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BREVIBLOC PREMIXED 10MG/ML SOLUTION FOR INJECTION

Active substance(s): ESMOLOL HYDROCHLORIDE

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ARTWORK DESIGN CENTRE

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EMEA ARTWORK DESIGN CENTRE

Artworker: Wendy Martin

Date: 24 Apr 2015

ARTWORK APPROVAL

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Package leaflet: Information for the patient



BREVIBLOC Premixed 10 mg/ml Solution for
Injection
Esmolol hydrochloride



If any of the above apply to you (or you are not sure), talk to your doctor,
nurse or pharmacist before being given this medicine. You may need to be
checked carefully and your treatment may be changed.

Other medicines and Brevibloc

Keep this leaflet. You may need to read it again
If you have any further questions, ask your doctor, nurse or pharmacist
If you get any side effects, talk to your doctor, nurse or pharmacist.
This includes any possible side effects not listed in this leaflet.

Tell your doctor, nurse or pharmacist if you are taking, have recently taken
or might take any other medicines. This includes medicines that you have
obtained yourself, without a prescription, including herbal medicines and
natural products. Your doctor will check that any other medicines you are
taking will not alter the way that Brevibloc works.

Throughout this leaflet, BREVIBLOC Premixed 10 mg/ml Solution for Injection
will be called Brevibloc.

In particular, tell your doctor, nurse or pharmacist if you are taking any of the
following:
• Medicines that can lower the blood pressure or slow the heart rate
• Medicines used to treat heart rhythm problems or chest pain (angina)
such as verapamil and diltiazem. You should not receive Brevibloc
within 48 hours of stopping verapamil
• Nifedipine, which is used to treat chest pain (angina), high blood
pressure and Raynaud’s disease
• Medicines used to treat heart rhythm problems (such as quinidine,
disopyramide, amiodarone) and heart failure (such as digoxin, digitoxin,
digitalis)
• Medicines used to treat diabetes, including insulin and medicines taken
by mouth
• Medicines known as ganglion blocking agents (such as trimetaphan)
• Medicines used as pain killers, such as non-steroidal anti-inflammatory
drugs known as NSAIDs
• Floctafenine, which is a pain killer
• Amisulpride, a medicine that is used to treat mental problems
• ‘Tricyclic’ antidepressant medicines (such as imipramine and
amitriptyline) or any other drugs for mental health problems
• Barbiturates (such as phenobarbital, used to treat epilepsy) or
phenothiazines (such as chlorpromazine, used to treat mental disorders)
• Clozapine which is used to treat mental disorders
• Epinephrine, which is used to treat allergic reactions
• Medicines used to treat asthma
• Medicines used to treat colds or a blocked nose, called ‘nasal
decongestants’
• Reserpine, which is used to treat high blood pressure
• Clonidine, which is used to treat high blood pressure and migraine
• Moxonidine, which is used to treat high blood pressure
• Ergot derivates, medicines mainly used to treat Parkinson's disease
• Warfarin, which is used to thin your blood
• Morphine, which is a strong pain killer
• Suxamethonium chloride (also known as succinylcholine or scoline) or
mivacurium, which are used to relax your muscles, usually during an
operation. Your doctor will also take special care when using Brevibloc
during operations, when you will be having anaesthetics and other
treatments.

What is in this leaflet:
What Brevibloc is and what it is used for
What you need to know before you are given Brevibloc
How you will be given Brevibloc
Possible side effects
How to store Brevibloc
Contents of the pack and other information

1. What Brevibloc is and what it is used for
Brevibloc contains a medicine called esmolol. It belongs to a group of
medicines called ‘beta-blockers’. It works by controlling the rate and force of
your heartbeat. It can also help to reduce your blood pressure.
It is used to treat:
• Heartbeat problems, when your heart beats too fast
• Heartbeat problems and an increase in your blood pressure if this
happens during or straight after an operation.

2. What you need to know before you are given
Brevibloc
Your doctor will not give you Brevibloc if:















You have kidney problems. If you have kidney disease or you need
kidney dialysis you could develop high blood potassium levels
(hyperkalemia). This can cause serious heart problems
You have any allergies or are at risk of anaphylactic reactions (severe
allergic reactions). Brevibloc can make allergies more severe and more
difficult to treat
You or any of your family have a history of psoriasis (where your skin
produces scaly patches)
You have a disease called hyperthyroidism (an overactive thyroid gland).

Changing the dose is not usually necessary if you have liver problems.

Read all of this leaflet carefully before you are given this
medicine. It contains important information for you.

1.
2.
3.
4.
5.
6.

You are allergic (hypersensitive) to esmolol, to other beta-blocker
medicines, or any of the other ingredients of this medicine (listed in section
6).
The signs of an allergic reaction include shortness of breath, wheezing,
rash, itching or swelling of your face and lips
You have a very slow heartbeat (less than 50 beats per minute)
You have a fast or alternating fast and slow heartbeat
You have something called “severe heart block”. Heart block is a
problem with the electrical messages that control your heartbeat
You have low blood pressure
You have a problem with the blood supply to your heart
You have serious heart failure symptoms
You are receiving or have recently received verapamil. You must not be
given Brevibloc within 48 hours of when you stop receiving verapamil
You have a gland disease called phaeochromocytoma which has not
been treated. Phaeochromocytoma arises from the adrenal gland and
may cause a sudden increase in blood pressure, severe headache,
sweating and increased heartbeat
You have increased blood pressure in the lungs (pulmonary hypertension)
You have asthma symptoms that are worsening rapidly
You have increased levels of acids in your body (metabolic acidosis).

If you are not sure if any of the above applies to you talk to your doctor,
nurse or pharmacist before having Brevibloc.

Tests you may have while Brevibloc is used
The use of medicines such as Brevibloc over a long period of time can cause
a reduction in the force of your heartbeat.
Since Brevibloc is only used for a limited time, this is unlikely to happen
to you. During treatment you will be carefully monitored and Brevibloc
treatment will be reduced or stopped if the force of your heartbeat is
reduced.
Your doctor will also check your blood pressure while you are being treated
with Brevibloc.

You will not be given Brevibloc if any of the above applies to you. If you are
not sure if you have any of these conditions, talk to your doctor, nurse or
pharmacist before having Brevibloc.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.

Warnings and Precautions

You should not be given Brevibloc if you are pregnant, or if you think you
may be pregnant.

Talk to your doctor, nurse or pharmacist before being given Brevibloc. Your
doctor will take special care with this medicine if:
• You are being treated for certain heart rhythm disorders called
supraventricular arrhythmias and you:
− Have other heart problems or
− Are taking other heart medicines

Use of Brevibloc in this way can lead to severe reactions which may be
fatal including:
− Loss of consciousness
− Shock (when your heart does not pump enough blood)
− Heart attack (cardiac arrest)
• You develop low blood pressure (hypotension). The signs of this may
be feeling dizzy or light headed, especially when standing up. Low
blood pressure usually gets better within 30 minutes of the end of your
Brevibloc treatment
• You have a low heart rate before treatment
• Your heart rate decreases to less than 50 to 55 beats per minute. If this
happens your doctor may give you a lower dose or stop treatment with
Brevibloc
• You have heart failure
• You have problems with the electrical messages that control your
heartbeat (heart block)
• You have a gland disease called phaeochromocytoma which has been
treated with medicines called alpha-receptor blockers
• You are being treated for high blood pressure (hypertension) which has
been caused by low body temperature (hypothermia)
• You have narrowing of your airways or wheezing, such as with asthma
• You have diabetes or low blood sugar. Brevibloc can increase the effects
of your diabetes medicines
• You develop skin problems. These can be caused by the solution leaking
around the site of the injection. If this happens your doctor will use a
different vein for your injection
• You have a particular type of angina (chest pain) called ‘Prinzmetal’s
angina’
• You have low blood volume (with low blood pressure). You could develop
circulatory collapse more easily
• You have circulation problems, such as paleness of your fingers
(Raynaud’s disease) or aching, tired and sometimes burning pains in
your legs

Tell your doctor if you are breast-feeding. Brevibloc may pass into breast
milk, so you should not be given Brevibloc if you are breast-feeding.

Brevibloc contains sodium
Brevibloc contains approximately 28 mg of sodium per vial. This may be
important if you are controlling the sodium in your diet.

3. How you will be given Brevibloc
The recommended dose
Your doctor will decide how much of the medicine you will need and for how
long it will be given to you. Brevibloc will not normally be given for longer
than 24 hours.

How Brevibloc is given
Brevibloc is ready to use. You will be given Brevibloc by a slow injection
(infusion) through a needle inserted into a vein in your arm.
Brevibloc must not be mixed with sodium bicarbonate or other medicinal
products.
• The treatment is given in two stages:
– Stage one: a large dose is given over one minute. This increases
the levels in your blood quickly
– Stage two: a smaller dose is then given over four minutes
– Stage one and two may then be repeated and adjusted according to
your heart’s response. As soon as an improvement has happened,
stage one (the large dose) will be stopped and stage two (the small
dose) will be reduced as necessary
– After reaching a stable condition, you may be given another heart
drug, while your dose of Brevibloc is gradually reduced.
• If your heart rate or blood pressure increases during an operation
or straight after recovering from it, you will be given larger doses of
Brevibloc for a short time.

Table 2
Volume of BREVIBLOC 10 mg/ml required to provide
MAINTENANCE DOSES at infusion rates between 12.5 and
300 mcg/kg/minute

The following information is intended for medical or healthcare
professionals only:
This section contains practical information regarding administration. Read
the SPC for full information on posology and method of administration,
contraindications, warnings etc.

Infusion Dose Rate (mcg/kg/min)

Posology and method of administration

Patient
weight
(kg)

Brevibloc Premixed 10 mg/ml Solution for Injection is a ready-to-use
10 mg/ml solution recommended for intravenous administration. This dosage
form is used to administer the appropriate Brevibloc loading dose or bolus
dose by hand held syringe.

Table 1
Volume of BREVIBLOC 10 mg/ml required for an
INITIAL LOADING DOSE of 500 mcg/kg/minute
Patient weight (kg)
40

50

60

70

80

90

100

110

120

2

2.5

3

3.5

4

4.5

5

5.5

6

1
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12.5

25

50

100

150

200

300

Amount to administer per hour to achieve the dose rate
(ml/hr)

Posology is summarised in the following tables.

Volume (ml)

PR2:

Comments:

b




PR1:

Size
Text
Format
Barcode(s)
Edge Code
BGS Y N NA
Trademark Y N NA
Sign...........................:
Date...........................:

DATE
PLANT APPROVAL
HALLE ONLY
N/A

Name

Draft: 2nd

40

3

6

12

24

36

48

72

50

3.75

7.5

15

30

45

60

90

60

4.5

9

18

36

54

72

108

70

5.25

10.5

21

42

63

84

126

80

6

12

24

48

72

96

144

90

6.75

13.5

27

54

81

108

162

100

7.5

15

30

60

90

120

180

110

8.25

16.5

33

66

99

132

198

120

9

18

36

72

108

144

216

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Reporting of side effects

The Elderly
Your doctor will start your treatment with a lower dose.

If you get any side effects, talk to your doctor, nurse or pharmacist. This
includes any possible side effects not listed in this leaflet.

Children
Children up to the age of 18 years should not receive Brevibloc.

Ireland
You can also report side effects directly via HPRA Pharmacovigilance,
Earlsfort Terrace,
IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517.
Website: www.hpra.ie; Email: medsafety@hpra.ie.

If you have too much Brevibloc
As you are being given Brevibloc by a trained and qualified person, it is
unlikely that you will have too much. However, if this happens the doctor will
stop Brevibloc and give you additional treatment, if necessary.

United Kingdom
You can also report side effects Via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard

If you think that a dose of Brevibloc has been forgotten
As you are being given Brevibloc by a trained and qualified person, it is
unlikely that you will miss a dose. However, if you think that you have missed
a dose, talk to your doctor, nurse or pharmacist as soon as possible.

By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Brevibloc

If you stop having Brevibloc
Suddenly stopping Brevibloc may cause symptoms of rapid heartbeat
(tachycardia) and high blood pressure (hypertension) to return. To avoid this
your doctor should stop your treatment gradually. If you are known to have
coronary artery disease (this may be associated with a history of angina or
heart attack) your doctor will take special care when stopping treatment
with Brevibloc.







If you have any further questions on the use of this product ask
your doctor, nurse or pharmacist.

Keep this medicine out of the sight and reach of children
Do not use Brevibloc after the expiry date which is stated on the label
after EXP. The expiry date refers to the last day of that month
Do not store above 25°C
The opened product is stable for 24 hours at 2 to 8°C. However, it should
be used immediately after opening
Do not use Brevibloc if you notice particles or discolouration of the
solution.

Do not throw 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.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them. Most side effects disappear within 30 minutes of
stopping treatment with Brevibloc. The following side effects have been
reported with Brevibloc:

6. Contents of the pack and other information
What Brevibloc contains

Tell your doctor, nurse or pharmacist straight away if you notice any of the
following side effects, which can be serious. The infusion may also need
to be stopped.



The active substance is esmolol hydrochloride. One ml contains
10 mg of esmolol hydrochloride. Each vial contains 100 mg esmolol
hydrochloride in 10 ml solution.
The other ingredients are sodium acetate and glacial acetic acid,
sodium chloride, sterile water (called ‘water for injections’). Sodium
hydroxide or hydrochloric acid may be added to ensure the correct pH.

Very common (may affect more than 1 in 10 people)
• Fall in blood pressure. This can be rapidly corrected by reducing the
dose of Brevibloc or stopping the treatment. Your blood pressure will be
measured often during treatment
• Excessive sweating.



Common (may affect less than 1 in 10 people)
• Loss of appetite
• Feeling anxious or depressed
• Dizziness
• Feeling sleepy
• Headache
• Tingling or ‘pins and needles’
• Difficulty concentrating
• Feeling confused or agitated
• Feeling or being sick (nausea and vomiting)
• Feeling weak
• Feeling tired (fatigue)
• Irritation and hardening of your skin where Brevibloc was injected.

Brevibloc is a clear, colourless to light yellow, sterile solution for intravenous
injection. It is available in 10 ml amber glass vials.

What Brevibloc looks like and contents of the pack

Pack sizes of 3, 5, 10 and 20 vials containing 100 mg/10 ml. Not all pack
sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation holder is:
Baxter Healthcare Ltd
Caxton Way
Thetford
Norfolk, UK
IP24 3SE

Uncommon (may affect less than 1 in 100 people)
• Abnormal thoughts
• Sudden loss of consciousness
• Feeling faint or fainting
• Fits (seizures or convulsions)
• Problems with speech
• Problems with eyesight
• Slow heart rate
• Problems with the electrical messages that control your heartbeat
• Increased pressure in the arteries of the lungs
• Inability of the heart to pump enough blood (heart failure)
• A disruption in the rhythm of the heart sometimes known as palpitations
(ventricular extrasystoles)
• A heartbeat disorder (nodal rhythm)
• Chest discomfort caused by poor blood flow through the blood vessels
of the heart muscle (angina pectoris)
• Poor circulation in your arms or legs
• Looking pale or flushed
• Fluid on your lungs
• Shortness of breath or tightness of the chest making it difficult to
breathe
• Wheezing
• Blocked nose
• Abnormal rattling/crackling sounds when breathing
• Changes in your sense of taste
• Indigestion
• Constipation
• Dry mouth
• Pain in your stomach area
• Discoloured skin
• Reddening of the skin
• Pain in your muscles or tendons, including around the shoulder blades
and ribs
• Problems passing urine (urinary retention)
• Feeling cold or high temperature (fever)
• Pain and swelling (oedema) of your vein where Brevibloc was injected
• Burning feeling or bruising at the site of injection.

Brevibloc is manufactured by:
Baxter Healthcare Ltd
Caxton Way
Thetford
Norfolk, UK
IP24 3SE
This medicinal product is authorised in the Member States of the EEA
under the following names:
Member State

Name

Belgium

Brevibloc 10 mg/ml, solution injectable

Denmark

Brevibloc

Finland

Brevibloc 10 mg/ml injektioneste, liuos

Germany

Brevibloc 10 mg/ml Injektionslösung

Ireland

Brevibloc Premixed 10mg/ml, Solution for Injection

Luxembourg

Brevibloc 10 mg/ml, solution injectable

Netherlands

Brevibloc 10 mg/ml, oplossing voor injectie

Norway

Brevibloc 10 mg/ml, Injeksjonsvæske, oppløsning

Poland

Brevibloc 10 mg/ml, Roztwór do wstrzykiwań

Portugal

Brevibloc Premixed 10 mg/ml, Solução injectável

Spain

Brevibloc 10 mg/ml, solución para inyección

Sweden

Brevibloc 10 mg/ml, Injektionsvätska, lösning

UK

Brevibloc Premixed 10mg/ml, Solution for Injection

This leaflet was last revised in May 2015

Other sources of information

For information about Brevibloc or to request
this leaflet in formats such as audio or large
print please contact the Marketing Authorisation
Holder: Tel +44 (0)1635 206345

Very rare (may affect less than 1 in 10,000 people)
• Severe reduction in heart rate (sinus arrest)
• No electrical activity in the heart (asystole)
• Tender blood vessels with an area of hot red skin (thrombophlebitis)
• Dead skin caused by the solution leaking around the site of the
injection.

Baxter and Brevibloc are trademarks of Baxter International Inc.

Not known (the number of people affected is unknown)
• Increased levels of potassium in the blood (hyperkalemia)
• Increased levels of acids in your body (metabolic acidosis)
• Increased rate of contraction of the heart (accelerated idioventricular
rhythm)
• Spasm of the artery in the heart
• Failure of the normal circulation of the blood (cardiac arrest)
• Psoriasis (where your skin produces scaly patches)
• Swelling of the skin of the face, limbs, tongue or throat (angioedema)
• Hives (urticaria)
• Inflammation of a vein or blistering at the site of infusion.

Perioperative tachycardia and hypertension

Incompatibilities

For perioperative tachycardia and hypertension the dosing regimen may vary
as follows:

This medicinal product must not be mixed with other medicinal products or
sodium bicarbonate solutions.

For intraoperative treatment – during anaesthesia when immediate control
is required:
• A bolus injection of 80 mg is given over 15 to 30 seconds followed by a
150 micrograms/kg/minute infusion. Titrate the infusion rate as required
up to 300 micrograms/kg/minute. The volume of infusion required for
different patient weights is provided in Table 2.

Special precautions for disposal and other handling
• Each vial is intended for single use only.
• Avoid contact with alkali.
• The solution should be visually inspected for particulate matter and
discoloration prior to administration. Only a clear and colourless or
slightly coloured solution should be used.
• Any unused solution and the containers should be disposed of in
accordance with local requirements.

Upon awakening from anaesthesia
• An infusion of 500 micrograms/kg/minute is given for 4 minutes
followed by a 300 micrograms/kg/minute infusion. The volume of
infusion required for different patient weights is provided in Table 2.
For post-operative situations when time for titration is available
• A loading dose of 500 micrograms/kg/minute is given over 1 minute
before each titration step to produce a rapid onset of action. Use
titration steps of 50, 100, 150, 200, 250 and 300 micrograms/kg/minute
given over 4 minutes and stopping at the desired therapeutic effect. The
volume of infusion required for different patient weights is provided in
Table 2.

Baxter and Brevibloc are trademarks of Baxter International Inc.

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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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