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 ADRENALINE JR VIATRIS?
ADRENALINE JR VIATRIS contains the active ingredient adrenaline (epinephrine). In
some countries, adrenaline is known as epinephrine. ADRENALINE JR VIATRIS 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 ADRENALINE JR VIATRIS?
ADRENALINE JR VIATRIS 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 ADRENALINE JR VIATRIS and affect how it works.
4. How do I use ADRENALINE JR VIATRIS?
ADRENALINE JR VIATRIS delivers one measured dose of adrenaline intended for a child
who weighs 15 kg to 30 kg.
5. What should I know while using ADRENALINE JR VIATRIS?
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Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are using ADRENALINE JR
VIATRIS.
Check the expiry date on ADRENALINE JR VIATRIS and request for replacement prior to
the expiry date.
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Things you should not do
|
Do not use ADRENALINE JR VIATRIS to treat any other medical conditions including other
types of shock unless advised by the doctor.
Do not use ADRENALINE JR VIATRIS 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
|
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 ADRENALINE JR VIATRIS in a cool dry place below 25°C. Temperature excursions
between 15°C to 25°C permitted. Do not refrigerate. Protect ADRENALINE JR VIATRIS
from light. Keep ADRENALINE JR VIATRIS in the protective carry tube until required.
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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 ADRENALINE JR VIATRIS. 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 ADRENALINE JR VIATRIS.
Where to find information in this leaflet:
1. Why am I using ADRENALINE JR VIATRIS?
ADRENALINE JR VIATRIS contains the active ingredient adrenaline (epinephrine).
ADRENALINE JR VIATRIS 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 VIATRIS.
ADRENALINE JR VIATRIS 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 ADRENALINE JR VIATRIS 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 VIATRIS Auto-Injector is intended for use in children who have been
assessed and advised by their doctor or pharmacist as needing an ADRENALINE JR VIATRIS
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 ADRENALINE VIATRIS Auto-Injector. (The ADRENALINE JR VIATRIS 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 VIATRIS. in some adults, based
on careful medical assessment.
If you have any questions about this, talk to your doctor or pharmacist.
ADRENALINE JR VIATRIS
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 VIATRIS may be prescribed by your doctor. You can also purchase it
directly from a pharmacy.
2. What should I know before I use ADRENALINE JR VIATRIS?
The ADRENALINE JR VIATRIS 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 VIATRIS
and are ready to use it. The safety release stops ADRENALINE JR VIATRIS 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.
Warnings
ADRENALINE JR VIATRIS 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 VIATRIS Auto-Injector has a clear “viewing window” so you can see
the contents.
Do not use ADRENALINE JR VIATRIS 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 ADRENALINE JR VIATRIS
after the expiry date on the ADRENALINE JR VIATRIS Auto-Injector and carton or
if the packaging is torn, doesn’t look quite right or shows signs of tampering.
If the ADRENALINE JR VIATRIS packaging is damaged or it is past the expiry date, return
it to your pharmacist for disposal.
Help in using ADRENALINE JR VIATRIS
It is important to know how to use an ADRENALINE JR VIATRIS Auto-Injector BEFORE a
severe allergic reaction causes a medical emergency.
Ask your doctor or pharmacist to show you how use an ADRENALINE JR VIATRIS Auto-Injector.
It is important to regularly ask your doctor or pharmacist how to use an ADRENALINE
JR VIATRIS Auto-Injector.
ADRENALINE JR VIATRIS 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 ADRENALINE
JR VIATRIS.
Take care also when giving ADRENALINE JR VIATRIS to those
having an anaesthetic
or who have:
diabetes
heart disease
allergy to ADRENALINE JR VIATRIS
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 ADRENALINE JR VIATRIS 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 VIATRIS 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 ADRENALINE JR VIATRIS.
4. How do I use ADRENALINE JR VIATRIS?
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
VIATRIS Auto-Injector, ask your doctor or pharmacist for help.
How much to use
ADRENALINE JR VIATRIS 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 VIATRIS.
NOTE: Your child’s doctor or pharmacist may advise ADRENALINE JR VIATRIS 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 VIATRIS. in some adults, based on careful medical assessment.
When to use ADRENALINE JR VIATRIS
Use ADRENALINE JR VIATRIS 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 ADRENALINE JR VIATRIS
General
Grip only the mid-section of the ADRENALINE JR VIATRIS Auto-Injector. Avoid touching
either end, except when you remove the blue safety release. The blue safety release
stops the ADRENALINE JR VIATRIS 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 VIATRIS away from the face and eyes.
Never inject ADRENALINE JR VIATRIS into the buttock.
Carefully follow the step-by-step directions to make the ADRENALINE JR VIATRIS work
properly.
Step 1
Flip open the green cap on the protective carry tube. Carefully tip and slide the
ADRENALINE JR VIATRIS 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 VIATRIS 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 VIATRIS Auto-Injector has already “fired” and cannot be used again.
Step 2
Make a fist around the ADRENALINE JR VIATRIS Auto-Injector, with your thumb nearest
to the blue safety release (see FIGURE 1).
FIGURE 1
Step 3
Activate the ADRENALINE JR VIATRIS Auto-Injector by removing the blue safety release
with your other hand (also shown in FIGURE 1). This “triggers” the ADRENALINE JR VIATRIS.
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 VIATRIS 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 ADRENALINE JR VIATRIS Auto-Injector firmly against the
thigh for approximately 3 seconds (see FIGURE 3).
FIGURE 3
NOTE: ADRENALINE JR VIATRIS may be used either
through clothing, as shown in FIGURE 3, or
directly on to skin.
When you press the orange end of the ADRENALINE JR VIATRIS 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 VIATRIS 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 ADRENALINE
JR VIATRIS has not “fired” or worked. If the “viewing window” is not obscured, repeat
steps 2-6 above.
Step 7
Record the time ADRENALINE JR VIATRIS was given.
Step 8
Seek further medical attention for your child immediately. Although the child has
received adrenaline from ADRENALINE JR VIATRIS, 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 ADRENALINE
JR VIATRIS may be necessary. The ADRENALINE JR VIATRIS 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 VIATRIS unless under
medical supervision.
Step 10
Explain to the doctor that your child has had ADRENALINE JR VIATRIS (intramuscular
adrenaline).
Take your used ADRENALINE JR VIATRIS Auto-Injector with you.
Additional information about treatment of insect sting allergy
Use ADRENALINE JR VIATRIS 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 ADRENALINE JR VIATRIS
Because each ADRENALINE JR VIATRIS 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 that you have used too much ADRENALINE JR VIATRIS, you may need urgent
medical attention.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26), 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 ADRENALINE JR VIATRIS?
Things you should do
Check what the expiry date is on your ADRENALINE JR VIATRIS Auto-Injector.
Mark this expiry date on your calendar or diary.
Replace your ADRENALINE JR VIATRIS Auto-Injector prior to this expiry date.
Also note on your calendar or diary to check the contents of your ADRENALINE JR VIATRIS
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 VIATRIS Auto-Injector immediately.
If the “viewing window” is obscured this means the ADRENALINE JR VIATRIS 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 VIATRIS Auto-Injector immediately.
The ADRENALINE JR VIATRIS Auto-Injector can be damaged and made unusable if it is
mishandled.
ADRENALINE JR VIATRIS is NOT a toy. Keep it out of reach of children.
Things you should not do
Do not use ADRENALINE JR VIATRIS
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 VIATRIS 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 VIATRIS is being prescribed.
Do not take off the blue safety release until you need to use ADRENALINE JR VIATRIS
and are ready to use it.
Remember that the ADRENALINE JR VIATRIS 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 VIATRIS Auto-Injector. The ADRENALINE
JR VIATRIS Auto-Injector does not work like a retractable ball-point pen (see How
to use ADRENALINE JR VIATRIS - Step 3 in Section
4. How do I use ADRENALINE JR VIATRIS?
).
Do not bump the ADRENALINE JR VIATRIS Auto-Injector until you intentionally push the
orange end firmly into the child's thigh (see How to use ADRENALINE JR VIATRIS - Step
4 in Section
4. How do I use ADRENALINE JR VIATRIS?
).
This will help prevent accidental activation of the ADRENALINE JR VIATRIS 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 ADRENALINE JR VIATRIS Auto-Injector carefully, so as not to accidentally
activate it or make it “fire” or work.
Keep ADRENALINE JR VIATRIS available with the person for whom it is intended.
Keep ADRENALINE JR VIATRIS in a cool dry place below 25°C. Temperature excursions
between 15°C to 25°C permitted.
Do not place ADRENALINE JR VIATRIS in the fridge. Do not leave ADRENALINE JR VIATRIS
in your car. Extreme temperatures may cause the auto-injector unit to malfunction.
Protect ADRENALINE JR VIATRIS from light. Keep ADRENALINE JR VIATRIS in the protective
carry tube until required.
Store ADRENALINE JR VIATRIS 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 ADRENALINE JR VIATRIS 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 VIATRIS Auto-Injector safely and with care. Do this even if you think
the ADRENALINE JR VIATRIS Auto-Injector has not “triggered”, “fired” or worked properly.
You CANNOT RE-USE the ADRENALINE JR VIATRIS Auto-Injector even though some adrenaline
is left inside it.
After use, do not just throw away the ADRENALINE JR VIATRIS 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 VIATRIS 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 VIATRIS Auto-Injector, 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
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Less serious side effects
|
What to do
|
|
fast or noticeable heartbeat
difficulty breathing
chest pain
shortness of breath
dizziness
flushing or redness of face and skin.
pale skin colour
weakness
tremor
headache
throbbing
sweating
nausea or vomiting
sleeplessness
coldness
hallucinations
restlessness
anxiety
fear
|
Speak to your doctor if your child has any of these less serious side effects and
they worry you.
These side effects are minor and short lasting.
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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
ADRENALINE JR VIATRIS 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 ADRENALINE JR VIATRIS 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 VIATRIS.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
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 available with a doctor's prescription or over-the-counter without
a doctor's prescription.
What ADRENALINE JR VIATRIS contains
|
Active ingredient
(main ingredient)
|
Adrenaline (epinephrine)
|
|
Other ingredients
(inactive ingredients)
|
sodium chloride
sodium metabisulfite
hydrochloric acid.
|
|
Potential allergens
|
Sulfites
|
What ADRENALINE JR VIATRIS looks like
ADRENALINE JR VIATRIS (AUST R 296843) delivers one x 0.3 mL dose of adrenaline (epinephrine).
This ADRENALINE JR VIATRIS dose provides 150 mcg of adrenaline (epinephrine).
The ADRENALINE JR VIATRIS Auto-Injector holds 2 mL of adrenaline (epinephrine) 1:2,000
solution.
The ADRENALINE JR VIATRIS 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 ADRENALINE JR VIATRIS
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in March 2023.
Made in USA
ADRENALINE JR VIATRIS_cmi\
Mar23
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