Kirsty

Package leaflet: Information for the user

Kirsty 100 units/ml solution for injection in vial

insulin aspart
Please read all of 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 give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

1. What Kirsty is and what it is used for

Kirsty is a modern insulin (insulin analogue) with rapid action. Modern insulins are
improved versions of human insulin.
Kirsty is used to reduce high blood sugar levels in adults, adolescents, and children from the age of 1 year onwards who have diabetes mellitus (diabetes). Diabetes is a disease in which the body does not
produce enough insulin to control blood sugar levels. Treatment with
Kirsty helps to prevent complications of diabetes.
Kirsty will begin to reduce blood sugar levels 10-20 minutes after injection, reaches its maximum effect between 1 and 3 hours after injection, and its effect lasts for 3-5 hours. Due to this
short duration of action, Kirsty is usually administered in combination with intermediate- or long-acting insulin preparations. Additionally, Kirsty can be used for continuous subcutaneous infusion via insulin pumps.

2. What you need to know before using Kirsty

Do not use Kirsty

• If you are allergic to insulin aspart or to any of the other ingredients of this medicine (listed in section 6).
• If you suspect the onset of a hypoglycemic crisis, i.e. low blood sugar levels (see a) Summary of serious and very common adverse reactions in section 4).
• If the protective cap is loose or missing. Each vial has a plastic anti-tampering protective cap. If the cap is not in perfect condition at the time of purchase, return the vial to the supplier.
• If it has not been stored correctly or has been frozen (see section 5, How to store Kirsty).
• If the insulin does not appear clear and colourless.

Do not use Kirsty if any of these situations apply. Speak with your doctor, nurse, or pharmacist for advice.

Before using Kirsty

• Check the label to make sure you are using the correct type of insulin.
• Remove the protective cap.
• Always use a new needle for each injection to prevent contamination.
• Needles and syringes must not be shared with others.

Warnings and precautions

• Certain conditions and activities may affect your insulin requirements. Consult your doctor:
• If you have kidney or liver problems, or disorders of the adrenal, pituitary, or thyroid glands.
• If you have increased physical activity or changes in your usual diet, as this may affect your blood sugar levels.
• If you become ill, continue your insulin therapy and consult your doctor.
• If you plan to travel abroad, travelling across different time zones may alter your insulin requirements and injection schedule.

Skin changes at the injection site
The injection site should be rotated to help prevent changes in the fatty tissue beneath the skin, such as skin thickening, skin thinning, or the appearance of lumps under the skin.
Insulin may not work as effectively if injected into an area with lumps, thinning, or thickening (see section 3, How to use Kirsty). Inform your doctor if you notice any skin changes at the injection site. If you are currently injecting into one of these affected areas, consult your doctor before switching to a new injection site. Your doctor may advise you to monitor your blood glucose more closely and possibly adjust your insulin dose or other antidiabetic medications.

Children and adolescents
Do not administer this medicine to children under 1 year of age, as no clinical studies have been conducted in children under 1 year of age.

Other medicines and Kirsty
Inform your doctor, nurse, or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines affect blood sugar levels and may alter your insulin requirements. Listed below are the most important medicines that can influence insulin treatment.

Blood sugar levels may decrease (hypoglycemia) if you take:

• Other medicines for the treatment of diabetes
• Monoamine oxidase inhibitors (MAOIs) (used to treat depression)
• Beta-blockers (used to treat high blood pressure)
• Angiotensin-converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood pressure)
• Salicylates (used to relieve pain and reduce fever)
• Anabolic steroids (such as testosterone)
• Sulfonamides (used to treat infections)

Blood sugar levels may increase (hyperglycemia) if you take:

• Oral contraceptives (birth control pills)
• Thiazides (used to treat high blood pressure or fluid retention)
• Glucocorticoids (such as 'cortisone' used to treat inflammation)
• Thyroid hormones (used to treat thyroid gland disorders)
• Sympathomimetics, such as epinephrine (adrenaline), salbutamol, terbutaline, used to treat asthma
• Growth hormone (a medicine used to stimulate skeletal and somatic growth and that significantly affects the body's metabolic processes)
• Danazol (a medicine that affects ovulation)

Octreotide and lanreotide (used to treat acromegaly, a rare hormonal disorder usually occurring in middle-aged adults, caused by excessive production of growth hormone by the pituitary gland) may either increase or decrease blood sugar levels.
Beta-blockers (used to treat high blood pressure) may weaken or completely suppress the warning symptoms that help you recognize low blood sugar levels.

Pioglitazone (tablets used to treat type 2 diabetes)
Some patients with long-standing type 2 diabetes and heart problems or a history of stroke who were treated with pioglitazone and insulin have developed heart failure. Inform your doctor immediately if you experience signs of heart failure such as unusual shortness of breath, rapid weight gain, or localized swelling (edema).
If you are taking any of the medicines listed above, inform your doctor, nurse, or pharmacist.

Kirsty and alcohol

• If you consume alcohol, your insulin requirements may change because blood sugar levels may increase or decrease. Careful monitoring is recommended.

Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine. Kirsty can be used during pregnancy. Your insulin requirements may need adjustment during pregnancy and after delivery. It is important to carefully control diabetes, particularly to prevent episodes of hypoglycemia, for the health of both mother and baby.
• There are no restrictions on using Kirsty during breastfeeding.

Consult your doctor, nurse, or pharmacist before taking any medicine during pregnancy or breastfeeding.

Driving and using machines
Contact your doctor regarding the suitability of driving or operating machinery:

• if you experience frequent episodes of hypoglycemia
• if you have difficulty recognizing the warning signs of hypoglycemia.

If your blood sugar is high or low, your ability to concentrate and react may be impaired, and consequently your ability to drive or operate machinery may also be affected. Be aware that you could be putting yourself and others at risk.
Kirsty acts rapidly; therefore, if hypoglycemia occurs, it may appear earlier after injection compared to soluble human insulin.

Kirsty contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially 'sodium-free'.

3. How to use Kirsty

Dose and when to take insulin
Always use insulin exactly as prescribed by your doctor and follow his or her advice carefully. If you are
unsure, consult your doctor, nurse, or pharmacist.
Kirsty is generally used just before meals. Eat a meal or snack within 10 minutes after injection to
avoid low blood sugar levels. If necessary, Kirsty may be administered immediately after a meal. See
"How and where to inject" for further information.
Do not change your insulin unless your doctor tells you to do so. If your doctor has changed the type or
brand of insulin you are using, a dose adjustment may be required.

Use in children and adolescents
Kirsty can be used in adolescents and children from the age of 1 year onwards instead of soluble human
insulin when a rapid onset of action is preferred. For example, when it is difficult to match insulin dosing
to meals in children.

Use in specific patient groups
If you have renal or hepatic impairment, or if you are over 65 years old, you should monitor your blood
glucose regularly and discuss insulin dose adjustments with your doctor.

How and where to inject
Kirsty is administered by subcutaneous injection or by continuous infusion using insulin pumps.
Administration via insulin pump requires detailed instructions from healthcare professionals. Never
inject insulin directly into a vein (intravenous route) or into muscle (intramuscular route). If necessary,
Kirsty may be administered intravenously, but this must be performed exclusively by physicians or
healthcare professionals.
With each injection, rotate the injection site within the particular area of skin you usually use. This may
reduce the risk of developing lumps or skin depressions (see section 4, Possible side effects). The best
areas for injection are: the abdominal area, the upper arm, or the front of the thigh. Insulin acts more
rapidly when injected into the abdomen.
Check your blood glucose levels regularly.

How to use Kirsty

1. Draw into the syringe an amount of air equal to the dose of insulin you need to inject. Inject this air into the vial.
2. Invert the vial and syringe and draw the correct dose of insulin into the syringe. Remove the needle from the vial. Then expel the air from the syringe and check that the dose is correct.

How to inject Kirsty

• Inject the insulin under the skin. Use the injection technique shown to you by your doctor or nurse.
• Wait at least 6 seconds before removing the needle from the subcutaneous tissue to ensure the full dose of insulin has been delivered.
• Dispose of the needle after each injection.

Use in insulin pumps
Never mix Kirsty with other types of insulin in insulin pumps.
Follow the instructions and recommendations provided by your doctor regarding the use of Kirsty in an
insulin pump. Before using Kirsty in an insulin pump, make sure you fully understand the instructions for
use and information on any actions to take in case of illness, high or low blood sugar levels, or insulin pump
malfunction.

• Before inserting the needle, wash your hands and the skin at the infusion site thoroughly with soap and water to prevent infections at the infusion site.
• When inserting a new reservoir, ensure that there are no air bubbles in either the syringe or the tubing.
• The infusion set (tubing and needle) must be changed according to the instructions provided with the infusion set. To fully benefit from insulin infusion and to detect possible insulin pump malfunctions, measure your blood sugar levels regularly.

What to do in case of insulin pump malfunction
Always keep an alternative method of insulin administration available for subcutaneous injection in case
of insulin pump malfunction.

If you take more insulin than you should
If you take too much insulin, your blood sugar level may become too low (hypoglycaemia). See a)
Summary of serious and very common side effects in section 4.

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

If you stop taking your insulin
Do not stop treatment with insulin without first discussing it with your doctor, who will advise you on what
to do. Stopping treatment may lead to high blood sugar levels (severe hyperglycaemia) and ketoacidosis.
See c) Effects of diabetes in section 4.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
a) Summary of serious and very common side effects
Low blood sugar level (hypoglycaemia) is a very common side effect. It may occur in more than 1 person out of 10.
You may experience low blood sugar if:

• You inject too much insulin.
• You eat too little or skip meals.
• You are more physically active than usual.
• You consume alcohol (see Drinking alcohol and taking Kirsty in section 2).

Signs of low blood sugar: cold sweating; cold, pale skin; headache; rapid heartbeat; feeling unwell; intense hunger; temporary visual disturbances; drowsiness; unusual tiredness and weakness; nervousness or trembling; anxiety; confusion; difficulty concentrating.
A severe drop in blood sugar level can lead to loss of consciousness. If a severe and prolonged drop in blood sugar is not treated, it may cause brain damage (transient or permanent) and even death. You may regain consciousness more quickly with an injection of the hormone glucagon administered by someone who knows how to use it.
If you are given glucagon, you will need glucose or a sweet snack as soon as you regain consciousness. If you do not respond to glucagon treatment, you must be taken to hospital.
What to do if your blood sugar level is low:

• If your blood sugar is too low, eat sugar cubes or another high-sugar snack (sweets, biscuits, fruit juice). Check your blood sugar if possible, then rest. Always carry sugar cubes or high-sugar snacks for use in emergencies.
• When hypoglycaemia symptoms have disappeared or when your blood sugar level has stabilized, continue your insulin treatment as usual.
• If you experience low blood sugar, lose consciousness, require a glucagon injection, or have frequent episodes of low blood sugar, speak to your doctor. You may need to adjust your insulin dose, timing of insulin administration, food intake, and physical activity.

Inform people close to you that you have diabetes and what the possible consequences are, including the risk of fainting due to low blood sugar. Explain that if you faint, they should turn you onto your side and seek immediate medical help. It is important not to give you food or drink, as these could cause choking.
Severe allergic reaction to Kirsty or one of its excipients (called systemic allergic reaction) is a very rare side effect that may be potentially life-threatening. It may occur in fewer than 1 person out of 10,000.
Contact your doctor immediately:

• if signs of allergy spread to other parts of the body
• if you suddenly feel unwell and: begin to sweat; feel sick (vomiting); have difficulty breathing; your heartbeat becomes rapid; you feel dizzy. If you notice any of these signs, contact your doctor immediately.

Skin changes at the injection site: If you inject insulin in the same spot repeatedly, fatty tissue may become thinner (lipoatrophy) or thicker (lipohypertrophy) (may affect fewer than 1 in 100 people). Lumps under the skin may also be caused by the accumulation of a protein called amyloid (cutaneous amyloidosis; frequency not known). Insulin may not work as effectively if you inject into an area with lumps, thinning, or thickening. Change your injection site with each injection to prevent these skin changes.
b) List of other side effects Uncommon side effects
May affect fewer than 1 in 100 people.
Signs of allergy: local allergic reactions (pain, redness, hives, inflammation, bruising, swelling, and itching) at the injection site. These symptoms usually disappear within a few weeks of treatment. If symptoms do not disappear or spread to other parts of the body, contact your doctor immediately. See also Severe allergic reaction.
Visual disturbances: visual disturbances may occur at the beginning of insulin treatment, but these are usually temporary.
Swollen joints: at the start of insulin treatment, fluid retention may cause swelling around the ankles and other joints. This usually resolves quickly. If not, contact your doctor.
Diabetic retinopathy (a diabetes-related eye disorder that may lead to vision loss): if you have diabetic retinopathy and your blood sugar improves very rapidly, your retinopathy may worsen. Consult your doctor.
Rare side effects
May affect fewer than 1 in 1,000 people.
Peripheral neuropathy (pain due to nerve damage): if your blood sugar improves very rapidly, it may cause pain originating in the nerve fibres. This is known as acute painful neuropathy, which is usually transient.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to 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.
c) Other effects of diabetes
High blood sugar level (hyperglycaemia)
You may experience high blood sugar if:

• You have not injected enough insulin.
• You have forgotten to take insulin or stopped taking it.
• You repeatedly take less insulin than needed.
• You have an infection or fever.
• You eat more than usual.
• You are less physically active than usual.

Warning signs of high blood sugar:
Warning signs develop gradually and include: passing more urine than normal; thirst; loss of appetite; feeling unwell (nausea or vomiting); drowsiness or tiredness; dry, flushed skin; dry mouth and fruity breath (acetone).
What to do if your blood sugar level is high:

• If you experience any of these symptoms: check your blood sugar, and if possible, check for the presence of ketones in your urine, and contact a doctor immediately.
• These may be symptoms of a very serious condition called diabetic ketoacidosis (build-up of acid in the blood because the body is metabolizing fat instead of sugar). If untreated, it may lead to diabetic coma and possibly death.

5. How to store Kirsty

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and packaging after 'Exp.'. The expiry date refers to the last day of that month.
Keep the medicine in its outer packaging to protect it from light.
Before opening: store in the refrigerator at 2-8°C, away from refrigerating elements. Do not freeze.
After first opening: the product may be stored for a maximum of 28 days. Store below 30°C. Do not refrigerate or freeze.
Dispose of the needle after each injection.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Kirsty contains

• The active substance is insulin aspart. Each ml contains 100 units of insulin aspart. Each vial contains 1,000 units of insulin aspart in 10 ml of injectable solution.
• The other components are: glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide (see section 2, "Kirsty contains sodium") and water for injections.

Description of the appearance of Kirsty and contents of the pack
Kirsty is a clear, colourless injectable solution.
Packs of 1 or 5 vials or multiple pack containing 5 packs of 1 vial. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Biosimilar Collaborations Ireland Limited
Unit 35/36 Grange Parade,
Baldoyle Industrial Estate,
Dublin 13
DUBLIN
Ireland D13 R20R

Manufacturer
Biosimilar Collaborations Ireland Limited
Block B, The Crescent Building, Santry Demesne
Dublin
D09 C6X8
Ireland

For further information on this medicinal product, contact the local representative of the Marketing Authorisation Holder in your country:

België/Belgique/Belgien Lietuva
Biocon Biologics Belgium BV Biosimilar Collaborations Ireland Limited
Tél/Tel: 0080008250910 Tel: 0080008250910

България Luxembourg/Luxemburg
Biosimilar Collaborations Ireland Limited Biocon Biologics France S.A.S
Тел: 0080008250910 Tél/Tel: 0080008250910
(Belgique/Belgien)

Česká republika Magyarország
Biocon Biologics Germany GmbH Biosimilar Collaborations Ireland Limited
Tel: 0080008250910 Tel.: 0080008250910

Danmark Malta
Biocon Biologics Finland OY Biosimilar Collaborations Ireland Limited
Tlf: 0080008250910 Tel.: 0080008250910

Deutschland Nederland
Biocon Biologics Germany GmbH Biocon Biologics France S.A.S
Tel: 0080008250910 Tel: 0080008250910

Eesti Norge
Biosimilar Collaborations Ireland Limited Biocon Biologics Finland OY
Tel: 0080008250910 Tlf: +47 800 62 671

Ελλάδα Österreich
Biocon Biologics Greece ΜΟΝΟΠΡΟΣΩΠΗ Biocon Biologics Germany GmbH
Ι.Κ.Ε Tel: 0080008250910
Τηλ.: 0080008250910

España Polska
Biocon Biologics Spain S.L. Biosimilar Collaborations Ireland Limited
Tel: 0080008250910 Tel: 0080008250910

France Portugal
Laboratories Biogaran Biocon Biologics Spain S.L.
Tél: +33 (0) 800 970 109 Tel: 0080008250910

Hrvatska România
Biocon Biologics Germany GmbH Biosimilar Collaborations Ireland Limited
Tel: 0080008250910 Tel: 0080008250910

Ireland Slovenija
Biosimilar Collaborations Ireland Limited Biosimilar Collaborations Ireland Limited
Tel: 1800 777 794 Tel: 0080008250910

Ísland Slovenská republika
Biocon Biologics Finland OY Biocon Biologics Germany GmbH
Sími: +345 800 4316 Tel: 0080008250910

Italia Suomi/Finland
Biocon Biologics Spain S.L. Biocon Biologics Finland OY
Tel: 0080008250910 Puh/Tel: 99980008250910

Κύπρος Sverige
Biosimilar Collaborations Ireland Limited Biocon Biologics Finland OY
Τηλ: 0080008250910 Tel: 0080008250910

Latvija
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910

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

Package leaflet: Information for the user

Kirsty 100 units/ml injection solution in a pre-filled pen

insulin aspart
Please read this leaflet carefully before using this medicine because 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

1. What Kirsty is and what it is used for

Kirsty is a modern (insulin analogue) rapid-acting insulin. Modern insulins are improved versions of human insulin.
Kirsty is used to reduce high blood sugar levels in adults, adolescents, and children from the age of 1 year onwards with diabetes mellitus (diabetes). Diabetes is a condition in which the body does not produce enough insulin to control blood sugar levels. Treatment with Kirsty helps prevent complications of diabetes.
Kirsty begins to lower blood sugar levels 10–20 minutes after injection, reaches its maximum effect between 1 and 3 hours after injection, and its effect lasts for 3–5 hours. Due to this short duration of action, Kirsty is usually taken in combination with intermediate- or long-acting insulin preparations.

2. What you need to know before using Kirsty

Do not use Kirsty

• If you are allergic to insulin aspart or to any of the other ingredients of this medicine (listed in section 6).
• If you suspect the onset of hypoglycemia, i.e. low blood sugar levels (see a) Summary of serious and very common side effects in section 4).
• If Kirsty is leaking, damaged, or cracked.
• If it has not been stored correctly or has been frozen (see section 5 How to store Kirsty).
• If the insulin does not appear clear and colorless. Do not use Kirsty if any of these situations occur. Speak with your doctor, nurse, or pharmacist for advice.

Before using Kirsty

• Check the label to make sure it is the correct type of insulin.
• Always use a new needle for each injection to prevent contamination.
• Needles and the Kirsty pre-filled pen must not be shared.
• The Kirsty pre-filled pen is suitable only for subcutaneous injections. Speak with your doctor if you need to administer insulin by another method.

Warnings and precautions

• Certain conditions and activities may affect your insulin requirement. Consult your doctor:
• If you have kidney, liver, or adrenal, pituitary, or thyroid gland disorders.
• If you have increased physical activity or changes in your usual diet, as these may affect your blood sugar levels.
• If you become ill, continue your insulin therapy and consult your doctor.
• If you plan to travel abroad, traveling across different time zones may alter your insulin requirements and injection schedule.

Changes in the skin at the injection site
The injection site should be rotated to help prevent changes in the fatty tissue under the skin, such as skin thickening, skin thinning, or the appearance of lumps under the skin.
Insulin may not work as effectively if injected into an area with lumps, thinning, or thickening of the skin (see section 3, How to use Kixell). Inform your doctor if you notice any skin changes at the injection site. If you are currently injecting into one of these affected areas, consult your doctor before switching to another injection site. Your doctor may advise you to monitor your blood glucose more closely and possibly adjust your insulin dose or other antidiabetic medications.

Children and adolescents
Do not administer this medicine to children under 1 year of age, as no clinical studies have been conducted in children under 1 year.

Other medicines and Kirsty
Inform your doctor, nurse, or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines affect blood sugar levels and may alter your insulin requirements. Listed below are the most important medicines that can affect insulin treatment.
Your blood sugar level may decrease (hypoglycemia) if you take:

• Other medicines for the treatment of diabetes
• Monoamine oxidase inhibitors (MAOIs) (used to treat depression)
• Beta-blockers (used to treat high blood pressure)
• Angiotensin-converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood pressure)
• Salicylates (used to relieve pain and reduce fever)
• Anabolic steroids (such as testosterone)
• Sulfonamides (used to treat infections)

Your blood sugar level may increase (hyperglycemia) if you take:

• Oral contraceptives (birth control pills)
• Thiazides (used to treat high blood pressure or fluid retention)
• Glucocorticoids (such as 'cortisone' used to treat inflammation)
• Thyroid hormones (used to treat thyroid gland disorders)
• Sympathomimetics, such as epinephrine (adrenaline), salbutamol, terbutaline, used to treat asthma
• Growth hormone (a medicine used to stimulate skeletal and somatic growth and significantly affecting the body's metabolic processes)
• Danazol (a medicine affecting ovulation)

Octreotide and lanreotide (used to treat acromegaly, a rare hormonal disorder usually occurring in middle-aged adults, caused by excessive production of growth hormone by the pituitary gland) may either increase or decrease blood sugar levels.
Beta-blockers (used to treat high blood pressure) may weaken or completely suppress the warning symptoms that help you recognize low blood sugar levels.
Pioglitazone (tablets used to treat type 2 diabetes)
Some patients with long-standing type 2 diabetes and heart disease or a history of stroke who were treated with pioglitazone and insulin have developed heart failure. Inform your doctor immediately if you experience signs of heart failure such as unusual shortness of breath, rapid weight gain, or localized swelling (edema).
If you are taking any of the medicines listed above, inform your doctor, nurse, or pharmacist.

Kirsty and alcohol

• If you consume alcohol, your insulin requirement may change, as blood sugar levels may increase or decrease. Careful monitoring is recommended.

Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, or are planning a pregnancy, ask your doctor for advice before taking this medicine. Kirsty can be used during pregnancy. Insulin requirements may need adjustment during pregnancy and after delivery. It is important to carefully control diabetes, especially to prevent episodes of hypoglycemia, for the health of both mother and baby.
• There are no restrictions on the use of Kirsty during breastfeeding.

Consult your doctor, nurse, or pharmacist before taking any medicine during pregnancy or breastfeeding.

Driving and using machines
Contact your doctor regarding whether it is safe for you to drive or operate machinery:

• If you have frequent episodes of hypoglycemia
• If you have difficulty recognizing the warning signs of hypoglycemia.

If your blood sugar is too high or too low, your ability to concentrate and react may be impaired, thereby affecting your ability to drive or operate machinery. Be aware that you could be putting yourself and others at risk.
Kirsty acts rapidly; therefore, if hypoglycemia occurs, it may appear earlier after injection compared to soluble human insulin.

Kirsty contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially 'sodium-free'.

3. How to use Kirsty

Dose and when to take insulin
Always use insulin exactly as prescribed by your doctor and follow his or her instructions carefully. If you are
not sure, consult your doctor, nurse, or pharmacist.
Kirsty is generally used just before meals. Eat a meal or snack within 10 minutes after the injection to avoid low blood sugar levels. If necessary, Kirsty may be administered immediately after a meal. See How and where to inject for further information.
Do not change your insulin unless your doctor tells you to do so. If your doctor has changed the type or brand of insulin you are using, a dose adjustment by your doctor may be necessary.
Use in children and adolescents
Kirsty can be used in adolescents and children from the age of 1 year onwards instead of soluble human insulin when a rapid onset of action is preferred. For example, when it is difficult to dose the child in relation to meals.
Use in particular patient groups
If you have renal or hepatic impairment, or if you are over 65 years of age, monitor your blood sugar levels regularly and discuss insulin dose adjustments with your doctor.
How and where to inject
Kirsty is administered by subcutaneous injection (under the skin). Never inject insulin directly into a vein (intravenous route) or into muscle (intramuscular route). The Kirsty pre-filled pen is intended for subcutaneous use only. Speak with your doctor if you need to administer insulin by another method.
With each injection, rotate the injection site within the particular area of skin you usually use. This may reduce the risk of developing lumps or skin depressions (see section 4, Possible side effects). The best areas for injection are: the abdominal area, the upper arm, or the front of the thigh. Insulin will act more rapidly when injected into the abdomen.
Always check your blood sugar levels regularly.
How to handle the Kirsty pre-filled pen
The Kirsty pre-filled pen is a disposable pre-filled pen containing insulin aspart.
Read carefully the instructions on how to use the Kirsty pre-filled pen provided in this package leaflet. You must use the pen exactly as described in the instructions for use of the Kirsty pre-filled pen.
Always make sure you are using the correct pen before injecting insulin.
If you take more insulin than you should
If you take too much insulin, your blood sugar level will drop too low (hypoglycaemia). See a) Summary of serious and very common side effects in section 4.
If you forget to take your insulin
If you forget to take your insulin, your blood sugar level will become too high (hyperglycaemia).
See c) Effects of diabetes in section 4.
If you stop treatment with your insulin
Do not stop treatment with insulin without first talking to your doctor, who will advise you what to do. This could lead to high blood sugar levels (severe hyperglycaemia) and ketoacidosis. See c) Effects of diabetes in section 4.
If you have any further questions about the use of this product, ask your doctor, nurse, or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
a) Summary of serious and very common side effects
Low blood sugar (hypoglycaemia) is a very common side effect. It may occur in more than 1 in 10 people.
You may experience low blood sugar if:

• You inject too much insulin.
• You eat too little or skip meals.
• You do more physical activity than usual.
• You drink alcohol (see Drinking alcohol and taking Kirsty in section 2).

Signs of low blood sugar: cold sweating; cold, pale skin; headache; rapid heartbeat; feeling unwell; intense hunger; temporary visual disturbances; drowsiness; unusual tiredness and weakness; nervousness or trembling; anxiety; confusion; difficulty concentrating.
Severe and prolonged low blood sugar can lead to loss of consciousness. If untreated, it may cause brain damage (temporary or permanent) and even death. You may regain consciousness more quickly with an injection of the hormone glucagon given by someone trained to administer it. If glucagon is administered, you will need glucose or a sweet snack as soon as you regain consciousness. If you do not respond to glucagon treatment, you must be taken to hospital immediately.
What to do if your blood sugar is low:

• If your blood sugar is too low, eat sugar lumps or another sugary snack (candy, biscuits, fruit juice). Check your blood sugar if possible, then rest. Always carry sugar lumps or sugary snacks for use in emergencies.
• When hypoglycaemia symptoms have disappeared or when blood sugar levels have stabilized, continue your insulin treatment as usual.
• If you experience low blood sugar, lose consciousness, require a glucagon injection, or have frequent episodes of low blood sugar, speak to your doctor. You may need adjustments to your insulin dose, timing of insulin injections, food intake, or physical activity.

Inform those close to you that you have diabetes and explain the possible consequences, including the risk of fainting due to low blood sugar. Explain that if you faint, they should turn you onto your side and seek immediate medical help. It is important that no food or drink is given, as this could cause choking.
Severe allergic reaction to Kirsty or one of its excipients (called systemic allergic reaction) is a very rare side effect that may be life-threatening. It may occur in fewer than 1 in 10,000 people.
Contact your doctor immediately:

• if signs of allergy spread to other parts of the body
• if you suddenly feel unwell and: begin to sweat; feel sick (vomiting); have difficulty breathing; your heartbeat becomes rapid; you feel dizzy.
• If you notice any of these signs, contact your doctor immediately.

Skin changes at the injection site:
If you inject insulin in the same spot repeatedly, fatty tissue may thin (lipoatrophy) or thicken (lipohypertrophy) (may affect fewer than 1 in 100 people). Lumps under the skin may also be caused by the buildup of a protein called amyloid (cutaneous amyloidosis; frequency is unknown). Insulin may not work as effectively if injected into an area with lumps, thinning, or thickening. Rotate your injection site with each dose to prevent these skin changes.
b) List of other side effects Non-common side effects
May affect fewer than 1 in 100 people.
Signs of allergy: local allergic reactions (pain, redness, urticaria, inflammation, bruising, swelling, and itching) at the injection site. These symptoms usually disappear within a few weeks of treatment. If symptoms do not resolve or spread to other parts of the body, contact your doctor immediately. See also Severe allergic reaction.
Visual disturbances: visual disturbances may occur at the beginning of insulin treatment, but these are generally temporary.
Swollen joints: at the start of insulin treatment, fluid retention may cause swelling around the ankles and other joints. This usually resolves quickly. If not, contact your doctor.
Diabetic retinopathy (an eye disorder related to diabetes that may lead to vision loss): if you have diabetic retinopathy and your blood glucose improves very rapidly, the retinopathy may worsen. Consult your doctor.
Rare side effects
May affect fewer than 1 in 1,000 people.
Peripheral neuropathy (nerve damage causing pain): if blood glucose improves very rapidly, it may cause nerve-related pain. This is known as acute painful neuropathy, which is usually temporary.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.
c) Other effects of diabetes
High blood sugar (hyperglycaemia)
You may experience high blood sugar if:

• You have not injected enough insulin.
• You have forgotten to take insulin or stopped taking it.
• You repeatedly take less insulin than needed.
• You have an infection or fever.
• You eat more than usual.
• You do less physical activity than usual.

Warning signs of high blood sugar:
Warning signs develop gradually and include: increased urination; thirst; loss of appetite; feeling unwell (nausea or vomiting); drowsiness or tiredness; dry, flushed skin; dry mouth and fruity breath (acetone).
What to do if your blood sugar is high:

• If you experience any of these symptoms: check your blood glucose, if possible check for ketones in your urine, and contact a doctor immediately.
• These may be symptoms of a serious condition called diabetic ketoacidosis (build-up of acid in the blood because the body is metabolizing fat instead of sugar). If untreated, this may lead to diabetic coma and possibly death.

5. How to store Kirsty

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and on the pre-filled pen packaging after 'Exp.'. The expiry date refers to the last day of that month.
Keep the medicine in the outer packaging to protect it from light.
Before first use: Kirsty pre-filled pen not in use must be stored in the refrigerator at 2-8°C, away from refrigerating elements. Do not freeze.
After first use: you may carry Kirsty pre-filled pen with you and store it at a temperature below 30°C or in the refrigerator (2-8°C) for up to 28 days. If stored in the refrigerator, keep it away from refrigerating elements. Do not freeze.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Kirsty pre-filled pen contains

• The active substance is insulin aspart. Each ml contains 100 units of insulin aspart. Each pre-filled pen contains 300 units of insulin aspart in 3 ml of injectable solution.
• The other components are: glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide (see section 2 "Kirsty contains sodium") and water for injections.

Description of the appearance of Kirsty and contents of the pack

• Pre-filled plastic pen with cap containing 3 ml of clear, colourless solution.

Packs of 1, 5, 10 pre-filled pens or multiple pack containing 10 (2 packs of 5)
pre-filled pens.
Not all pack sizes may be marketed. The solution is clear and colourless.
Marketing Authorisation Holder
Biosimilar Collaborations Ireland Limited
Unit 35/36 Grange Parade,
Baldoyle Industrial Estate,
Dublin 13
DUBLIN
Ireland
D13 R20R
Manufacturer
Biosimilar Collaborations Ireland Limited
Block B, The Crescent Building, Santry Demesne Dublin
D09 C6X8
Ireland
For further information on this medicinal product, contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
Biocon Biologics Belgium BV Biosimilar Collaborations Ireland Limited
Tél/Tel: 0080008250910 Tel: 0080008250910
България Luxembourg/Luxemburg
Biosimilar Collaborations Ireland Limited Biocon Biologics France S.A.S
Тел: 0080008250910 Tél/Tel: 0080008250910
(Belgique/Belgien)
Česká republika Magyarország
Biocon Biologics Germany GmbH Biosimilar Collaborations Ireland Limited
Tel: 0080008250910 Tel.: 0080008250910
Danmark Malta
Biocon Biologics Finland OY Biosimilar Collaborations Ireland Limited
Tlf: 0080008250910 Tel.: 0080008250910
Deutschland Nederland
Biocon Biologics Germany GmbH Biocon Biologics France S.A.S
Tel: 0080008250910 Tel: 0080008250910
Eesti Norge
Biosimilar Collaborations Ireland Limited Biocon Biologics Finland OY
Tel: 0080008250910 Tlf: +47 800 62 671
Ελλάδα Österreich
Biocon Biologics Greece ΜΟΝΟΠΡΟΣΩΠΗ Biocon Biologics Germany GmbH
Ι.Κ.Ε Tel: 0080008250910
Τηλ.: 0080008250910
España Polska
Biocon Biologics Spain S.L. Biosimilar Collaborations Ireland Limited
Tel: 0080008250910 Tel: 0080008250910
France Portugal
Laboratories Biogaran Biocon Biologics Spain S.L.
Tél: +33 (0) 800 970 109 Tel: 0080008250910
Hrvatska România
Biocon Biologics Germany GmbH Biosimilar Collaborations Ireland Limited
Tel: 0080008250910 Tel: 0080008250910
Ireland Slovenija
Biosimilar Collaborations Ireland Limited Biosimilar Collaborations Ireland Limited
Tel: 1800 777 794 Tel: 0080008250910
Ísland Slovenská republika
Biocon Biologics Finland OY Biocon Biologics Germany GmbH
Sími: +345 800 4316 Tel: 0080008250910
Italia Suomi/Finland
Biocon Biologics Spain S.L. Biocon Biologics Finland OY
Tel: 0080008250910 Puh/Tel: 99980008250910
Κύπρος Sverige
Biosimilar Collaborations Ireland Limited Biocon Biologics Finland OY
Tel: 0080008250910 Tel: 0080008250910
Latvija
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910
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
Kirsty pre-filled pen

INSTRUCTIONS FOR USE

Read the following instructions and the package leaflet carefully before using the Kirsty pre-filled pen.
If you do not follow these instructions exactly, you may inject too much or too little insulin, which could lead to blood sugar levels that are too high or too low.
The Kirsty pre-filled pen is a pre-filled pen for insulin administration. You can select a dose between 1 and 80 units in 1-unit increments.

Compatible needle sizes for this pen:

• 31G, 5 mm
• 32G, 4 mm
• 34G, 4 mm

As a precaution, always carry a spare insulin delivery device in case your Kirsty pre-filled pen is lost or damaged.

Kirsty pre-filled pen

Each time you use the pen

• Wash your hands before using the pen.
• Check the name and the colored label on your pen to make sure it contains the correct type of insulin. This is especially important if you use more than one type of insulin. Using the wrong type of insulin may cause your blood sugar level to become too high or too low.
• Check the insulin in the cartridge. Kirsty must be clear, colourless, and free of particles. If not, do not use the pen.

Step 1. Prepare the pen
1a- Remove the pen cap (see Figure A)
1b- Clean the rubber stopper with an alcohol swab

Step 2. Attach the needle
2a- Remove the protective seal from a new, single-use needle.
2b- Screw the needle securely and firmly onto the Kirsty pre-filled pen (see Figure B).

2c- Remove the outer needle cap and keep it for later use (see Figure C).

2d- Remove and discard the inner needle cap (see Figure D).
Never attempt to re-sheathe the inner needle cap. You may prick yourself with the needle.

Important information.

• Always use a new needle for each injection. This reduces the risk of contamination, insulin leakage, needle blockage, and incorrect dosing.
• Be careful not to bend or damage the needle before use.

Step 3. Check insulin flow
During normal use, small amounts of air may accumulate in the cartridge. To avoid injecting air and to ensure proper insulin delivery:
3a- Turn the dose selector and select 2 units (see Figure E).

3b- Hold the Kirsty pre-filled pen with the needle pointing upward and gently tap the cartridge several times with your finger so that air bubbles collect at the top of the cartridge (see Figure F).

3c- With the needle pointing upward, press the injection button fully. The dose selector will return to 0. A drop of insulin should appear at the tip of the needle (see Figure G).
If this does not happen, replace the needle and repeat steps 3a to 3c no more than 6 times. If no drop appears after 6 attempts, the pen is faulty and you must use a new one.

Important information.

• Always make sure a drop appears at the needle tip before injecting. This ensures proper insulin flow. If no drop appears, you will not inject insulin, even if the dose selector moves. This may indicate a blocked or damaged needle.
• Always check the flow before each injection. If you do not check the flow, you may inject too little insulin or no insulin at all, which could lead to high blood sugar levels.

Step 4: Select the dose
4a- Make sure the dose selector is at 0.
4b- Turn the dose selector to the number of units to be injected (see Figure H).
The dose can be increased or decreased by turning the selector in either direction until the indicator shows the correct dose. When turning the dose selector, be careful not to press the injection button, as this may cause insulin to leak out. You cannot select a dose greater than the number of units remaining in the cartridge.

Important information.

• Before injecting insulin, always use the dose selector and indicator to confirm how many units have been selected.
• Do not count the clicks of the pen to select the dose. Selecting or injecting the wrong dose may cause your blood sugar level to become too high or too low. Do not use the graduated scale, which only approximately shows how much insulin remains in the pen.

Step 5. Injection
5a- Use the injection technique shown to you by your doctor or nurse.
Kirsty can be injected under the skin (subcutaneously) in the stomach area, buttocks, upper legs (thighs), or upper arms (see Figure I).

5b- Always rotate (change) your injection site within the area of skin you usually use. Do not use the same injection site for every injection.
5c- Insert the needle into the skin. Administer the insulin dose by pressing the injection button until the indicator reaches 0 (see Figure J). Be careful to press only the injection button.
Rotating the dose selector will not deliver insulin.

5d- Keep the injection button fully pressed and leave the needle in the skin for at least 6 seconds (see Figure K).
This ensures complete delivery of the dose.

5e- After holding the button and slowly counting to 6, remove the needle from the skin and release pressure on the injection button.
Important information:
Always make sure the dose selector returns to 0 after injection. If the dose selector stops before reaching 0, the full dose has not been delivered, which may result in high blood sugar levels.

Step 6: After injection
6a- Carefully place the outer needle cap back onto the needle (see Figure L). Unscrew the needle. After each use, safely remove the needle from the Kirsty pre-filled pen.

Dispose of the needle in a sharps container.
6b. Replace the pen cap on the Kirsty pre-filled pen (see Figure M) and store the pen without the needle attached.

Caring for the pen
The Kirsty pre-filled pen must be handled with care. If it has been dropped, damaged, or scratched, there is a risk of insulin leakage. This could lead to incorrect dosing, which may cause blood sugar levels to become too high or too low.
You may clean the outside of your Kirsty pre-filled pen with an alcohol wipe. Do not immerse, wash, or lubricate the pen, as this may damage its mechanism.
Do not refill the Kirsty pre-filled pen. When empty, it must be discarded.

Additional important information

• Anyone caring for you should take great care when handling used needles to reduce the risk of needlestick injuries and cross-infections.
• Dispose of the used Kirsty pre-filled pen (without needle attached) carefully.
• Never share the pen or needles with other people. This could lead to cross-infections.
• Never share the pen with other people. The medicine may be harmful to their health.
• Always keep the pen and needles out of sight and reach of others, especially children.