150 micrograms, 300 micrograms, 500 micrograms solution for injection in a pre-filled pen 
adrenaline

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
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 packaging and other information 

1. What Emerade is and what it is used for

Emerade is an autoinjector that contains adrenaline in a solution for injection that is injected into the muscle ( intramuscularly ).

Adrenaline counteracts blood pressure drops in severe allergic (anaphylactic) reactions. It also stimulates the heart and facilitates breathing.

Emerade is used in the acute treatment of life-threatening allergic reactions (anaphylactic shock ) caused by food, medicine, insect bites or bites, and other allergens as well as those that have been triggered by physical exertion or unknown causes.

2. What you need to know before using Emerade

Your doctor should have explained to you when and how to use Emerade. If you are not sure or have any questions, talk to your doctor.

Warnings and cautions

Emerade can always be used in an acute life-threatening allergic situation. If you are allergic (hypersensitive) to sodium metabisulfite or any of the other ingredients of Emerade, your doctor will need to instruct you in what circumstances Emerade should be used.

Talk to your doctor before using Emerade if you have:

  • heart disease
  • high blood pressure
  • overactive thyroid gland
  • diabetes
  • a tumor of the adrenal gland
  • elevated pressure in the eye
  • renal impairment
  • prostate disease
  • low potassium or high calcium in the blood

If you have asthma, you may be at increased risk of a severe allergic reaction.

Anyone who has had anaphylaxis should visit their doctor to test for substances they may be allergic to so that these can be absolutely avoided in the future. It is important to be aware that an allergy to a substance can lead to allergies to several related substances.

If you have food allergies, it is important to check the ingredients in everything you eat (including medicines) as even small amounts can cause serious reactions.

If you are older or pregnant, the risk of side effects increases.

The operating instructions must be followed carefully to avoid accidental injection.

Emerade should be injected intramuscularly on the outside of the thigh. It should not be given in the buttocks due to the risk of accidentally injecting into a blood vessel.

Warning

Accidental injection into hands or feet can lead to decreased blood flow to these parts. Seek medical attention immediately for treatment if you accidentally inject it into your hands or feet.

If you have a thick layer of subcutaneous fat, there is a risk that a dose of Emerade will not be enough. Then the second injection of Emerade may be needed. Follow the user instructions in section 3 carefully.

Children

Emerade should not be used for children under 15 kg.

A dose below 150 micrograms cannot be given with sufficient accuracy to children weighing less than 15 kg and use is therefore not recommended except in life-threatening situations and on the advice of a physician.

Other drugs and Emerade

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

This is especially important if you use any of the following:

  • Antidepressants such as tricyclic antidepressants or monoamine oxidase inhibitors ( MAOIs ), as the effect of adrenaline, may be enhanced.
  • Drugs for the treatment of Parkinson’s disease such as catechol-O-methyltransferase inhibitors (COMT inhibitors), as the effect of adrenaline, may be enhanced.
  • Drugs that can make the heartbeat unevenly ( arrhythmias ), such as digitalis and quinidine.
  • Drugs used to treat heart disease or drugs used to treat diseases of the nervous system, so-called alpha- and beta-blockers, can reduce the effect of adrenaline.

Diabetics should carefully monitor their blood sugar levels after using Emerade as adrenaline can raise blood sugar.

Pregnancy and breastfeeding

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 using this medicine.

There is limited experience with the use of adrenaline during pregnancy. If you are pregnant, do not hesitate to use Emerade in an emergency as your life may be in danger.

You can breast-feed after using Emerade.

Driving and using machines

The ability to drive a motor vehicle or use machines is not affected by injection of adrenaline, however, it can be affected by a severe anaphylactic reaction. If your driving ability is affected, do not drive.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Emerade contains sodium metabisulfite and sodium

Sodium metabisulphite can in rare cases cause severe allergic reactions or difficulty breathing ( bronchospasm ). If you are allergic (hypersensitive) to sodium metabisulphite, your doctor will instruct you in which situations Emerade should be used.

Emerade contains less than 1 mmol sodium (23 mg) per dose, ie it is essentially ‘sodium-free’.

3. How to use Emerade

Use Emerade immediately if signs of an acute severe allergic reaction occur. Symptoms of a severe allergic reaction may occur within a few minutes after contact with the allergen and maybe, for example, skin rash, redness, or swelling. More severe reactions also affect blood circulation and respiration.

Always use Emerade exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Before using Emerade, make sure you understand the situations in which you will use Emerade. You must always Emerade available if there is a risk of an acute allergic reaction.

You must store Emerade in the outer original box. However, the patient/caregiver may store the pen in a specially designed case that is included. The pen should always be stored in the case to protect it and the label describing how to use the pen in an emergency. Always keep this leaflet in case.

Dosage

Dose one is determined by the doctor, who will adjust it individually for you for example depending on your body weight.

Adults

Adults weighing less than 60 kg

The usual dose is 300 micrograms.

Adults weighing more than 60 kg

The usual dose is 300 to 500 micrograms.

Children and young people

Emerade 500 micrograms are not recommended for use in children.

Children weighing between 15 kg and 30 kg 

The usual dose is 150 micrograms.

Children weighing more than 30 kg

The usual dose is 300 micrograms.

Adolescents weighing more than 30 kg

The dose recommendations for adult patients should be followed.

How Emerade is given

The operating instructions must be followed carefully to avoid accidental injection.

It is recommended that your family members, caregivers, or teachers also receive instructions on the proper use of Emerade.

Emerade should only be used for injection into the outside of the thigh. Injection occurs when Emerade is pressed lightly against the thigh. It can be done through clothing. Never inject into the buttocks.





1. Remove the needle cover.




2. Place and press Emerade against the outside of the thighA click is heard when an injection enters the muscle.

3. Hold the Emerade firmly against the thigh for about 5 seconds. Massage the injection site lightly afterward. Contact a doctor or hospital immediately

The needle in Emerade is protected before, during, and after injection.

After injection one, the plunger rod is visible in the display window, if you lift the label.

Sometimes a dose of adrenaline is not enough to eliminate a severe allergic reaction. This is why your doctor will probably prescribe more than one Emerade. If the symptoms have not improved or worsened within 5-15 minutes after the first injection, either you or the person you are with should give a second injection. For this reason, you should always have more than one Emerade with you.

Emerade is only intended for emergency treatment. You should always seek help immediately after using Emerade. “anaphylaxis” even if symptoms seem to improve. You will need to go to the hospital for observation and further treatment as needed. This is because the reaction may return later. Take your used autoinjector with you.

While waiting for an ambulance, you should lie down with your feet up, 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 in a supine position.

Do not remove the needle cover until it is time to use Emerade.

Some liquid may remain in the Emerade after use. The autoinjector cannot be reused.

If you use more Emerade than you should  

If you have taken too much medicine, if you have accidentally injected Emerade into a blood vessel or in a hand or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

Blood pressure can rise sharply. Overdose of adrenaline can cause a sudden increase in blood pressure, irregular heartbeat, and accumulation of fluid in the lungs that 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 on experience with treatment with adrenaline, but the frequency of side effects can not be calculated:

  • heart problems such as irregular or rapid heartbeat, chest pain
  • high blood pressure, vasoconstriction
  • sweating
  • nausea, vomiting
  • breathing difficulties
  • headache, dizziness
  • weakness, tremors
  • anxiety, hallucinations
  • fainting
  • changes in blood values ​​such as increased blood sugar decreased potassium and increased acidity.

5. How to store Emerade

Keep this medicine out of the sight and reach of children.

Store Emerade in the outer carton. However, the patient/caregiver may store the pen in a specially designed case that is included. The pen should always be stored in the case to protect it.

Do not store above 25 ° C. Do not freeze.

Do not use this medicine after the expiry date which is stated on the labels and the outer carton after EXP. The expiration date is the last day of the specified month. Discard and replace Emerade after the expiration date. Check the solution regularly, by lifting the label over the display window on the auto-injector, to ensure that the solution is clear and colorless. Discard and replace Emerade if the solution is discolored or contains a precipitate.

Inspect the auto-injector if it is dropped. Replace it if you discover damage or leakage.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is adrenaline (like adrenaline tartrate).

Emerald 150 micrograms provide 150 micrograms of adrenaline in 0.15 ml solution for injection.

Emerade 300 micrograms provide 300 micrograms of adrenaline in 0.3 ml solution for injection.

Emerade 500 micrograms provide 500 micrograms of adrenaline in 0.5 ml solution for injection.

The other ingredients are sodium chloride, sodium metabisulfite (E223), disodium edetate, hydrochloric acid, and water for injections.

What the medicine looks like and the contents of the pack

Emerade is a pen that provides a single dose of adrenaline. Emerade contains a clear and colorless injection solution in an ice cream syringe. Emerade is latex-free.

The pen is a white cylinder with a needle cover that covers the needle and the activation mechanism.

The exposed length of the cannula

Emerade 150 micrograms: 16 mm

Emerade 300 micrograms and Emerade 500 micrograms: 23 mm

Pack sizes: 1 or 2 pre-filled pens.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer


Marketing Authorisation Holder

PharmaSwiss Czech Republic sro

Jankovcova 1569 / 2c

170 00 Prague 7

The Czech Republic

Information providing companies:

Medica Pharma AB

Box 24005

750 24 UPPSALA

Phone 018-25 85 30

Manufacturer

Rechon Life Science AB

Box 60043

216 10 Limhamn

Muhammad Nadeem

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