection.
Pen maintenance
Treat the pen with care. Improper or incorrect use can cause incorrect dosages, which can lead to blood sugar levels that are too high or too low.
Do not leave the pen in the caror in other places where it may overheat or become too cold.
Do not expose the pen to dust, dirt or liquids.
Do not wash, immerse or lubricate the pen.If necessary, clean it with a mild detergent on a damp cloth.
Do not drop the penor knock it against hard surfaces. If you drop it or suspect a problem, attach a new needle and check the insulin flow before injecting.
Do not try to refill the pen.When it is empty, it must be disposed of.
Do not try to repairor disassemble the pen.
Fiasp 100 units/mL Penfill injectable solution in cartridge
insulin aspart
Read this leaflet carefully before you start to use this medicine as it contains important
information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet
1. What Fiasp is and what it is used for
2. What you need to know before you use Fiasp
3. How to use Fiasp
4. Possible side effects
5. How to store Fiasp
6. Contents of the pack and other information
1. What is Fiasp and what is it used for
Fiasp is a prandial insulin with a rapid effect of reducing blood sugar. Fiasp is an
injectable solution containing insulin aspart and is used to treat diabetes mellitus in adults,
adolescents and children aged 1 year or older. Diabetes is a disease in which the body does not
produce enough insulin to control blood sugar levels. Treatment with Fiasp
helps to prevent complications of diabetes.
Fiasp should be injected up to 2 minutes before the start of a meal, with the possibility of injecting it
up to 20 minutes after the start of the meal.
The maximum effect of the medicine will be achieved between 1 and 3 hours after the injection and the effect will last for 3-5 hours.
This medicine should normally be used in association with insulin preparations with intermediate or prolonged action.
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 precautions
Talk to your doctor, pharmacist or nurse before using Fiasp. Pay particular attention
to:
Low blood sugar (hypoglycemia) - if your blood sugar is too low, follow the instructions for low blood sugar in section 4 ‘Possible side effects’. Fiasp starts to lower blood sugar faster than other prandial insulins. Hypoglycemia may occur more quickly after an injection of Fiasp.
High blood sugar (hyperglycemia) - if your blood sugar is too high, follow the instructions for high blood sugar in section 4 ‘Possible side effects’.
Transferring from other insulin medicines - your doctor may need to advise you on the insulin dose.
If your insulin treatment is in combination with pioglitazone (oral antidiabetic medicine used to treat type 2 diabetes) - Tell your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid weight gain or localized swelling caused by fluid retention (edema).
Eye problems - rapid improvement in blood sugar control can lead to a temporary worsening of eye problems such as diabetic retinopathy.
Pain due to nerve damage - if your blood sugar improves very rapidly, you may experience nerve-related pain, which is usually temporary.
Swelling around the joints - at the beginning of use of the medicine, the body may retain more water than it should. This effect causes swelling around the ankles and other joints. It usually lasts only a short time.
Make sure you use the correct type of insulin: always check the insulin label before each injection to avoid accidental exchange between insulin products.
Treatment with insulin can induce the body to produce antibodies against insulin (substances that act against insulin). However, only very rarely will this require a change in the insulin dose.
If you have vision problems, see section 3 ‘How to use Fiasp’.
Some conditions and activities can affect your insulin needs. Talk to your doctor:
if you have problems with your kidneys, liver, or adrenal, pituitary or thyroid glands
if you do more physical activity than usual or if you want to change your usual diet, as this can affect your blood sugar level
if you become ill, continue to use insulin and talk to your doctor.
if you are going abroad, traveling through different time zones can affect your insulin needs and injection timing.
When using Fiasp, it is strongly recommended to record the name and batch number of
each pack in order to keep a record of the batches used.
Skin changes at the injection site
The injection site must be rotated to help prevent changes in the fatty tissue under the
skin, such as thickening of the skin, thinning of the skin or the appearance of nodules under the skin.
Insulin may not work very well if you inject into an area with nodules, into an area
thinned or into an area thickened (see section 3 ‘How to use Fiasp’). Tell your doctor if you notice
skin changes at the injection site. If you are currently injecting into one of these
affected areas, talk to your doctor before starting to inject into another area. Your doctor
may ask you to check your blood sugar more carefully and adjust the dose of insulin or other
antidiabetic medicines.
Children and adolescents
This medicine is not recommended for use in children under 1 year of age.
Other medicines and Fiasp
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other
medicines. Some medicines affect blood sugar levels; this could
mean a change in your insulin dose is needed.
The most common medicines that can affect insulin treatment are listed below.
Your blood sugar level may be lowered (hypoglycemia) if you use:
other medicines for diabetes (oral and injectable)
sulfonamide antibiotics (used to treat infections)
anabolic steroids (e.g. testosterone)
beta-blockers (used to treat high blood pressure or angina)
salicylates (used to relieve pain and lower fever)
monoamine oxidase inhibitors (MAOIs) (used to treat depression)
angiotensin converting enzyme (ACE) inhibitors (for some heart conditions or high blood pressure)
Your blood sugar level may be raised (hyperglycemia) if you use:
danazol (a medicine that affects ovulation)
oral contraceptives (birth control pills)
thyroid hormones (for thyroid problems)
growth hormone (for growth hormone deficiency)
glucocorticoids (such as ‘cortisone’ - for inflammation)
sympathomimetics (such as epinephrine (adrenaline), salbutamol, terbutaline - for asthma)
thiazides (for high blood pressure or excessive water retention).
Octreotide and lanreotide - used for the treatment of a rare disease characterized by excessive
production of growth hormone (acromegaly). They can increase or decrease your blood
sugar level.
If any of these situations apply to you (or if 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 more frequently than usual.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding, ask your doctor for advice before using this medicine. This medicine can be
used during pregnancy, although it may be necessary to adjust your insulin dose
during pregnancy and after delivery. The amount of insulin you need usually decreases
during the first 3 months of pregnancy and increases for the remaining 6 months.
During pregnancy, you need to carefully control your diabetes and it is particularly
important to prevent blood sugar from becoming too low
(hypoglycemia) for the health of the baby. After having the baby, your insulin needs will probably return to what
you needed before pregnancy.
There are no restrictions on the use of Fiasp during breastfeeding.
Driving and using machines
Blood sugar that is too low can affect your ability to drive or use
tools or machines. If your blood sugar is too low, your ability to concentrate
or react may be impaired. This can endanger yourself or others. Ask your
doctor if you can drive if:
your blood sugar becomes too low frequently
you have difficulty recognizing the signs of low blood sugar.
Important information about some ingredients of Fiasp
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. it is essentially ‘sodium-free’.
3. How to use Fiasp
Use this medicine following exactly the instructions of your doctor. If you have doubts, consult your
doctor or pharmacist.
If you are blind or have severe vision problems and cannot read the dose counter, do not use
this insulin medicine without help. Ask someone with good eyesight, who is
trained to use the pen, to help you.
When to use Fiasp
Fiasp is a prandial insulin.
Adults: Fiasp must be injected immediately before (0-2 minutes) the start of a meal, with the possibility of
injecting it up to 20 minutes after the start of the meal.
Children: Fiasp must be injected immediately before (0-2 minutes) the start of a meal, with the possibility of
injecting up to 20 minutes after the start of the meal, when there is uncertainty that the child will eat.
Ask your doctor for advice in these situations.
The maximum effect of the medicine will be achieved between 1 and 3 hours after the injection and the effect will last for 3-5 hours.
Dose of Fiasp
Dose for type 1 and type 2 diabetes
The doctor will decide together with you:
how much Fiasp you will need at each meal
when to check your blood sugar level and whether a higher or lower dose is needed.
If you want to change your usual diet, ask your doctor, pharmacist or
nurse for advice first, because a change in diet can alter your insulin requirement.
When using Fiasp with other medicines, ask your doctor if the treatment needs to be modified.
Dose adjustment for type 2 diabetes
The daily dose should be based on blood sugar levels with meals and at bedtime the previous day.
Before breakfast - the dose should be adjusted according to the blood sugar level before lunch the previous day.
Before lunch - the dose should be adjusted according to the blood sugar level before dinner the previous day.
Before dinner - the dose should be adjusted according to the blood sugar level at bedtime the previous day.
Use in elderly patients (65 years or older)
This medicine can be used in elderly patients. Talk to your doctor about dose changes.
If you have kidney or liver problems
If you have kidney or liver problems, you may need to check your blood sugar level more frequently. Talk to your doctor about dose changes.
Injection of Fiasp
Table 1 Dose adjustment
I Blood sugar level at meals or at bedtime Dose adjustment
a mmol/L mg/dL
less than 4 less than 71 Reduce the dose by 1 unit
i z 4-6 71-108 No dose adjustment
n more than 6 more than 108 Increase the dose by 1 unit
This medicine is only suitable for injection under the skin (subcutaneous injection) with a reusable pen
Novo Nordisk.
Before using Fiasp for the first time, your doctor or nurse must show you how to use it. Talk
to your doctor if you need to inject insulin in another way.
Where to inject
The best areas to inject are the front of the abdomen or the upper arms.
Do not inject the medicine into a vein or muscle.
Vary the injection site within the area where you inject each day to reduce the risk of developing changes under the skin (see section 4).
Do not use Fiasp
if the cartridge or reusable pen you are using is damaged. Return it to the supplier. For further instructions, see the reusable pen manual.
if the cartridge has not been stored correctly (see section 5 ‘How to store Fiasp’).
if the insulin does not appear clear (e.g. is cloudy) and colourless.
How to inject Fiasp
Read the leaflet provided with the reusable pen.
Check the name and dosage on the cartridge (Penfill) label to make sure it is Fiasp.
Always use a new needle for each injection to prevent contamination.
Needles must not be shared.
If you use more Fiasp than you should
If you use too much insulin, your blood sugar level may drop too low (hypoglycemia), see the
advice in section 4 in ‘Blood sugar level too low’.
If you forget to use Fiasp
If you forget to use insulin, your blood sugar level may rise too high (hyperglycemia).
See section 4 in ‘Blood sugar level too high’.
Three simple precautions that can help avoid your blood sugar level being
too low or too high are:
Always carry spare Fiasp cartridges with you.
Always carry something that shows you have diabetes.
Always carry sugar-containing products. See section 4 in ‘What to do if your blood sugar level is too low’.
If you stop using Fiasp
Do not stop treatment with insulin without talking to your doctor. If you stop using
insulin, a very high blood sugar level (severe hyperglycemia) and
ketoacidosis (a condition characterized by too much acid in the blood, which can be life-threatening) may develop. See symptoms and advice in section 4 in ‘Blood sugar level too high’.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
A blood sugar level that is too low (hypoglycemia)is very common with insulin treatment (may affect more than 1 in 10 people). It can become very serious. If your blood sugar level drops too low, you may lose consciousness. Severe hypoglycemia can cause damage to the
brain and be life-threatening. If you feel the symptoms of a low blood sugar level,
act immediatelyto raise it. See the advice in the ‘Blood sugar level too low’ section below.
If you experience a severe allergic reaction(including anaphylactic shock) to insulin or any
of the ingredients of Fiasp (the frequency with which this occurs is not known), stop using
this medicine and seek immediate medical attention at the emergency room.
Signs of a severe allergic reaction may include:
localized reactions (skin rashes, redness and itching) spread to other parts of the body
you suddenly feel unwell and start to sweat
you begin to feel sick (vomiting)
you have difficulty breathing
your heartbeat is fast or you feel dizzy.
Allergic reactionssuch as a widespread skin rash and swelling of the face may occur.
These are uncommon and may affect up to 1 in 100 people. Contact a doctor if the
symptoms worsen or do not improve within a few weeks.
Changes to the skin at the injection site:If you inject insulin into the same place, the fatty
tissue may become thinner (lipoatrophy) or thicker (lipohypertrophy) (these are uncommon effects and
may affect less than 1 in 100 people). Lumps under the skin can also be caused
by a build-up of a protein called amyloid (cutaneous amyloidosis; the frequency with which this
occurs is not known). Insulin may not work as well as it should if you inject into
an area with lumps, an area that is thinned or an area that is thickened. Change the injection site with each
injection to prevent these skin changes.
Other side effects include:
Common(may affect up to 1 in 10 people)
Reaction at the injection site: Local reactions can occur at the injection site. Signs may include: rash, redness, inflammation, bruising,
irritation, pain and itching. Reactions usually disappear within a few days.
Skin reactions: Signs of allergy may appear on the skin, such as eczema, rash,
itching, hives and dermatitis.
General effects of insulin treatment including Fiasp
Blood sugar level too low (hypoglycemia)(very common) Your blood sugar level may become too low if:You drink alcohol; you use too much insulin; you do more physical activity than usual; you eat too little or miss a meal.
Early warning signs of a blood sugar level that is too low, which can occur
suddenly:
headache; confusion; fast heartbeat; cold sweat; cold and pale skin; feeling unwell; extreme hunger; trembling or feeling nervous or anxious;
unusual tiredness, weakness and sleepiness; confusion; difficulty concentrating; temporary visual disturbances.
What to do if your blood sugar level is too low
If you are conscious, treat the low blood sugar immediately with 15-20 g of fast-acting carbohydrates: eat glucose tablets or a sugary snack, such as fruit juice, sweets or biscuits (always carry glucose tablets or a sugary snack with you).
It is recommended to measure your blood sugar level after 15-20 minutes and treat again if the blood sugar levels are still less than 4 mmol/L.
Wait until the signs of low blood sugar have disappeared or your blood sugar level has stabilized, then continue your insulin treatment as usual.
What others should do if you faint
Tell everyone you spend time with that you have diabetes and what the
consequences can be, including the risk of fainting due to a blood sugar level that is too
low.
Explain to them that, if you should faint, they must:
turn you onto your side to prevent choking
seek immediate medical help
do notgive you food or drink as this could cause you to choke.
You may regain consciousness more quickly with a glucagon injection, which should only be given by someone who knows how to use it.
If you are given glucagon, you will need sugar or a sweet snack as soon as you regain consciousness.
If you do not respond to the glucagon injection, you will need to be taken to hospital.
If severe hypoglycemia is not treated in time, it can cause brain damage, temporary or
permanent, and can also cause death.
See your doctor if:
your blood sugar level has become so low that you have fainted
you have been given a glucagon injection
you have recently had more episodes of low blood sugar. It may be necessary to change the dose or timing of your insulin injections, your diet or your exercise.
Blood sugar level too high (hyperglycemia)Your blood sugar level may become too high if:You eat more or exercise less than usual; you drink alcohol; you get an infection or a fever; you do not use enough insulin; you continue to use less insulin than you need; you forget to use your insulin or stop using insulin.
Early warning signs of a blood sugar level that is too high, which usually occur
gradually:
flushed skin; dry skin; feeling sleepy or tired; dry mouth; fruity-smelling breath
(acetone); passing urine more often; thirst; loss of appetite; feeling unwell (nausea or
vomiting).
These can be signs of a very serious condition called ketoacidosis. This is a build-up of acid in the blood because the body is metabolizing fat instead of sugar. If not
treated, it can lead to diabetic coma and eventually death.
What to do if your blood sugar level is too high
Measure your blood sugar level.
Use a corrective dose of insulin, if you have been taught how to do so.
Check for ketones in your urine.
If ketones are present, seek immediate medical attention.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system listed in Annex V. By reporting side
effects you can help provide more information on the safety of this medicine.
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 the package after
‘Exp.’. The expiry date refers to the last day of that month.
Before first use:
Store in a refrigerator (2°C – 8°C). Do not freeze. Keep away from refrigerating elements.
Keep the cartridge in the packaging to protect the medicine from light.
After first opening or carried with you as a supply
Do not refrigerate. You can carry with you as a supply the cartridge (Penfill) and keep it at room temperature
(at a temperature below 30°C) for up to 4 weeks. Always keep the cartridge in the packaging to
protect the medicine from light.
Dispose of the needle after each injection.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Fiasp contains
The active substance is insulin aspart. 1 mL of the solution contains 100 units of insulin aspart. Each cartridge contains 300 units of insulin aspart in 3 mL of solution.
The other components are phenol, metacresol, glycerol, zinc acetate, disodium phosphate dihydrate, arginine hydrochloride, nicotinamide (vitamin B3), hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) (see at the end of paragraph 2 in ‘Important information about some ingredients of Fiasp’) and water for injections.
Description of the appearance of Fiasp and contents of the pack
Fiasp is presented as a clear and colourless aqueous injectable solution contained in a
cartridge.
Packs of 5 and 10 cartridges of 3 mL. Not all pack sizes may be
marketed.
Marketing authorisation holder and manufacturer
Novo Nordisk A/S,
Novo Allé,
DK-2880 Bagsværd, Denmark
Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu .

Не уверены, подходит ли вам это лекарство?
Обсудите симптомы и варианты лечения с врачом онлайн.