Adenosine 3 m injection in p – patient leaflet, side effects, dosage

what it is used for

Adenosine contains a m belongs to a group of me Adenosine works by slo between the upper and lo slows the fast or uneven h

edicine called adenosine. This dicines called ’antiarrhythmics’. wing down electrical impulses wer chambers of the heart. This eartbeats called ’arrhythmias’.

Adenosine is used in adul

ts:

• During a test. This is type of arrhythmia (u

  to help doctors find out what neven heartbeat) you have eat back to normal if you have ythmia called ‘paroxysmal hycardia (SVT)’ or ‘Wolff- rome’.

• To bring your heart b a type of arrh supraventricular tac Parkinson-White Synd

2. What you need to kno

w before you use Adenosine

Do not use Adenosine if:

• you are allergic to a ingredients of this Signs of an allergi swallowing or breath lips, face, throat or to

  denosine or any of the other medicine (listed in section 6). c reaction include: a rash, ing problems, swelling of your ngue

• you have problems do not have a pacem atrioventricular block

  with your heart rhythm and aker (second or third degree , sick sinus syndrome)

• you have very lo hypotension)

  w blood pressure (severe

• you have asthma or problem

  any other severe breathing

• you have a type of he not pumping out enou

  art failure where your heart is gh blood

• you have been told y This is a rare heart p heart beat and faintin

  ou have ‘Long QT syndrome’. roblem that can lead to a fast g

Do not have this medici to you. If you are not sur pharmacist before you ar

ne if any of the above applies e, talk to your doctor, nurse or e given Adenosine.

Warnings and precaution Talk to your doctor or n if you have:

s urse before using Adenosine

• low blood volume corrected by medicin

  (hypovolaemia) which is not es

• narrowing of the left your heart (left main

  main artery supplying blood to coronary stenosis)

• been told that you h the electrical impuls longer than normal t (prolonged QT interva

  ave a heart problem whereby es in parts of your heart take

  o discharge and then recharge l)

• narrowing of the mai artery). This means th to the brain (cerebrov

  n arteries in the neck (carotid at not enough blood is getting ascular insufficiency)

• heart disease due to

  narrowing of your heart valves

  (stenotic valvular hea

  rt disease)

• a left-right shunt in y goes directly from th right side

  our heart. This will mean blood e left side of your heart to the

• problems with a part the ‘autonomic nervo

  of your nervous system called us system’

• inflammation of the heart (pericarditis) or heart (pericardial effu

  membrane surrounding your a build-up of fluid around your sion)

• had severe heart failu

  re

• had a recent heart at transplant in the last

  tack or if you have had a heart year

• any minor problem AtrioVentricular block conditions may be te are given adenosine.

  with your heart (first degree or bundle branch block). These mporarily aggravated when you

• an unusual heart rhyt is very fast or unev flutter) and in particul your heart has (‘accessory conductio

  hm, for example your heartbeat en (atrial fibrillation or atrial ar if you have a condition where abnormal electrical activity n pathway’)

• difficulty in breathing

  (bronchospasm)

• ever had fits or convu

  lsions

If you get a very slow h respiratory failure, a he (asystole), severe chest p pressure (severe hypote adenosine should be stop

eartbeat (severe bradycardia), art problem that can be fatal ains (angina) or very low blood nsion), then treatment with ped.

If you are not sure if any o to your doctor or nurse b

f the above applies to you, talk efore being given Adenosine.

Other medicines and Ad

enosine

Tell your doctor or nurse used or might use an medicines obtained witho This is because adenosine medicines work. Also som adenosine works.

if you are using, have recently y other medicines, including ut a prescription.

can affect the way some other e medicines can affect the way

In particular, check with y if you are taking any of th

our doctor, nurse or pharmacist e following:

• Dipyridamole (a med Make sure your do dipyridamole. Your d not have Adenosine dipyridamole 24 h Adenosine or may ne Adenosine

  icine used to thin the blood). ctor knows you are taking octor may decide you should or may tell you to stop taking ours before you are given ed to give you a lower dose of

• Aminophylline or th help breathing). You taking it 24 hours bef

  eophylline (medicines used to r doctor may tell you to stop ore you are given Adenosine found in headache medicines)

• Caffeine (sometimes

Adenosine with food and

drink

Food and drinks containin chocolate and cola should

g caffeine such as tea, coffee, be avoided for at least 12 hours

before you are given Ade

nosine.

Pregnancy, breast-feedi

ng and fertility

Talk to your doctor or nur if:

se before having this medicine

• You are pregnant, mi that you may be preg Adenosine if you are pregnant, unless clea

  ght become pregnant, or think nant. You should not be given pregnant or think you may be rly necessary

• You are breast-feedi Adenosine if you are If you are pregnant may be pregnant or a your doctor or pharm this medicine.

  ng. You should not be given breast-feeding

  or breast-feeding, think you re planning to have a baby, ask acist for advice before taking

Adenosine contains sodi

um

Adenosine contains 3.54 1 ml pre-filled syringe, 7.08 14.16 mg/4ml pre-filled syr This should be taken into controlled sodium diet.

mg sodium per ml (3.54 mg/ mg/2 ml pre-filled syringe and inge).

consideration by patients on a

1. 1. Draft
2. 1. Corr
3. 2. Corr
4. 3.

   Corr

   24.07.2023, 10:30

3. How to use Adenosine

How Adenosine is given

Adenosine is a medicine for us It will be given to you by a doct into your vein

e in hospitals or or nurse as an injection

Your heart and blood pressure

will be closely monitored

How much Adenosine is given

If you are not sure why you are have any questions about how given to you, speak to your doc

being given Adenosine or much Adenosine is being tor, nurse or pharmacist.

Adults

• The first dose is 3mg give given by rapid injection int

  n over 2 seconds. This is

  o your vein

• If the first dose does not normal then you will be g second dose is 6 mg given

  bring your heart beat to iven a second dose. The as a rapid injection

• If the second dose does no normal then you will be giv dose is 12mg given as a rap

  t bring your heart beat to en a third dose: The third id injection

• You should not have any m dose

  ore doses after the 12mg

Infants and Children

These pre-filled syringes administration of small volume

are not suitable for s required for children.

Older people

See recommended dose for ad

ults.

If you are given more Adenos

ine than you should

As this medicine is given to yo is unlikely that you will be giv will carefully work out how mu be given.

u by a doctor or nurse it en too much. Your doctor ch Adenosine you should

If you have more of this medi following effects may happen:

cine than you should, the

• Very low blood pressure (s

  evere hypotension)

• Slow heartbeat (bradycard

  ia)

• A heart problem (asystole) Your doctor will be monitoring procedure.

  your heart throughout the

As the length of time adenosin short, any side effects of too quickly stop when the injection i may need an injection of a med or theophylline to help with an

e stays in the blood is very much Adenosine would s stopped. Sometimes you icine called aminophylline y side effects.

If you have any further ques medicine, ask your doctor or n

tions on the use of this urse.

4. Possible side effects

Like all medicines, this medici although not everybody gets t While you are being given Aden of the following side effects. If any of the following side eff doctor or nurse and they may

ne can cause side effects, hem.

osine you may have some ects get worse, tell your stop the injection:

The side effects normally s minutes after the injection is fi your doctor or nurse if any of t

ettle within seconds or nished but you should tell hem happen.

Very common (may affect mo

re than 1 in 10 people)

• Reddening of skin with a fe

  eling of heat (flushing) ia)

• Slow heartbeat (bradycard

• Skipped heart beats or ext

  ra heart beats

• A heart problem called where the heart starts to b

  an atrioventricular block eat slowly

• Severe heart problems wh or uneven heartbeat

  ich can be fatal (asystole)

• Shortness of breath or th (dyspnoea)

  e urge to breathe deeply

• Chest pain or pressure on t

  he chest

Common (may affect up to 1 i

n 10 people)

• Feeling dizzy or light-head

  ed

• Feeling sick (nausea)
• Headache

• Unusual skin sensations su

  ch as burning

• Feeling nervous

Uncommon (may affect up to

1 in 100 people)

• Blurred vision

• Being aware of your heart (palpitations)

  beat or feeling it ‘racing’

• Metallic taste in your mout

  h

• Breathing more quickly or (hyperventilation)

  more deeply than normal

• Feeling pressure in your feeling in your arms

  head, or weighed down

• Feeling of general discomf

  ort, weakness or pain

• Sweating

Very rare (may affect up to 1

in 10,000 people)

• Severe breathlessness or p

  roblems in breathing t the site of injection ng the injection

• Redness, pain or swelling a
• Feeling uncomfortable duri

• Worsening of high blood brain (intracranial hyperte

  pressure that affects the nsion)

• Very slow, fast or uneven h

  eartbeats

• Severe bradycardia (very s

  low heartbeat)

Not known (frequency canno available data) loss of conscio

t be estimated from the usness or fainting

• Fits (convulsions)
• Feeling sick (vomiting)
• Low blood pressure

• Your heart does not work p

  roperly to circulate blood around your body (cardiac

  arrest). This can be fatal.

• Your lungs do not work

• Stopping breathing (respir

  atory arrest)

• Allergic reaction (includin reactions such as urticaria

  g rapid swelling and skin and rash)

• Spasm of the artery in the heart attack

  heart which may lead to a

Reporting of side effects

If you get any side effects, talk or nurse. This includes any listed in this leaflet.

to your doctor, pharmacist possible side effects not

You can also report side eff below). By reporting side effe more information on the safety

ects directly (see details cts you can help provide of this medicine.

Ireland

HPRA Pharmacovigilance Web

site: www.hpra.ie

United Kingdom

Yellow Card Scheme Website: w or search for MHRA Yellow Ca Apple App Store.

ww.mhra.gov.uk/yellowcard rd in the Google Play or

5. How to store Adenosine

This medicine will be kept b pharmacist in a safe place whe

y your doctor, nurse or re children cannot see or reach it.

Keep this medicine out of the s

ight and reach of children.

Do not use this medicine, afte stated on the carton. The exp day of that month.

r the expiry date which is iry date refers to the last

Adenosine should not be refrig

erated.

The product is for single use straight away after opening. A syringe not used at once shoul

only and should be used ny portion of the pre-filled d be disposed of.

Adenosine should not be use notice any particles in the solu before they give you the medic If the appearance of the medic filled syringe must be thrown a

d if your doctor or nurse tion or any discolouration ine.

ine has changed, the pre-way.

Do not throw away any med household waste. Your doctor medicines you no longer use. protect the environment.

icines via wastewater or and nurse will throw away These measures will help

M094002/03 UK/IE V004

6. Contents of the pack

and other information

What Adenosine contain

s

• The active substance dose pre-filled syring Each 2 ml single do 6 mg of adenosin pre-filled syringe con other ingredients are: injections.

  is adenosine. . Each 1 ml single e contains 3 mg of adenosine. se pre-filled syringe contains e. Each 4 ml single dose tains 12 mg of adenosine. The sodium chloride and water for

What Adenosine looks li

ke and contents of the pack

Adenosine is a clear, colo Adenosine is supplied as filled syringes.

urless solution for injection. packs containing 1, 6 or 10 pre-

Not all pack sizes may be

marketed.

Marketing Authorisation

Holder and Manufacturer

Marketing Authorisation For UK

Fresenius Kabi Limited Cestrian Court,

Eastgate Way,

Manor Park,

Runcorn,

Cheshire,

WA7 1NT

UK

Holder

For IRL

Fresenius Kabi Deutschla Else-Kroener Strasse 1, Bad Homburg v.d.H. 61352 Germany

nd GmbH

,

Manufacturer

Fresenius Kabi Austria Gm Hafnerstrasse 36,

bH

8055 Graz,

Austria

This medicinal product States of the EEA under

is authorised in the Member the following names:

Belgium Aden oplos voorg Denmark Aden Italy Aden Ireland Aden inject Netherlands Aden

osine Fresenius Kabi 3 mg/ml, sing voor injectie in een evulde spuit

osin Fresenius Kabi

osina Kabi

osine 3 mg/ml solution for ion in pre-filled syringe

osine Fresenius Kabi 3 mg/ml,

oplos voorg Norway Aden injeks ferdig Poland Aden Portugal Aden Spain Aden inyec preca United Aden Kingdom inject

sing voor injectie in een evulde spuit

osin Fresenius Kabi 3 mg/ml jonsvæske, oppløsning i fylt sprøyte

osine Kabi

osina Kabi

osina Kabi 3mg/ml solución table en jeringa rgada

osine 3 mg/ml solution for ion in pre-filled syringe

This leaflet was last rev

ised in July 2023.

--------------------------------

---------------------------------------

The following informatio professionals only:

n is intended for healthcare

Adenosine3 mg/ml solu syringe

tion for injection in pre-filled

Please refer to the Summ (SmPC) for further details

ary of Product Characteristics on this product.

Qualitative and quantita

tive composition

1 ml solution contains 3 m Each 1 ml single dose pre adenosine.

g of adenosine.

-filled syringe contains 3 mg of

Each 2 ml single dose pre adenosine.

-filled syringe contains 6 mg of

Each 4 ml single dose pr of adenosine.

e-filled syringe contains 12 mg

For the full list of excipien

ts, see section 6.1.

Pharmaceutical form

Solution for injection in p

re-filled syringe

Therapeutic indications

Rapid conversion to a nor supraventricular tachycar with accessory by-pass Syndrome).

mal sinus rhythm of paroxysmal dias, including those associated tracts (Wolff-Parkinson-White

Diagnostic Indications

Aid to diagnosis of

broad or narrow complex

supraventricular tachyca not convert atrial flutter, tachycardia to sinus rhyth helps diagnosis of atrial a

rdias. Although Adenosine will atrial fibrillation or ventricular m, the slowing of AV conduction ctivity.

Sensitisation of intra-investigations.

cavitary electrophysiological

Posology and method of

administration

Adenosine is intended monitoring and car equipment available for i

for hospital use only with diorespiratory resuscitation mmediate use.

Adenosine should only b cardiac monitoring. Patie block at a particular dos dosage increments.

e used when facilities exist for nts who develop high-level AV e should not be given further

Posology

Adult:

Initial dose: 3mg given as 2 seconds).

a rapid intravenous bolus (over

Second dose: If the first do of the supraventricular ta 6mg should be given also Third dose: If the seco elimination of the supra 1 to 2 minutes. 12mg sh intravenous bolus.

se does not result in elimination chycardia within 1 to 2 minutes, as a rapid intravenous bolus. nd dose does not result in ventricular tachycardia within ould be given also as a rapid

Additional or higher dose

s are not recommended.

Paediatric population

These pre-filled syringes use.

are not suitable for paediatric

Elderly

See dosage recommenda

tions for adults.

Diagnostic dose

The above ascending employed until sufficien

dosage schedule should be t diagnostic information has

been obtained.

Method of administra administered by rapid in into a vein or into an IV should be injected throug followed by a rapid saline a peripheral vein, a large

tion: Adenosine should be travenous (IV) bolus injection line. If given into an IV line it h as proximally as possible, and flush. If administered through bore cannula should be used.

Pharmaceutical particul List of excipients

ars

Sodium chloride

Water for injections

Incompatibilities

In the absence of comp product must not be mixe

atibility studies, this medicinal d with other medicinal products.

Shelf life

3 years.

The product should be us

ed immediately after opening.

Special precautions for

Do not refrigerate.

storage

Nature and contents of cont

ainer

1 ml plastic pre-filled syringe closed with a halobutyl tip cap Packs containing:

containing 1 ml (3mg/1ml),

1 pre-filled syringe

6 pre-filled syringes

10 pre-filled syringes

5 ml plastic pre-filled syringe c closed with a halobutyl tip cap Packs containing:

ontaining 2 ml (6 mg/2 ml)

1 pre-filled syringe

6 pre-filled syringes

10 pre-filled syringes

5 ml plastic pre-filled syringe ml) closed with a halobutyl tip Packs containing:

1 pre-filled syringe

6 pre-filled syringes

10 pre-filled syringes

containing 4 ml (12 mg/4 cap

Not all pack sizes may be mark

eted.

Special precautions for dispo

sal

Do not use if any particles or in the solution.

discolouration are noticed

Any unused medicinal produc be disposed of in accordance w

t or waste material should ith local requirements.

Instructions for use of pre-fi

lled syringe:

When using the 5 ml pre-fille (12 mg adenosine/4 ml) to ad 2 ml must be first discarded administering the remaining 2

d syringe containing 4 ml minister only a 6 mg dose, from the syringe before ml to the patient.

Use Aseptic Technique

1. 1. Remove tip cap
2. 2.

   Hold plunger and push barre resistance that may be pres

   l forward to relieve any ent.

3. 3.

   Pull the barrel down until air syringe.

   is expelled from the