Adrenaline (Epinephrine) 1:10,000 Sterile Solution Minijet

Ireland - English - HPRA (Health Products Regulatory Authority)

Buy It Now

Active ingredient:
Adrenaline
Available from:
International Medication Systems (UK) Ltd
ATC code:
C01CA; C01CA24
INN (International Name):
Adrenaline
Dosage:
0.1 milligram(s)/millilitre
Pharmaceutical form:
Solution for injection
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Adrenergic and dopaminergic agents; epinephrine
Authorization status:
Not marketed
Authorization number:
PA0255/002/003
Authorization date:
1978-01-25

Adrenaline (Epinephrine)

1:10,000 Sterile Solution Minijet

Solution for Injection

Please note this medicine is

mainly used in emergency

situations and the doctor will have

decided that you needed it.

It is unlikely, therefore, that you

the medicine was administered

to you.

to read it again

− If you have any further

questions, ask the doctor or

nurse

− This medicine has been

prescribed for you. Do not pass

it onto others. It may harm

them, even if their symptoms

are the same as yours.

− If any of the side effects get

serious, or if you notice any side

please tell the doctor or nurse.

1:10,000 Sterile Solution

Minijet will be called

Adrenaline Minijet

1. What Adrenaline Minijet is and

what it is used for

2. Before you are given Adrenaline

Minijet

3. How Adrenaline Minijet is used

4. Possible side effects

5. How to store Adrenaline Minijet

6. Further information.

1. What Adrenaline Sterile

Solution Minijet is and

what it is used for

Adrenaline is a type of drug that

constricts blood vessels, makes

the heart pump more strongly and

opens airways.

It is used in life-threatening

emergencies such as when the

heart has stopped beating. It will

have been used to save your life.

2. Before you are given

Adrenaline Minijet

In emergencies, it may be

impossible for the people looking

after you to get all your details

before they have to treat you. They

will have assessed the situation

and decided it was better to give

you the injection now and ask

questions later.

Please tell your doctor if:

you are allergic to any of the

ingredients (listed in section

rarely cause hypersensitivity

reactions and bronchospasm

6). Sodium metabisulfite may

you suffer from

hyperthyroidism (overactive

thyroid gland)

you suffer from hypertension

(high blood pressure)

you suffer from heart disease or

long standing chest disease like

asthma or emphysema

you suffer from diabetes

you suffer from closed angle

glaucoma (an eye condition that

causes sudden blurred vision

with pain and redness)

you are allergic to

sympathomimetic drugs

you have a problem with the rate

or rhythm of your heartbeat

you have had a spinal cord

injury and are suffering from

over-activity of the involuntary

nervous system which causes

your blood pressure to be

uncontrolled

you suffer from an enlarged

urinating

you have an overactive thyroid

you have mental disturbances

you have recently had an

anaesthetic.

Taking other medicines

Please tell your doctor if you are

taking any medicines.

In particular those:

for depression or other

psychiatric illness (e.g.

monoamine oxidase

inhibitors (MAOIs), tricyclic

antidepressants, imipramine)

for heart problems or

high blood pressure (e.g.

propranolol, digoxin, quinidine,

guanethidine, alpha blockers or

sympathomimetric drugs such

as isoproterenol)

for diabetes (e.g. glibenclamide)

for migraine (e.g. ergot

alkaloids)

for post natal bleeding (e.g.

oxytocin)

for Parkinson’s disease (e.g.

levodopa, entacapone)

drugs which cause potassium

loss (corticosteroids,

potassium-depleting diuretic,

aminophylline, theophylline).

Pregnancy and breast feeding

Tell your doctor if you are

pregnant as the heartbeat of the

unborn child can be affected.

However, it is safe to continue

breastfeeding.

Driving and using machines

Not applicable; this medicine is

intended for emergency use only.

Adrenaline Minijet contains

Sodium

This medicinal product contains

not more than 5 mg/ml sodium.

To be taken into consideration by

patients on a controlled sodium

diet.

3. How Adrenaline Minijet

is used

Adults are usually given 10ml

(1mg) into a vein. Sometimes

20-30ml (2-3mg) is given through

a breathing tube, or 1-10ml (0.1-

1mg) directly into the chamber of

the heart.

Children are usually given 0.1ml

for every kg they weigh.

If you think you have been given

too much medicine, please tell

your doctor.

Sterile Solution Minijet Solution for Injection Adrenaline (epinephrine)

STB-144022-03

4. Possible side-effects

Like all medicines Adrenaline Minijet

can cause side effects, although not

everyone gets them.

The heart may beat an odd rhythm,

heart attack

Blood pressure may rise

dangerously high, leading to a stroke

If Adrenaline was given to you by

a tube through your nose or mouth,

you may get congestion of the

mucous membranes of your nose or

mouth

Stress which causes the symptoms

of a heart attack

The cells of your bowel may die

Pallor

Feeling anxious, breathless, restless,

weak, shaky or dizzy

You may be aware of your heartbeat

or have a fast heart rate

Headache

Extreme chest pain which does not

go away when you rest

Your blood sugar levels may be

altered, making you feel ill.

5. How to store Adrenaline

Minijet

Keep out of the reach and sight of

children.

Do not use Adrenaline Minijet after

the expiry date stated on the carton or

syringe label. The expiry date refers to

the last day of the month.

Do not store above 25°C.

Keep container in outer carton in

order to protect from light.

Use immediately after opening.

For single use only. Discard any

remaining contents after opening.

Do not use Adrenaline Minijet if the

solution is discoloured.

The medicines should not be disposed

of via waste water or household waste.

Ask your pharmacist how to dispose

of medicines no longer required.

These measures will help protect the

environment.

6. Further information

What Adrenaline Minijet contains

The active substance is adrenaline

(epinephrine). Each 1 ml of solution

contains 0.1 mg of adrenaline.

The other ingredients are citric acid

monohydrate, sodium citrate (E331),

(E223), dilute hydrochloric acid (for

pH adjustment), water for injections.

What Adrenaline Minijet looks like

and contents of the pack

Adrenaline Minijet is a sterile solution

for injection. The solution is clear and

colourless and comes in 2 different

pack sizes as follows:

10 ml clear glass syringe with a luer

lock connector

3 ml clear glass vial with a separate

injector. Not all pack sizes may be

marketed.

Marketing Authorisation holder:

International Medication Systems

(UK) Ltd.,

First Floor, Templeback,

10 Temple Back, Bristol, BS1

6FL,

Manufacturer:

UCB Pharma Ltd, 208 Bath Road,

Slough, Berkshire, SL1 3WE, UK

January 2018

or you would like it in a different

format, please contact International

Medication Systems (UK) Ltd.,

First Floor, Templeback, 10

Temple Back, Bristol, BS1 6FL

Reporting of side effects

If you get any side effects, talk to your

doctor, pharmacist or nurse. This

includes any possible side effects not

listed in this leaflet. You can also

report side effects directly via:

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.

United Kingdom

Yellow Card Scheme

Website:

www.mhra.gov.uk/yellowcard

By reporting side effects, you can help

provide more information on the

safety of this medicine.

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Adrenaline (Epinephrine) 1:10,000 Sterile Solution Minijet.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Adrenaline (Epinephrine) 0.1 mg per ml, in total volume presentations of 0.3 mg / 3 ml and 1 mg / 10 ml.

Excipients with known effect: sodium metabisulfite (E223) 1 mg in 1 ml and total sodium 2.7mg in 1 ml.

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Solution for injection.

Clear, colourless solution.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Adjunctive use in the management of cardiac arrest.

In cardiopulmonary resuscitation. Intracardiac puncture and intramyocardial injection of adrenaline may be effective

when external cardiac compression and attempts to restore the circulation by electrical defibrillation or use of a

pacemaker fail.

4.2 Posology and method of administration

Ventricular fibrillation (pulseless ventricular tachycardia)

Adults:

Intravenous injection

10ml (1mg) by intravenous injection repeated every 3-5 minutes as necessary.

Endotracheal

20-30ml (2-3mg) via an endotracheal tube, repeated as necessary.

Intracardiac injection

1 to 10ml (0.1 to 1mg), direct into the atrium of the heart.

Intracardiac injection should only be considered if

there is no other

access available.

should be undertaken by

personnel trained in the technique.

Children:

Intravenous injection

Initially 0.1ml/kg body weight (10mcg/kg); e.g. 2kg infant would receive 0.2ml of Adrenaline 1:10,000.

Subsequent

doses should be 1ml/kg (100mcg/kg).

Intraosseous

0.1ml/kg body weight (10mcg/kg).

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Endotracheal

A dose has not been established; 10 times the intravenous dose may be appropriate.

Asystole

Adults:

Intravenous

10ml (1mg) by intravenous injection repeated every 3-5 minutes as necessary.

If there is no response after three cycles,

consider injections of adrenaline 5mg.

Endotracheal

20-30 ml (2-3mg) via an endotracheal tube, repeated as necessary.

Children:

Intravenous

0.1ml/kg initially (10mcg/kg).

If no response give 1ml/kg (100mcg/kg).

After 3 cycles consider alkalising or

antiarrhytmic agents.

Intraosseus

0.1 ml/kg initially (10mcg/kg).

If no response give 1ml/kg (100mcg/kg).

After 3 cycles consider alkalising or

antiarrhythmic agents.

Electromechanical Dissociation (EMD)

Adults:

Intravenous: 10ml (1mg) by intravenous injection repeated every 3-5 minutes as necessary.

If normal rhythm does not

return after standard measures, consider adrenaline 5mg intravenous.

Children:

Intravenous: 0.1ml/kg initially (10mcg/kg) every 3 minutes, until underlying cause identified.

Subsequent doses

should be 1ml/kg (100mcg/kg).

4.3 Contraindications

Contraindications are relative as this product is intended for use in life-threatening emergencies.

Other than in the emergency situation, the following contraindications should be considered: Hyperthyroidism,

hypertension, ischaemic heart disease, diabetes mellitus, closed angle glaucoma and hypersensitivity to

sympathomimetic amines.

4.4 Special warnings and precautions for use

These special warnings and precautions are relative as this product is intended for use in life-threatening situations.

Administer slowly with caution to elderly patients and to patients with ischaemic heart disease, hypertension, diabetes

mellitus, hyperthyroidism or psychoneurosis.

Use with extreme caution in patients with long-standing bronchial asthma and emphysema who have developed

degenerative heart disease.

Anginal pain may be induced when coronary insufficiency is present.

Use with caution in patients with pre-existing cardiac arrhythmias.

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Tissue necrosis at injection site may arise if this product is administered to an inappropriate injection site such as digits

or buttocks.

Intravenous administration should be performed with caution in order to avoid an accidental intra-arterial injection.

Administer with caution: In patients suffering from autonomic dysreflexia (hyperreflexia), particularly in spinal cord

injury (e.g., tetraplegics).

Patients with hypersensitivity to sulfites and patients with prostatic hypertrophy or urination

difficulty.

Endotracheal administration of adrenaline can contaminate the colorimeter carbon dioxide detector and lead to its false

positive colour change (fixed yellow discoloration).

4.5 Interaction with other medicinal products and other forms of interaction

The effects of adrenaline may be potentiated by tricyclic antidepressants.

Volatile anaesthetics such as halothane increase the risk of

adrenaline-induced ventricular

arrhythmias and acute

pulmonary oedema if hypoxia is present.

Severe hypertension and bradycardia may occur with non-selective beta-

blocking drugs such as propranolol.

Propranolol

also inhibits the bronchodilator effect

of adrenaline.

The risk of

cardiac arrhythmias is higher when adrenaline is given to patients receiving digoxin or quinidine.

Adrenaline –induced

hyperglycaemia may lead to loss of blood-sugar control in diabetic patients treated with hypoglycaemic agents.

The vasoconstrictor and pressor effects of adrenaline, mediated by its alpha-adrenergic action, may be enhanced by

concomitant administration of drugs with similar effects, such as ergot alkaloids or oxytocin.

Adrenaline specifically reverses the antihypertensive effects of adrenergic neurone blockers such as guanethidine with

the risk of severe hypertension.

Concurrent

within

weeks

monoamine

oxidase

inhibitor

increases

risk

adverse

events.

Sympathomimetic drugs (e.g. isoproterenol) increase the risk of serious cardiac arrhythmias.

Alpha blockers increase

the risk of

hypotension and tachycardia.

Drugs which cause potassium loss (corticosteroids,

potassium-depleting

diuretic,

aminophylline,

theophylline)

increases the risk of

hypokalemia.

Levodopa increases the risk of

cardiac

adverse effects of levodopa

Use of Entacapone may potentiate the chronotropic and arrhtmogenic effects of adrenaline.

4.6 Fertility, pregnancy and lactation

Adrenaline crosses the placenta.

There is some evidence of a slightly increased incidence of congenital abnormalities.

Injection of adrenaline may cause foetal tachycardia, cardiac irregularities, extrasystoles and louder heart sounds.

labour, adrenaline may delay the second stage. Adrenaline should only be used in pregnancy if the potential benefits

outweigh the risks to the foetus.

Adrenaline is excreted in breast milk, but as pharmacologically active plasma concentrations are not achieved by the

oral route, the use of adrenaline in breast feeding mothers is presumed to be safe.

4.7 Effects on ability to drive and use machines

Not applicable; this preparation is intended for use only in emergencies.

4.8 Undesirable effects

The potentially severe adverse effects of adrenaline arise from its effect upon blood pressure and cardiac rhythm.

Anginal pain, ventricular fibrillation , myocardial ischaemia and myocardial infarction may occur .

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Severe hypertension may lead to cerebral haemorrhage and pulmonary oedema.

Local vasoconstriction and hypoxia of

mucosa, which may lead to compensatory rebound congestion of the mucosa (in case of endotracheal administration).

Stress cardiomyopathy, bowel necrosis, pallor and thrombocytosis.

Symptomatic adverse effects are anxiety,

dyspnoea, restlessness, palpitations, tachycardia, tremor, weakness, dizziness, headache and cold extremities.

Other effects that may occur include difficulty in micturition and urinary retention.

Biochemical effects include inhibition of insulin secretion, stimulation of growth hormone secretion, hyperglycaemia

(even with low doses), gluconeogenesis, glycolysis, lipolysis and ketogenesis.

Please cross refer to section 4.4

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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;

Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

4.9 Overdose

Symptoms

Cardiac arrhythmias leading to ventricular fibrillation and death; severe hypertension leading to pulmonary oedema and

cerebral haemorrhage.

Treatment

Combined alpha- and beta-adrenergic blocking agents such as labetalol may counteract the effects of adrenaline, or a

beta-blocking agent may be used to treat any supraventricular arrhythmias and phentolamine to control the alpha-

mediated effects on the peripheral circulation.

Rapidly acting vasodilators such as nitrates and sodium nitroprusside

may also be helpful.

Immediate resuscitation support must be available.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

ATC code: C01 CA24

Adrenaline is a direct-acting sympathomimetic agent exerting its effect on alpha- and beta-adrenoceptors.

The overall

effect of epinephrine depends on the dose used, and may be complicated by the homeostatic reflex responses.

resuscitation procedures it is used to increase the efficacy of basic life support. It is a positive cardiac inotrope.

Major

effects are increased systolic blood pressure, reduced diastolic pressure (increased at higher doses), tachycardia,

hyperglycaemia and hypokalaemia.

5.2 Pharmacokinetic properties

Adrenaline is rapid in onset and of short duration.

After i.v. infusion the half-life is approximately 5-10 minutes.

It is

rapidly distributed to the heart, spleen, several glandular tissues and adrenergic nerves.

It crosses the placenta and is

excreted in breast milk.

It is approximately 50% bound to plasma proteins.

Adrenaline is rapidly metabolised in the liver and tissues by oxidative deamination and O-methylation followed by

reduction or by conjugation with glucuronic acid or sulfate.

Up to 90% of the i.v. dose is excreted in the urine as

metabolites.

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5.3 Preclinical safety data

Not applicable since Adrenaline (Epinephrine) Injection has been used in clinical practice for many years and its effects

in man are well known.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Citric Acid Monohydrate

Sodium Citrate (E331)

Sodium Chloride

Sodium metabisulfite (E223)

Dilute Hydrochloric Acid (for pH adjustment)

Water for Injection

6.2 Incompatibilities

In the absence of compatability studies, this medicinal product must not be mixed with other medicinal products.

Adrenaline should not be mixed with sodium bicarbonate; the solution is oxidised to adrenochrome and then forms

polymers.

6.3 Shelf life

3ml - 18 months unopened.

10ml -

15 months unopened.

The solution should be used immediately after opening.

Discard any unused portion.

6.4 Special precautions for storage

Do not store above 25°C.

Keep the container in the outer carton in order to protect from light.

6.5 Nature and contents of container

The solution is contained in a 10 ml Type I glass syringe with a polycarbonate Leur lock connector, polystyrene

plunger rod and latex-free bromobutyl rubber plunger stopper. One syringe per carton.

The solution of the 3ml pack is contained in a Type I glass vial with a rubber elastomeric closure for use with a separate

injector.

Not all pack sizes maybe marketed.

6.6 Special precautions for disposal of a used medicinal product or waste materials derived from

such medicinal product and other handling of the product

For single use only. Do not use if discoloured. Discard any unused solution.

Any unused product or waste material should be disposed of in accordance with local requirements

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7 MARKETING AUTHORISATION HOLDER

International Medicines Systems (UK) Ltd

First Floor, Templeback, 10 Temple Back

Bristol

United Kingdom

BS1 6FL

8 MARKETING AUTHORISATION NUMBER

PA0255/002/003

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 25

January 1978

Date of last renewal: 25

January 2008

10 DATE OF REVISION OF THE TEXT

March 2018

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