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JEXT 300 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED PEN

Active substance: ADRENALINE TARTRATE

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1057331

1057331_Pil_UK_Jext_draft141202_JEXT UK 15-12-2014 12:22 Side 1

Package leaflet:
Information for the patient

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 because it
contains important information for you.
- 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 you get any side effects talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet:
1. What Jext is and what it is used for
2. What you need to know beforeyou 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 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);
flushing; swelling of the lips, throat, tongue,
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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
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: Jext contains sodium
metabisulphite and sodium chloride.
Warnings and precautions
Talk to your doctor when you are prescribed
Jext
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.
If you have asthma you may be at increased
risk of a severe allergic reaction.
Anyone who has an episode of anaphylaxis
should see their doctor about testing for
substances they may be allergic to, so these
can be strictly avoided in future. It is
important to be aware that an allergy to one
substance can lead to allergies to a number
of related substances.
If you have food allergies it is important to
check the ingredients in everything you
ingest (including medicines) as even small
amounts can cause severe reactions.
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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.
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.
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 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.
Pregnancy, breast-feeding 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.
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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.
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.
Jext contains sodium metabisulphite
and sodium chloride
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 have 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
Adults and Children over 30kg – the
recommended dose for allergic emergencies is
300 micrograms adrenaline for injection into
the outer thigh muscle (intramuscular use).
Children between 15kg and 30kg - the
recommended 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.
If you notice the signs of an acute allergic
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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.
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- Do not remove the yellow cap until you
need to use Jext
For correct administration, look at the
diagrams and follow these steps:
Before Use

After Use
Yellow cap

Window

Black Injector Tip

Window

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
K
has started, then keep it
IC
CL
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.

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.
Jext is designed as emergency treatment. You
should always get medical help immediately
after using Jext. Dial 999, ask for an ambulance
and state 'anaphylaxis’ even if symptoms
appear to be improving. You will need to
go to hospital for observation and further
treatment as required. This is because the
reaction may happen again at some time later.
While waiting for the ambulance you should
lie down with your feet raised unless this
makes you breathless 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 injection of
adrenaline. 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
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.

4. Possible side effects
Like all medicines this medicine can cause side
effects, although not everybody gets them.
The following side effects are based upon
experience with the use of adrenaline
(frequency not known: frequency cannot be
estimated from the available data)
• Heart problems such as irregular and rapid
heartbeat, feeling your heartbeat, chest pain
• High blood pressure, narrowing of the
blood vessels
• Sweating
• Nausea, vomiting
• Difficulty breathing
• Headache, dizziness, fainting
• Weakness, tremor
• Anxiety, hallucinations
• Changes in your blood such as increased
blood sugar levels, decreased potassium
levels and harmful collection of acid in the
body
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.
Reporting of side effects
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet.
You can also report side effects directly via
the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard
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 carton

Dial 999, ask for ambulance state
'anaphylaxis'.
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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 through
the window in the label from time to
time to make sure the liquid is still
clear and colourless. Replace Jext by
the expiry date or earlier. Do not use
this medicine if you notice 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.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will help
protect the environment.

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,
Iceland, Ireland, Italy,
Luxembourg,
The Netherlands, Norway,
Slovakia, Spain, Sweden,
United Kingdom.

This leaflet was last revised in
November 2014

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.
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.
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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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