Adrenaline (epinephrine)* 300 mcg/0.3 mL Auto-Injector
CONSUMER MEDICINE INFORMATION
* In some countries, adrenaline is known as epinephrine.
What is in this leaflet?
This leaflet answers some common questions about ADRENALINE MYLAN Auto-Injector. It
does not contain all the available information. It does not take the place of talking
to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor or pharmacist has weighed the
risks of you receiving ADRENALINE MYLAN against the benefits this medicine is expected
to have for you.
If you have any concerns about receiving this medicine, talk to your doctor or pharmacist
before there is a situation where ADRENALINE MYLAN is needed.
Please read this leaflet carefully before an emergency arises.
Keep this leaflet safely, with the ADRENALINE MYLAN Auto-Injector. You will probably
want to read it again.
What ADRENALINE MYLAN is used for
ADRENALINE MYLAN 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 ADRENALINE MYLAN.
ADRENALINE MYLAN is used to treat people who have a severe allergic reaction caused
by, for example, hypersensitivity to
other allergens, possibly unidentified.
See Side effects for information regarding allergy to sodium metabisulfite.
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
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.
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 ADRENALINE MYLAN 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.
relaxes the lungs. This eases breathing and lessens wheezing.
- swelling, for example, of the face and lips
- skin rash and/or
The ADRENALINE MYLAN Auto-Injector is intended for use in people who have been assessed
and advised by their doctor or pharmacist as needing an ADRENALINE MYLAN Auto-Injector
to treat their severe allergic reaction and who
weigh more than 30 kg, and
are having a severe allergic reaction.
Note: Selection of the appropriate dosage is determined according to patient body
For a person 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 ADRENALINE MYLAN Auto-Injector. (The ADRENALINE JR MYLAN Auto-Injector delivers
a smaller amount of adrenaline).
If you have any questions about this, talk to your doctor or pharmacist.
provides convenient first-aid
may be self-administered or administered by a carer
has a spring-activated, hidden needle
automatically injects one pre-measured dose of adrenaline
is for single use only.
ADRENALINE MYLAN may be prescribed by your doctor. You can also purchase it directly
from a pharmacy.
Before you use ADRENALINE MYLAN
The ADRENALINE MYLAN Auto-Injector is simple to use. Please read and follow the step-by-step
Do not remove the blue safety release until you need to use ADRENALINE MYLAN and are
ready to use it.
The safety release stops ADRENALINE MYLAN 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.
When you must not use it
ADRENALINE MYLAN 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 ADRENALINE MYLAN Auto-Injector has a clear "viewing window" so you can see the
Do not use ADRENALINE MYLAN 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.
Check your ADRENALINE MYLAN regularly (see Things you must do).
Do not use ADRENALINE MYLAN
after the expiry date on the ADRENALINE MYLAN Auto-Injector and carton or
if the packaging is torn, doesn't look quite right or shows signs of tampering.
If the ADRENALINE MYLAN packaging is damaged or it is past the expiry date, return
it to your pharmacist for disposal.
Help in using ADRENALINE MYLAN
It is important to know how to use an ADRENALINE MYLAN Auto-Injector BEFORE a severe
allergic reaction causes a medical emergency.
Ask your doctor or pharmacist to show you how to use an ADRENALINE MYLAN Auto-Injector.
It is important to regularly ask your doctor or pharmacist how to use an ADRENALINE
ADRENALINE MYLAN 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
high pressure in the eye (narrow-angle glaucoma).
Take care also when giving ADRENALINE MYLAN to those
having an anaesthetic
or who have:
allergy to ADRENALINE MYLAN
You should tell your doctor or pharmacist if you have:
depression, or are on medication for depression
thyroid problems, or are on thyroid medication
heart disease or high blood pressure
high pressure in the eye (narrow angle glaucoma)
are pregnant or planning to become pregnant
ever had an allergic reaction to sodium metabisulfite.
Taking other medicines
Tell your doctor or pharmacist if you are taking other medicines, including any medicines
that you buy without a prescription from your pharmacy, supermarket or health food
shop. Some medicines may interfere with ADRENALINE MYLAN including:
medicines for high blood pressure, especially those known as "beta-blockers", and
other medicines for heart problems
medicines for depression, especially "tricyclic antidepressants"
medicines for diabetes
These medicines may affect how well the adrenaline in ADRENALINE MYLAN works. Your
doctor or pharmacist can tell you what to do if you are taking any of these medicines.
You should discuss any concerns you have with your doctor or pharmacist.
How to use ADRENALINE MYLAN
It is important to know how to use your ADRENALINE MYLAN in an emergency (see Help
in using ADRENALINE MYLAN).
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 ADRENALINE MYLAN
Auto-Injector, ask your doctor or pharmacist for help.
When to use it
Use ADRENALINE MYLAN immediately if you have 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:
difficulty in breathing
swelling, especially of the face, lips, tongue or throat
flushing of the face
irregular or faint pulse
vomiting, diarrhoea, stomach cramps
skin rash, hives
How much to use
ADRENALINE MYLAN Auto-Injector delivers one measured dose of adrenaline. This dose
is intended for a person who weighs more than 30 kg and has been assessed by their
doctor or pharmacist as needing ADRENALINE MYLAN.
Your doctor or pharmacist may also advise ADRENALINE MYLAN Auto-Injector for a child
who weighs from 15 kg up to 30 kg.
NOTE: Unless otherwise advised by the doctor or pharmacist, ADRENALINE JR MYLAN Auto-Injector
should be used for children who weigh from 15 kg up to 30 kg.
See also "What ADRENALINE MYLAN is used for" above.
How to use it
Grip only the mid-section of the ADRENALINE MYLAN Auto-Injector. Avoid touching either
end, except when you remove the blue safety release. The blue safety release stops
the ADRENALINE MYLAN 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 person who has
the severe allergic reaction.
Always hold the leg firmly during injection especially in people who are uncooperative
and kick or move during an injection. This will reduce the risk of injection related
Keep ADRENALINE MYLAN away from the face and eyes.
Never inject ADRENALINE MYLAN into the buttock.
Carefully follow the step-by-step directions to make the ADRENALINE MYLAN Auto-Injector
Flip open the yellow cap on the protective carry tube. Carefully tip and slide the
ADRENALINE MYLAN 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 ADRENALINE
MYLAN Auto-Injector through the "viewing window". Make sure the solution is clear,
colourless and sediment-free. If the "viewing window" is obscured, the ADRENALINE
MYLAN Auto-Injector has already "fired" and cannot be used again.
Make a fist around the ADRENALINE MYLAN Auto-Injector, with your thumb nearest to
the blue safety release.
Activate the ADRENALINE MYLAN Auto-Injector by removing the blue safety release with
your other hand. This "triggers" the ADRENALINE MYLAN Auto-Injector. It is now ready
"fire" the needle and
inject the medicine through the needle into the 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.
Hold the ADRENALINE MYLAN 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.
If you are administering the ADRENALINE MYLAN Auto-Injector to another person, hold
their leg firmly, especially if they are uncooperative.
Push the orange end FIRMLY into the outer mid-thigh until a "click" is heard or felt.
Keep pressing the ADRENALINE MYLAN Auto-Injector firmly against the thigh for approximately
NOTE: ADRENALINE MYLAN may be used either
through clothing, or
directly on to skin.
When you press the orange end of the ADRENALINE MYLAN Auto-Injector firmly against
the thigh, the hidden needle "fires". It injects the measured dose of adrenaline into
the thigh muscle.
Carefully take the ADRENALINE MYLAN Auto-Injector away from the thigh.
The orange needle cover will extend to cover the needle.
Check the "viewing window" - it should now be obscured. If it isn't, the ADRENALINE
MYLAN Auto-Injector has not "fired" or worked. If the "viewing window" is not obscured,
repeat steps 2-6 above.
Record the time ADRENALINE MYLAN was given.
Seek further medical attention for yourself immediately. Although you have received
adrenaline from ADRENALINE MYLAN, you may need more medical treatment.
Contact your doctor or
Call an ambulance (telephone 000 in Australia). State that adrenaline treatment may
With severe, persistent allergic reactions, repeat injections with an additional ADRENALINE
MYLAN may be necessary. The ADRENALINE MYLAN 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 ADRENALINE MYLAN unless under medical
Explain to the doctor that you have had ADRENALINE MYLAN (intramuscular adrenaline).
Take your used ADRENALINE MYLAN Auto-Injector with you.
To avoid injury, follow the used ADRENALINE MYLAN disposal instructions below (see
Additional information about treatment of insect sting allergy
Use ADRENALINE MYLAN immediately if you 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 (overdose)
Because each ADRENALINE MYLAN Auto-Injector 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 you or anyone else may have used too much of this medicine,
consult your doctor immediately or
telephone the Poisons Information Centre (telephone 13 11 26 in Australia) for advice,
go to Accident and Emergency at your nearest hospital. Do this even if there are
no signs of discomfort or poisoning. Urgent medical attention may be required.
Things to note about ADRENALINE MYLAN
Things you must do
Check what the expiry date is on your ADRENALINE MYLAN Auto-Injector.
Mark this expiry date on your calendar or diary.
Replace your ADRENALINE MYLAN Auto-Injector prior to this expiry date.
Also note on your calendar or diary to check the contents of your ADRENALINE MYLAN
Auto-Injector each month. Do this through the "viewing window".
Make sure the solution is clear, colourless and sediment-free. If not, obtain a new
ADRENALINE MYLAN Auto-Injector immediately.
If the "viewing window" is obscured this means the ADRENALINE MYLAN Auto-Injector
has already "fired" or worked. It cannot be used again. Return it to your doctor or
pharmacist for disposal. Obtain a new ADRENALINE MYLAN Auto-Injector immediately.
The ADRENALINE MYLAN Auto-Injector can be damaged and made unusable if it is mishandled.
ADRENALINE MYLAN is NOT a toy. Keep it out of reach of children.
Things you must not do
Do not use ADRENALINE MYLAN
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 15 kg to 30 kg unless advised by your doctor or pharmacist.
ADRENALINE JR MYLAN is generally recommended for children who weigh 15 kg to 30 kg.
(See also "What ADRENALINE MYLAN is used for" above).
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 child's weight and the life-threatening nature of the reaction(s) for
which ADRENALINE MYLAN is being prescribed.
Do not take off the blue safety release until you need to use ADRENALINE MYLAN and
are ready to use it.
Remember that the ADRENALINE MYLAN 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 ADRENALINE MYLAN Auto-Injector.
The ADRENALINE MYLAN Auto-Injector does not work like a retractable ball-point pen
(see How to use it step 3).
Do not bump the ADRENALINE MYLAN Auto-Injector until you intentionally push the orange
end firmly into the thigh (see How to use it step 4).
This will help prevent accidental activation of the ADRENALINE MYLAN Auto-Injector
prior to use.
Do not inject into hands, feet, ears, nose, buttocks, genital area or into a blood
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
Like all medicines, ADRENALINE MYLAN can
cause some side effects. Side effects not listed in this leaflet may occur in some
Tell your doctor or pharmacist if you experience any unpleasant side effects after
using ADRENALINE MYLAN, even if you do not think the effect is connected with the
medicine or is listed in this leaflet. Ask your doctor or pharmacist to answer any
questions you may have.
Do not be alarmed by the following list of side effects. You may not experience any
Tell your doctor or pharmacist if you have any of the following:
fast or noticeable heart beat
shortness of breath
pale skin colour
nausea or vomiting
flushing or redness of face and skin.
These side effects are minor and short lasting.
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
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
More severe side effects can occur occasionally. They are caused by adrenaline stimulating
the heart and increasing the blood pressure. Rarely, these side effects can cause,
for example, a stroke, lung problems or severe irregular heartbeat.
Adrenaline may also cause disorientation and impaired memory.
ADRENALINE MYLAN 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 asthma. However, the active ingredient, adrenaline, in ADRENALINE MYLAN 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 ADRENALINE MYLAN.
Storing ADRENALINE MYLAN before use
Always handle the ADRENALINE MYLAN Auto-Injector carefully, so as not to accidentally
activate it or make it "fire" or work.
Keep ADRENALINE MYLAN available with the person for whom it is intended.
Keep ADRENALINE MYLAN in a cool dry place below 25°C. Temperature excursions between
15°C to 25°C permitted.
Do not place ADRENALINE MYLAN in the fridge. Do not leave ADRENALINE MYLAN in your
car. Extreme temperatures may cause the auto-injector unit to malfunction.
Protect ADRENALINE MYLAN from light. Keep ADRENALINE MYLAN in the protective carry
tube until required.
Do not store ADRENALINE MYLAN or any other medicine in the bathroom or near a sink.
Do not leave it on a windowsill or in the car.
Heat and dampness can destroy some medicines.
Keep ADRENALINE MYLAN where children cannot accidentally reach it.
After using ADRENALINE MYLAN
After the ADRENALINE MYLAN Auto-Injector has "fired" or worked, the orange needle
cover will extend to cover the exposed needle. After use, continue to handle the ADRENALINE
MYLAN Auto-Injector safely and with care. Do this even if you think the ADRENALINE
MYLAN Auto-Injector has not "triggered", "fired" or worked properly.
You CANNOT RE-USE the ADRENALINE MYLAN Auto-Injector even though some adrenaline is
left inside it.
After use, do not just throw away the ADRENALINE MYLAN 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
Give your used ADRENALINE MYLAN Auto-Injector, to the doctor's office or to a hospital.
This is for inspection, if required, and also for safe disposal. The used ADRENALINE
MYLAN Auto-Injector, should be placed in a rigid sharps disposal unit.
ADRENALINE MYLAN delivers one x 0.3 mL dose of adrenaline (epinephrine). This ADRENALINE
MYLAN dose provides 300 mcg of adrenaline (epinephrine).
The ADRENALINE MYLAN Auto-Injector holds 2 mL of adrenaline (epinephrine) 1:1,000
The injection also contains small amounts of
It does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.
The ADRENALINE MYLAN Auto-Injector is packed in a protective plastic carry tube.
This carry tube has a yellow cap. The carry tube is supplied in a cardboard pack.
The Australian Registration Number is AUST R 296842.
This is not all the information available on ADRENALINE MYLAN. If you have any more
questions or are unsure about anything, ask your doctor or pharmacist.
ADRENALINE MYLAN is distributed in Australia by:
Alphapharm Pty Ltd
(ABN 93 002 359 739)
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: (02) 9298 3999
Phone: 1800 274 276
This leaflet was prepared in March 2018.
Made in USA