FASTJEKT 150 MICROGRAMS Инъекционный раствор

Содержание инструкции

1. Fastjekt 300 micrograms, pre-filled pen injection solution
   1. What is Fastjekt and what is it used for
   2. What you need to know before using Fastjekt
   3. How to use Fastjekt
   4. Possible side effects
   5. How to store Fastjekt
   6. Contents of the pack and other information
2. Fastjekt 150 micrograms, pre-filled pen injection solution
   1. What is Fastjekt and what is it used for
   2. What you need to know before using Fastjekt
   3. How to use Fastjekt
   4. Possible side effects
   5. How to store Fastjekt
   6. Contents of the pack and other information

Fastjekt 300 micrograms, pre-filled pen injection solution

Adrenaline

Read this leaflet carefully before you 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 Fastjekt is and what it is used for
• 2. What you need to know before you use Fastjekt
• 3. How to use Fastjekt
• 4. Possible side effects
• 5. How to store Fastjekt
• 6. Contents of the pack and other information

1. What is Fastjekt and what is it used for

Fastjekt is a sterile solution in a pre-filled pen for emergency injection into the muscle (intramuscularly).
Fastjekt must be used for the emergency treatment of severe allergic reactions (anaphylaxis),
caused by allergens, for example in food, medications, stings or insect bites, as well as triggered
by exertion or of unknown causes.
Fastjekt auto-injectors are designed for immediate administration to patients who are actually at
increased risk of anaphylaxis, including those with a history of anaphylactic reactions.
Symptoms indicating the onset of an anaphylactic reaction include: itching of the skin;
widespread rash (similar to hives); flushing; swelling of lips, throat, tongue, hands and
feet; wheezing; hoarseness; nausea; vomiting; abdominal cramps and, in some cases, loss of consciousness.
The medicine in the auto-injector (the pen) is epinephrine, which is an adrenergic drug.
It works directly on the cardiovascular (heart and circulation) and respiratory (lungs) systems,
counteracting the potentially fatal effects of anaphylaxis, causing rapid constriction of blood
vessels, relaxing the muscles in the lungs to improve breathing, reducing swallowing and
stimulating the heartbeat.

2. What you need to know before using Fastjekt

Do not use Fastjekt
There are no absolute contraindications to the use of Fastjekt during a type 1 allergic emergency.

Warnings and precautions
If you suffer from asthma, you may have an increased risk of experiencing a severe allergic reaction.
Anyone who experiences an episode of anaphylaxis should consult a doctor to test for the substances to which
they may be allergic, so that these can be strictly avoided in the future. It is important
to be aware that an allergy to a substance can lead to becoming allergic to a range of
related substances.
If you have food allergies, it is important to check the ingredients in everything you ingest (including
medicines) as even small amounts can cause serious reactions.
Inform your doctor if you have

• a heart condition
• hyperthyroidism
• hypertension
• diabetes
• increased pressure in the eyes (glaucoma)
• severe kidney problems
• prostate cancer
• high levels of calcium or low levels of potassium in the blood
• Parkinson's disease

Despite these risks, adrenaline is essential in the treatment of anaphylaxis. Patients who are
in these conditions, or anyone who may need to administer Fastjekt to a
patient with an ongoing allergic reaction, must be adequately trained regarding the
situations in which administration is required.
For those who play sports: the use of the drug without therapeutic need constitutes doping and may
still result in a positive doping test.

Instructions for use must be followed carefully to avoid accidental injections.
Fastjekt must only be injected into the outer thigh. It should not be injected into the
buttocks due to the risk of accidental intravenous injection.

Warnings:accidental injection into the hands or fingers can cause blood to leak
from the affected area. In case of accidental injection into one of these areas, go immediately to the
nearest hospital emergency room for appropriate treatment.
If you have a thick layer of subcutaneous fat, there is a risk that a single dose of Fastjekt may not
be sufficient. A second injection may be necessary. Follow the instructions for
use described in section 3 carefully.

Children and adolescents
Children weighing between 15 kg and 30 kg:
For children weighing between 15 kg and 30 kg, Fastjekt 150 micrograms is available,
the auto-injector containing 150 micrograms of adrenaline per dose.
Children weighing less than 15 kg:
The appropriateness of Fastjekt 150 micrograms must be assessed individually by the doctor.
Use in children weighing less than 7.5 kg is not recommended unless in potentially
life-threatening situations and under the advice of a doctor.

Other medicines and Fastjekt
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
It is especially important if you are taking any of the following medicines:

• Antidepressants such as tricyclic antidepressants or monoamine oxidase inhibitors (MAO inhibitors), as the effects of adrenaline may be increased
• Medicines for the treatment of Parkinson's disease, such as catechol-O-methyltransferase (COMT) inhibitors, and levodopa as the effect of adrenaline may be amplified
• Medicines that can make the heart sensitive to irregular heartbeats (arrhythmias), such as digitalis and quinidine
• Beta-blockers for heart disease or medicines for the treatment of nervous system disorders, as they may reduce the effect of adrenaline
• Medicines for thyroid disease
• Medicines that make you breathe more easily, used for asthma (theophylline)
• Medicines used during labor (oxytocin)
• Medicines used to treat allergies such as diphenhydramine or chlorpheniramine (antihistamines)
• Medicines that act on the nervous system (parasympatholytics)

Diabetic patients should carefully monitor their glucose levels after using Fastjekt,
as adrenaline can affect the amount of insulin produced by the body, increasing
blood glucose levels.

Fastjekt with food, drinks and alcohol
Food or drinks have no influence on the use of Fastjekt.
Tell your doctor if you are drinking alcohol as the effect of adrenaline may be
increased.

Pregnancy and breastfeeding
Pregnancy
If you are pregnant, suspect you are pregnant, are planning a pregnancy or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
In a potentially life-threatening situation, do not hesitate to use Fastjekt, as your life and that of your
child may be in danger.
Clinical experience with the use of adrenaline during pregnancy is limited.

Breastfeeding
Fastjekt should have no effect on the breastfed infant.

Driving and operating machinery
Administering an adrenaline injection does not impair the ability to drive and use
machinery, which however may be altered by an anaphylactic reaction. In this case, do not drive.

Fastjekt contains sodium metabisulfite (E223) and sodium chloride.
Sodium metabisulfite can rarely cause severe allergic reactions or breathing difficulties
(bronchospasm).
This medicine contains less than 1 mmol of sodium (23 mg) per dose, meaning it is
essentially “sodium-free”.

3. How to use Fastjekt

When your doctor prescribes Fastjekt, they must ensure you understand why it has been prescribed to you. You must be sure you know exactly how to use the device. Use this medicine following the doctor’s or pharmacist’s instructions exactly. If you are not sure how to use it, ask your doctor, nurse or pharmacist to repeat the instructions.
It is recommended that family members, caregivers, or teachers also be instructed on the correct use of Fastjekt.
In case of injection performed by an assistant, immobilization of the patient's leg must be ensured during the injection to minimize the risk of leg laceration.
Under no circumstances reinsert the used needle.
A Fastjekt training device is available for demonstration and practice purposes (without medication, without a needle). The training device and the functioning Fastjekt auto-injector should not be carried together in everyday life to avoid confusion in emergency situations.
Fastjekt is indicated for use in people weighing more than 30 kg.
For children weighing less than 30 kg, see the “Children and adolescents” section above.

Dosage
The dose will be decided by your doctor, who will adjust it according to your needs. The usual dose for adults in case of type 1 allergic emergencies is 300 micrograms of adrenaline intramuscularly.
If you experience signs of an acute allergic reaction, use Fastjekt immediately.
Each Fastjekt auto-injector delivers a single dose of 0.3 ml of liquid, which is equivalent to 300 micrograms of adrenaline. After use, a small volume of solution remains in the auto-injector that cannot be reused.
Sometimes a single dose of adrenaline may not be sufficient to neutralize the effects of a severe allergic reaction. For this reason, your doctor is likely to prescribe more than one Fastjekt auto-injector. If your symptoms do not improve or worsen within 5-15 minutes of the first injection, you or those with you should administer a second injection. For this reason, you should always carry more than one Fastjekt auto-injector with you.
How Fastjekt is administered
Fastjekt is designed to be used easily by people without any medical training. Fastjekt should simply be pressed firmly against the outer thighfrom a distance of approximately 10 cm. You do not need to choose a specific point on the outer thigh. When you press Fastjekt firmly into the thigh, a spring-loaded plunger is released, which pushes the retracted needle into the thigh muscle, delivering a dose of adrenaline. Fastjekt can be injected through clothing, if you are wearing it.
The instructions for use of Fastjekt must be followed carefully.
Fastjekt must be injected ONLY into the outer thigh. It must not be injected into the buttock.
Instructions for use
You must know exactly how to use Fastjekt and when.

Blue safety cap Orange tip
Inspection window
Follow these instructions only when you are ready to use the medicine.
Hold the auto-injector in the center, never at the ends. For correct administration, look at the figures and follow these steps:

• Do not place thumb, fingers or hand over the orange tip. Do not press or push the orange tip with your thumb, fingers or hand.
• The needle will come out of the orange tip.
• DO NOT remove the blue safety cap unless immediately before use.
• 1. Hold Fastjekt in your dominant hand (the hand you use to write), with your thumb as close as possible to the blue safety cap and form a fist around the body of the auto-injector (with the orange tip pointing downwards).
• 2. Remove the blue safety cap by pulling it upwards with your other hand.

• 3. Hold Fastjekt at a distance of approximately 10 cm from the outer thigh. The orange tip should point towards the outer thigh.

• 4. Press firmlyFastjekt into the outer thigh at a right angle (90 degrees) (you will hear a “click”).
• 5. Hold the device firmly against the thigh for 3 seconds. The injection is complete and the inspection window of the auto-injector is dark.

• 6. Fastjekt must be removed (the orange cap of the needle will extend to cover it) and disposed of safely.

Massage the injection site gentlyfor 10 seconds.
Call 112, request an ambulance for anaphylactic condition.

A small bubble may remain in the Fastjekt auto-injector. This does not affect the effectiveness of the product in any way.
Although most of the liquid (about 90%) remains in Fastjekt after use, it cannot be used again. However, if the orange tip of the needle is extended and the inspection window is dark, you have received the correct dose of the medicine. After use, dispose of Fastjekt safely, inserting it into the tube provided and bring it with you when you go to the doctor, hospital or pharmacy.

Because Fastjekt is exclusively an emergency treatment,immediately after its use you must always request medical attention. Call 112, request an ambulance for a condition of “anaphylaxis”, even if the symptoms appear to have improved. You will need to go to the hospital for observation and further treatments as needed. This is because the reaction could occur again later.
While waiting for the ambulance, lie down with your legs raised unless this causes you to become short of breath, in which case you should sit up. Ask someone to stay with you until the ambulance arrives in case you feel unwell again.
Unconscious patients should be turned onto their side in the recovery position.

If you use more Fastjekt than you should
In case of overdose or accidental injection of adrenaline, you must immediately request medical attention.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rare cases of serious skin and soft tissue infections (infection at the injection site) have been reported. If you
experience signs of infection at the injection site such as swelling, redness, heat or pain, always seek
immediate medical attention.
Accidental injections of the pens into the hands or feet have been reported, which can cause bleeding from
the affected area. In case of accidental injection, always seek immediate medical attention.
Patients with sensitivity to sodium metabisulfite may experience allergic reactions.
In rare cases (may affect up to 1 in 1,000 patients), stress cardiomyopathy has been found in patients
treated with adrenaline.
Not known: frequency cannot be estimated based on available data): fast or irregular heartbeat, sometimes
strong, severe chest pain, high blood pressure, difficulty breathing, paleness, sweating, nausea,
vomiting, headache, dizziness, weakness, tremor and agitation or anxiety, injection site injuries such
as bruising, bleeding, redness.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also
report side effects directly through the national reporting system at https://aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Fastjekt

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 carton and label after
Exp. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C. Do not refrigerate or freeze.
Keep the container in the carton to protect the medicine from light. If exposed to air or
light, adrenaline rapidly degrades and becomes pink or brown. Periodically check the
contents of the glass cartridge of the Fastjekt auto-injector to ensure that the liquid is
clear and colourless. Replace the auto-injector within the expiry date or sooner if the solution is
discoloured or contains precipitate (solid material).
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 Fastjekt contains
The active ingredient is adrenaline. Each dose contains 300 micrograms of adrenaline.
The other ingredients are:
Sodium chloride
Sodium metabisulfite (E223)
Hydrochloric acid
Water for injections.

Description of Fastjekt and contents of the pack
Clear and colourless solution in a pre-filled pen (auto-injector).
The auto-injector contains 2 ml of injectable solution. Each auto-injector delivers a single dose
(0.3 ml) of 0.3 mg adrenaline.
The length of the exposed and protected needle is approximately 15 mm.
Pack sizes:
1 auto-injector.
2 auto-injectors.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15, Dublin
Ireland

Manufacturer responsible for batch release
MEDA Pharma GmbH & Co. KG
Benzstraße 1
D-61352 Bad Homburg
Germany

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:

Fastjekt 150 micrograms, pre-filled pen injection solution

Adrenaline

Read this leaflet carefully before you use 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 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 Fastjekt is and what it is used for
• 2. What you need to know before you use Fastjekt
• 3. How to use Fastjekt
• 4. Possible side effects
• 6. How to store Fastjekt
• 6. Contents of the pack and other information

1. What is Fastjekt and what is it used for

Fastjekt is a sterile solution in a pre-filled pen for emergency injection into the muscle (intramuscularly).
Fastjekt must be used for the emergency treatment of severe allergic reactions (anaphylaxis),
caused by allergens, for example in foods, medicines, stings or insect bites, as well as triggered
by exertion or of unknown causes.
Fastjekt auto-injectors are designed for immediate administration to patients who are actually at
increased risk of anaphylaxis, including those with a history of anaphylactic reactions.
Symptoms indicating the onset of an anaphylactic reaction include: itching of the skin;
widespread rash (similar to hives); flushing; swelling of lips, throat, tongue, hands and
feet; wheezing, hoarseness; nausea; vomiting; abdominal cramps and, in some cases, loss of consciousness.
The medicine in the auto-injector (the pen) is adrenaline, which is an adrenergic drug.
It works directly on the cardiovascular (heart and circulation) and respiratory (lungs) systems,
counteracting the potentially fatal effects of anaphylaxis, causing rapid constriction of blood
vessels, relaxing the muscles in the lungs to improve breathing, reducing swallowing and
stimulating the heartbeat.

2. What you need to know before using Fastjekt

Do not use Fastjekt
There are no absolute contraindications to the use of Fastjekt during a type 1 allergic emergency.

Warnings and precautions
If you suffer from asthma, you may have an increased risk of experiencing a severe allergic reaction.
Anyone experiencing an episode of anaphylaxis should consult a doctor to test for the substances to which
they may be allergic, so that these can be strictly avoided in the future. It is important
to be aware that an allergy to a substance can lead to becoming allergic to a range of
related substances.
If you have food allergies, it is important to check the ingredients in everything you ingest (including
medicines) as even small amounts can cause serious reactions.
Inform your doctor if you have

• a heart condition
• hyperthyroidism
• hypertension
• diabetes
• increased pressure in the eyes (glaucoma)
• severe kidney problems
• prostate tumor
• high levels of calcium or low levels of potassium in the blood
• Parkinson's disease

Despite these risks, adrenaline is essential in the treatment of anaphylaxis. Patients who are
in these conditions, or anyone who may need to administer Fastjekt to a
patient with an ongoing allergic reaction, must be adequately trained regarding the
situations in which administration is required.
For those involved in sports: the use of the drug without therapeutic need constitutes doping and may
still result in a positive doping test.

Instructions for use must be followed carefully to avoid accidental injections.
Fastjekt must only be injected into the outer thigh. It should not be injected into the
buttocks due to the risk of accidental injection into a vein.

Warnings:accidental injection into the hands or fingers can cause blood to leak
from the affected area. In case of accidental injection into one of these areas, go immediately to the
nearest hospital emergency room for appropriate treatment.
If you have a thick layer of subcutaneous fat, there is a risk that a single dose of Fastjekt may not
be sufficient. A second injection may be necessary. Follow the instructions for
use described in section 3 carefully.

Children and adolescents
Children weighing less than 15 kg:
The appropriateness of Fastjekt 150 micrograms should be assessed individually by the doctor.
Use in children weighing less than 7.5 kg is not recommended unless in potentially
life-threatening situations and under the advice of a doctor.
Children and adolescents weighing more than 30 kg:
The Fastjekt 300 micrograms auto-injector is available for these patients, containing 300
micrograms of adrenaline per dose.

Other medicines and Fastjekt
Inform your doctor or pharmacist if you are taking, have recently taken or may take
any other medicine.
It is particularly important if you are taking any of the following medicines:

• Antidepressants such as tricyclic antidepressants or monoamine oxidase inhibitors (MAO inhibitors), as the effects of adrenaline may be increased
• Medicines for the treatment of Parkinson's disease, such as catechol-O-methyltransferase (COMT) inhibitors, and levodopa, as the effect of adrenaline may be amplified
• Medicines that can make the heart sensitive to irregular heartbeats (arrhythmias), such as digitalis and quinidine
• Beta-blockers for heart disease or medicines for the treatment of nervous system disorders, as they may reduce the effect of adrenaline
• Medicines for thyroid disease
• Medicines that make you breathe more easily, used for asthma (theophylline)
• Medicines used during labour (oxytocin)
• Medicines used to treat allergies such as diphenhydramine or chlorpheniramine (antihistamines)
• Medicines that act on the nervous system (parasympatholytics)

Diabetic patients should carefully monitor their glucose levels after using Fastjekt,
as adrenaline can affect the amount of insulin produced by the body, increasing
blood glucose levels.

Fastjekt with food, drinks and alcohol
Food or drinks have no influence on the use of Fastjekt.
Inform your doctor if you are drinking alcohol as the effect of adrenaline may be
increased.

Pregnancy and breastfeeding
Pregnancy
If you are pregnant, suspect you are pregnant, are planning a pregnancy or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
In a potentially life-threatening situation, do not hesitate to use Fastjekt, as your life and that of your
baby may be in danger. Clinical experience on the use of adrenaline during
pregnancy is limited.

Breastfeeding
Fastjekt should have no effect on the breastfed infant.

Driving and operating machinery
Not applicable.

Fastjekt contains sodium metabisulfite (E223) and sodium chloride.
Sodium metabisulfite can rarely cause severe allergic reactions or breathing difficulties
(bronchospasm).
This medicine contains less than 1 mmol of sodium (23 mg) per dose, meaning it is
essentially “sodium-free”.

3. How to use Fastjekt

When your doctor prescribes Fastjekt, they must ensure you understand why it has been prescribed to you. You must be sure you know exactly how to use the device. Use this medicine following the doctor's or pharmacist's instructions exactly. If you are not sure how to use it, ask your doctor, nurse, or pharmacist to repeat the instructions. It is recommended that family members, caregivers, or teachers also be instructed on the correct use of Fastjekt. In case of an injection performed by an assistant, the patient's leg must be immobilized during the injection to minimize the risk of leg laceration. Under no circumstances reinsert the used needle. A Fastjekt training device is available for demonstration and practice purposes (without medicine, without a needle). The training device and the functioning Fastjekt auto-injector should not be carried together in daily life to avoid confusion in emergency situations. Fastjekt is indicated for use in children weighing between 15-30 kg. For adults, adolescents, and children weighing over 30 kg, the Fastjekt auto-injector containing 300 micrograms of adrenaline per dose is available. For children weighing less than 15 kg, see the “Children and adolescents” section above.

Dosage
The dose will be decided by your doctor, who will adjust it according to your needs. The usual pediatric dose (15-30 kg) for type 1 allergic emergencies is 150 micrograms of adrenaline intramuscularly. If you experience signs of an acute allergic reaction, use Fastjekt immediately. Each Fastjekt auto-injector delivers a single dose of 0.3 ml of liquid, which is equal to 150 micrograms of adrenaline. After use, a small volume of solution will remain in the auto-injector but cannot be reused. Sometimes a single dose of adrenaline may not be sufficient to neutralize the effects of a severe allergic reaction. For this reason, your doctor is likely to prescribe more than one Fastjekt auto-injector. If your symptoms do not improve or worsen within 5-15 minutes of the first injection, you or those with you should administer a second injection. For this reason, you should always carry more than one Fastjekt auto-injector with you.
How Fastjekt is administered
Fastjekt is designed to be used easily by people without any medical training. Fastjekt should simply be pressed firmly against the outer thighfrom a distance of approximately 10 cm. You do not need to choose a specific point on the outer thigh. When you press Fastjekt firmly into the thigh, a spring-loaded plunger is released, which pushes the retracted needle into the thigh muscle, delivering a dose of adrenaline. Fastjekt can be injected through clothing, if you are wearing it. The instructions for use of Fastjekt must be followed carefully. Fastjekt must be injected ONLY into the outer thigh. It must not be injected into the buttock.
Instructions for use
You need to know exactly how to use Fastjekt and when.

Blue safety cap Orange tip
Inspection window
Follow these instructions only when you are ready to use the medicine. Hold the auto-injector in the center, never at the ends. For correct administration, look at the figures and follow these steps:

• Do not place thumb, fingers, or hand over the orange tip. Do not press or push the orange tip with your thumb, fingers, or hand.
• The needle will come out of the orange tip.
• DO NOT remove the blue safety cap unless immediately before use.
• 1. Hold Fastjekt in your dominant hand (the hand you use to write), with your thumb as close as possible to the blue safety cap and form a fist around the body of the auto-injector (with the orange tip pointing downwards).
• 2. Remove the blue safety cap by pulling it upwards with your other hand.

• 3. Hold Fastjekt at a distance of approximately 10 cm from the outer thigh. The orange tip should point towards the outer thigh.

• 4. Press firmlyFastjekt into the outer thigh at a right angle (90 degrees) (you will hear a “click”).
• 5. Hold the device firmly against the thigh for 3 seconds. The injection is complete and the inspection window of the auto-injector is dark.

• 6. Fastjekt must be removed (the orange cap of the needle will extend to cover it) and disposed of safely.

Massage the injection site gentlyfor 10 seconds.
Call 112, request an ambulance for anaphylactic condition.

A small bubble may remain in the Fastjekt auto-injector. This does not affect the effectiveness of the product in any way. Although most of the liquid (about 90%) remains in Fastjekt after use, it cannot be used again. However, if the orange tip of the needle is extended and the inspection window is dark, you have received the correct dose of the medicine. After use, dispose of Fastjekt safely by inserting it into the tube provided and bring it with you when you go to the doctor, hospital, or pharmacy.

Since Fastjekt is exclusively an emergency treatment, you must always request medical attention immediately after its use. Call 112, request an ambulance for a condition of “anaphylaxis”, even if the symptoms appear to have improved. You will need to go to the hospital for observation and further treatments as needed. This is because the reaction could occur again later. While waiting for the ambulance, lie down with your feet elevated unless this causes you to become short of breath, in which case you should sit up. Ask someone to stay with you until the ambulance arrives in case you feel unwell again. Unconscious patients should be turned onto their side in the recovery position.

If you use more Fastjekt than you should
In case of overdose or accidental injection of adrenaline, you should immediately request medical attention.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rare cases of serious skin and soft tissue infections (infection at the injection site) have been reported. If you notice signs of infection at the injection site such as swelling, redness, heat or
pain, always seek immediate medical attention.
Accidental injections of the pens into the hands or feet have been reported, which can cause
bleeding from the affected area. In case of accidental injection, always seek
immediate medical attention.
Patients with sensitivity to sodium metabisulfite may experience allergic reactions.
In rare cases (may affect up to 1 in 1,000 patients), stress cardiomyopathy has been found
in patients treated with adrenaline.
Not known: frequency cannot be estimated based on available data): fast or irregular heartbeat, sometimes strong, severe chest pain, high blood pressure, difficulty
breathing, paleness, sweating, nausea, vomiting, headache, dizziness, weakness, tremor and agitation
or anxiety, injection site injuries such as bruising, bleeding, redness.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at https://aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Fastjekt

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 box and label after
Exp. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C. Do not refrigerate or freeze.
Keep the container in the box to protect the medicine from light. If exposed to air or
light, adrenaline rapidly degrades and becomes pink or brown. Check the
contents of the Fastjekt auto-injector glass cartridge periodically to ensure that the liquid is
clear and colourless. Replace the auto-injector within the expiry date or sooner if the solution is
discoloured or contains precipitate (solid material).
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 Fastjekt contains
The active ingredient is adrenaline. Each dose contains 150 micrograms of adrenaline.
The other ingredients are:
Sodium chloride
Sodium metabisulfite (E223)
Hydrochloric acid
Water for injections.

Description of the appearance of Fastjekt and contents of the pack
Clear and colourless solution in a pre-filled pen (auto-injector).
The auto-injector contains 2 ml of injectable solution. Each auto-injector delivers a single dose
(0.3 ml) of 0.15 mg adrenaline.
The length of the exposed and protected needle is approximately 13 mm
Packs:
1 auto-injector.
2 auto-injectors.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15, Dublin
Ireland

Manufacturer responsible for batch release
MEDA Pharma GmbH & Co. KG
Benzstraße 1
D-61352 Bad Homburg
Germany

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations: