Jext

Patient Information Leaflet

Jext, 150 micrograms, solution for injection in pre-filled auto-injector
Jext, 300 micrograms, solution for injection in pre-filled auto-injector
Adrenalinum
Please read all of 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 further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Jext is and what it is used for

Jext contains a sterile solution of adrenaline in a pre-filled auto-injector, intended for immediate
administration of a single dose of adrenaline into the outer side of the thigh muscle (intramuscular
injection).
Jext is intended for use in the emergency treatment of life-threatening allergic reactions
(anaphylactic shock) caused by insect stings or bites, food, medications, or physical exercise.
Symptoms indicating an anaphylactic reaction appear within minutes of exposure to the allergen
and include: skin itching, raised rash (resembling urticaria), sudden flushing of the face, swelling of
lips, throat, tongue, hands or feet, wheezing, hoarseness, shortness of breath, nausea, vomiting,
abdominal cramps, and in some cases, loss of consciousness.

2. Important information before using Jext

In the event of a sudden allergic reaction, the medicine Jext may always be used. If the patient is allergic
(hypersensitive) to sodium metabisulfite or any of the other ingredients of Jext, the doctor will
instruct the patient in which situations Jext should be used. For further information
regarding sulfite sensitivity, please refer to the section: Jext contains sodium
metabisulfite and sodium chloride.
Warnings and precautions
If your doctor has prescribed Jext, discuss this with your doctor:

• if the patient has heart disease
• if the patient has hyperthyroidism
• if the patient has high blood pressure
• if the patient has diabetes
• if the patient has a tumour of the adrenal gland (pheochromocytoma)
• if the patient has increased intraocular pressure (glaucoma)
• if the patient has severe kidney or prostate gland disease
• if the patient has low potassium or high calcium levels in the blood
• and (or) if the patient is elderly, the patient is pregnant, or the patient is a child weighing less than 15 kg, due to an increased risk of adverse reactions.

Patients with asthma may be at increased risk of allergic reactions.
Every patient who has experienced an anaphylactic reaction should see a doctor for testing to identify substances to which they may be allergic, in order to avoid them in the future.
It is important to be aware that allergy to one substance may lead to allergy to numerous related substances.
If the patient has a food allergy, it is important to check all ingested ingredients (including medicines), as even small amounts may cause severe allergic reactions.
The doctor or nurse will carefully instruct the patient in which situations and how to correctly use Jext.
To avoid accidental injection of the medicine, strictly follow the instructions for use.
Jext must be injected intramuscularly only, into the outer side of the thigh. The medicine must not be injected into the buttock due to the risk of accidental intravenous injection.
Warning
Accidental injection into the hand or fingers may result in impaired blood flow to the affected area. In case of accidental injection into these areas, seek immediate medical attention at the nearest hospital emergency department for appropriate treatment.
If the patient has a thick layer of subcutaneous fatty tissue, there is a risk that a single dose of Jext may be insufficient. A second dose may be necessary. Follow the instructions for use described in section 3.
If the injection is administered by another person and the patient's leg is not stabilized during injection, injury may occur. To avoid leg injury, strictly follow the instructions for use provided in section 3.
Jext with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
This is particularly important for patients taking the following medicines:

• Antidepressants such as tricyclic antidepressants or monoamine oxidase inhibitors (MAO inhibitors).
• Medicines used in the treatment of Parkinson's disease, such as catechol-O-methyltransferase inhibitors (COMT inhibitors) and levodopa.
• Medicines increasing the heart's susceptibility to rhythm disturbances (arrhythmias), such as digoxin or quinidine.
• Medicines used for thyroid disorders (e.g. levothyroxine).
• Medicines used to ease breathing in asthma (theophylline).
• Medicines used during childbirth (oxytocin).
• Medicines used to treat allergies, such as diphenhydramine or chlorpheniramine (first-generation antihistamines).
• Alpha- or beta-adrenergic blocking agents used in heart diseases.
• Medicines affecting the autonomic nervous system, which regulates involuntary bodily functions such as heartbeat and lung function (parasympatholytics, parasympathomimetics).

Patients with diabetes should carefully monitor blood glucose levels after using Jext,
as adrenaline may increase blood glucose levels.
Jext and alcohol
Alcohol may intensify the effects of adrenaline.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult her doctor or pharmacist before using this medicine.
Data on the use of adrenaline during pregnancy are limited. In life-threatening emergencies, pregnant women may use Jext without hesitation due to the risk to their own life or the life of their unborn child.
Jext is not expected to have any effect on breastfed infants.
Driving and operating machinery
It is unlikely that adrenaline injection will affect the ability to drive or operate machinery, but this ability may be impaired due to the severe anaphylactic reaction itself. In such a case, driving should not be undertaken.
Jext contains sodium metabisulfite and sodium chloride
In rare cases, sodium metabisulfite (E 223) may cause severe allergic reactions or breathing difficulties (bronchospasm). The doctor must instruct the patient in which situations Jext should be used.
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. the medicine is considered "sodium-free".

3. How to use Jext

This medicine should always be used exactly as directed by a doctor or pharmacist. The patient should
ensure they know in which situations Jext should be administered. If in doubt, consult a doctor or pharmacist.
Dosage
Adults and children weighing over 30 kg – the recommended dose in life-threatening conditions
caused by allergy is 300 micrograms of adrenaline administered by injection into the outer side of the thigh muscle (intramuscular administration).
Children weighing between 15 kg and 30 kg – the recommended dose in life-threatening conditions
caused by allergy is 150 micrograms of adrenaline administered by injection into the outer side of the thigh muscle (intramuscular administration). For easy reference: the correct dose of Jext depends on body weight. The dose should be adjusted as the child grows, and this should be discussed with a doctor.
Jext should be administered immediately when the patient observes symptoms of a severe allergic reaction,
if necessary, through clothing.
After injection, a certain volume of solution remains in the auto-injector, which cannot be reused.
Sometimes a single dose of adrenaline may not be sufficient to completely relieve symptoms of a severe allergic reaction. For this reason, the doctor will likely prescribe more than one Jext auto-injector to the patient. If symptoms do not improve or worsen within 5 to 15 minutes after the first injection, a second injection should be administered by either the patient or a caregiver. For this reason, more than one Jext auto-injector should always be carried.
Method of administration
Jext has been designed to be injected through clothing or directly through the skin into the outer side of the thigh. When the auto-injector is pressed firmly against the thigh, a spring-loaded plunger is released, driving the hidden needle through the safety guard at the tip of the black needle cover, penetrating the thigh muscle and delivering the dose of adrenaline.
The instructions for use of Jext provided below must be followed exactly.
Jext must be injected exclusively into the outer side of the thigh.
Do not inject into the buttock.
Instructions for using Jext
Before using Jext, the patient should be certain they fully understand when and how to use this device. For training purposes, the doctor may use a Jext Trainer demonstration auto-injector to ensure the patient, family members, or caregivers know how to act in case of a sudden allergic reaction.
It is also recommended to instruct family members, caregivers, or teachers on the correct use of the Jext auto-injector. When the injection is administered by a caregiver, the patient should be instructed not to move, or if necessary, the patient's leg should be immobilized during the injection to minimize the risk of injury.
The auto-injector is for single use only and cannot be reused. Follow the instructions only when administration of the medicine is necessary.

• Never touch the black tip, which is the needle cover, with the thumb, fingers, or hand, as the needle emerges from this area.
• DO NOT remove the yellow protective cap until the auto-injector is ready for use.

To administer the medicine correctly, refer to the diagram and follow the steps below:

	1. Hold the Jext auto-injector in your dominant hand (the hand you write with), positioning your thumb close to the yellow protective cap.
	2. With the other hand, remove the yellow protective cap.
	3. Place the black end of the auto-injector against the outer side of the thigh at a right angle (approximately 90°).
	4. Firmly press the black end into the outer side of the thigh until a "click" is heard, indicating that the injection has started. Keep it pressed firmly against the thigh for 10 seconds (count slowly to 10), then remove it. The black needle cover will automatically extend and cover the needle.
	5. Gently massage the injection site for 10 seconds. Seek immediate medical assistance. Call the emergency number 112, request an ambulance, and report an anaphylactic reaction.

A coloured plastic rod (white in Jext 300 and blue in Jext 150) is located in the viewing window to confirm activation of the auto-injector and injection of the adrenaline solution.
A small air bubble may be present in the Jext auto-injector. This does not affect the effectiveness of the medicine.
Although most of the solution remains in the Jext auto-injector after use, it cannot be reused.
Jext is intended for use in emergency situations. After administering Jext, medical assistance must always be sought immediately. Call the emergency number 112, request an ambulance, and report an "anaphylactic reaction", even if symptoms improve.
Proceed to a hospital for observation or further treatment if necessary, as an anaphylactic reaction may recur after some time.
While waiting for the ambulance, lie down with legs elevated, unless this causes difficulty in breathing; in such a case, sit down. Ask someone to stay with the patient until the ambulance arrives, in case symptoms return.
Unconscious patients should be placed in a stable lateral position.
Inform medical personnel that the patient has received intramuscular adrenaline. The used Jext device may also be handed over for safe disposal.
Use of a higher than recommended dose of Jext
In case of overdose or accidental injection of adrenaline, seek medical help immediately. Contact a doctor as soon as possible to replace the used Jext device.
The patient's blood pressure may rise sharply. Overdose may lead to sudden increase in blood pressure, irregular heart function, impaired kidney function, reduced blood flow, and fluid accumulation in the lungs.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The adverse reactions listed below are based on experience with adrenaline.
Frequency unknown (frequency cannot be estimated from the available data):

• Tremor
• Injection site reactions such as bruising, pain, and swelling
• Dizziness
• Fainting
• Headache
• Tingling or numbness sensation
• Sensation of rapid or irregular heartbeat
• Muscle stiffness
• Nausea
• Vomiting
• Dry mouth
• Reduced blood flow to hands and feet in case of accidental injection into these areas
• Increased blood pressure
• Feeling of weakness
• Excessive sweating
• Chest discomfort or pain
• Changes in blood laboratory test results, such as increased blood glucose levels, decreased potassium levels, and accumulation of harmful acids in the body.

Accidental injection of adrenaline into the hand or foot has been reported, which may cause
cessation of blood flow to the affected area, as well as cooling, pallor, tingling and numbness,
cyanosis, painful bleeding, and swelling at the injection site. In the event of accidental
injection with Jext, immediate medical attention must always be sought. Jext contains sodium
metabisulfite, which may rarely cause severe allergic reactions, including breathing difficulties.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions
of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: +48 22 49 21 301,
fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Jext

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 carton after:
"Expiry date (EXP)". The expiry date refers to the last day of the specified month.
Store below 25°C.
Do not freeze.
Remember to periodically check the contents of the glass cartridge of the auto-injector
through the viewing window to ensure that the solution is clear, colourless, and free from
visible particles. Replace the Jext medicine before the expiry date or earlier. Do not use this medicine
if you notice that the solution has changed colour or appears as a suspension (visible solid particles are present).
It may be helpful to record the expiry date in a calendar or diary to ensure that Jext is replaced in a timely manner.
Jext is supplied in a plastic carrying case to protect the Jext medicine during transport or storage.
The Jext medicine should be removed from the case before use or when inspecting the Jext.
After inspection, place the Jext medicine back into the case.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.
These measures will help protect the environment.

6. Contents of the pack and other information

What Jext contains
The active substance is adrenaline.
1 mL of solution contains 1 mg of adrenaline (as tartrate).
One Jext 150 microgram pre-filled auto-injector delivers 150 micrograms of adrenaline in 0.15 mL of injection solution.
One Jext 300 microgram pre-filled auto-injector delivers 300 micrograms of adrenaline in 0.3 mL of injection solution.
The other ingredients are:
Sodium chloride
Sodium metabisulphite (E 223)
Hydrochloric acid
Water for injections

What Jext looks like and contents of the pack
Jext is a solution for injection in a pre-filled semi-automatic auto-injector, supplied in a cardboard box. The auto-injector contains a clear, colourless solution free from visible particles, in a glass cartridge with a rubber stopper not containing latex. The factory-filled auto-injector is supplied in a plastic carrying case.
Length of exposed needle:
Jext 150 micrograms: 13 mm
Jext 300 micrograms: 15 mm
Pack size: single pack containing one pre-filled, single-dose, semi-automatic auto-injector.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Miguel Fleta 19
28037 Madrid
Spain

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names: