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

What Jext is and what it is used for

Jext contains a sterile adrenaline solution in an auto-injector for use in an emergency. It provides a single dose of adrenaline that is injected on the outside of the thigh muscle ( intramuscular injection ).

Jext is used in emergency treatment of sudden life-threatening allergic reactions (anaphylactic shock , anaphylaxis ) caused by insect bites or bites, food, medicine or physical exertion.

Symptoms of an anaphylactic reaction may occur within minutes of contact with the allergen and may include: itchy skin, raised rash (such as hives ), redness , swelling of the lips, throat, tongue, hands and feet, wheezing, hoarseness, difficulty breathing, nausea , vomiting, stomach cramps and in some cases unconsciousness.

What you need to know before using Jext

Jext can always be used in an acute allergic reaction . If you are allergic (hypersensitive) to sodium metabisulfite or any of the other ingredients of Jext, your doctor should have instructed you in which situations Jext should be used. For more information on hypersensitivity to sulphite, see section “Jext contains sodium metabisulphite and sodium chloride” .

Warnings and cautions

Talk to your doctor when you receive your prescription for Jext:

  • if you have heart disease
  • if you have an overactive thyroid gland
  • if you have high blood pressure
  • if you have diabetes
  • if you have a tumor in 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 in your blood
  • if you are older, pregnant or if the child weighs less than 15 kg, then the risk of side effects is greater.

If you have asthma , you may have an increased risk of a severe allergic reaction .

Anyone who suffers from an anaphylactic reaction should contact their doctor to test which substances they may be allergic to, so that these can be completely avoided in the future. It is important to be aware that allergies to a substance can lead to allergies to a number of related substances.

If you have a food allergy, it is important to check the ingredients of everything you eat (including medicines), as even small amounts can cause severe reactions.

Your doctor or nurse should have carefully explained to you when and how to use Jext correctly.

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

Jext should only be given on the outside of the thigh ( intramuscularly ). It should not be given in the buttocks due to the risk of accidentally injecting directly into a blood vessel.

Warning

Accidental injection into hands or feet can lead to decreased blood flow to these parts. Seek medical attention immediately for treatment if you accidentally inject into your hands or feet.

If you have a thick layer of subcutaneous fat, there is a risk that a dose of Jext is not enough. A second injection may be needed. Carefully follow the instructions for use in section 3.

Tear ulcers can occur if injection is given by someone other than the patient himself and the patient’s legs are not kept still during injection . Carefully follow the instructions for use in section 3 to prevent damage.

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 ( MAOIs ).
  • Drugs for the treatment of Parkinson’s disease such as catechol-O-methyltransferase inhibitors (COMT inhibitors) and levodopa .
  • Drugs that cause the heart to start beating unevenly ( arrhythmias ) such as digitalis or quinidine .
  • Medicines used for thyroid disease (eg levothyroxine).
  • Drugs that make it easier to breathe, used in asthma (theophylline).
  • Medicines used in childbirth ( oxytocin ).
  • Drugs used to treat allergies such as diphenhydramine, chlorpheniramine (first generation antihistamines ).
  • Alpha and beta blockers used to treat heart disease.
  • Drugs that act on the parasympathetic nervous system that regulate the body’s involuntary functions, such as heartbeat and lung function (parasympatolytics, parasympatomimetics).

Diabetics should carefully monitor their blood sugar levels after using Jext as adrenaline can raise blood sugar.

Jext with alcohol

Alcohol can enhance the effects of adrenaline .

Pregnancy, breastfeeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. There is limited experience with the use of adrenaline during pregnancy. If you are pregnant, do not hesitate to use Jext in an emergency as you and your baby’s lives may be in danger. Jext is not expected to have any effect on the breast-feeding baby.

Driving and using machines

The ability to drive or use machines is not affected by an injection of adrenaline , however, it can be affected by an anaphylactic reaction . If your driving ability is affected, do not drive.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and / or side effects . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Jext contains sodium metabisulfite and sodium chloride

Jext contains sodium metabisulfite, which in rare cases can cause severe allergic reactions (hypersensitivity) or difficulty breathing ( bronchospasm ). Your doctor will instruct you when to use Jext.

Jext contains less than 1 mmol sodium (23 mg) per dose , ie it is essentially ‘sodium-free’.

How to use Jext

Always use this medicine exactly as your doctor or pharmacist has told you. Make sure you understand when to use Jext. Ask your doctor or pharmacist if you are unsure.

Dosage

Adults and children over 30 kg – the recommended dose for acute allergic reactions is 300 micrograms of adrenaline injected on the outside of the thigh ( intramuscular use).

Children between 15 and 30 kg – the recommended dose for acute allergy reactions should be 150 micrograms of adrenaline injected on the outside of the thigh ( intramuscular use). Note: the correct dose of Jext depends on body weight and should, in consultation with a doctor, be increased as your child grows.

If you notice any signs of an acute allergic reaction , use Jext immediately; through the clothes if necessary.

After use, liquid remains in the auto-injector, but it can not be used again.

Sometimes a dose of adrenaline is not enough to completely eliminate a severe allergic reaction . This is why your doctor will probably prescribe more than one Jext. If the symptoms have not improved or if they worsen within 5-15 minutes after the first injection , either you or the person you are with should give a second injection . For this reason, you should always have more than one Jext with you.

Administration

Jext can be given through clothing or directly through the skin on the outside of the thigh. Jext should be pressed hard against the outside of the thigh in the largest part of the thigh muscle. When you press Jext firmly against the thigh, a needle is pushed out, which goes into the thigh muscle and gives a dose of adrenaline .

The instructions for use for Jext below must be followed carefully.

Jext should only be injected on the outside of the thigh.

Never inject into the buttocks.

Instructions for use

Before you need to use it, make sure you understand when and how to use Jext. There is a training pen (Jext Training Pen) that your doctor can use to ensure that you and other family members or carers know what to do in the event of an acute allergic reaction . It is recommended that your family members, carers or teachers also receive instructions on the proper use of Jext. If you are a caregiver, instruct the patient not to move and, if necessary, hold the patient’s legs during injection to reduce the risk of lacerations. The pen is for single use only and cannot be reused.

Follow these instructions only when using.

  • Never place your thumb, foot or hand over the black needle cover as this is where the needle comes out.
  • Do not remove the yellow hat until it is time to use Jext.

For proper handling, see the pictures and follow the instructions:Show larger

   
1. Hold the Jext with the hand you normally use (the hand you type with) with your thumb closest to the yellow hat.
   
2. Remove the yellow hat with the other hand.
   
3. Place the black tip at a right angle (approx. 90 degrees) to the outside of the thigh.
   
4. Press the black tip firmly against the outside of the thigh until you hear a click. The click means that injection has started. Hold the pen firmly in place, pressed against the thigh, for 10 seconds (slowly count to 10). Remove Jext. The black tip will automatically extend and hide the needle.
   
5. Massage the injection site for about 10 seconds. Contact healthcare immediately. Call 112, ask for an ambulance, state anaphylaxis .

There is a display window on the label where a colored plastic rod becomes visible (white for Jext 300 micrograms and blue for Jext 150 micrograms) when the adrenaline has been injected.

There may be a small air bubble in the Jext. It has no effect on the effect of the medicine.

Although most of the liquid remains in the Jext after use, it cannot be reused.

Jext is intended for emergency treatment. You should always seek medical attention immediately after using Jext.  This is because the reaction may occur again some time later.

While waiting for an ambulance, lie down with your feet high. If this makes you short of breath, sit up. Ask someone to stay with you until the ambulance arrives, in case you start to feel worse again.

Unconscious patients should be placed in a stable lateral position.

Inform your healthcare provider that you have received an intramuscular injection of adrenaline . You can also hand over your used Jext for destruction.

If you take more Jext than you should

If you have ingested too much medicine or injected adrenaline by mistake, contact a doctor, hospital or the Poison Information Center (tel. 112) immediately for risk assessment and advice. See your doctor as soon as possible to have a new Jext prescribed.

Blood pressure can rise sharply. Overdose of adrenaline can cause a sudden increase in blood pressure , irregular heartbeat, abnormal kidney function, impaired blood flow and accumulation of fluid in the lungs.

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

Possible side effects

Like all medicines, this medicine can cause side effects , although not everybody gets them.

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

No known frequency (can not be calculated from the available data):

  • Tremors
  • Injection site reactions, such as bruising, pain and swelling
  • Dizziness
  • Fainting
  • Headache
  • Feeling of tingling or numbness
  • Feeling of fast or irregular heartbeat
  • Muscle stiffness
  • Nausea
  • Vomiting
  • Dry mouth
  • Impaired blood flow in hands and feet due to accidental injection in these areas
  • High blood pressure
  • Feeling weak
  • Sweating
  • Discomfort or pain in the chest
  • Changes in the blood, such as increased blood sugar levels, decreased potassium levels and harmful accumulation of acid in the body

Accidental injection of adrenaline into fingers or toes has been reported and may lead to impaired blood flow to affected areas as well as coldness, pallor, tingling and numbness, bruising, pain, bleeding and swelling at the injection site. Always consult a doctor if you accidentally inject. Jext contains sodium metabisulfite, which in rare cases can cause severe hypersensitivity reactions , including difficulty breathing.

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 carton and label after EXP. The expiration date is the last day of the specified month.

Do not store above 25 ° C.

Do not freeze.

Be sure to check the contents of the Jext from time to time through the display window on the label, to make sure that the liquid is still clear and colorless. Get a new Jext no later than the expiration date or earlier. Do not use this medicine if you notice that the liquid is discolored or contains a precipitate (solid particles). In order for you to remember to get a new Jext on time, it may be a good idea to note the expiration date in your calendar or calendar.

Jext is provided in a plastic case that is intended to protect the Jext when it is transported or stored. Jext must be removed from the case before use and during inspection of Jext. Put the Jext back in the case after inspection.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

  • The active substance is adrenaline .1 ml solution contains adrenaline tartrate corresponding to 1 mg adrenaline .
    Jext 150 micrograms provides a single dose of 150 micrograms adrenaline in 0.15 ml solution for injection .Jext 300 micrograms provides a single dose of 300 micrograms adrenaline in 0.3 ml solution for injection .
  • The other ingredients are sodium chloride, sodium metabisulfite (E223), hydrochloric acid , water for injections.

What the medicine looks like and contents of the pack

Jext is an injection solution in a pre-filled pen . It contains a clear and colorless solution in a cartridge of glass with latex-free rubber seals.

The pre-filled pen is delivered in a plastic case.

Exposed needle length:

Jext 150 micrograms: 13 mm

Jext 300 micrograms: 15 mm

Packaging: 1 pre-filled pen . 2×1 pre-filled pen .

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

ALK Abelló A / S

Bøge Allé 6-8

2970 Hørsholm

Denmark

Manufacturer

ALK-Abelló SA

Miguel Fleta 19

28037 Madrid

Spain

Information is provided by

ALK Nordic A / S, Denmark Branch

Box 10073

434 21 Kungsbacka

tel: 0300 – 185 45

email: infose@alk.net

This medicine is authorized in the European Economic Area under the name Jext:

Austria, Belgium, Denmark, Finland, France, Germany, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Slovakia, Spain, Sweden, UK.

Muhammad Nadeem

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