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 VIATRIS?
ADRENALINE VIATRIS contains the active ingredient adrenaline (epinephrine). In some
countries, adrenaline is known as epinephrine. ADRENALINE 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 VIATRIS?
ADRENALINE 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 you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with ADRENALINE VIATRIS and affect how it works.
4. How do I use ADRENALINE VIATRIS?
ADRENALINE VIATRIS delivers one measured dose of adrenaline intended for a person
who weighs more than 30 kg. It may be prescribed for a child who weighs from 15 kg
up to 30 kg.
5. What should I know while using ADRENALINE VIATRIS?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using ADRENALINE VIATRIS.
Check the expiry date on ADRENALINE VIATRIS and request for replacement prior to the
expiry date.
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Things you should not do
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Do not use ADRENALINE VIATRIS to treat any other medical conditions including other
types of shock unless advised by the doctor.
Do not use ADRENALINE 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
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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 ADRENALINE VIATRIS in a cool dry place below 25°C. Temperature excursions between
15°C to 25°C permitted. Do not refrigerate. Protect ADRENALINE VIATRIS from light.
Keep ADRENALINE VIATRIS in the protective carry tube until required.
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6. Are there any side effects?
Tell your doctor or pharmacist if you experience 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 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 VIATRIS.
Where to find information in this leaflet:
1. Why am I using ADRENALINE VIATRIS?
ADRENALINE VIATRIS contains the active ingredient adrenaline (epinephrine).
ADRENALINE 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 VIATRIS.
ADRENALINE VIATRIS is used to treat people 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 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 VIATRIS Auto-Injector is intended for use in people who have been assessed
and advised by their doctor or pharmacist as needing an ADRENALINE VIATRIS 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
weight.
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 VIATRIS Auto-Injector. (The ADRENALINE JR VIATRIS Auto-Injector delivers
a smaller amount of adrenaline).
If you have any questions about this, talk to your doctor or pharmacist.
ADRENALINE VIATRIS
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 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 VIATRIS?
The ADRENALINE 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 VIATRIS and
are ready to use it. The safety release stops ADRENALINE VIATRIS 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 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 VIATRIS Auto-Injector has a clear “viewing window” so you can see the
contents.
Do not use ADRENALINE 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 VIATRIS
after the expiry date on the ADRENALINE VIATRIS Auto-Injector and carton or
if the packaging is torn, doesn’t look quite right or shows signs of tampering.
If the ADRENALINE VIATRIS packaging is damaged or it is past the expiry date, return
it to your pharmacist for disposal.
Help in using ADRENALINE VIATRIS
It is important to know how to use an ADRENALINE VIATRIS Auto-Injector BEFORE a severe
allergic reaction causes a medical emergency.
Ask your doctor or pharmacist to show you how to use an ADRENALINE VIATRIS Auto-Injector.
It is important to regularly ask your doctor or pharmacist how to use an ADRENALINE
VIATRIS Auto-Injector.
ADRENALINE 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
VIATRIS.
Take care also when giving ADRENALINE VIATRIS to those
having an anaesthetic
or who have:
diabetes
heart disease
allergy to ADRENALINE VIATRIS
brain damage.
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
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?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are 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 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 VIATRIS works.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect ADRENALINE VIATRIS.
4. How do I use ADRENALINE 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 VIATRIS
Auto-Injector, ask your doctor or pharmacist for help.
How much to use
ADRENALINE VIATRIS 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 VIATRIS.
Your doctor or pharmacist may also advise ADRENALINE JR VIATRIS Auto-Injector for
a child who weighs from 15 kg up to 30 kg.
NOTE: Unless otherwise advised by the doctor or pharmacist, ADRENALINE VIATRIS Jr.
Auto-Injector should be used for children who weigh from 15 kg up to 30 kg.
When to take ADRENALINE VIATRIS
Use ADRENALINE VIATRIS 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:
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 VIATRIS
General
Grip only the mid-section of the ADRENALINE VIATRIS Auto-Injector. Avoid touching
either end, except when you remove the blue safety release. The blue safety release
stops the ADRENALINE 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 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
injuries.
Keep ADRENALINE VIATRIS away from the face and eyes.
Never inject ADRENALINE VIATRIS into the buttock.
Carefully follow the step-by-step directions to make the ADRENALINE VIATRIS Auto-Injector
work properly.
Step 1
Flip open the yellow cap on the protective carry tube. Carefully tip and slide the
ADRENALINE 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 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
VIATRIS Auto-Injector has already “fired” and cannot be used again.
Step 2
Make a fist around the ADRENALINE VIATRIS Auto-Injector, with your thumb nearest to
the blue safety release (see FIGURE 1).
FIGURE 1
Step 3
Activate the ADRENALINE VIATRIS Auto-Injector by removing the blue safety release
with your other hand (also shown in FIGURE 1). This “triggers” the ADRENALINE VIATRIS
Auto-Injector. It is now ready to
“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.
Step 4
Hold the ADRENALINE 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
If you are administering the ADRENALINE VIATRIS 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 VIATRIS Auto-Injector firmly against the thigh for approximately
3 seconds (see FIGURE 3).
FIGURE 3
NOTE: ADRENALINE 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 VIATRIS Auto-Injector firmly against
the thigh, the hidden needle “fires”. It injects the measured dose of adrenaline into
the thigh muscle.
Step 6
Carefully take the ADRENALINE 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
VIATRIS 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 VIATRIS was given.
Step 8
Seek further medical attention for yourself immediately. Although you have received
adrenaline from ADRENALINE VIATRIS, you may need more medical treatment.
Either
Contact your doctor or
Call an ambulance (telephone 000 in Australia). State that adrenaline treatment may
be needed.
Step 9
With severe, persistent allergic reactions, repeat injections with an additional ADRENALINE
VIATRIS may be necessary. The ADRENALINE 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 VIATRIS unless under medical
supervision.
Step 10
Explain to the doctor that you have had ADRENALINE VIATRIS (intramuscular adrenaline).
Take your used ADRENALINE VIATRIS Auto-Injector with you.
Additional information about treatment of insect sting allergy
Use ADRENALINE VIATRIS 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 ADRENALINE VIATRIS
Because each ADRENALINE 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 VIATRIS, you may need urgent medical
attention.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) 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 ADRENALINE VIATRIS?
Things you should do
Check what the expiry date is on your ADRENALINE VIATRIS Auto-Injector.
Mark this expiry date on your calendar or diary.
Replace your ADRENALINE VIATRIS Auto-Injector prior to this expiry date.
Also note on your calendar or diary to check the contents of your ADRENALINE 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 VIATRIS Auto-Injector immediately.
If the “viewing window” is obscured this means the ADRENALINE VIATRIS has already
“fired” or worked. It cannot be used again. Return it to your doctor or pharmacist
for disposal. Obtain a new ADRENALINE VIATRIS Auto-Injector immediately.
The ADRENALINE VIATRIS Auto-Injector can be damaged and made unusable if it is mishandled.
ADRENALINE VIATRIS is NOT a toy. Keep it out of reach of children.
Things you should not do
Do not use ADRENALINE 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 15 kg to 30 kg unless advised by your doctor or pharmacist.
ADRENALINE JR VIATRIS is generally recommended for children who weigh 15 kg to 30
kg. (see also Section
1. Why am I using ADRENALINE VIATRIS?).
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 VIATRIS is being prescribed.
Do not take off the blue safety release until you need to use ADRENALINE VIATRIS and
are ready to use it.
Remember that the ADRENALINE 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 VIATRIS Auto-Injector. The ADRENALINE
VIATRIS Auto-Injector does not work like a retractable ball-point pen (see How to
use ADRENALINE VIATRIS - Step 3 in Section
4. How do I use ADRENALINE VIATRIS?
).
Do not bump the ADRENALINE VIATRIS Auto-Injector until you intentionally push the
orange end firmly into the thigh (see How to use ADRENALINE VIATRIS - Step 4 in Section
4. How do I use ADRENALINE VIATRIS?
).
This will help prevent accidental activation of the ADRENALINE 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 VIATRIS Auto-Injector carefully, so as not to accidentally
activate it or make it “fire” or work.
Keep ADRENALINE VIATRIS available with the person for whom it is intended.
Keep ADRENALINE VIATRIS in a cool dry place below 25°C. Temperature excursions between
15°C to 25°C permitted.
Do not place ADRENALINE VIATRIS in the fridge. Do not leave ADRENALINE VIATRIS in
your car. Extreme temperatures may cause the auto-injector unit to malfunction.
Protect ADRENALINE VIATRIS from light. Keep ADRENALINE VIATRIS in the protective carry
tube until required.
Store ADRENALINE 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 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 VIATRIS Auto-Injector safely and with care. Do this even if you think
the ADRENALINE VIATRIS Auto-Injector has not “triggered”, “fired” or worked properly.
You CANNOT RE-USE the ADRENALINE VIATRIS Auto-Injector even though some adrenaline
is left inside it.
After use, do not just throw away the ADRENALINE 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 VIATRIS, to the doctor’s office or to a hospital. This is
for inspection, if required, and also for safe disposal. The used ADRENALINE 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
|
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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
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
These side effects are minor and short lasting.
|
Serious side effects
|
Serious side effects
|
What to do
|
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stroke
lung problems
severe irregular heartbeat
disorientation and impaired memory.
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More severe side effects can occur occasionally. They are caused by adrenaline stimulating
the heart and increasing the blood pressure.
Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital
if you notice any of these serious side effects.
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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 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 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
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 VIATRIS contains
|
Active ingredient
(main ingredient)
|
Adrenaline (epinephrine)
|
|
Other ingredients
(inactive ingredients)
|
sodium chloride
sodium metabisulfite
hydrochloric acid.
|
|
Potential allergens
|
Sulfites
|
What ADRENALINE VIATRIS looks like
ADRENALINE VIATRIS (AUST R 296842) delivers one x 0.3 mL dose of adrenaline (epinephrine).
This ADRENALINE VIATRIS dose provides 300 mcg of adrenaline (epinephrine).
The ADRENALINE VIATRIS Auto-Injector holds 2 mL of adrenaline (epinephrine) 1:1,000
solution.
The ADRENALINE VIATRIS Auto-Injector is packed in a non-waterproof protective plastic
carry tube. This carry tube has a yellow cap. The carry tube is supplied in a cardboard
pack.
Who distributes ADRENALINE 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 VIATRIS_cmi\
Mar23
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