Jext

Package leaflet: Information for the user

Jext, 150 micrograms, solution for injection in an auto-injector
Jext, 300 micrograms, solution for injection in an auto-injector
Adrenalinum
Please read all of this leaflet carefully before using this medicine, as it contains important
information for you.

• Keep this leaflet as 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 a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, 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 semi-automatic auto-injector, designed for the
immediate injection of a single dose of adrenaline into the outer thigh muscle (intramuscular
injection).
Jext is intended for use in the treatment of sudden, life-threatening allergic reactions
(anaphylactic shock) caused by insect stings or bites, food, medications, or physical exercise.
Symptoms indicating anaphylactic shock appear within minutes of exposure to the allergen and
include skin itching, raised rash (resembling hives), sudden facial flushing, swelling of the 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 an acute allergic reaction, Jext may always be used. If the patient is hypersensitive
(hypersensitive) to sodium metabisulfite or any of the other ingredients of Jext, the doctor
will instruct the patient on when to use Jext. For further information
on sulfite hypersensitivity, please refer to the section: Jext contains sodium
metabisulfite and sodium chloride.
Warnings and precautions
If a doctor has prescribed Jext to the patient, discuss with the 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.

If the patient has asthma, they may be at increased risk of an allergic reaction.
Every patient who has experienced an anaphylactic reaction should consult a doctor to
be tested for 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 ingredients consumed
(including medicines), as even small amounts may cause severe allergic reactions.
The doctor or nurse will carefully instruct the patient on when and how
to correctly use Jext.
To avoid accidental injection of the medicine, strictly follow the instructions for
use.
Jext may be administered only intramuscularly into the outer 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 cause loss of 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 fat tissue, there is a risk that a single dose
of Jext may be insufficient. A second dose of the medicine 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 of the medicine provided in section 3.
Jext and other medicines
Inform the 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 cardiac rhythm disturbances (arrhythmias), such as digoxin or quinidine.
• Medicines used in thyroid disorders (e.g. levothyroxine).
• Medicines used to facilitate breathing in asthma (theophylline).
• Medicines used during childbirth (oxytocin).
• Medicines used in the treatment of 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 body 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 a 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 of losing their life or the life of their 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 a severe
anaphylactic reaction. In such cases, 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 on when to use Jext.
This medicine contains less than 1 mmol of sodium (23 mg) per dose, meaning the medicine is considered "sodium-free".

3. How to use Jext

This medicine should always be used as directed by a doctor or pharmacist. The patient should
make sure 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 injection).
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 injection). For reference: the appropriate Jext dose
depends on body weight. The dose should be increased 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, some 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 the patient more than one Jext auto-injector.
If symptoms do not improve or worsen within 5 to 15 minutes after the first injection, a second injection
should be given by either the patient or a bystander. For this reason, always carry more than one Jext auto-injector.
Method of administration
Jext has been designed so that it can be injected through clothing or directly through the skin on the
outer side of the thigh. When the auto-injector is pressed against the thigh, a spring-activated plunger
is released, driving the hidden needle through the protective shield at the tip of the black needle cover,
piercing into the thigh muscle and injecting the dose of adrenaline.
The instructions for use of Jext provided below must be carefully followed.
Jext should be injected only into the outer side of the thigh.
Do not inject the medicine into the buttock.
Instructions for use of 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 device to ensure
that the patient, family members, or caregivers know how to respond 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 an 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 injection to minimize the
risk of injury to the leg.
The auto-injector is intended for single use only and cannot be reused. Follow the instructions only when
administration of the medicine is necessary.

• Never touch the black tip (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 with your dominant hand (the hand you write with), positioning your thumb as close as possible 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, confirming that the injection has started. Keep pressing firmly. Hold the auto-injector in place on the thigh for 10 seconds (count slowly to 10), then remove it. The black needle shield 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 visible in the viewing window to confirm activation of the auto-injector and delivery 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 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.
The patient should go to 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 raised, unless this causes breathing difficulties; 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 side 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 arterial blood pressure, irregular heart function, impaired kidney function, reduced blood flow, and fluid accumulation in the lungs.
If there are any further doubts concerning the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences 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
• Dryness of the mouth
• Reduced blood flow to hands and feet in case of accidental injection into these areas
• Increased blood pressure
• Feeling of weakness
• Excessive sweating
• Discomfort or chest 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 case of accidental injection of Jext,
immediate medical assistance must always be sought. Jext contains sodium metabisulfite, which
rarely may cause severe hypersensitivity reactions, including breathing difficulties.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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, tel.: +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 the Jext medicine

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton following:
"Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Store below 25°C.
Do not freeze.
It is important to periodically check the contents of the glass cartridge of the Jext auto-injector
through the viewing window to ensure that the solution is clear, colourless, and free of
visible solid particles. The Jext medicine should be replaced 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 the Jext medicine is replaced at the appropriate
time.
Jext is supplied in a plastic protective 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, the Jext medicine should be returned to the case.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This 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 auto-injector delivers 150 micrograms of adrenaline in 0.15 mL of injection solution.
One Jext 300 microgram 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 latex-free rubber stopper. The pre-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 single-dose, pre-filled semi-automatic auto-injector.

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

This medicine is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names: