Adrenaline Viatris Drug / Medication Data

Client Medication Data (CMI) abstract

ADRENALINE VIATRIS incorporates the energetic ingredient adrenaline (epinephrine). In some
international locations, adrenaline is called epinephrine. ADRENALINE VIATRIS is barely for use
for the speedy EMERGENCY TREATMENT of a SEVERE ALLERGIC REACTION (also referred to as
ANAPHYLAXIS).

ADRENALINE VIATRIS is a life-saving therapy within the emergency administration of extreme
allergic reactions. Subsequently, it shouldn’t be withheld from anybody who is taken into account
to want it. Discuss to your physician in case you have some other medical circumstances, take some other medicines,
or are pregnant or plan to grow to be pregnant or are breastfeeding.

Some medicines might intrude with ADRENALINE VIATRIS and have an effect on the way it works.

ADRENALINE VIATRIS delivers one measured dose of adrenaline meant for an individual
who weighs greater than 30 kg. It could be prescribed for a kid who weighs from 15 kg
as much as 30 kg.

Inform your physician or pharmacist should you expertise a quick or noticeable heartbeat, problem
respiratory, chest ache or shortness of breath.

Energetic ingredient(s):
adrenaline (epinephrine)

Client Medication Data (CMI)

This leaflet offers necessary details about utilizing ADRENALINE VIATRIS. You also needs to converse to your physician or pharmacist if you want additional info
or in case you have any issues or questions on utilizing ADRENALINE VIATRIS.

The place to seek out info on this leaflet:

ADRENALINE VIATRIS incorporates the energetic ingredient adrenaline (epinephrine).

ADRENALINE VIATRIS is barely for use for the speedy EMERGENCY TREATMENT of a SEVERE
ALLERGIC REACTION (also referred to as ANAPHYLAXIS). Your physician or pharmacist will clarify
what that is like, in order that when it’s essential to use ADRENALINE VIATRIS.

ADRENALINE VIATRIS is used to deal with individuals who have a extreme allergic response brought on
by, for instance, hypersensitivity to

meals

medicines

stinging bugs

insect bites

latex or

different allergens, probably unidentified.

Avoidance of identified allergens is most necessary in stopping extreme allergic reactions.

A extreme allergic response, in any other case generally known as anaphylaxis, is overwhelming and life-threatening.

It impacts the entire physique, particularly the

coronary heart and blood circulation.

This will likely trigger, for instance, low blood stress and collapse, or irregular coronary heart beat
or perform.

air passages and lungs.

This causes problem in respiratory, with noisy wheezing or gasping, probably with
sneezing and a really runny nostril.

abdomen and bowels.

This will likely trigger nausea, vomiting, diarrhoea and belly cramps, typically extreme.

pores and skin (quite common).

This causes flushing, itching, pores and skin rash, hives or swelling, which can be widespread
or in a single a part of the physique.

mind.

There could also be suits or confusion as a consequence of lack of oxygen.

Often a number of components of the physique are affected. The affected person feels extraordinarily unwell.

You will need to act shortly to deal with a extreme allergic response.

The adrenaline in ADRENALINE VIATRIS treats allergic emergencies. It

shrinks abnormally large blood vessels and

makes the center beat strongly.

This helps enhance the very low blood stress and poor circulation that happen in
a extreme allergic response.

Adrenaline additionally

relaxes the lungs. This eases respiratory and lessens wheezing.

The ADRENALINE VIATRIS Auto-Injector is meant to be used in individuals who have been assessed
and suggested by their physician or pharmacist as needing an ADRENALINE VIATRIS Auto-Injector
to deal with their extreme allergic response and who

weigh greater than 30 kg, and

are having a extreme allergic response.

Be aware: Choice of the suitable dosage is set in accordance with affected person physique
weight.

For an individual who weighs from 15 kg as much as 30 kg, the physician or pharmacist might assess
their extreme allergic response as needing the bigger dosage of adrenaline as offered
by an ADRENALINE VIATRIS Auto-Injector. (The ADRENALINE JR VIATRIS Auto-Injector delivers
a smaller quantity of adrenaline).

When you’ve got any questions on this, speak to your physician or pharmacist.

ADRENALINE VIATRIS

offers handy first-aid

could also be self-administered or administered by a carer

has a spring-activated, hidden needle

robotically injects one pre-measured dose of adrenaline

is for single use solely.

ADRENALINE VIATRIS could also be prescribed by your physician. You may also buy it instantly
from a pharmacy.

The ADRENALINE VIATRIS Auto-Injector is straightforward to make use of. Please learn and observe the
step-by-step directions.

Don’t take away the blue security launch till it is advisable use ADRENALINE VIATRIS and
are prepared to make use of it. The protection launch stops ADRENALINE VIATRIS from “firing” or
working.

There is no such thing as a seen needle. This helps overcome worry of injection. The hidden needle
may be very effective in order that the injection doesn’t normally harm.

Warnings

ADRENALINE VIATRIS is a life-saving therapy within the emergency administration of extreme
allergic reactions. Subsequently, it shouldn’t be withheld from anybody who is taken into account
to want it.

The ADRENALINE VIATRIS Auto-Injector has a transparent “viewing window” so you possibly can see the
contents.

Don’t use ADRENALINE VIATRIS if the contents:

are cloudy or

are colored or

include sediment or

if the “viewing window” is obscured.

These adjustments point out that the effectiveness of the drug product could also be decreased.

When the “viewing window” is obscured, the auto-injector has already “fired” and can’t
be used once more.

Don’t use ADRENALINE VIATRIS

after the expiry date on the ADRENALINE VIATRIS Auto-Injector and carton or

if the packaging is torn, doesn’t look fairly proper or reveals indicators of tampering.

If the ADRENALINE VIATRIS packaging is broken or it’s previous the expiry date, return
it to your pharmacist for disposal.

Assist in utilizing ADRENALINE VIATRIS

You will need to know how you can use an ADRENALINE VIATRIS Auto-Injector BEFORE a extreme
allergic response causes a medical emergency.

Ask your physician or pharmacist to indicate you how you can use an ADRENALINE VIATRIS Auto-Injector.

You will need to repeatedly ask your physician or pharmacist how you can use an ADRENALINE
VIATRIS Auto-Injector.

ADRENALINE VIATRIS is efficient as emergency therapy of a extreme allergic response
ONLY when used in accordance with the instructions on this leaflet.

Give WITH CAUTION to those that have

hypertension

• thyroid issues

excessive stress within the eye (narrow-angle glaucoma).

Take care additionally when giving ADRENALINE VIATRIS to these

having an anaesthetic

or who’ve:

diabetes

coronary heart illness

allergy to ADRENALINE VIATRIS

mind injury.

It’s best to inform your physician or pharmacist in case you have:

melancholy, or are on treatment for melancholy

thyroid issues, or are on thyroid treatment

coronary heart illness or hypertension

diabetes

excessive stress within the eye (slim angle glaucoma)

bronchial asthma

ever had an allergic response to sodium metabisulfite.

Being pregnant and breastfeeding

Verify together with your physician in case you are pregnant or intend to grow to be pregnant.

Discuss to your physician in case you are breastfeeding or intend to breastfeed.

Inform your physician or pharmacist in case you are taking some other medicines, together with any
medicines, nutritional vitamins or dietary supplements that you simply purchase with no prescription out of your pharmacy,
grocery store or well being meals store.

Some medicines might intrude with ADRENALINE VIATRIS together with:

medicines for hypertension, particularly these generally known as “beta-blockers”, and
different medicines for coronary heart issues

medicines for melancholy, particularly “tricyclic antidepressants”

thyroid hormone

medicines for diabetes

antihistamines.

These medicines might have an effect on how nicely the adrenaline in ADRENALINE VIATRIS works.

Verify together with your physician or pharmacist in case you are undecided about what medicines, nutritional vitamins
or dietary supplements you’re taking and if these have an effect on ADRENALINE VIATRIS.

Comply with rigorously all instructions given to you by your physician or pharmacist.

They might differ from the data contained on this leaflet.

If you don’t perceive the directions on this leaflet or on the ADRENALINE VIATRIS
Auto-Injector, ask your physician or pharmacist for assist.

How a lot to make use of

ADRENALINE VIATRIS Auto-Injector delivers one measured dose of adrenaline. This dose
is meant for an individual who weighs greater than 30 kg and has been assessed by their
physician or pharmacist as needing ADRENALINE VIATRIS.

Your physician or pharmacist may additionally advise ADRENALINE JR VIATRIS Auto-Injector for
a baby who weighs from 15 kg as much as 30 kg.

NOTE: Until in any other case suggested by the physician or pharmacist, ADRENALINE VIATRIS Jr.
Auto-Injector must be used for youngsters who weigh from 15 kg as much as 30 kg.

When to take ADRENALINE VIATRIS

Use ADRENALINE VIATRIS instantly in case you have indicators and signs of a extreme allergic
response, as described by your physician or pharmacist. Signs do differ. Nevertheless,
the signs are prone to embrace:

collapse

problem in respiratory

wheezing

swelling, particularly of the face, lips, tongue or throat

flushing of the face

irregular or faint pulse

vomiting, diarrhoea, abdomen cramps

pores and skin rash, hives

itching.

How one can use ADRENALINE VIATRIS

Basic

Grip solely the mid-section of the ADRENALINE VIATRIS Auto-Injector. Keep away from touching
both finish, besides while you take away the blue security launch. The blue security launch
stops the ADRENALINE VIATRIS from “firing” or working.

By no means place thumb, fingers or hand over the orange finish as this incorporates the needle.

At all times level the orange finish (which holds the needle) away from any a part of any physique,
besides the deliberate injection website. That is normally the thigh of the one that has
the extreme allergic response.

At all times maintain the leg firmly throughout injection particularly in people who find themselves uncooperative
and kick or transfer throughout an injection. This can scale back the chance of injection associated
accidents.

Preserve ADRENALINE VIATRIS away from the face and eyes.

By no means inject ADRENALINE VIATRIS into the buttock.

Fastidiously observe the step-by-step instructions to make the ADRENALINE VIATRIS Auto-Injector
work correctly.

Step 1

Flip open the yellow cap on the protecting carry tube. Fastidiously tip and slide the
ADRENALINE VIATRIS Auto-Injector out of the carry tube. By no means place thumb, fingers
or hand over the orange finish as this incorporates the needle. Verify the contents of the
ADRENALINE VIATRIS Auto-Injector by the “viewing window”. Ensure the answer
is obvious, colourless and sediment-free. If the “viewing window” is obscured, the ADRENALINE
VIATRIS Auto-Injector has already “fired” and can’t be used once more.

Step 2

Make a fist across the ADRENALINE VIATRIS Auto-Injector, together with your thumb nearest to
the blue security launch (see FIGURE 1).

FIGURE 1

Step 3

Activate the ADRENALINE VIATRIS Auto-Injector by eradicating the blue security launch
together with your different hand (additionally proven in FIGURE 1). This “triggers” the ADRENALINE VIATRIS
Auto-Injector. It’s now able to

“hearth” the needle and

inject the medication by the needle into the thigh muscle.

After you take away the blue security launch don’t contact or place thumb, fingers or hand
over the orange finish as this incorporates the needle.

Step 4

Maintain the ADRENALINE VIATRIS Auto-Injector at a 90° angle (proper angle) to the outer
a part of the thigh. Maintain the orange finish about 5cm away from the thigh (see FIGURE 2).

FIGURE 2

Step 5

In case you are administering the ADRENALINE VIATRIS Auto-Injector to a different individual, maintain
their leg firmly, particularly if they’re uncooperative.

Push the orange finish FIRMLY into the outer mid-thigh till a “click on” is heard or felt.
Preserve urgent the ADRENALINE VIATRIS Auto-Injector firmly towards the thigh for roughly
3 seconds (see FIGURE 3).

FIGURE 3

NOTE: ADRENALINE VIATRIS could also be used both

• by clothes, as proven in FIGURE 3, or

• instantly on to pores and skin.

While you press the orange finish of the ADRENALINE VIATRIS Auto-Injector firmly towards
the thigh, the hidden needle “fires”. It injects the measured dose of adrenaline into
the thigh muscle.

Step 6

Fastidiously take the ADRENALINE VIATRIS Auto-Injector away from the thigh.

The orange needle cowl will lengthen to cowl the needle (see FIGURE 4).

FIGURE 4

Verify the “viewing window” – it ought to now be obscured. If it isn’t, the ADRENALINE
VIATRIS Auto-Injector has not “fired” or labored. If the “viewing window” is just not obscured,
repeat steps 2-6 above.

Step 7

Report the time ADRENALINE VIATRIS was given.

Step 8

Search additional medical consideration for your self instantly. Though you could have obtained
adrenaline from ADRENALINE VIATRIS, chances are you’ll want extra medical therapy.

Both

Contact your physician or

Name an ambulance (phone 000 in Australia). State that adrenaline therapy might
be wanted.

Step 9

With extreme, persistent allergic reactions, repeat injections with an extra ADRENALINE
VIATRIS could also be mandatory. The ADRENALINE VIATRIS dose could also be repeated each 5 to fifteen
minutes if signs recur or haven’t subsided.

Don’t inject greater than two sequential doses of ADRENALINE VIATRIS except beneath medical
supervision.

Step 10

Clarify to the physician that you’ve got had ADRENALINE VIATRIS (intramuscular adrenaline).

Take your used ADRENALINE VIATRIS Auto-Injector with you.

Extra details about therapy of insect sting allergy

Use ADRENALINE VIATRIS instantly in case you have been stung or bitten by the insect
and expertise the indicators and signs as described by your physician or pharmacist.

If the insect’s sting is definitely accessible, take away the sting together with your fingernails.
Don’t squeeze, pinch or push the sting deeper into the pores and skin. If out there, ice packs
or sodium bicarbonate soaks might then be utilized to the stung space.

Preserve heat, calm, and as nonetheless as doable.

Should you use an excessive amount of ADRENALINE VIATRIS

As a result of every ADRENALINE VIATRIS Auto-Injector incorporates just one dose, overdosage is
unlikely. Overdosage might result in an increase in blood stress. This will likely trigger bleeding
within the mind or fluid within the lung.

Should you assume that you’ve got used an excessive amount of ADRENALINE VIATRIS, chances are you’ll want pressing medical
consideration.

It’s best to instantly:

telephone the Poisons Data Centre
(Australia phone 13 11 26) for recommendation, or

contact your physician, or

go to the Emergency Division at your nearest hospital.

It’s best to do that even when there aren’t any indicators of discomfort or poisoning.

Issues you must do

Verify what the expiry date is in your ADRENALINE VIATRIS Auto-Injector.

Mark this expiry date in your calendar or diary.

Change your ADRENALINE VIATRIS Auto-Injector previous to this expiry date.

Additionally word in your calendar or diary to verify the contents of your ADRENALINE VIATRIS
Auto-Injector every month. Do that by the “viewing window”.

Ensure the answer is obvious, colourless and sediment-free. If not, acquire a brand new
ADRENALINE VIATRIS Auto-Injector instantly.

If the “viewing window” is obscured this implies the ADRENALINE VIATRIS has already
“fired” or labored. It can’t be used once more. Return it to your physician or pharmacist
for disposal. Acquire a brand new ADRENALINE VIATRIS Auto-Injector instantly.

The ADRENALINE VIATRIS Auto-Injector could be broken and made unusable whether it is mishandled.

ADRENALINE VIATRIS is NOT a toy. Preserve it out of attain of youngsters.

Issues you shouldn’t do

Don’t use ADRENALINE VIATRIS

to deal with some other medical circumstances together with different kinds of shock except your physician
tells you to.

if the answer is brown or incorporates any particles or cloudiness.

in a baby who weighs lower than 15 kg. Discuss to your physician or pharmacist if that is
the case so {that a} cautious evaluation could be made and the suitable dose chosen
primarily based on the kid’s weight and the life-threatening nature of the response(s) for
which ADRENALINE VIATRIS is being prescribed.

Don’t take off the blue security launch till it is advisable use ADRENALINE VIATRIS and
are prepared to make use of it.

Keep in mind that the ADRENALINE VIATRIS Auto-Injector is activated (“triggered”, prepared
to “hearth”) as quickly as you’re taking off the blue security launch.

Don’t contact the orange finish on any individual or object while you’re taking off the blue
security launch and/or after you could have taken off the blue security launch.

The orange finish holds the hidden needle, able to “hearth” and inject the adrenaline.

After you’re taking off the blue security launch

This can assist stop unintentional activation of the ADRENALINE VIATRIS Auto-Injector
prior to make use of.

Don’t inject into palms, ft, ears, nostril, buttocks, genital space or right into a blood
vessel.

If this does occur by chance it’s essential to instantly search medical consideration.

Don’t inject into the buttock.

Uncommon circumstances of significant pores and skin infections have been reported following injection into
the buttock. Should you develop indicators or signs of an infection, equivalent to persistent redness,
heat, swelling, or tenderness, on the adrenaline injection website it’s essential to search medical
consideration instantly.

Driving or utilizing machines

Your capacity to drive and use machines could also be affected by the anaphylactic response
and doable antagonistic results to adrenaline.

Taking care of your medication

At all times deal with the ADRENALINE VIATRIS Auto-Injector rigorously, in order to not by chance
activate it or make it “hearth” or work.

Preserve ADRENALINE VIATRIS out there with the individual for whom it’s meant.

Preserve ADRENALINE VIATRIS in a cool dry place beneath 25°C. Temperature excursions between
15°C to 25°C permitted.

Don’t place ADRENALINE VIATRIS within the fridge. Don’t depart ADRENALINE VIATRIS in
your automotive. Excessive temperatures might trigger the auto-injector unit to malfunction.

Defend ADRENALINE VIATRIS from gentle. Preserve ADRENALINE VIATRIS within the protecting carry
tube till required.

Retailer ADRENALINE VIATRIS in a cool dry place away from moisture, warmth or daylight;
for instance, don’t retailer it:

within the rest room or close to a sink, or

within the automotive or on window sills.

Warmth and dampness can destroy some medicines.

Comply with the directions within the carton on how you can care for your medication correctly.

Preserve it the place youngsters can’t by chance attain it.

When to discard your medication (as related)

After the ADRENALINE VIATRIS Auto-Injector has “fired” or labored, the orange needle
cowl will lengthen to cowl the uncovered needle. After use, proceed to deal with the
ADRENALINE VIATRIS Auto-Injector safely and with care. Do that even should you assume
the ADRENALINE VIATRIS Auto-Injector has not “triggered”, “fired” or labored correctly.

You CANNOT RE-USE the ADRENALINE VIATRIS Auto-Injector though some adrenaline
is left inside it.

After use, don’t simply throw away the ADRENALINE VIATRIS Auto-Injector.

Don’t tamper with the orange needle cowl.

Don’t change the blue security launch.

The used auto-injector with prolonged needle cowl is not going to match again into the carry
tube.

Give your used ADRENALINE VIATRIS, to the physician’s workplace or to a hospital. That is
for inspection, if required, and in addition for protected disposal. The used ADRENALINE VIATRIS
Auto-Injector, must be positioned in a inflexible sharps disposal unit.

All medicines can have unwanted effects. Should you do expertise any unwanted effects, most of
them are minor and short-term. Nevertheless, some unwanted effects may have medical consideration.

See the data beneath and, if it is advisable, ask your physician or pharmacist should you
have any additional questions on unwanted effects.

Much less severe unwanted effects

Critical unwanted effects

Inform your physician or pharmacist should you discover anything which may be making you
really feel unwell.

Different unwanted effects not listed right here might happen in some individuals.

Unintentional injection into the palms, fingers or ft might outcome within the following:

quick or noticeable coronary heart beat

pale pores and skin color on the website of unintentional injection

feeling of coldness on the website of unintentional injection

bruising or discolouration on the website of unintentional injection

bleeding

If an unintentional injection happens at one among these areas, search medical consideration instantly

Injection associated accidents, equivalent to needle cuts and bent needles, have been reported
in people who find themselves uncooperative and kick or transfer through the injection.

Uncommon circumstances of significant pores and skin infections have been reported following injection into
the buttock.

Sodium metabisulfite

ADRENALINE VIATRIS incorporates a really small amount of sodium metabisulfite as a preservative.
In people who find themselves allergic to sodium metabisulfite, this might trigger, for instance,
extreme allergic reactions (hypersensitivity) or respiratory problem (bronchospasm)
in sure teams of individuals, particularly these with historical past of bronchial asthma. Nevertheless, the
energetic ingredient, adrenaline, in ADRENALINE VIATRIS is predicted to beat any allergic
response to sodium metabisulfite. In an emergency, the chance of publicity to the very
small quantity of sodium metabisulfite is usually outweighed by the advantages of ADRENALINE
VIATRIS.

Reporting unwanted effects

At all times be sure you converse to your physician or pharmacist earlier than you determine to cease
taking any of your medicines.

This medication is out there with a physician’s prescription or over-the-counter with out
a physician’s prescription.

What ADRENALINE VIATRIS incorporates

What ADRENALINE VIATRIS seems like

ADRENALINE VIATRIS (AUST R 296842) delivers one x 0.3 mL dose of adrenaline (epinephrine).
This ADRENALINE VIATRIS dose offers 300 mcg of adrenaline (epinephrine).

The ADRENALINE VIATRIS Auto-Injector holds 2 mL of adrenaline (epinephrine) 1:1,000
answer.

The ADRENALINE VIATRIS Auto-Injector is packed in a non-waterproof protecting plastic
carry tube. This carry tube has a yellow cap. The carry tube is provided in a cardboard
pack.

Who distributes ADRENALINE VIATRIS

Alphapharm Pty Ltd buying and selling as Viatris

Stage 1, 30 The Bond

30-34 Hickson Highway

Millers Level NSW 2000

www.viatris.com.au

Cellphone: 1800 274 276

This leaflet was ready in January 2022.

Made in USA

ADRENALINE VIATRIS_cmiJan22/00