JEXT 300 MICROGRAMS Pre-filled pen injectable solution

Содержание инструкции

1. Jext 150 micrograms, injectable solution in pre-filled pen, 300 micrograms, injectable solution in pre-filled pen
   1. What is Jext 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. Package Contents and Other Information

Jext – injectable solution in pre-filled pen

Jext 150 micrograms, injectable solution in pre-filled pen, 300 micrograms, injectable solution 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. Do not pass it on to others even if they have the same symptoms as you because it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you use 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 is Jext 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 muscle of the thigh (intramuscular injection).
Jext can be used for the emergency treatment of sudden, potentially life-threatening allergic reactions (anaphylactic shock) due to insect stings or bites, food, medications or exercise.
Symptoms indicating the onset of anaphylactic shock appear within minutes of exposure to the allergen and include: itching of the skin; raised skin rash (like 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 of Jext, your doctor will need to advise you on
under what circumstances Jext should be used. For further information on hypersensitivity to sulfites
consult the section: Jext contains sodium metabisulfite and sodium chloride.
Jext – injectable solution in pre-filled pen

Warnings and precautions
Consult your doctor when Jext is prescribed to 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 have an increased risk of a severe allergic reaction.
Anyone who has an episode of anaphylaxis should consult their doctor to undergo testing for
the substances to which they may be allergic, so that these can be strictly avoided
in the future. It is important to remember that an allergy to a substance can 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 informed by your doctor or nurse about when and how to use
Jext correctly.
The instructions for use must be followed carefully to avoid accidental injection.
Jext must be injected only intramuscularly into the outer thigh. It should not
be injected into the buttock due to the risk of accidental injection into a vein.
Caution
Accidental injection into the hands or feet can cause a reduction in blood supply to
these areas. If an accidental injection occurs in these areas, you should go
immediately to the nearest emergency room for treatment.
If you have a thick subcutaneous layer of fat, there is a risk that a single
administration of Jext may not be sufficient. A second injection may be necessary.
For use, follow the instructions in paragraph 3 carefully.
If the injection is performed by someone other than the patient and the patient's leg is not
immobilized during the injection, laceration may occur. To avoid injury, the instructions
provided in section 3 must be followed carefully.
For those who play sports: the use of the drug without therapeutic need constitutes doping:
it can determine doping effects and also cause positive results in doping tests even at therapeutic doses.
Jext – injectable solution in pre-filled pen

Other medicines and Jext
Tell 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 the treatment of Parkinson's disease such as catechol-O-methyl transferase (COMT) inhibitors and levodopa.
• Medicines that can stimulate the heart causing irregular heartbeats (arrhythmias), such as digitalis and quinidine.
• Medicines for thyroid disease (e.g. levothyroxine)
• Medicines that improve breathing used for asthma (theophylline)
• Medicines used during labour (oxytocin)
• Medicines used to treat allergies such as diphenhydramine, chlorphenamine (first-generation antihistamines)
• Alpha and beta-blockers for heart disease
• Medicines that have an inhibitory activity on the parasympathetic nervous system, which regulate the involuntary functions of the body such as, for example, breathing and lung functions (parasympatholytics, parasympathomimetics) Diabetic patients should carefully monitor their glucose levels after using Jext as adrenaline can increase blood glucose levels.

Jext and alcohol
Alcohol can increase the effect of adrenaline.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.
There is limited experience in the use of adrenaline during pregnancy. If you are pregnant, do not
hesitate to use Jext in an emergency, as your life and that of your baby may be in danger.
Jext should have no effect on the infant.

Driving and operating machinery
It is very unlikely that the ability to drive vehicles and operate machinery will be affected
by the administration of an adrenaline injection, but it may be altered by an
anaphylactic reaction. If such a reaction occurs, do not drive.

Jext contains sodium metabisulfite and sodium chloride
Jext contains sodium metabisulfite, which can rarely cause severe allergic
reactions (hypersensitivity) or difficulty breathing (bronchospasm). Your doctor should inform you about
the circumstances in 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 – solution for injection in a pre-filled pen
Use this medicine following exactly the instructions of your doctor or pharmacist. Make sure you
understand in which situation you need to use Jext. If you are not sure, check with your
doctor or pharmacist.

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

Children between 15 kg and 30 kg:the recommended dose for allergic type emergencies is 150
micrograms of adrenaline to be injected into the outer muscle of the thigh (intramuscular
use). Remember: the correct dose of Jext depends on body weight. The dose will need to be
increased as the child grows and should be discussed with your doctor.
If you notice signs of an acute allergic reaction, use Jext immediately, if necessary through
your clothes.
After use, some of the liquid remains in the auto-injector and cannot be reused.
Sometimes a single dose of adrenaline may not be enough to neutralize the effects of a
severe allergic reaction. For this reason, your doctor is likely to prescribe more than one
Jext auto-injector. If, within 5-15 minutes of the first injection, your symptoms do not improve or
worsen, you or those with you must 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 of the outer
thigh. Jext must be pressed firmly against the outer thigh
in the widest part of the thigh muscle. When Jext is pressed firmly against
your thigh, a piston activated by a spring is released, pushing the hidden needle,
through the seal at the end of the black protective cover, into the thigh muscle and
injects a dose of adrenaline.
The instructions for using Jext below must be carefully followed.
Jext must be injected onlyinto the outer thigh.

It must not be injected into the buttock (your buttocks)
Instructions for use
Before the need arises to use it, become fully familiar with Jext, and be aware of when
and how it should be used. When instructing you on the correct use of Jext, your doctor may use Jext
Trainer to ensure that you and other family members or people who may assist you are
confident about what to do when an allergic emergency occurs.
It is recommended that family members, caregivers, or
teachers also be instructed on the correct use of Jext. If you are responsible for taking care of
the patient, you must inform the patient not to move and, if necessary, immobilize the patient's leg during the administration of the injection in order to minimize the risk of
skin injury.
The injector is intended for a single use only and cannot be reused.
Jext – solution for injection in a pre-filled pen
Follow these instructions only when you are ready for use.

• Never place your thumb, feet, or hand over the black needle guard as this is where the needle comes out.
• Do not remove the yellow cap until you need to use Jext.

For correct administration, look at the figures and follow the following steps:

• 1. Grip the Jext injector with your dominant hand (the one you use to write) and with your thumb near the yellow cap.

• 2. Remove the yellow cap with your other hand.

• 3. Place the black tip of the injector against the outer thigh, keeping the injector at a right angle (approximately 90°) to the thigh.

• 4. Press the black tip firmly onto the outer thigh until you hear a ‘click’ to confirm that the injection has started, then hold it pressed. Hold the injector firmly in place against the thigh for 10 seconds (count slowly to 10) then remove it. The black tip will automatically extend hiding the needle.

• 5. Massage the injection area for 10 seconds. Seek immediate medical assistance. Call 112, request an ambulance, declare a state of anaphylaxis.

Jext – solution for injection in a pre-filled pen
The inspection window on the label is filled with a 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 be present in Jext. This does not affect how the
product works.
Although most of the liquid remains in Jext after use, it cannot be reused.
Jext is designed as emergency treatment. You should always receive medical
assistance immediately after using Jext. Call 112, request an ambulance, declare a state of anaphylaxis

even if symptoms apparently improve. You will need to go to hospital for
observation and further treatment if necessary. This is because the reaction may happen again
at a later time.
While waiting for the ambulance, lie down with your feet raised unless this causes
breathing problems, 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 placed on their side in the recovery position.
Inform the healthcare professional that you have received an intramuscular adrenaline injection. You can
also hand over the used Jext for safe disposal.

If you use more Jext than you should
In case of overdose or accidental injection of adrenaline, you should always seek
immediatemedical help. You should consult your doctor to replace the used Jext as soon as possible.
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 buildup in the lungs. If you have
further questions about the use of this product, ask 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 based on available data):

• Tremor
• Reactions at the injection site such as bruising, pain and swelling
• Dizziness
• Fainting
• Headache

Jext – injectable solution in a pre-filled pen

• Sensation of tingling or numbness
• Sensation of a fast or irregular heartbeat
• Muscle stiffness
• Nausea
• Vomiting
• Dry mouth
• Decreased blood flow in the hands and feet in case of accidental injection into these areas
• Increased blood pressure
• Feeling of weakness
• Sweating
• Discomfort or chest pain
• Changes in some 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 can
cause a decrease in 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 can rarely cause serious hypersensitivity reactions
including difficulty breathing.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
inform your doctor or pharmacist. You can also report side effects directly
through 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 which is stated on the label and on the
outer packaging after the words “Exp.”. The expiry date refers to the last day of the
month.
Store at a temperature below 25°C.
Do not freeze.

Remember to periodically check the contents of the glass cartridge of Jext through the
window on the label to ensure that the liquid is still clear and colourless.
Replace Jext within the expiry date or before. Do not use this medicine if you notice that the
solution discolours or you observe a precipitate (solid particles). It may be helpful to record
the expiry date in your calendar or diary to be sure to replace Jext in time.
Jext – pre-filled pen injector solution
Jext is supplied in a plastic case to protect Jext during transport or during
storage.
Before use Jext must be removed from the carrier case and must be removed
during the inspection of Jext.
Return Jext to the carrier case after inspection.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Jext contains
The active ingredient is adrenaline
1 ml of solution contains 1 mg of adrenaline (as tartrate)
Jext 150 micrograms injects a single dose of 150 micrograms of adrenaline in 0.15 ml of
injectable solution.
Jext 300 micrograms injects 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 Jext’s appearance and package contents
Jext is an injection solution in a prefilled pen. It contains a clear and
colorless solution in a glass cartridge with a latex-free rubber stopper. The prefilled
pen comes in a plastic case.
Exposed needle length:
Jext 150 micrograms: 13 mm
Jext 300 micrograms: 15 mm
Pack sizes: single pack with 1 prefilled pen. Multipack with 2 pens
prefilled.
Not all pack sizes may be marketed.

Marketing Authorisation 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

Distributor for sale
ALK-Abelló S.p.A.
Via Nino Bixio 31
20129 Milano (MI)
Jext – injectable solution in prefilled pen
Italy

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