Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using EPIPEN JR?
EPIPEN JR contains the active ingredient adrenaline (epinephrine). In some countries,
adrenaline is known as epinephrine. EPIPEN JR is only to be used for the immediate
EMERGENCY TREATMENT of a SEVERE ALLERGIC REACTION (also known as ANAPHYLAXIS).
2. What should I know before I use EPIPEN JR?
EPIPEN JR is a life-saving treatment in the emergency management of severe allergic
reactions. Therefore, it should not be withheld from anyone who is considered to need
it. Talk to your doctor if your child has any other medical conditions, or take any other
medicines.
3. What if I am taking other medicines?
Some medicines may interfere with EPIPEN JR and affect how it works.
4. How do I use EPIPEN JR?
EPIPEN JR delivers one measured dose of adrenaline intended for a child who weighs
15 kg to 30 kg.
5. What should I know while using EPIPEN JR?
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Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are using EPIPEN JR.
Check the expiry date on EPIPEN JR and request for replacement prior to the expiry
date.
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Things you should not do
|
Do not use EPIPEN JR to treat any other medical conditions including other types of
shock unless advised by the doctor.
Do not use EPIPEN JR if the solution is cloudy, coloured, contains sediment or the
viewing window is obscured.
Do not take off the blue safety release until required.
Do not touch the orange end on any person or object while you are taking off the blue
safety release and/or after you have taken off the blue safety release.
Do not inject into hands, feet, ears, nose, buttocks, genital area or into blood vessels.
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Driving or using machines
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Your ability to drive and use machines may be affected by the anaphylactic reaction
and possible adverse effects to adrenaline.
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|
Looking after your medicine
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Keep EPIPEN JR in a cool dry place below 25°C. Temperature excursions between 15°C
to 25°C permitted. Do not refrigerate. Protect EPIPEN JR from light. Keep EPIPEN JR
in the protective carry tube until required.
|
6. Are there any side effects?
Tell your doctor or pharmacist if your child experiences a fast or noticeable heartbeat,
difficulty breathing, chest pain or shortness of breath.
Active ingredient(s):
adrenaline (epinephrine)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using EPIPEN JR. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using EPIPEN JR.
Where to find information in this leaflet:
1. Why am I using EPIPEN JR?
EPIPEN JR contains the active ingredient adrenaline (epinephrine).
EPIPEN JR is only to be used for the immediate EMERGENCY TREATMENT of a SEVERE ALLERGIC
REACTION (also known as ANAPHYLAXIS). Your doctor or pharmacist will explain what
this is like, so that you know when you must use EPIPEN JR.
EPIPEN JR is used to treat children who have a severe allergic reaction caused by,
for example, hypersensitivity to
food
medicines
stinging insects
insect bites
latex or
other allergens, possibly unidentified.
Avoidance of known allergens is most important in preventing severe allergic reactions.
A severe allergic reaction, otherwise known as anaphylaxis, is overwhelming and life-threatening.
It affects the whole body, in particular the
heart and blood circulation.
This may cause, for example, low blood pressure and collapse, or abnormal heart beat
or function.
air passages and lungs.
This causes difficulty in breathing, with noisy wheezing or gasping, possibly with
sneezing and a very runny nose.
stomach and bowels.
This may cause nausea, vomiting, diarrhoea and abdominal cramps, often severe.
skin (very common).
This causes flushing, itching, skin rash, hives or swelling, which may be widespread
or in one part of the body.
brain.
There may be fits or confusion due to lack of oxygen.
Usually several parts of the body are affected. The patient feels extremely unwell.
It is important to act quickly to treat a severe allergic reaction.
The adrenaline in EPIPEN JR treats allergic emergencies. It
shrinks abnormally wide blood vessels and
makes the heart beat strongly.
This helps improve the very low blood pressure and poor circulation that occur in
a severe allergic reaction.
Adrenaline also
relaxes the lungs. This eases breathing and lessens wheezing.
helps stop
swelling, for example, of the face and lips
skin rash and/or
itching.
The EPIPEN JR Auto-Injector is intended for use in children who have been assessed
and advised by their doctor or pharmacist as needing an EPIPEN JR Auto-Injector to
treat their severe allergic reaction and who
weigh 15 kg to 30 kg, and
are having a severe allergic reaction.
Note: Selection of the appropriate dosage is determined according to patient body
weight.
For a child who weighs from 15 kg up to 30 kg, the doctor or pharmacist may assess
their severe allergic reaction as needing the larger dosage of adrenaline as provided
by an EPIPEN JR Auto-Injector. (The EPIPEN JR Auto-Injector delivers a smaller dosage
of adrenaline). Similarly, there may be instances where the doctor or pharmacist will
recommend the use of EpiPen Jr. in some adults, based on careful medical assessment.
If you have any questions about this, talk to your doctor or pharmacist.
EPIPEN JR
provides convenient first-aid
may be self-administered or administered by a carer to the child
has a spring-activated, hidden needle
automatically injects one pre-measured dose of adrenaline
is for single use only.
EPIPEN JR may be prescribed by your doctor. You can also purchase it directly from
a pharmacy.
2. What should I know before I use EPIPEN JR?
The EPIPEN JR Auto-Injector is simple to use. Please read and follow the step-by-step
instructions.
Do not remove the blue safety release until you need to use EPIPEN JR and are ready
to use it. The safety release stops EPIPEN JR from “firing” or working.
There is no visible needle. This helps overcome fear of injection. The hidden needle
is very fine so that the injection does not usually hurt.
Warnings
EPIPEN JR is a life-saving treatment in the emergency management of severe allergic
reactions. Therefore, it should not be withheld from anyone who is considered to need
it.
The EPIPEN JR Auto-Injector has a clear “viewing window” so you can see the contents.
Do not use EPIPEN JR if the contents:
are cloudy or
are coloured or
contain sediment or
if the “viewing window” is obscured.
These changes indicate that the effectiveness of the drug product may be decreased.
When the “viewing window” is obscured, the auto-injector has already “fired” and cannot
be used again.
Do not use EPIPEN JR
after the expiry date on the EPIPEN JR Auto-Injector and carton or
if the packaging is torn, doesn’t look quite right or shows signs of tampering.
If the EPIPEN JR packaging is damaged or it is past the expiry date, return it to
your pharmacist for disposal.
Help in using EPIPEN JR
It is important to know how to use an EPIPEN JR BEFORE a severe allergic reaction
causes a medical emergency.
Ask your doctor or pharmacist how you can get an EPIPEN JR Training Device for practice.
An EPIPEN JR Training Device is similar to the real EPIPEN JR. However, the EPIPEN
JR Training Device has
NO medicine (adrenaline) and
NO needle and
“fires” quietly and less forcefully.
Ask your doctor or pharmacist to show you how to practice with the EPIPEN JR Training
Device. If you practice using the EPIPEN JR Training Device, it will help you to learn
how to use the real EPIPEN JR.
It is important to regularly ask your doctor or pharmacist to demonstrate use with
an EPIPEN JR Training Device.
EPIPEN JR is effective as emergency treatment of a severe allergic reaction ONLY when
used according to the directions in this leaflet.
Give WITH CAUTION to those who have
high blood pressure
thyroid problems
high pressure in the eye (narrow-angle glaucoma).
If you have a thick-subcutaneous fat layer, there is a risk of the adrenaline not
reaching the muscle tissue resulting in a suboptimal effect. In such individuals there
may be a higher likelihood of needing a second injection with an additional EpiPen
JR.
Take care also when giving EPIPEN JR to those
having an anaesthetic
or who have:
diabetes
heart disease
allergy to EPIPEN JR
brain damage.
You should tell your doctor or pharmacist if your child has:
depression, or is on medication for depression
thyroid problems, or is on thyroid medication
heart disease or high blood pressure
diabetes
high pressure in the eye (narrow angle glaucoma)
asthma
ever had an allergic reaction to sodium metabisulfite.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
3. What if I am taking other medicines?
Tell your doctor or pharmacist if your child is taking any other medicines, including
any medicines, vitamins or supplements that you buy without a prescription from your
pharmacy, supermarket or health food shop.
Some medicines may interfere with EPIPEN JR including:
medicines for high blood pressure, especially those known as “beta-blockers”, and
other medicines for heart problems
medicines for depression, especially “tricyclic antidepressants”
thyroid hormone
medicines for diabetes
antihistamines.
These medicines may affect how well the adrenaline in EPIPEN JR works.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements your child is taking and if these affect EPIPEN JR.
4. How do I use EPIPEN JR?
Follow carefully all directions given to you by your doctor or pharmacist.
They may differ from the information contained in this leaflet.
If you do not understand the instructions in this leaflet or on the EPIPEN JR Auto-Injector,
ask your doctor or pharmacist for help.
How much to use
EPIPEN JR Auto-Injector delivers one measured dose of adrenaline. This dose is intended
for a child who weighs 15 kg to 30 kg and has been assessed by their doctor or pharmacist
as needing EPIPEN JR.
NOTE: Your child’s doctor or pharmacist may advise EpiPen Auto-Injector for the treatment
of an anaphylactic attack in children who weigh from 15 kg up to 30 kg after careful
assessment of their body weight and the severity of their symptoms.
Similarly, there may be instances where the doctor or pharmacist will recommend the
use of EpiPen Jr. in some adults, based on careful medical assessment.
When to use EPIPEN JR
Use EPIPEN JR immediately if your child has signs and symptoms of a severe allergic
reaction, as described by your doctor or pharmacist. Symptoms do vary. However, the
symptoms are likely to include:
collapse
difficulty in breathing
wheezing
swelling, especially of the face, lips, tongue or throat
flushing of the face
irregular or faint pulse
vomiting, diarrhoea, stomach cramps
skin rash, hives
itching.
How to use EPIPEN JR
General
Grip only the mid-section of the EPIPEN JR Auto-Injector. Avoid touching either end,
except when you remove the blue safety release. The blue safety release stops the
EPIPEN JR from “firing” or working.
Never place thumb, fingers or hand over the orange end as this contains the needle.
Always point the orange end (which holds the needle) away from any part of any body,
except the planned injection site. This is usually the thigh of the child who has
the severe allergic reaction.
Always hold the leg firmly during injection especially in children who are uncooperative
and kick or move during an injection. This will reduce the risk of injection related
injuries.
Keep EPIPEN JR away from the face and eyes.
Never inject EPIPEN JR into the buttock.
Carefully follow the step-by-step directions to make the EPIPEN JR work properly.
Step 1
Flip open the green cap on the protective carry tube. Carefully tip and slide the
EPIPEN JR Auto-Injector out of the carry tube. Never place thumb, fingers or hand
over the orange end as this contains the needle. Check the contents of the EPIPEN
JR Auto-Injector through the “viewing window”. Make sure the solution is clear, colourless
and sediment-free. If the “viewing window” is obscured, the EPIPEN JR has already
“fired” and cannot be used again.
Step 2
Make a fist around the EPIPEN JR Auto-Injector, with your thumb nearest to the blue
safety release (see FIGURE 1).
FIGURE 1
Step 3
Activate the EPIPEN JR Auto-Injector by removing the blue safety release with your
other hand (also shown in FIGURE 1). This “triggers” the EPIPEN JR. It is now ready
to
“fire” the needle and
inject the medicine through the needle into the child's thigh muscle.
After you remove the blue safety release do not touch or place thumb, fingers or hand
over the orange end as this contains the needle.
Step 4
Hold the EPIPEN JR Auto-Injector at a 90° angle (right angle) to the outer part of
the thigh. Hold the orange end about 5cm away from the thigh (see FIGURE 2).
FIGURE 2
Step 5
Hold the child’s leg firmly, especially if they are uncooperative or may kick or move
during the injection.
Push the orange end FIRMLY into the child's outer mid-thigh until a “click” is heard
or felt. Keep pressing the EPIPEN JR Auto-Injector firmly against the thigh for approximately
3 seconds (see FIGURE 3).
FIGURE 3
NOTE: EPIPEN JR may be used either
through clothing, as shown in FIGURE 3, or
directly on to skin.
When you press the orange end of the EPIPEN JR Auto-Injector firmly against the thigh,
the hidden needle “fires”. It injects the measured dose of adrenaline into the child's
thigh muscle.
Step 6
Carefully take the EPIPEN JR Auto-Injector away from the thigh.
The orange needle cover will extend to cover the needle (see FIGURE 4).
FIGURE 4
Check the “viewing window” - it should now be obscured. If it isn’t, the EPIPEN JR
has not “fired” or worked. If the “viewing window” is not obscured, repeat steps 2-6
above.
Step 7
Record the time EPIPEN JR was given.
Step 8
Seek further medical attention for your child immediately. Although the child has
received adrenaline from EPIPEN JR, he/she may need more medical treatment.
Either
Contact your doctor or
Call an ambulance (telephone 000 in Australia or 111 in New Zealand). State that adrenaline
treatment may be needed.
Step 9
With severe, persistent allergic reactions, repeat injections with an additional EPIPEN
JR may be necessary. The EPIPEN JR dose may be repeated every 5 to 15 minutes if symptoms
recur or have not subsided.
Do not inject more than two sequential doses of EPIPEN JR unless under medical supervision.
Step 10
Explain to the doctor that your child has had EPIPEN JR (intramuscular adrenaline).
Take your used EPIPEN JR Auto-Injector with you.
Additional information about treatment of insect sting allergy
Use EPIPEN JR immediately if you or your child have been stung or bitten by the insect
and experience the signs and symptoms as described by your doctor or pharmacist.
If the insect’s sting is easily accessible, remove the sting with your fingernails.
Do not squeeze, pinch or push the sting deeper into the skin. If available, ice packs
or sodium bicarbonate soaks may then be applied to the stung area.
Keep warm, calm, and as still as possible.
If you use too much EPIPEN JR
Because each EPIPEN JR contains only one dose, overdosage is unlikely. Overdosage
may lead to a rise in blood pressure. This may cause bleeding in the brain or fluid
in the lung.
If you think that you have used too much EPIPEN JR, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26, New Zealand telephone 0800 POISON or 0800 764 766)
for advice, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using EPIPEN JR?
Things you should do
Check what the expiry date is on your EPIPEN JR.
Mark this expiry date on your calendar or diary.
Replace your EPIPEN JR prior to this expiry date.
Also note on your calendar or diary to check the contents of your EPIPEN JR each month.
Do this through the “viewing window”.
Make sure the solution is clear, colourless and sediment-free. If not, obtain a new
EPIPEN JR immediately.
If the “viewing window” is obscured this means the EPIPEN JR has already “fired” or
worked. It cannot be used again. Return it to your doctor or pharmacist for disposal.
Obtain a new EPIPEN JR immediately.
The EPIPEN JR Auto-Injector can be damaged and made unusable if it is mishandled.
EPIPEN JR is NOT a toy. Keep it out of reach of children.
Things you should not do
Do not use EPIPEN JR
to treat any other medical conditions including other types of shock unless your doctor
tells you to.
if the solution is brown or contains any particles or cloudiness.
in a child who weighs more than 30 kg unless advised by your doctor or pharmacist.
EPIPEN is generally recommended for any adult or child who weighs more than 30 kg.
in a child who weighs less than 15 kg. Talk to your doctor or pharmacist if this is
the case so that a careful assessment can be made and the appropriate dose selected
based on the individual’s weight and the life-threatening nature of the reaction(s)
for which EPIPEN JR is being prescribed.
Do not take off the blue safety release until you need to use EPIPEN JR and are ready
to use it.
Remember that the EPIPEN JR Auto-Injector is activated (“triggered”, ready to “fire”)
as soon as you take off the blue safety release.
Do not touch the orange end on any person or object while you are taking off the blue
safety release and/or after you have taken off the blue safety release.
The orange end holds the hidden needle, ready to “fire” and inject the adrenaline.
After you take off the blue safety release
Do not “click” on either end of the EPIPEN JR Auto-Injector. The EPIPEN JR Auto-Injector
does not work like a retractable ball-point pen (see How to use EPIPEN JR - Step 3
in Section
4. How do I use EPIPEN JR?
).
Do not bump the EPIPEN JR Auto-Injector until you intentionally push the orange end
firmly into the child's thigh (see How to use EPIPEN JR - Step 4 in Section
4. How do I use EPIPEN JR?
).
This will help prevent accidental activation of the EPIPEN JR Auto-Injector prior
to use.
Do not inject into hands, feet, ears, nose, buttocks, genital area or into a blood
vessel.
If this does happen accidentally you must immediately seek medical attention.
Do not inject into the buttock.
Rare cases of serious skin infections have been reported following injection into
the buttock. If you develop signs or symptoms of infection, such as persistent redness,
warmth, swelling, or tenderness, at the adrenaline injection site you must seek medical
attention immediately.
Driving or using machines
Your ability to drive and use machines may be affected by the anaphylactic reaction
and possible adverse effects to adrenaline.
Looking after your medicine
Always handle the EPIPEN JR Auto-Injector carefully, so as not to accidentally activate
it or make it “fire” or work.
Keep EPIPEN JR available with the person for whom it is intended.
Keep EPIPEN JR in a cool dry place below 25°C. Temperature excursions between 15°C
to 25°C permitted.
Do not place EPIPEN JR in the fridge. Do not leave EPIPEN JR in your car. Extreme
temperatures may cause the auto-injector unit to malfunction.
Protect EPIPEN JR from light. Keep EPIPEN JR in the protective carry tube until required.
Store EPIPEN JR in a cool dry place away from moisture, heat or sunlight; for example,
do not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Heat and dampness can destroy some medicines.
Follow the instructions in the carton on how to take care of your medicine properly.
Keep it where children cannot accidentally reach it.
When to discard your medicine (as relevant)
After the EPIPEN JR Auto-Injector has “fired” or worked, the orange needle cover will
extend to cover the exposed needle. After use, continue to handle the EPIPEN JR Auto-Injector
safely and with care. Do this even if you think the EPIPEN JR Auto-Injector has not
“triggered”, “fired” or worked properly.
You CANNOT RE-USE the EPIPEN JR Auto-Injector even though some adrenaline is left
inside it.
After use, do not just throw away the EPIPEN JR Auto-Injector.
Do not tamper with the orange needle cover.
Do not replace the blue safety release.
The used auto-injector with extended needle cover will not fit back into the carry
tube.
Give your used EPIPEN JR, to the doctor’s office or to a hospital. This is for inspection,
if required, and also for safe disposal. The used EPIPEN JR, should be placed in a
rigid sharps disposal unit.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Accidental injection into the hands, fingers or feet may result in the following:
fast or noticeable heart beat
pale skin colour at the site of accidental injection
feeling of coldness at the site of accidental injection
bruising or discolouration at the site of accidental injection
bleeding
If an accidental injection occurs at one of these areas, seek medical attention immediately
Injection related injuries, such as needle cuts and bent needles, have been reported
in people who are uncooperative and kick or move during the injection.
Rare cases of serious skin infections have been reported following injection into
the buttock.
Sodium metabisulfite
EPIPEN JR contains a very small quantity of sodium metabisulfite as a preservative.
In people who are allergic to sodium metabisulfite, this could cause, for example,
severe allergic reactions (hypersensitivity) or breathing difficulty (bronchospasm)
in certain groups of people, especially those with history of asthma. However, the
active ingredient, adrenaline, in EPIPEN JR is expected to overcome any allergic reaction
to sodium metabisulfite. In an emergency, the risk of exposure to the very small amount
of sodium metabisulfite is generally outweighed by the benefits of EPIPEN JR.
Reporting side effects
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What EPIPEN JR contains
|
Active ingredient
(main ingredient)
|
Adrenaline (epinephrine)
|
|
Other ingredients
(inactive ingredients)
|
sodium chloride
sodium metabisulfite
hydrochloric acid.
|
|
Potential allergens
|
Sulfites
|
Do not take this medicine if you are allergic to any of these ingredients.
What EPIPEN JR looks like
EPIPEN JR (AUST R 42980) delivers one x 0.3 mL dose of adrenaline (epinephrine). This
EPIPEN JR dose provides 150 µg of adrenaline (epinephrine).
The EPIPEN JR Auto-Injector holds 2 mL of adrenaline (epinephrine) 1:2,000 solution.
The EPIPEN JR Auto-Injector is packed in a non-waterproof protective plastic carry
tube. This carry tube has a green cap. The carry tube is supplied in a cardboard pack.
Who distributes EPIPEN JR
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
Distributed in New Zealand by:
Viatris Ltd
PO Box 11-183
Ellerslie
AUCKLAND
Telephone 0800 168 169
This leaflet was prepared in Mar 2023.
EPIPEN JR® is a Viatris company trade mark.
Made in USA
EPIPEN JR_cmi\Mar23/00