JEXT 150 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED PEN

Active substance: ADRENALINE TARTRATE

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Package leaflet:
Information for the user

150 micrograms
300 micrograms

Jext 150 micrograms, solution for
injection in pre-filled pen
Jext 300 micrograms, solution for
injection in pre-filled pen
Adrenaline
Read all of this leaflet carefully before
you start using this medicine.
- Keep this leaflet. You may need to read it
again.
- If you have any further questions, ask your
doctor or pharmacist.
- This medicine has been prescribed for you
only. Do not pass it on to others. It may
harm them, even if their signs of illness are
the same as yours.
- If any of the side effects get serious, or if
you notice any side effects not listed in
this leaflet, please tell your doctor or
pharmacist.
What is in this leaflet:
1. What Jext is and what it is used for
2. Before you use Jext
3. How to use Jext
4. Possible side effects
5. How to store Jext
6. Further Information
®

1. What Jext is and what it is used for
Jext contains a sterile solution of adrenaline
within an auto-injector for emergency injection
of a single dose of adrenaline into the outer
part of the thigh muscle (intramuscular
injection).
Jext is to be used for the emergency
treatment of sudden life threatening allergic
reactions (anaphylactic shock) to insect
stings or bites, foods or drugs or exercise.
Symptoms that signal the onset of an
anaphylactic shock occur within minutes of
exposure to the allergen and include: itching
of the skin; raised rash (like a nettle rash);
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flushing; 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. Before you use Jext

Jext can always be used during an allergic
emergency. If you are allergic (hypersensitive)
to sodium metabisulphite or to any of the
other ingredients of Jext your doctor will need
to instruct you under which circumstances
Jext should be used. For further information
on hypersensitivity to sulphites please look
in the section:
Important information about some of the
ingredients of Jext.
Warnings and precautions
Talk to your doctor or pharmacist before
using Jext
• if you have heart disease
• if you have an overactive thyroid
• if you have high blood pressure
• if you have diabetes
• if you have a tumour on the adrenal gland
(phaeochromocytoma)
• if you have increased pressure in the eye
(glaucoma)
• if you have renal or prostate disease
• if you have low potassium levels or high
calcium levels in your blood
• and/or if you are elderly, pregnant or the
child weighs less than 15 kg as there is a
greater risk of getting side effects.
Make sure that you discuss this with your
doctor if any of the above conditions apply
to you.
You should have been carefully instructed by
your doctor or nurse when and how to correctly use Jext.
The instructions for use must be carefully
followed in order to avoid accidental injection.
Jext should only be injected intramuscularly
into the outer thigh. It should not be injected
into the buttock due to the risk of accidental
injection into a vein.
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Warning
Accidental injection into the hands or feet
may result in reduced blood supply to these
areas. If there is an accidental injection into
these areas, you should go immediately to
the nearest hospital emergency department
for treatment.
Taking other medicines
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
This is especially important if you take any of
the following:
• Antidepressants such as tricyclic
antidepressants or monoamine oxidase
inhibitors (MAO inhibitors), since the
effects of adrenaline may be increased.
• Medicines for treatment of Parkinsons
disease such as catechol-O-methyl
transferase inhibitors (COMT inhibitors),
since the effect of adrenaline may be
increased.
• Medicines that may make the heart
sensitive to uneven beats (arrhythmias),
such as digitalis or quinidine.
• Alpha and beta blocking medicines for heart
disease or medicines to treat disorders of
the nervous system as they can reduce the
effect of adrenaline.
Diabetic patients should carefully monitor
their glucose levels after use of Jext as
adrenaline can increase the blood glucose level.

Driving and using machines
The ability to drive and use machines is
unlikely to be affected by the administration
of an adrenaline injection, but may be affected
by an anaphylactic reaction. If affected, do
not drive.
Important information about some of
the ingredients of Jext
Jext contains sodium metabisulphite which
may rarely cause severe allergic reactions
(hypersensitivity) or breathing difficulty
(bronchospasm). Your doctor must instruct
you under which circumstances Jext should
be used.
®

Jext contains less than 1 mmol sodium (23 mg)
per dose, i.e. essentially sodium free.
®

3. How to use Jext

Always use this medicine exactly as your
doctor or pharmacist has told you. Make
sure you understand in what situations you
should use Jext. Check with your doctor or
pharmacist if you are not sure.
Dosage
The dose will be decided by your doctor,
who will adjust it individually for you.
Adults and Children over 30kg – the
usual dose for allergic emergencies is 300
micrograms adrenaline for injection into the
outer thigh muscle (intramuscular use).

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice
before taking any medicine.
There is limited experience of the use of
adrenaline during pregnancy. If you are
pregnant, do not hesitate to use Jext in an
emergency, since you and your baby's life may
be in danger.
Jext would not be expected to have any effect
on the nursing infant.
Discuss this with your doctor if you are
pregnant or breast-feeding.

Children Between 15kg and 30kg the usual dose for allergic emergencies is
150 micrograms adrenaline for injection into
the outer thigh muscle (intramuscular use).
Remember: the correct dose of Jext depends
on bodyweight. The dose will need to be
increased as your child develops and will need
to be discussed with your doctor.

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If you notice the signs of an acute allergic
reaction, use Jext immediately, through your
clothing if necessary.
After use some liquid will remain in the
auto-injector but this cannot be reused.

Sometimes a single dose of adrenaline may
not be sufficient to completely reverse the
effects of an allergic reaction. For this reason,
your doctor may prescribe more than one
Jext for you. Repeated injection may be
administered after 5-15 minutes if the
symptoms are still present and your doctor
has told you that you can do this. For this
reason you should carry more than one Jext
with you at all times.
Method of administration
Jext has been designed to inject through the
clothes or directly through the skin of the
outer thigh.
Jext should be pushed firmly against the
outer portion of the thigh into the largest
part of the thigh muscle. When you push
Jext firmly into your thigh, a spring activated
plunger will be released, which pushes the
hidden needle through the seal at the end of
the black needle shield, into the thigh muscle
and injects a dose of adrenaline.
The instructions for use of Jext given below
must be carefully followed.
Jext should only be injected into the outer
thigh. It should not be injected into the
buttock (your bottom).
Instructions for use
Before you ever need to use it, you should
fully familiarise yourself with Jext, when and
how it should be used. During instruction in
correct use of Jext, your doctor may use a
Jext Simulator to ensure that you and any
other family members or carers are confident
in what to do when an allergic emergency
happens.
Follow these directions only when ready to
use.
- Never put thumb, feet or hand over the
black needle shield as this is where the
needle comes out.
- Do not remove yellow cap until you need
to use Jext.

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For correct administration, look at the
diagrams and follow these steps:
Before Use

After Use
Yellow cap

Window

Window

Black Injector Tip

The inspection window in the label is filled
by a coloured plastic rod (white in Jext 300
and blue in Jext 150) to confirm that the
auto-injector has activated and the adrenaline
solution has been injected.
A small air bubble may be present in Jext. It
does not affect the way the product works.
Even though most of the liquid remains in
Jext after use, it cannot be reused.

Black Injector Tip

1. Grasp the Jext injector in
your dominant hand (the
one you use to write
with) with your thumb
closest to the yellow cap.
2. Pull off the yellow cap
with your other hand.

3. Place the black injector tip
against your outer thigh,
holding the injector at a
right angle (approx 90°)
to the thigh.
4. Push the black tip firmly
into your outer thigh
SEC
until you hear a ‘click’
confirming the injection
has started, then keep it
CK
LI
C
pushed in. Hold the
injector firmly in place against the thigh for
10 seconds (a slow count to 10) then remove.
The black tip will extend automatically and
hide the needle.
5. Massage the injection
area for 10 seconds. Seek
immediate medical help.

Dial 999, ask for ambulance state
'anaphylaxis'.

As Jext is designed as emergency
treatment only, you should always seek
medical help immediately after using
Jext. Dial 999, ask for ambulance, state
anaphylaxis. Make sure that you inform the
healthcare professional that you have received
an intramuscular injection of adrenaline and
hand over the used Jext for safe disposal.
®

If you use more Jext than you should
In case of overdose or accidental injection of
the adrenaline, you should always seek
immediate medical help. You should see
your doctor to replace the used Jext as soon
as possible.
Your blood pressure may rise sharply.
Overdose may cause a sudden increase in
blood pressure, irregular heartbeat, abnormal
kidney function, reduced 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.

Accidental injection of the adrenaline into
hands or feet has been reported and may
result in lack of blood supply to these areas.
In case of accidental injection, always seek
immediate medical help. Jext contains sodium
metabisulphite which may rarely cause severe
hypersensitivity reactions including difficult
breathing.
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
®

5. How to store Jext

Keep this medicine out of the reach and sight
of children.
Do not use this medicine after the expiry
date which is stated on the label and carton
after EXP. The expiry date refers to the last
day of that month.
Do not freeze.
Please remember to check the
contents of the glass cartridge in Jext
from time to time through the window
in the label to make sure the liquid is
still clear and colourless.
Replace Jext by the expiry date or
earlier if the solution is discoloured or
contains a precipitate (solid particles).
You may find it useful to put the expiry
date in your calendar or diary to ensure
that you replace Jext in time.

4. Possible side effects
Like all medicines this medicine can cause side
effects, although not everybody gets them.
Usual side effects include: irregular heartbeat
(including palpitations and rapid heartbeats),
high blood pressure, chest pain (angina
pectoris), narrowing of the blood vessels,
sweating, nausea, vomiting, difficulty breathing,
headache, dizziness, weakness, tremor or
anxiety. Hallucinations, fainting, changes in
your blood such as increased blood sugar
levels, decreased potassium levels in your
blood, harmful collection of acid in the body
and heart problems (stress cardiomyopathy).

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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.

Jext 300 micrograms injects one single dose
of 300 micrograms adrenaline in 0.3ml
solution for injection.
The other ingredients are:
Sodium chloride,
Sodium metabisulphite (E223),
Hydrochloric acid,
Water for injections.
®

What Jext looks like and contents of
the pack
Jext is a solution for injection in a pre-filled
pen. It contains a clear and colourless
solution inside a glass cartridge with latex
free rubber seals.
Pack size: 1 pre-filled pen.
Marketing Authorisation Holder and
Manufacturer
ALK-Abelló A/S,
Bøge Allé 6-8,
DK-2970 Hørsholm
This medicinal product is authorised in
Member States of the EEA under the
name Jext .
®

Austria, Belgium, Denmark,
Finland, France, Germany,
Greece, Iceland, Ireland, Italy,
Luxembourg,
The Netherlands, Norway,
Slovakia, Spain, Sweden,
United Kingdom.

This leaflet was last revised in
March 2013

6. Further information
®

What Jext contains
The active substance is adrenaline.
1 ml solution contains 1 mg adrenaline
(as tartrate).
Jext 150 micrograms injects one single dose
of 150 micrograms adrenaline in 0.15ml
solution for injection.
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®

Jext

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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