Jext

Jext – solution for injection in pre-filled pen

Package Leaflet: Information for the patient

Jext 150 micrograms, solution for injection in pre-filled pen, 300 micrograms, solution for injection in pre-filled pen

Adrenaline
Please read this entire 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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Jext is and what it is used for
2. What you need to know 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 within an auto-injector for the emergency injection of a single dose of adrenaline into the outer thigh muscle (intramuscular injection).
Jext can be used for the emergency treatment of sudden, potentially life-threatening allergic reactions (anaphylactic shock) caused by insect stings or bites, foods, medications, or physical exercise.
Symptoms indicating the onset of anaphylactic shock appear within minutes of exposure to the allergen and include: skin itching; raised skin rash (such as hives); redness; swelling of the lips, throat, tongue, hands, and feet; wheezing; hoarseness; shortness of breath; nausea; vomiting; stomach cramps; and, in some cases, loss of consciousness.

2. What you need to know before using Jext

Jext can always be used during an allergic emergency. If you are allergic (hypersensitive) to
sodium metabisulfite or any of the excipients in Jext, your doctor will need to advise you on
the circumstances under which Jext should be used. For further information on sulfite
hypersensitivity, see section: Jext contains sodium metabisulfite and sodium chloride.
Jext – injectable solution in a pre-filled pen
Warnings and precautions
Talk to your doctor when Jext is prescribed for you

• if you have heart disease
• if you have an overactive thyroid (hyperthyroidism)
• if you have high blood pressure
• if you have diabetes
• if you have a tumor of the adrenal gland (pheochromocytoma)
• if you have increased pressure in the eye (glaucoma)
• if you have kidney or prostate disease
• if you have low potassium levels or high calcium levels in the blood
• and/or if you are elderly, pregnant, or the child weighs less than 15 kg, as there is an increased risk of side effects.

If you suffer from asthma, you may be at increased risk of a severe allergic reaction.
Anyone who has experienced an episode of anaphylaxis should consult their doctor to undergo testing for substances to which they may be allergic, so these can be strictly avoided in the future. It is important to remember that an allergy to one substance may lead to allergies to a number of related substances.
If you have food allergies, it is important to check the ingredients of everything you consume (including medicines), as even small amounts can cause severe reactions.
You must be carefully instructed by your doctor or nurse on when and how to correctly use Jext.
The instructions for use must be followed carefully to avoid accidental injection.
Jext must be injected intramuscularly only into the outer thigh. It must not be injected into the buttock due to the risk of accidental intravenous injection.
Caution
Accidental injection into the hands or feet may cause reduced blood flow to these areas. If an accidental injection occurs in these areas, you must go immediately to the nearest emergency department for treatment.
If you have a thick subcutaneous layer of fat, there is a risk that a single dose of Jext may not be sufficient. A second injection may be necessary.
For use, carefully follow the instructions provided in section 3.
If the injection is administered by someone other than the patient and the patient’s leg is not immobilized during injection, a laceration may occur. To avoid injury, the instructions for use provided in section 3 must be carefully followed.
For athletes: using this medicine without therapeutic need constitutes doping: it may produce performance-enhancing effects and may lead to a positive result in anti-doping tests, even at therapeutic doses.
Jext – injectable solution in a pre-filled pen
Other medicines and Jext
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This is especially important if you are taking any of the following medicines:

• Antidepressants such as tricyclic antidepressants or monoamine oxidase inhibitors (MAO inhibitors).
• Medicines for Parkinson’s disease such as catechol-O-methyltransferase inhibitors (COMT inhibitors) and levodopa.
• Medicines that can stimulate the heart and cause irregular heartbeats (arrhythmias), such as digitalis and quinidine.
• Medicines for thyroid disorders (e.g., levothyroxine)
• Medicines that improve breathing used in asthma (theophylline)
• Medicines used during labor (oxytocin)
• Medicines used to treat allergies such as diphenhydramine, chlorpheniramine (first-generation antihistamines)
  • Alpha and beta-blockers for heart conditions
  • Medicines with inhibitory activity on the parasympathetic nervous system, which regulates involuntary body functions such as breathing and lung function (parasympatholytics, parasympathomimetics). Diabetic patients should carefully monitor their glucose levels after using Jext, as adrenaline may increase blood glucose levels.

Jext and alcohol
Alcohol may enhance the effect of adrenaline.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Experience with the use of adrenaline during pregnancy is limited. If you are pregnant, do not hesitate to use Jext in an emergency, as your life and your baby’s life may be at risk.
Jext is not expected to have any effect on the breastfed infant.
Driving and using machines
It is very unlikely that the ability to drive or operate machinery will be affected by the administration of an adrenaline injection, but it may be impaired by an anaphylactic reaction. If such a reaction occurs, do not drive.
Jext contains sodium metabisulfite and sodium chloride
Jext contains sodium metabisulfite, which rarely may cause severe allergic reactions (hypersensitivity) or breathing difficulties (bronchospasm). Your doctor must advise you on the circumstances under which Jext should be used.
Jext contains less than 1 mmol of sodium (23 mg) per dose, i.e., it is essentially sodium-free.

3. How to use Jext

Jext – pre-filled syringe injection solution
Use this medicine exactly as instructed by your doctor or pharmacist.
Make sure you understand when you should use Jext. If you are unsure, check with your doctor or pharmacist.

Dosage
Adults and children over 30 kg: the recommended dose for allergic emergencies is 300 micrograms of adrenaline to be injected into the outer thigh muscle (intramuscular use).

Children between 15 kg and 30 kg: the recommended dose for allergic emergencies is 150 micrograms of adrenaline to be injected into the outer thigh muscle (intramuscular use).
Remember: the correct dose of Jext depends on body weight. The dose should be increased as the child grows, and this should be discussed with the doctor.

If you notice signs of an acute allergic reaction, use Jext immediately, even through clothing if necessary.

After use, some liquid will remain in the auto-injector and cannot be reused.

Sometimes a single dose of adrenaline may not be sufficient to counteract the effects of a severe allergic reaction. For this reason, your doctor may prescribe more than one Jext auto-injector. If your symptoms do not improve or worsen within 5–15 minutes after the first injection, you or those with you should administer a second injection. For this reason, you should always carry more than one Jext auto-injector with you.

Method of administration
Jext is designed to be injected through clothing or directly into the skin on the outer side of the thigh. Jext must be firmly pressed against the outer thigh, in the area with the largest muscle mass. When Jext is firmly pressed against the thigh, a spring-activated plunger is released, driving the hidden needle through the seal at the end of the black protective cap, into the muscle, and injecting a dose of adrenaline.

The instructions for using Jext provided below must be carefully followed.

Jext must be injected only into the outer part of the thigh.

It must not be injected into the buttock (your buttocks).
Instructions for use
Before an emergency occurs, become fully familiar with Jext and know when and how it should be used.
Your doctor may use the Jext Trainer to train you and other family members or caregivers on the correct use of Jext, so that everyone knows exactly what to do in case of an allergic emergency.
It is recommended that family members, caregivers, or teachers also be trained in the proper use of Jext.
If you are responsible for administering the injection to a patient, instruct the patient not to move and, if necessary, immobilize the patient’s leg during injection to minimize the risk of skin injury.
The injector is intended for single use only and cannot be reused.
Jext – injectable solution in a pre-filled pen
Follow these instructions only when you are ready to use it.

• Never place your thumb, feet, or hand over the black needle shield, as this is where the needle emerges.
• Do not remove the yellow cap until you are ready to use Jext.

For correct administration, refer to the figures and follow the steps below:

1. Hold the Jext injector in your dominant hand (the hand you write with), with your thumb close to the yellow cap.
2. Remove the yellow cap with the other hand.

3. Place the black tip of the injector against the outer part of the thigh, holding the injector at a right angle (approximately 90°) to the thigh.
4. Press the black tip firmly against the outer thigh until you hear a 'click', confirming that the injection has started. Then continue to hold it in place. Keep the injector firmly pressed against the thigh for 10 seconds (count slowly to 10), then remove it. The black tip will automatically extend, covering and shielding the needle.

5. Massage the injection site for 10 seconds. Seek immediate medical assistance. Call 112, request an ambulance, and state that an anaphylactic reaction has occurred.

Jext – injectable solution in a pre-filled pen
The inspection window in the label contains a colored plastic rod (white in Jext 300 and blue in Jext 150), confirming that the auto-injector has been activated and the adrenaline solution has been injected.
A small air bubble may be present in Jext. This does not affect how the product works.
Even if most of the liquid remains in Jext after use, it must not be reused.
Jext is designed as an emergency treatment. You must always seek medical assistance immediately after using Jext. Call 112, request an ambulance, and report an anaphylactic reaction even if symptoms appear to improve. You will need to go to the hospital for observation and further treatment if necessary. This is because the reaction may recur at a later time.
While waiting for the ambulance, lie down with your feet elevated, unless this causes breathing difficulties; in that case, sit up. Ask someone to stay with you until the ambulance arrives, in case your condition worsens.
Unconscious patients should be placed in the recovery position (on their side).
Inform healthcare professionals that you have received an intramuscular adrenaline injection. You may also hand over the used Jext device for safe disposal.
If you use more Jext than you should
In case of overdose or accidental adrenaline injection, you must always seek immediate medical help. Consult your doctor as soon as possible to replace the used Jext.
Your blood pressure may rise sharply. Overdose can cause a sudden increase in blood pressure, irregular heartbeat, impaired kidney function, reduced blood flow, and fluid accumulation in the lungs.
If you have any further questions about the use of this product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following side effects are based on experience with adrenaline.

Frequency not known (frequency cannot be estimated from the available data):

• Tremor
• Reactions at the injection site such as bruising, pain and swelling
• Dizziness
• Fainting
• Headache
• Tingling sensation or numbness
• Sensation of rapid or irregular heartbeat
• Muscle stiffness
• Nausea
• Vomiting
• Dry mouth
• Decreased blood flow to the hands and feet in case of accidental injection into these areas
• Increased blood pressure
• Feeling of weakness
• Sweating
• Discomfort or pain in the chest
• Changes in certain blood values, specifically increased blood sugar levels, decreased potassium levels, and harmful accumulation of acid in the body

Accidental injection of adrenaline into the fingers of the hands or feet has been reported, which may cause reduced blood flow to these areas as well as coldness, paleness, tingling and numbness, bruising, pain, bleeding, and swelling at the injection site. In case of accidental injection, always seek immediate medical help.

Jext contains sodium metabisulfite, which may rarely cause severe hypersensitivity reactions, including breathing difficulties.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at the website:
https://www.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 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 outer packaging following the word "Exp.". The expiry date refers to the last day of the month.
Store below 25°C.
Do not freeze.
Remember to periodically check the contents of the Jext glass cartridge through the viewing window in the label to ensure that the liquid is still clear and colourless.
Replace Jext before the expiry date or earlier. Do not use this medicine if you notice that the solution has turned yellow or if you see a precipitate (solid particles). It may be helpful to record the expiry date in your calendar or diary to ensure timely replacement of Jext.
Jext – injectable solution in a pre-filled pen
Jext is supplied in a plastic carrier case to protect Jext during transport or storage.
Before use, Jext must be removed from the carrier case and must be removed during inspection of Jext.
After inspection, return Jext to the carrier case.
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 Jext contains
The active substance is adrenaline.
1 ml of solution contains 1 mg of adrenaline (as tartrate).
Jext 150 micrograms delivers a single dose of 150 micrograms of adrenaline in 0.15 ml of
injectable solution.
Jext 300 micrograms delivers a single dose of 300 micrograms of adrenaline in 0.3 ml of
injectable solution.
The other ingredients are:
Sodium chloride,
Sodium metabisulfite (E223),
Hydrochloric acid,
Water for injections.

Description of the appearance of Jext and contents of the pack
Jext is an injectable solution in a pre-filled pen. It contains a clear, colourless solution in a glass cartridge with a latex-free rubber seal. The pre-filled pen is supplied in a plastic carrying case.
Exposed needle length:
Jext 150 micrograms: 13 mm
Jext 300 micrograms: 15 mm
Pack sizes: single pack containing 1 pre-filled pen. Multipack containing 2 pre-filled pens.
Not all pack sizes may be marketed.

Marketing Authorization Holder
ALK-Abelló A/S, Bøge Allé 6-8, DK-2970 Hørsholm – Denmark

Manufacturer
ALK-Abelló S.A., Miguel Fleta 19, ES-28037 Madrid – Spain

Sales Licensee
ALK-Abelló S.p.A.
Via Nino Bixio 31
20129 Milano (MI)
Jext – injectable solution in pre-filled pen
Italy

This medicinal product is authorized in the European Economic Area countries under the following names:

This patient information leaflet was approved on: