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JEXT 300 MICROGRAM SOLUTION FOR INJECTION IN PRE-FILLED PEN

Active substance(s): ADRENALINE

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Ref: 1644/130616/1/F

5. HOW TO STORE JEXT












Keep out of the sight and reach of children.
Do not store above 25°C.
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.
If your doctor tells you to stop using this
injection return any unused injections to your
pharmacist (chemist) for safe disposal. Only
keep this solution if your doctor tells you to.
If the solution becomes discoloured or shows
any other signs of deterioration, you should
seek the advice of your pharmacist who will tell
you what to do.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines that
are no longer required. These measures will
help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Jext contains
• Each pre-filled pen delivers one dose of 0.30ml
solution for injection containing 300 micrograms
of adrenaline (as tartrate)
• The other ingredients are sodium metabisulphite
(E223), sodium chloride, water for injections,
hydrochloric acid for pH adjustment.
What Jext looks like and contents of the pack
• A clear and colourless solution for injection in
pre-filled pen.
• Each pack contains 1 pre-filled pen
• Exposed needle length:
Jext 300 micrograms: 15 mm

Manufacturer and Licence Holder
Manufactured by ALK-Abelló A/S, Boge Alle 6-8,
DK-2970 Horsholm and is procured from within the
EU and repackaged by the Product Licence
Holder: Lexon (UK) Limited, Unit 18, Oxleasow
Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

POM

PL 15184/1644 Jext 300 micrograms
Solution for injection in
pre-filled pen

Jext is registered trademarks of the ALK-Abllo A/S
Leaflet revision date: 13/06/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

PATIENT INFORMATION LEAFLET

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.
Your medicine is called Jext 300 micrograms
Solution for injection in pre-filled pen and will be
referred to as Jext throughout the rest of this
leaflet
What is in 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 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, 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
• 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.
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
and 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. 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
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 a
serious allergic reaction. For this reason, your
doctor is likely to prescribe more than one Jext for
you. If your symptoms have not improved or have
deteriorated within 5-15 minutes after the first
injection, either you or the person with you should
give a second injection. 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.

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

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 until you hear
a ‘click’ confirming the injection
has started, then keep it
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..
Dial 999, ask for ambulance, state anaphylaxis.

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.
It is recommended that your family members,
carers or teachers are also instructed in the
correct use of Jext.
• Never put thumb, feet or hand over the
black needle shield as this is where the
needle comes out.
• Do not remove the yellow cap until you
need to use Jext.

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.
Ref:1644/130616/1/B

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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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