Jext 300 micrograms solution for injection in pre-filled pen

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Jext 150 microgrammes solution for injection in pre-filled pen

Jext 300 microgrammes solution for injection in pre-filled pen

Adrenaline

Read all of this leaflet carefully before you start 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. 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 emergency single-dose injection into the outer thigh muscle (intramuscular injection).

Jext is used for the emergency treatment of sudden, life-threatening allergic reactions (anaphylactic "shock") caused by insect stings or bites, foods, medications, or exercise.

Symptoms indicating the onset of an anaphylactic reaction occur within minutes of exposure to the allergen and include: skin itching, rash (such as hives); flushing; swelling of the lips, throat, tongue, hands, and feet; wheezing; hoarseness; difficulty breathing; nausea; vomiting; abdominal cramps; and, in some cases, loss of consciousness.

2. What you need to know before using Jext

Jext can always be used in an allergic emergency. If you are allergic (hypersensitive) to sodium metabisulfite or any other ingredient in Jext, your doctor must instruct you on the circumstances under which you should use Jext. For more information about sulfite hypersensitivity, please see section:

Jext contains sodium metabisulfite and sodium chloride.

Warnings and precautions Consult your doctor when Jext is prescribed to you

• If you have heart disease
• If you have overactive thyroid (hyperthyroidism)
• If you have high blood pressure
• If you have diabetes
• If you have a tumour 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 or high calcium levels in the blood.
• And/or if you are elderly, pregnant, or a child weighing less than 15 kg, as there is an increased risk of adverse effects.

If you suffer from asthma, you may be at greater risk of experiencing a severe allergic reaction.

Anyone who has experienced an episode of anaphylaxis should visit their doctor for allergy skin testing, in order to strictly avoid substances to which they are allergic in the future. It is important to know that allergy to one substance may lead to allergies to a number of related substances.

If you are allergic to foods, it is important that you check the ingredients of everything you consume (including medications), as even small amounts may cause severe reactions.

Your doctor or nurse must give you detailed instructions on when and how to use Jext correctly.

The instructions for use must be followed carefully to avoid accidental injection.

Jext must only be injected intramuscularly into the outer thigh. It must not be injected into the buttock due to the risk of accidental intravenous injection.

Precautions

Accidental injection into the hands or feet may result in reduced blood flow to the affected area. If an accidental injection occurs in these areas, you must go immediately to the nearest emergency department for treatment.

If you have a thick layer of subcutaneous fat, there is a risk that a single dose of Jext may not be sufficient. A second injection may be necessary. Follow carefully the detailed instructions for use in section 3.

Skin injuries (lacerations) may occur if the injection is administered by someone other than the patient and if the patient’s leg is not immobilized during injection. To prevent injuries, the detailed instructions for use in section 3 must be carefully followed.

Use in athletes:

This medicine contains adrenaline, which may lead to a positive result in doping tests. Adrenaline is not prohibited when used in association with local anaesthetics or when administered locally (e.g., nasal, ophthalmic).

Use of Jext with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

It 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-methyl transferase inhibitors (COMT inhibitors) and levodopa
• Medicines that may make the heart sensitive to irregular heartbeats (arrhythmias), such as digitalis or quinidine
• Medicines for thyroid disorders (e.g., levothyroxine)
• Medicines that make breathing easier; those used for asthma (theophylline)
• Medicines that facilitate childbirth (oxytocin)
• Medicines for the treatment of allergies, such as diphenhydramine, chlorphenamine (first-generation antihistamines)
• Alpha- and beta-blocking medicines for heart conditions
• Medicines acting on the parasympathetic nervous system, which regulates unconscious body functions such as heartbeat and lung function (parasympatholytics, parasympathomimetics)

Diabetic patients should carefully monitor their glucose levels after using Jext, as adrenaline may increase blood glucose levels.

Use of Jext with alcohol

Alcohol may increase the effect of adrenaline.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, 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 a critical situation, as your life and that of your child may be at risk.

Jext is not expected to have any effect on the breastfed infant.

Driving and use of machines

Your ability to drive and use machines is not expected to be affected by the administration of an adrenaline injection, but it may be affected by the anaphylactic reaction itself. If this occurs, do not drive.

Jext contains sodium metabisulfite and sodium chloride.

This medicine may cause serious allergic reactions and bronchospasm (sudden sensation of suffocation) because it contains sodium metabisulfite. Your doctor must instruct you on the circumstances under which you should use Jext.

This medicine contains less than 23 mg (1 mmol) of sodium per dose and is therefore considered essentially “sodium-free”.

3. How to use Jext

Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. Make sure you understand in which situations you should use Jext. If in doubt, consult your doctor or pharmacist again.

Dosage

Adults and children over 30 kg – The recommended dose for allergic emergencies is 300 micrograms of adrenaline for injection into the outer thigh (intramuscular use).

Children between 15 kg and 30 kg – The recommended dose for allergic emergencies is 150 micrograms of adrenaline for injection into the outer thigh (intramuscular use). Remember: The appropriate dose of Jext depends on body weight. The dose should be increased as the child grows, and this must be discussed with your 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, but it must not be reused.

Sometimes, a single dose of adrenaline may not be sufficient to completely reverse the effects of a severe allergic reaction. For this reason, your doctor may prescribe more than one Jext unit. If your symptoms have not improved or have worsened within 5–15 minutes after the first injection, you or the person with you must administer a second injection. For this reason, you should always carry more than one Jext unit with you.

Method of administration

Jext is designed to be used through clothing or directly through the skin on the outer side of the thigh.

Jext must be firmly pressed against the outer thigh, targeting the longest part of the thigh muscle. When Jext is firmly pressed against the thigh, a spring is activated, driving the plunger to release the hidden needle through the membrane at the end of the black needle cover, delivering a dose of adrenaline into the thigh muscle.

The instructions for use of Jext must be followed carefully.

Jext must only be injected into the outer side of the thigh. It must not be injected into the buttock (your bottom).

Instructions for use

Before you need to use it, you should become fully familiar with Jext, when and how to use it. During training on the proper use of Jext, your doctor may use a Jext Simulator to ensure that you, your family members, or caregivers know exactly what to do in case of an allergic emergency.

It is recommended that family members, caregivers, or teachers also be trained in the correct use of the Jext auto-injector. If you are a caregiver, you must instruct the patient not to move and, if necessary, immobilize the patient's leg during injection to minimize the risk of lacerations.

The auto-injector is for single use only and cannot be reused.

Follow these instructions only when you are ready to use it:

Never place your thumb, feet, or hand over the black needle cover, as this is where the needle comes out.

Do not remove the yellow cap until Jext is to be used.

For correct administration, refer to the diagrams and follow these steps:

The inspection window on the label is filled up to the level of the colored plastic rod (white in Jext 300 and blue in Jext 150) to confirm that the auto-injector has been activated and the adrenaline solution has been injected.

A small air bubble may appear in Jext. This does not affect the effectiveness of the product.

Although most of the liquid will remain in Jext after use, it must not be reused.

Jext is designed as an emergency treatment. Immediate medical assistance must always be sought after using Jext. Call 112, request an ambulance, and state that you are experiencing anaphylaxis, even if symptoms appear to be improving. You will need to go to a hospital for observation and further treatment if necessary. This is because the reaction may recur some time later.

While waiting for the ambulance, you should lie flat on your back with your legs elevated, unless this makes breathing difficult, in which case you should sit up. Ask someone to stay with you until the ambulance arrives, in case your condition worsens again.

Unconscious patients should be placed in the recovery position.

Inform healthcare professionals that you have received an intramuscular injection of adrenaline. You may also hand over the used Jext device so it can be safely disposed of.

If you use more Jext than you should

In case of overdose or accidental injection of adrenaline, seek immediate medical help. You should consult your doctor to replace the used Jext as soon as possible.

Your blood pressure may rise. An overdose could cause a sudden increase in blood pressure, irregular heartbeat, abnormal kidney function, reduced blood circulation, and fluid accumulation in the lungs.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

In case of overdose or accidental injection, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The following adverse effects are based on experience with the use of adrenaline.

Frequency unknown (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
• Decreased blood flow in hands and feet following accidental injection into these areas
• Increased blood pressure
• Feeling of weakness
• Sweating
• Chest discomfort or pain
• Changes in your blood such as increased blood sugar levels, decreased potassium levels, and harmful accumulation of acid in the body

Cases of accidental adrenaline injection into fingers or feet have been reported, which may cause reduced blood flow to the affected area, as well as coldness, pallor, 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 hypersensitivity reactions including breathing difficulty.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 on the carton after EXP. The expiry date refers to the last day of the month indicated.

Store below 25°C.

Do not freeze.

Remember to periodically inspect the contents of the glass cartridge of Jext through the window in the label from time to time, to ensure that the liquid remains clear, colourless, and free from visible particles. Replace Jext by its expiry date or earlier. Do not use this medicine if you notice that the solution has changed colour or contains a precipitate (solid particles). It may be helpful to write the expiry date in your calendar or diary to make sure you replace Jext on time.

Jext is supplied in a plastic case to protect it during transport or storage. Jext must be removed from its case before use as well as during inspection of Jext. Store Jext in its case after inspection.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the Punto Sigre collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Jext

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 components are:

Sodium chloride,

Sodium metabisulfite (E223),

Hydrochloric acid,

Water for injections.

Appearance of the product and contents of the pack

Jext is an injectable solution in a pre-filled pen. It contains a clear, colourless solution free from visible particles in a glass cartridge sealed with a rubber stopper that does not contain latex. The pre-filled pen is supplied in a plastic sheath.

Exposed needle length:

Jext 150 micrograms: 13 mm

Jext 300 micrograms: 15 mm

Pack size: Single pack containing 1 pre-filled pen. Multiple pack containing 2 pre-filled pens.

Only some pack sizes may be marketed.

Marketing Authorisation Holder

ALK-Abelló A/S, Bøge Allé 6-8, DK-2970 Hørsholm.

Manufacturer

ALK-Abelló, S.A. C/ Miguel Fleta, 19. 28037 – Madrid.

Local representative: ALK-Abelló, S.A. C/ Miguel Fleta, 19. 28037 – Madrid

This medicinal product is authorised in the Member States of the European Economic Area under the name:

Date of the last revision of this leaflet: 08/2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es.