EpiPen 300 mikrogram Injektionsvätska, lösning i förfylld injektionspenna

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

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Bipacksedel Bipacksedel (PIL)

29-05-2019

Produktens egenskaper Produktens egenskaper (SPC)

13-11-2020

Aktiva substanser:
adrenalin
Tillgänglig från:
Paranova Läkemedel AB
ATC-kod:
C01CA24
INN (International namn):
adrenaline
Dos:
300 mikrogram
Läkemedelsform:
Injektionsvätska, lösning i förfylld injektionspenna
Sammansättning:
adrenalin 0,3 mg Aktiv substans; natriummetabisulfit Hjälpämne
Receptbelagda typ:
Receptbelagt
Bemyndigande status:
Avregistrerad
Godkännandenummer:
52615
Tillstånd datum:
2015-12-09

Dokument på andra språk

Bipacksedel Bipacksedel - engelska

17-06-2021

Produktens egenskaper Produktens egenskaper - engelska

17-06-2021

Offentlig bedömningsrapport Offentlig bedömningsrapport - engelska

15-07-2019

Läs hela dokumentet

Package leaflet: Information for the user

EpiPen 300 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, pharmacist or nurse.

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, pharmacist or nurse. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What EpiPen is and what it is used for

What you need to know before you use EpiPen

How to use EpiPen

Possible side effects

How to store EpiPen

Contents of the pack and other information

1.

What EpiPen is and what it is used for

EpiPen is a sterile solution

in pre-filled pen

for emergency injection into the muscle (intramuscular).

EpiPen (adrenaline) Auto-Injectors are to be used in the emergency treatment of severe allergic reactions

(anaphylaxis) caused by allergens in e.g. foods, drugs, insect stings or bites as well as triggered by exercise

or by unknown causes.

EpiPen Auto-Injectors are intended for immediate administration in patients, who are determined to be at

increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions.

Symptoms that signal the onset of an anaphylactic reaction include: itching of the skin; raised rash (like a

nettle rash); flushing; swelling of the lips, throat, tongue, hands and feet; wheezing; hoarseness; nausea;

vomiting; abdominal cramps and in some cases, loss of consciousness.

The medicine in the Auto-Injector (the pen) is adrenaline which is an adrenergic drug.

It works directly on the cardiovascular (heart and circulation) system and respiratory (lung) system,

countering the potentially fatal effects of anaphylaxis by rapidly constricting the blood vessels, relaxing

muscles in the lungs to improve breathing, reducing swelling and stimulating heartbeat.

2.

What you need to know before you use EpiPen

Do Not Use EpiPen

There is no known reason why anyone should not use EpiPen during an allergic emergency.

Warnings and precautions

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.

Tell your doctor if you have

heart disease

an overactive thyroid

high blood pressure

diabetes

increased pressure in your eye (glaucoma)

severe kidney problems

a tumor in your prostate

high calcium levels or low potassium level in your blood

Parkinson’s disease

Despite these concerns, adrenaline is essential for the treatment of anaphylaxis. Patients with these

conditions, or anyone who may be in the position to give EpiPen to a patient experiencing an allergic

reaction, should be properly instructed as to the situations in which it should be given.

The instructions for use must be carefully followed in order to avoid accidental injection.

EpiPen should only be injected 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 fingers may result in loss of blood supply to the affected

area. If there is an accidental injection into these areas, you should go immediately to the nearest hospital

casualty department for treatment.

If you have a thick sub-cutaneous fat layer, there is a risk that a single dose of EpiPen may not be sufficient.

A second injection may be needed. Carefully follow the instructions for use given in section 3.

Children and adolescents

Children between 15 kg and 30 kg in weight:

For children with a body weight between 15 kg and 30 kg EpiPen Jr. Auto-Injector containing 150

micrograms adrenaline per dose is available.

Children below 15 kg in weight:

The suitability of EpiPen Jr. (150 micrograms) has to be judged individually by the doctor.

The use in children weighing less than 7.5 kg is not recommended unless in a life-threatening situation and

under medical advice.

Other medicines

and EpiPen

Tell your doctor or pharmacist if you are taking, have recently taken or might take 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), and levodopa since the effect of adrenaline may be increased

Medicines that may make the heart sensitive to uneven beats (arrhythmias), such as digitalis and

quinidine.

Beta blocking medicines for heart disease or medicines to treat disorders of the nervous system as they

can reduce the effect of adrenaline

Medicines for thyroid disease

Medicine that makes you breathe more easily, used for asthma (theophylline)

Medicine used in labour (oxytocin)

Medicines used to treat allergies such as diphenhydramine or chlorpheniramine (antihistamines)

Medicines that act on the nervous system (parasympatholytics)

Diabetic patients should carefully monitor their glucose levels after use of EpiPen as adrenaline can affect

the amount of insulin made by the body, thus increasing the blood glucose level.

EpiPen with food, drink and alcohol

Food or drink has no influence on the use of EpiPen.

Tell your doctor if you are taking alcohol since the effect of adrenaline can be increased.

Pregnancy and breast-feeding

Pregnancy

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby,

ask your doctor or pharmacist for advice before taking this medicine.

In an acute life-threatening situation, do not hesitate to use EpiPen, since your and your child’s lives may be

in danger. There is limited experience of the use of adrenaline during pregnancy.

Breast-feeding

EpiPen would not be expected to have any effect on the nursing infant.

Driving and using machines

The ability to drive and use machines will not be affected by the administration of an adrenaline injection,

but may be affected by an anaphylactic reaction. If affected, do not drive.

EpiPen contains sodium metabisulfite (E223) and sodium chloride.

Sodium metabisulfite may rarely cause severe allergic reactions or breathing difficulty(bronchospasm).

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.

3.

How to use EpiPen

When your doctor prescribes EpiPen, you must make sure you understand the reason it has been prescribed

for you. You should be confident that you know exactly how to use the device. Always use EpiPen exactly

as your doctor has told you. If you are at all unsure about how to use it, ask to have the instructions repeated

by your doctor, nurse or pharmacist.

It is recommended that your family members, carers or teachers are also instructed in the correct use of

EpiPen.

In case of injection performed by the caregiver, immobilization of the patient’s leg should be ensured during

injection to minimize the risk of injection site laceration.

In no case reinsert the used needle.

For training and demonstration purposes, an EpiPen training device (without drug, without needle) is

available. The training device and the active EpiPen Auto-Injector should not be routinely carried together in

order to avoid confusion in an emergency situation.

EpiPen is intended to be used by people with a body weight above 30 kg.

For children weighing less than 30 kg see section “Children and adolescents” above.

Dosage

The dose will be decided by your doctor, who will adjust it individually for you. The usual adult dose for

allergic emergencies is 300 micrograms adrenaline for intramuscular use.

If you detect signs of an acute allergic reaction, use EpiPen immediately.

Each EpiPen Auto-Injector delivers one single dose of 0.3 ml liquid which is equal to 300 micrograms

adrenaline. After use a small volume will remain in the Auto-Injector but this cannot be reused.

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 EpiPen 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

EpiPen with you at all times.

How EpiPen is given

The EpiPen is designed to be used easily by people without medical training. EpiPen should simply be

jabbed firmly against the outer portion of the thigh from a distance of approximately 10 cm. There is no need

for precise placement

in the outer portion of the thigh

. When you jab the EpiPen firmly into your thigh, a

spring activated plunger will be released, which pushes the hidden needle into the thigh muscle and

administers a dose of adrenaline. If you are wearing clothes the EpiPen can be injected through the clothes.

The instructions for use of the EpiPen must be carefully followed.

EpiPen should ONLY be injected into the outer thigh.

It should not be injected into the buttock.

Directions for use

Fully familiarise yourself with the EpiPen, when and how it should be used.

Blue Safety Cap

Viewing window

Orange tip

Follow these directions only when ready to use.

Hold the Auto-Injector by the middle, never by the ends. For proper administration, look at the diagrams and

follow these steps:

- Never put thumb, fingers or hand over the orange tip. Never press or push the orange tip with thumb,

fingers or hand.

- The needle comes out of orange tip.

- Do NOT remove blue safety cap until ready to use.

Grasp EpiPen

in dominant hand (the hand you use to write), with

thumb nearest blue cap and form fist around unit

(orange tip down).

2. Remove the blue safety cap by pulling it

straight up with the other hand.

3. Hold the EpiPen in a distance of approximately

10 cm away from the outer thigh. The orange tip

should point towards the outer thigh.

4. Jab the EpiPen

firmly

into outer thigh at a right

angle (90-degree angle). (listen for click).

5. Hold firmly against thigh for 5 seconds. The

injection is now complete and the viewing

window on the Auto-Injector is obscured.

6. EpiPen should be removed (the orange needle

cover will extend to cover needle) and safely

discarded.

Gently

massage the injection area for 10 seconds.

Dial 112, ask for ambulance, state anaphylaxis.

A small bubble may be present in the EpiPen Auto-Injector. It has no influence on the product’s

effectiveness.

Even though most of the liquid (about 90%) remains in the EpiPen after use, it cannot be reused. However,

you have received the correct dose of the medication if the orange needle tip is extended and the viewing

window is obscured. Discard EpiPen safely after use in the tube provided and bring it with you when you

visit your doctor, hospital or pharmacy.

EpiPen is designed as emergency treatment

.

You should always get medical help immediately after using

EpiPen. Dial 112, ask for an ambulance

and 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.

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.

If you use more EpiPen than you should

In case of overdose or accidental injection of the adrenaline, you should always seek immediate medical

help.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Rare cases of serious skin and soft tissue infections (injection site infection) have been reported. In case of

signs of injection site infection such as swelling, redness, heat or pain always seek immediate medical help.

Accidental injection of the pens in hands or feet have been reported and may result in loss of blood supply to

the affected area. In case of accidental injection always seek immediate medical help.

Allergic reactions can appear in patients sensitized to sodium metabisulfite. In rare cases (may affect up to 1

in 1.000 people) stress cardiomyopathy has been seen in patients treated with adrenaline.

Not known: (frequency cannot be estimated from the available data): Fast or irregular heartbeat sometimes

severe, severe pain in the chest, high blood pressure, difficulties in breathing, pallor, sweating, nausea,

vomiting, headache, dizziness, weakness, tremor and nervousness or anxiety, injury at the injection site such

as bruising, bleeding, redness.

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in the leaflet.

You can also report side effects directly via ˂[the national reporting system listed in Appendix V*] / [to be

completed nationally]>. By reporting side effects you can help provide more information on the safety of this

medicine.

5.

How to store EpiPen

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

Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry

date refers to the last day of that month.

Do not store above 25

C. Do not refrigerate or freeze.

Keep the container in the outer carton in order to protect from light. When exposed to air or light, adrenaline

deteriorates rapidly and will become pink or brown.

Please remember to check the contents of the glass

cartridge in the EpiPen Auto-Injector from time to time to make sure the liquid is still clear and

colourless. Replace the Auto-Injector by the expiry date or earlier if the solution is discoloured or

contains a precipitate (solid matter).

Do not away any medicines via wastewater or household waste. Ask your pharmacist how to throw away

medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What EpiPen contains

The active substance is adrenaline. Each dose contains 300 micrograms adrenaline.

The other ingredients are Sodium Chloride, Sodium Metabisulfite (E223), Hydrochloric Acid, Water for

Injections.

What EpiPen looks like and contents of the pack

Clear and colourless solution in a pre-filled pen (Auto-Injector).

The Auto-Injector contains 2 ml solution for injection. Each Auto-Injector delivers one single dose (0.3 ml)

of 0.3 mg adrenaline.

Exposed and protected needle length approx. 15 mm.

Pack sizes:

1 Auto-Injector.

2 x 1 Auto-Injector.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

[To be completed nationally]

Manufacturer

MEDA Pharma GmbH & Co. KG

Benzstrasse 1

D-61352 Bad Homburg

Germany

This medicinal product is authorised in the Member States of the EEA under the following names:

Name of Member State

Name of medicinal product

Netherlands, Belgium, Iceland, Norway, Finland,

Sweden, Denmark, Austria, Slovak Republic, Czech

Republic and Hungary

EpiPen

Poland

EpiPen Senior

Spain

ALTELLUS 0,3 adultos

This leaflet was last revised in 2021-05-27.

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SUMMARY OF PRODUCT CHARACTERISTICS

1.

NAME OF THE MEDICINAL PRODUCT

EpiPen 300 micrograms, solution for injection in pre-filled pen.

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

1 ml contains 1 mg adrenaline (epinephrine). A single dose (0.3 ml) contains 300 micrograms

(0.3 mg) adrenaline.

Excipient: Sodium Metabisulfite (E223) 0.5 mg/dose, sodium chloride 1.8 mg/dose.

For a full list of excipients, see section 6.1

3.

PHARMACEUTICAL FORM

Solution for injection in pre-filled pen (Auto-Injector).

Clear and colourless solution.

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

EpiPen (adrenaline) Auto-Injectors are indicated in the emergency treatment of severe allergic

reactions (anaphylaxis) to insect stings or bites, foods, drugs and other allergens, as well as

idiopathic or exercise induced anaphylaxis.

4.2

Posology and method of administration

Posology

Paediatric population

Usual paediatric dose is 0.01 mg/kg body weight. However, the prescribing physician has the

option of prescribing more or less than these amounts based on careful assessment of each

individual patient and recognizing the life-threatening nature of reactions for which this is

being described. A dosage below 150 micrograms cannot be administered with EpiPen

adrenaline Auto-Injector. The physician should consider using other forms of injectable

adrenaline if lower doses are felt to be necessary for small children.

Children and adolescents over 30 kg weight:

The usual dose is 300 micrograms for intramuscular use.

Children between 15 kg and 30 kg in weight*:

The usual dose is 150 micrograms for intramuscular use.

*For these patients EpiPen Jr. Auto-Injector containing 150 micrograms adrenaline per dose is

available

Children below 15 kg in weight:

The suitability of EpiPen Jr. has to be judged individually. The use in children weighing less

than 7.5 kg is not recommended unless in a life-threatening situation and under medical

advice.

Adults

The usual dose is 300 micrograms for intramuscular use.

An initial dose should be administered as soon as symptoms of anaphylaxis are recognized.

In the absence of clinical improvement or if deterioration occurs, a second injection with an

additional EpiPen Auto-Injector may be administered 5 – 15 minutes after the first injection.

It is recommended that patients are prescribed two EpiPen pens which they should carry at all

times.

The physician prescribing an EpiPen Auto-Injector must ensure that the patient understands

the indications for use and the correct method of application.

Therefore, the physician should discuss the patient information leaflet, the correct handling of

the Auto-Injector and the possible symptoms of an anaphylactic shock in detail with the

patient.

Method of administration

EpiPen

Auto-Injectors

intended

immediate

administration

patients,

determined to be at increased risk for anaphylaxis, including individuals with a history of

anaphylactic reactions.

For intramuscular administration into the anterolateral thigh, not the buttock. It is designed to

inject through clothing or directly through the skin.

See section "6.6 Special precautions for disposal and other handling".

The patient/carer should be informed that following each use of EpiPen:

They should call for immediate medical assistance, ask for an ambulance and state

“anaphylaxis”

even if symptoms appear to be improving (see section 4.4).

Conscious patients should preferably lie flat with feet elevated but sit up if they have

breathing difficulties. Unconscious patients should be placed on their side in the

recovery position.

The patient should if possible remain with another person until medical assistance

arrives.

4.3

Contraindications

There are no known absolute contraindications to the use of EpiPen during an allergic

emergency.

4.4

Special warnings and precautions for use

All patients who are prescribed EpiPen should be thoroughly instructed to understand the

indications for the use and the correct method of administration (see section 6.6). It is strongly

advised also to educate the patient’s immediate associates (e.g. parents, caregivers, teachers)

for the correct usage of the EpiPen in case support is needed in the emergency situation.

The patient should be instructed to dial 112, ask for ambulance, state anaphylaxis to seek

emergency medical assistance immediately after administering the first dose in order to have

close monitoring of the anaphylactic episode and further treatment as required.

The Auto-Injectors should be injected into the anterolateral aspect of the thigh. Patients

should be advised not to inject into the buttock.

In case of injection performed by a caregiver, immobilization of the patient’s leg should be

ensured during injection to minimize the risk of leg laceration, bent needle or other injuries.

The product is for single use only and in no case the used pen should be reused.

Adrenaline is ordinarily administered with extreme caution to patients who have a heart

disease. Adrenaline should only be prescribed to those patients, but also those suffering from

diabetes, hyperthyroidism, hypertension and elderly individuals if the potential benefit

justifies the potential risk. There is a risk of adverse reactions following epinephrine

administration in patients with high intraocular pressure, severe renal impairment, prostatic

adenoma leading to residual urine, hypercalcaemia and hypokalaemia. In patients with

Parkinson’s disease, epinephrine may be associated with a transient worsening of Parkinson

symptoms such as rigidity and tremor.

The patient/carer should be informed about the possibility of biphasic anaphylaxis which is

characterised by initial resolution followed by recurrence of symptoms some hours later.

Patients with concomitant asthma may be at increased risk of a severe anaphylactic reaction.

Accidental injection into hands or feet resulting in peripheral ischaemia has been reported.

Patients may need treatment following the accidental injection.

In patients with thick sub-cutaneous fat layer, there is a risk for adrenaline not reaching the

muscle tissue resulting in a suboptimal effect (see section 5.2). A second injection with an

additional EpiPen may be needed (see section 4.2).

EpiPen contains sodium metabisulfite which may rarely cause severe hypersensitivity

reactions including anaphylactic symptoms and bronchospasm in susceptible people,

especially those with a history of asthma. Patients with these conditions must be care-fully

instructed in regard to the circumstances under which EpiPen should be used.

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially

‘sodium-free’.

Patients should be warned regarding related allergens and should be investigated whenever

possible so that their specific allergens can be characterised.

4.5

Interaction with other medicinal products and other forms of interaction

Caution is indicated in patients receiving drugs that may sensitise the heart to arrhythmias,

including digitalis and quinidine. The effects of adrenaline may be potentiated by tricyclic

antidepressants, monoamine oxidase inhibitors (MAO-inhibitors) and catechol-O-methyl

transferase inhibitors (COMT inhibitors), thyroid hormones, theophylline, oxytocin,

parasympatholytics, certain antihistamines (diphenhydramine, chlorpheniramine), levodopa

and alcohol.

Adrenaline inhibits the secretion of insulin, thus increasing the blood glucose level. It may be

necessary for diabetic patients receiving adrenaline to increase their dosage of insulin or oral

hypoglycaemic drugs.

Observe

. The

-stimulating effect can be inhibited by simultaneous treatment with

blocking drugs.

4.6

Fertility, pregnancy and lactation

Pregnancy

Clinical experience in the treatment of pregnant is limited. Adrenaline should be used during

pregnancy only if the potential benefit justifies the potential risk for the foetus.

Breastfeeding

Adrenaline is not orally bioavailable; any adrenaline excreted in breast-milk would not be

expected to have any effect on the nursing infant.

Fertility

As adrenaline is a substance that naturally occurs in the body, it is unlikely that this drug

would have any detrimental effects on fertility.

4.7

Effects on ability to drive and use machines

It is not recommended that patients should drive or use machines following administration of

adrenaline, since patients will be affected by symptoms of the anaphylactic shock.

4.8

Undesirable effects

Side effects associated with adrenaline's alpha and beta receptor activity may include

symptoms such as tachycardia and hypertension as well as undesirable effects on the central

nervous system.

Evaluation of undesirable effects is based on the following frequency information:

Very common (≥ 1/10)

Common (≥ 1/100 to < 1/10)

Uncommon (≥ 1/1,000 to < 1/100)

Rare (≥ 1/10,000 to < 1/1,000)

Very rare (< 1/10,000)

Not known (Frequency cannot be estimated from the available data).

Organ System

Frequency

Adverse drug reaction

Infections and infestations

Frequency not known

Injection site infection *

Psychiatric disorders

Frequency not known

Anxiety

Nervous system disorders

Frequency not known

Headache, dizziness, tremor

Rare

Stress cardiomyopathy

Cardiac disorders

Frequency not known

Tachycardia, cardiac arrhythmia,

palpitations, angina pectoris,

ventricular fibrillation

Vascular disorders

Frequency not known

Hypertension, pallor,

peripheral ischaemia following

accidental injection of the pens in

hands or feet

Respiratory, thoracic and

mediastinal disorders

Frequency not known

Respiratory difficulties

Gastrointestinal disorders

Frequency not known

Nausea, vomiting

Skin and subcutaneous

tissue disorders

Frequency not known

Hyperhidrosis

General disorders and

administration site

conditions

Frequency not known

Asthenia

Injury, poisoning and

procedural complications

Frequency not known

Accidental needle injury

Accidental injections or inappropriate use can lead to injury at the injection site resulting in

bruising, bleeding, discoloration, erythema or skeletal injury

* rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and

myonecrosis caused by Clostridia (gas gangrene) are known from post-marketing experience

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is

important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Healthcare professionals are asked to report any suspected adverse reactions via <[the

national reporting system listed in Appendix V*]/ [to be completed nationally]>.

4.9

Overdose

Overdose or inadvertent intravascular injection of adrenaline may cause cerebral haemorrhage

resulting from a sharp rise in blood pressure. Fatalities may also result from pulmonary

oedema because of peripheral vascular constriction together with cardiac stimulation.

Pulmonary oedema may be treated with α-blocking agents such as phentolamine. In case of

arrhythmias these may be treated with β-blocking agents.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Cardiac stimulants excl

. cardiac glycosides, adrenergic and

dopaminergic agents

ATC code: C01CA24.

Adrenaline is a catecholamine which stimulates the sympathetic nervous system (both alpha

and beta receptors) by which cardiac rate, cardiac output and coronary circulation is raised.

Adrenaline through its action on beta receptors on bronchial smooth muscles causes bronchial

smooth muscle relaxation which alleviates wheezing and dyspnoea.

Adrenaline is rapidly inactivated and much of the dose of adrenaline is accounted for by

excretion of metabolites in the urine.

5.2

Pharmacokinetic properties

Adrenaline is a naturally occurring substance produced by the adrenal medulla and secreted in

response to exertion or stress. It is rapidly inactivated in the body mostly by the enzymes

COMT and MAO. The liver is rich in these enzymes and is an important, although not

essential, tissue in the degradation process. Much of the dose of adrenaline is accounted for by

excretion of metabolites in the urine.

The plasma half-life of adrenaline is about 2.5 min. However, by subcutaneous or

intramuscular routes, local vasoconstriction retards absorption, so that the effects occur

insidious and last much longer than the half-life would predict. Gently massage the injection

area is advised.

In a pharmacokinetic study in 35 healthy subjects, grouped by varying degrees of thickness in

the subcutaneous fat layer of the thigh and stratified by gender, a single 0.3 mg/0.3 ml

injection at the anterolateral aspect of the mid-thigh was made with an EpiPen Auto-Injector

and was compared in crossover design to a manual syringe-delivered dose with needles

individualized for delivery to muscle layer. The results indicate that female subjects with a

thick sub-cutaneous fat layer (> 20 mm skin to muscle distance under maximum compression)

had slower adrenaline absorption rate, reflected in a trend to lower plasma exposure in such

subjects in the first ten minutes following injection (see section 4.4). However, overall

adrenaline exposure from 0 to 30 min (AUC

0-30min

) for all groups of subjects receiving EpiPen

exceeded exposures resulting from syringe delivery. Importantly, a trend to higher plasma

adrenaline concentrations following EpiPen compared to manual intramuscular injection in

healthy subjects who will have well perfused subcutaneous tissue cannot necessarily be

extrapolated to patients in established anaphylactic shock in whom there may be diversion of

blood from skin to leg muscles. The possibility of existing cutaneous vasoconstriction at the

time of injection should be taken into consideration therefore.

Both inter-subject and intra-subject variability was however, high in this study and therefore

robust conclusions cannot be drawn.

5.3

Preclinical safety data

There is no preclinical data of importance to the prescriber.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Sodium Chloride

Sodium Metabisulfite

(E223)

Hydrochloric Acid (for pH adjustment)

Water for Injections

6.2

Incompatibilities

Adrenaline and its salts are rapidly destroyed in solution with oxidising agents. Oxidation can

be inhibited by addition of anti-oxidants. The solution darkens in colour upon exposure to air

or light.

6.3

Shelf life

2 years

6.4

Special precautions for storage

Keep the container in the outer carton in order to protect from light. Do not store above 25

Do not refrigerate or freeze.

Check the solution periodically through the viewing window of the unit to make sure the

solution is clear and colourless. Discard and replace the Auto-Injector if the solution is

discoloured or contains a precipitate, or at the latest by expiration date. The expiry date is

indicated on the label and the Auto-Injector should not be used after this date.

6.5

Nature and contents of container

The immediate container/closure system consists of a glass cartridge sealed by a rubber

plunger at one end and by rubber diaphragm which has been inserted into an aluminium hub

with attached stainless steel needle at the other end. The glass cartridge contains the product.

The Auto-Injector administration device:

Glass cartridge container:

Type I, Borosilicate Glass

Diaphragm - Stopper:

PH 701/50/Black (butyl rubber plunger)

Needle - Hub - Sheath:

Needle:

Siliconised Type 304 stainless steel, exposed and protected needle length after

activation approx. 15 mm

Hub:

Anodised 3003 aluminium alloy

Sheath:

Synthetic polyisoprene

The Auto-Injector contains 2 ml solution for injection. Each Auto-Injector delivers one single

dose (0.3 ml) of 300 micrograms adrenaline.

Pack sizes:

1 Auto-Injector.

2 x 1 Auto-Injector.

Not all pack sizes may be marketed.

6.6

Special precautions for disposal and other handling

For single use only. The Auto-Injectors must be discarded immediately after use.

During instruction of the patient in correct use of the EpiPen the prescribing doctor may use a

“EpiPen® TRAINER” (contains no solution for injection and no needle).

The EpiPen Auto-Injector contains 2 ml of adrenaline injection 1 mg/ml which is designed to

deliver a single dose (0.3 ml) of 300 micrograms adrenaline when activated. After activation

of the Auto-Injector 1.7 ml remains in the Auto-Injector.

Do not remove blue safety cap until ready for use.

Under no circumstances place the orange end of the EpiPen Auto-Injector on or near your

thumbs, fingers or hands. Accidental injection into hand or finger resulting in peripheral

ischaemia has been reported. See section 4.4. The EpiPen Auto-Injector should be used on the

outer thigh. The injection is activated immediately once the orange end of the EpiPen Auto-

Injector comes into contact with any skin or other surface.

The EpiPen Auto-Injectors are designed for easy use by the lay person and has to be

considered as a first aid. The Auto-Injector should simply be jabbed firmly against the outer

portion of the thigh from a distance of approximately 10 cm. There is no need for more

precise placement in the outer portion of the thigh. When EpiPen Auto-Injector is jabbed

against the thigh, it releases a spring activated plunger, pushing concealed needle into the

thigh muscle and expelling a dose of adrenaline:

Grasp EpiPen Auto-Injector in dominant hand, with thumb closest to blue safety cap.

Remove the blue safety cap by pulling it straight up with the other hand.

Hold the EpiPen Auto-Injector in a distance of approximately 10 cm away from the

outer thigh. The orange tip should point towards the outer thigh.

Jab firmly into the outer thigh, so that the EpiPen Auto-Injector is at a right angle to

(at a 90 degree angle) the outer thigh.

Hold firmly in place for 5 seconds. The injection is now complete and the viewing

window of the Auto-Injector is obscured. The EpiPen Auto-Injector should be

removed (the orange needle cover will extend to cover needle) and safely discarded.

Gently

massage the injection area for 10 seconds.

A small bubble may occur in the EpiPen Auto-Injector. It has no influence on either the use or

the efficacy of the product.

Instruction for use is enclosed in the package.

See Section 4.2 for instruction to be conveyed to the patient/carer regarding actions to be

taken following each use of EpiPen Auto-Injector.

7.

MARKETING AUTHORISATION HOLDER

<[to be completed nationally]>

8.

MARKETING AUTHORISATION NUMBER

<[to be completed nationally]>

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

<[to be completed nationally]>

Date of first authorisation: 25 October 1996

Date of latest renewal: 25 October 2011

10.

DATE OF REVISION OF THE TEXT

2021-05-27

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