Adrenaline (epinephrine)* 150 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 JR 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 your child receiving ADRENALINE JR MYLAN against the benefits this medicine is expected to have for them.
If you have any concerns about your child receiving this medicine, talk to your doctor or pharmacist before there is a situation where ADRENALINE JR MYLAN is needed.
Please read this leaflet carefully before an emergency arises.
Keep this leaflet safely, with the ADRENALINE JR MYLAN Auto-Injector. You will probably want to read it again.
What ADRENALINE JR MYLAN is used for
ADRENALINE JR 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 JR MYLAN
ADRENALINE JR MYLAN 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.
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 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 ADRENALINE JR 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.
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 ADRENALINE JR MYLAN Auto-Injector is intended for use in children who have been assessed and advised by their doctor or pharmacist as needing an ADRENALINE JR MYLAN Auto-Injector to treat their severe allergic reaction and who
weigh from 15 kg up 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 ADRENALINE MYLAN Auto-Injector. (The ADRENALINE JR MYLAN Auto-Injector delivers a smaller dosage of adrenaline). Similarly, there may be instances where the doctor or pharmacist will recommend the use of ADRENALINE JR MYLAN in some adults, based on careful medical assessment.
If you have any questions about this, talk to your doctor or pharmacist.
ADRENALINE JR MYLAN
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.
ADRENALINE JR MYLAN may be prescribed by your doctor. You can also purchase it directly from a pharmacy.
Before you use ADRENALINE JR MYLAN
The ADRENALINE JR MYLAN 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 ADRENALINE JR MYLAN and are ready to use it. The safety release stops ADRENALINE JR MYLAN Auto-Injector 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 JR 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 JR MYLAN Auto-Injector has a clear "viewing window" so you can see the contents.
Do not use ADRENALINE JR 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 JR MYLAN Auto-Injector regularly (see Things you must do).
Do not use ADRENALINE JR MYLAN
after the expiry date on the ADRENALINE JR MYLAN Auto-Injector and carton or
if the packaging is torn, doesn't look quite right or shows signs of tampering.
If the ADRENALINE JR MYLAN packaging is damaged or it is past the expiry date, return it to your pharmacist for disposal.
Help in using ADRENALINE JR MYLAN
It is important to know how to use an ADRENALINE JR 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 JR MYLAN Auto-Injector.
It is important to regularly ask your doctor or pharmacist how to use an ADRENALINE JR MYLAN Auto-Injector.
ADRENALINE JR 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
thyroid problems
high pressure in the eye (narrow-angle glaucoma).
Take care also when giving ADRENALINE JR MYLAN to those
having an anaesthetic
or who have:
diabetes
heart disease
allergy to ADRENALINE JR MYLAN
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.
Taking other medicines
Tell your doctor or pharmacist if your child is 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 JR 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"
thyroid hormone
medicines for diabetes
antihistamines.
These medicines may affect how well the adrenaline in ADRENALINE JR MYLAN works. Your doctor or pharmacist can tell you what to do if your child is taking any of these medicines.
You should discuss any concerns you have with your doctor or pharmacist.
How to use ADRENALINE JR MYLAN
It is important to know how to use your ADRENALINE JR MYLAN Auto-Injector in an emergency (see Help in using ADRENALINE JR 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 JR MYLAN Auto-Injector, ask your doctor or pharmacist for help.
When to use it
Use ADRENALINE JR MYLAN 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 much to use
ADRENALINE JR MYLAN 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 ADRENALINE JR MYLAN
NOTE: Your child's doctor or pharmacist may advise ADRENALINE MYLAN 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 ADRENALINE JR MYLAN in some adults, based on careful medical assessment.
See also "What ADRENALINE JR MYLAN is used for" above.
How to use it
General
Grip only the mid-section of the ADRENALINE JR MYLAN Auto-Injector. Avoid touching either end, except when you remove the blue safety release. The blue safety release stops the ADRENALINE JR 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 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 ADRENALINE JR MYLAN away from the face and eyes.
Never inject ADRENALINE JR MYLAN into the buttock.
Carefully follow the step-by-step directions to make the ADRENALINE JR MYLAN Auto-Injector work properly.
Step 1
Flip open the green cap on the protective carry tube. Carefully tip and slide the ADRENALINE JR 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 JR 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 JR MYLAN Auto-Injector has already "fired" and cannot be used again.
Step 2
Make a fist around the ADRENALINE JR MYLAN Auto-Injector, with your thumb nearest to the blue safety release.
Step 3
Activate the ADRENALINE JR MYLAN Auto-Injector by removing the blue safety release with your other hand. This "triggers" the ADRENALINE JR MYLAN Auto-Injector. 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 ADRENALINE JR MYLAN Auto-Injector at a 90° angle (right angle) to the outer part of the child's thigh. Hold the orange end about 5cm away from the thigh.
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 ADRENALINE JR MYLAN Auto-Injector firmly against the thigh for approximately 3 seconds.
NOTE: ADRENALINE JR MYLAN may be used either
through clothing, or
directly on to skin.
When you press the orange end of the ADRENALINE JR MYLAN 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 ADRENALINE JR 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 JR MYLAN Auto-Injector has not "fired" or worked. If the "viewing window" is not obscured, repeat steps 2-6 above.
Step 7
Record the time ADRENALINE JR MYLAN was given.
Step 8
Seek further medical attention for your child immediately. Although the child has received adrenaline from ADRENALINE JR MYLAN, he/she may need more medical treatment.
Step 9
With severe, persistent allergic reactions, repeat injections with an additional ADRENALINE JR MYLAN may be necessary. The ADRENALINE JR 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 JR MYLAN unless under medical supervision.
Step 10
Explain to the doctor that your child has had ADRENALINE JR MYLAN (intramuscular adrenaline).
Take your used ADRENALINE JR MYLAN Auto-Injector with you.
To avoid injury, follow the used ADRENALINE JR MYLAN disposal instructions below (see Disposal).
Additional information about treatment of insect sting allergy
Use ADRENALINE JR MYLAN 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(overdose)
Because each ADRENALINE JR 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 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 JR MYLAN
Things you must do
Check what the expiry date is on your ADRENALINE JR MYLAN Auto-Injector.
Mark this expiry date on your calendar or diary.
Replace your ADRENALINE JR MYLAN Auto-Injector prior to this expiry date.
Also note on your calendar or diary to check the contents of your ADRENALINE JR 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 JR MYLAN Auto-Injector immediately.
If the "viewing window" is obscured this means the ADRENALINE JR 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 JR MYLAN Auto-Injector immediately.
The ADRENALINE JR MYLAN Auto-Injector can be damaged and made unusable if it is mishandled.
ADRENALINE JR MYLAN is NOT a toy. Keep it out of reach of children.
Things you must not do
Do not use ADRENALINE JR 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 more than 30 kg unless advised by your doctor or pharmacist. ADRENALINE MYLAN 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 ADRENALINE JR MYLAN is being prescribed.
Do not take off the blue safety release until you need to use ADRENALINE JR MYLAN and are ready to use it.
Remember that the ADRENALINE JR 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 JR MYLAN Auto-Injector. The ADRENALINE JR MYLAN Auto-Injector does not work like a retractable ball-point pen (see How to use it step 3).
Do not bump the ADRENALINE JR MYLAN Auto-Injector until you intentionally push the orange end firmly into the child's thigh (see How to use it step 4). This will help prevent accidental activation of the ADRENALINE JR MYLAN 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.
Side effects
Like all medicines, ADRENALINE JR MYLAN can cause some side effects. Side effects not listed in this leaflet may occur in some patients.
Tell your doctor or pharmacist if your child experiences any unpleasant side effects after using ADRENALINE JR 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. Your child may not experience any of them.
Adrenaline
Tell your doctor or pharmacist if your child has any of the following:
fast or noticeable heart beat
difficulty breathing
chest pain
shortness of breath
dizziness
pale skin colour
weakness
tremor
headache
throbbing
sweating
nausea or vomiting
sleeplessness
coldness
hallucinations
restlessness
anxiety
fear
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
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.
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.
Sodium metabisulfite
ADRENALINE JR 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 JR 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 JR MYLAN
Storing ADRENALINE JR MYLAN before use
Always handle the ADRENALINE JR MYLAN Auto-Injector carefully, so as not to accidentally activate it or make it "fire" or work.
Storage
Keep ADRENALINE JR MYLAN available with the child for whom it is intended.
Keep ADRENALINE JR MYLAN in a cool dry place below 25°C. Temperature excursions between 15°C to 25°C permitted.
Do not place ADRENALINE JR MYLAN in the fridge. Do not leave ADRENALINE JR MYLAN in your car. Extreme temperatures may cause the auto-injector unit to malfunction.
Protect ADRENALINE JR MYLAN from light. Keep ADRENALINE JR MYLAN in the protective carry tube until required.
Do not store ADRENALINE JR 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 JR MYLAN where children cannot accidentally reach it.
After using ADRENALINE JR MYLAN
Disposal
After the ADRENALINE JR 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 JR MYLAN Auto-Injector safely and with care. Do this even if you think the ADRENALINE JR MYLAN Auto-Injector has not "triggered", "fired" or worked properly.
You CANNOT RE-USE the ADRENALINE JR MYLAN Auto-Injector even though some adrenaline is left inside it.
After use, do not just throw away the ADRENALINE JR 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 tube.
Give your used ADRENALINE JR 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 JR MYLAN Auto-Injector should be placed in a rigid sharps disposal unit.
Product description
Ingredients
ADRENALINE JR MYLAN delivers one x 0.3 mL dose of adrenaline (epinephrine). This ADRENALINE JR MYLAN dose provides 150 mcg of adrenaline (epinephrine).
The ADRENALINE JR MYLAN Auto-Injector holds 2 mL of adrenaline (epinephrine) 1:2,000 solution.
The injection also contains small amounts of
sodium chloride
sodium metabisulfite
hydrochloric acid.
It does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.
The ADRENALINE JR MYLAN Auto-Injector is packed in a protective plastic carry tube. This carry tube has a green cap. The carry tube is supplied in a cardboard pack.
This is not all the information available on ADRENALINE JR MYLAN. If you have any more questions or are unsure about anything, ask your doctor or pharmacist.
