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EMERADE 150 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED PEN

Active substance(s): ADRENALINE

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Package leaflet: Information for the user

620313

Emerade 150 micrograms solution for injection in pre-filled pen
Emerade 300 micrograms solution for injection in pre-filled pen
Emerade 500 micrograms solution for injection in pre-filled pen
Adrenaline

Read all of this leaflet carefully before you start using
this medicine because it contains important information
for you
-- Keep this leaflet. You may need to read it again.
-- If you have any further questions, ask your doctor or
pharmacist.
-- This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their signs
of illness are the same as yours.
-- If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
What is in this leaflet:
1. What Emerade is and what it is used for
2. What you need to know before you use Emerade
3. How to use Emerade
4. Possible side effects
5. How to store Emerade
6. Contents of the pack and other information
1. What Emerade is and what it is used for
Emerade is an auto-injector that contains adrenaline
in a solution for injection.
Adrenaline counteracts the fall of blood pressure
in anaphylactic reactions. It also stimulates the heart
and facilitates breathing.
Emerade is used for emergency treatment of severe allergic
reactions (anaphylaxis) caused by allergens in foods,
medicines, insect stings or bites and other allergens as well
as triggered by exercise or unknown causes.
2. What you need to know before you use Emerade
Your doctor should have explained when and how you
should use Emerade. If you are not completely sure or you
have questions you must contact your doctor.
Warnings and precautions
Emerade can always be used during an allergic emergency.
If you are allergic (hypersensitive) to sodium metabisulphite
or to any of the other ingredients of Emerade, your doctor
will need to instruct you under which circumstances
Emerade should be used.
Talk to your doctor before using Emerade if you have
• heart disease,
• high blood pressure,
• an overactive thyroid,
• diabetes,
• a tumour on the adrenal gland,
• increased pressure in the eye,
• reduced kidney function,
• prostate disease,
• low potassium levels or high calcium levels in your
blood.
If you have asthma you may be at increased risk of a severe
allergic reaction.
Anyone who has an episode of anaphylaxis should see their
doctor about testing for substances they may be allergic to,
so these can be strictly avoided in future. It is important
to be aware that an allergy to one substance can lead to
allergies to a number of related substances.
If you have food allergies it is important to check the
ingredients in everything you ingest (including medicines)
as even small amounts can cause severe reactions.
There is also a greater risk of getting side effects if you are
elderly or pregnant.
The instructions for use must be carefully followed in order
to avoid accidental injection.
Emerade should only be injected intramuscularly into the
outer thigh. It should not be injected into the buttock due to
the risk of accidental injection into a vein.
Warnings
Accidental injection into the hands or feet may result in
reduced blood supply to these areas. If there is an accidental
injection into these areas, you should go immediately to the
nearest hospital emergency department for treatment.
Children
Emerade should not be used in children under 15 kg.
A dosage below 150 micrograms cannot be administered
with sufficient accuracy in children weighing less than

15 kg and use is therefore not recommended unless during
a life-threatening situation and under medical advice.
Other medicines and Emerade
Tell your doctor if you are using, have recently used or
might use any other medicines.
This is especially important if you take any of the
following:
• Antidepressants such as tricyclic antidepressants or
monoamine oxidase inhibitors (MAO inhibitors), since
the effects of adrenaline may be increased.
• Medicines for treatment of Parkinson’s disease such
as catechol-O-methyl transferase inhibitors (COMT
inhibitors), since the effect of adrenaline may be
increased.
• Medicines that may make the heart sensitive to uneven
beats (arrhythmias), such as digitalis and quinidine.
• Medicines for heart disease or medicines to treat
disorders of the nervous system called alpha and beta
blocking medicines as they can reduce the effect of
adrenaline.
Diabetic patients should carefully monitor their glucose
levels after use of Emerade as adrenaline can increase
the blood glucose level.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor for
advice before taking this medicine.
The experience of using adrenaline during pregnancy is
limited. If you are pregnant you should however not avoid
using Emerade in an emergency situation because your life
can be in danger.
You can breast feed after you have used Emerade.
Driving and using machines
The ability to drive and use machines is unlikely to be
affected by the administration of an adrenaline injection, but
may be affected by a severe allergic reaction. If affected, do
not drive.
Emerade contains sodium metabisulphite and sodium
Sodium metabisulphite may rarely cause severe allergic
reactions or breathing difficulty (bronchospasm). If you
are allergic (hypersensitive) to sodium metabisulphite
your doctor must instruct you under which circumstances
Emerade should be used.
Emerade contains less than 1 millimole sodium (23 mg) per
dose, i.e. is essentially sodium free.
3. How to use Emerade
Use Emerade immediately if signs or symptoms of an acute
allergic reaction (anaphylaxis) begin. Reactions can arise
in a few minutes after the contact with the allergen and
the symptoms can be, for example, rash, flush or swelling.
More severe reactions also affect blood circulation and
breathing.
Always use Emerade exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are
not sure.
Before you need to use Emerade, make sure you understand
in what situations you should use Emerade. It is important
that you always carry Emerade with you if you are at risk
of anaphylaxis. You should store Emerade in the original
package, a specially designed case to protect the pen and the
label showing how to use the pen in an emergency situation.
Always keep this information leaflet in the case.
Dosage
The dose will be decided by your doctor, who will adjust
it individually for you for example depending on your
bodyweight.
Adults
Adults below 60 kg
The usual dose is 300 micrograms.
Adults over 60 kg
The usual dose is 300 to 500 micrograms.
Children and adolescents
Emerade 500 micrograms is not recommended for use in
children.

Children over 30 kg
The usual dose is 300 micrograms.
Adolescents over 30 kg
The dosage recommendations for adult patients should be
followed.
How Emerade is given
The instructions for use must be carefully followed in order
to avoid accidental injection.
It is recommended that your family members, carers or
teachers are also instructed in the correct use of Emerade.
Emerade should only be used for injection in the outer
thigh. The injection occurs when Emerade is pressed into
the thigh. It can be administered through clothing. It should
not be injected into the buttock (your bottom).

1. Remove the needle shield.

Press

Hold
5 secs.

2. Place and press Emerade
against the outer side of
the thigh. You will hear a
click when the injection
goes into the muscle.
3. Hold Emerade against the
thigh for about 5 seconds.
Lightly massage the
injection site afterwards.
Seek immediate medical
help.

The needle in Emerade is protected before, during and after
the injection.
When the injection is completed, the plunger is visible in
the inspection window by lifting the label.
Sometimes a single dose of adrenaline may not be sufficient
to completely reverse the effects of a serious allergic
reaction. For this reason, your doctor is likely to prescribe
more than one Emerade for you. If your symptoms have not
improved or have deteriorated within 5-15 minutes after the
first injection, either you or the person with you should give
a second injection. For this reason you should carry more
than one Emerade with you at all times.
Emerade is designed as emergency treatment. You should
always get medical help immediately after using Emerade.
Dial 999 and ask for an ambulance. State ’anaphylaxis’
even if symptoms appear to be improving. You
will need to go to hospital for observation and further
treatment as required. This is because the reaction may
happen again at some time later. Take the used autoinjector with you.
While waiting for the ambulance you should lie down with
your feet raised unless this makes you breathless in which
case you should sit up. Ask someone to stay with you until
the ambulance arrives in case you feel unwell again.
Unconscious patients should be placed on their side in the
recovery position.
Do not remove the needle shield unless injection is
required.
Some liquid remains in the auto-injector after the injection.
The auto-injector cannot be re-used.
If you use more Emerade than you should
If you have taken a too large dose, or if you have
accidentally injected Emerade into a blood vessel or into a
hand, you must immediately seek medical help.
Your blood pressure may rise sharply. Overdose may cause
a sudden increase in blood pressure, irregular heartbeat
and accumulation of fluid in the lungs which can make it
difficult to breathe.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.

The following side effects are based upon experience with
the use of adrenaline but the frequency of side effects
cannot be estimated:
• heart problems such as irregular and rapid heartbeat,
chest pain,
• high blood pressure, narrowing of the blood vessels,
• sweating,
• nausea, vomiting,
• difficulty breathing,
• headache, dizziness,
• weakness, shaking,
• anxiety, hallucinations,
• fainting,
• changes in your blood values such as increased blood
sugar, decreased potassium and increased acid.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via:
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace, IRL - Dublin 2
Tel: +353 1 6764971, Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Emerade
Keep this medicine out of the sight and reach of children.
Store in the original package, a specially designed case to
protect the pen and the labelling.
Do not freeze.
Do not use this medicine after the expiry date which is
stated on the label. The expiry date refers to the last day of
that month. Discard and replace Emerade after the expiry
date. The solution can be examined through the inspection
window at any time by lifting the label. Discard and
replace Emerade if the solution is discoloured or contains
precipitate.
Inspect the auto-injector if dropped. Replace if you notice
damage or leakage.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help to
protect the environment.
6. Contents of the pack and other information
What Emerade contains
The active substance is adrenaline as tartrate.
Emerade 150 micrograms delivers 150 micrograms
of adrenaline in 0.15 ml of solution.
Emerade 300 micrograms delivers 300 micrograms
of adrenaline in 0.3 ml of solution.
Emerade 500 micrograms delivers 500 micrograms
of adrenaline in 0.5 ml of solution.
The other ingredients are: sodium chloride, sodium
metabisulphite (E223), disodium edetate, hydrochloric acid
and water for injection.
What Emerade looks like and contents of the pack
Emerade is an auto-injector that delivers one single dose of
adrenaline. Emerade is a clear and colourless solution for
injection inside a glass syringe. Emerade is latex free.
The device is a white cylinder in which a needle shield
covers the needle and the triggering mechanism.
Exposed needle length:
Emerade 150 micrograms: 16 mm
Emerade 300 micrograms and Emerade 500 micrograms:
23 mm
Pack sizes: 1 or 2 pre-filled pens.
All pack sizes may not be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
PharmaSwiss Česká republika s.r.o.
Jankovcova 1569/2c, 170 00 Prague 7, Czech Republic
Manufacturer
Rechon Life Science AB
Soldattorpsvägen 5, SE-216 13 Limhamn, Sweden
This leaflet was last revised in 1 June 2016

P9UKIE02

Children between 15 kg and 30 kg
The usual dose is 150 micrograms.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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