BREVIBLOC 100 mg /10 Ml Roztwór Do Infuzji

Treść ulotki

1. BREVIBLOC 10 mg/ml Solution for Infusion
   1. What is BREVIBLOC and what is it used for
   2. What you need to know before you are given BREVIBLOC
   3. How BREVIBLOC will be administered to you
   4. Possible side effects
   5. How to store BREVIBLOC
   6. Package contents and other information
2. BREVIBLOC 10 mg/ml Solution for Infusion
   1. What is BREVIBLOC and what is it used for
   2. What you need to know before you are given BREVIBLOC
   3. How BREVIBLOC will be administered to you
   4. Possible side effects
   5. How to store BREVIBLOC
   6. Contents of the pack and other information

BREVIBLOC 10 mg/ml Solution for Infusion

Esmolol hydrochloride

Read this leaflet carefully before you are given this medicine
because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If any side effects occur, including any not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

• 1. What BREVIBLOC is and what it is used for
• 2. What you need to know before you are given BREVIBLOC
• 3. How BREVIBLOC will be given to you
• 4. Possible side effects
• 5. How to store BREVIBLOC
• 6. Contents of the pack and other information

1. What is BREVIBLOC and what is it used for

BREVIBLOC contains the active substance esmolol which belongs to the group of medicines called
“beta-blockers”. This medicine works by controlling the strength and frequency of your
heartbeat.
Brevibloc is used in adultsto treat:

• heart rhythm disturbances, when your heartbeat is too fast (tachycardia)
• heart rhythm disturbances (tachycardia) and increased blood pressure (hypertension), even when this happens during or immediately after surgery.

2. What you need to know before you are given BREVIBLOC

Your doctor will not give you BREVIBLOC

• if you are allergic to esmolol, to other beta-blockers, or to any of the other ingredients of this medicine (listed in section 6).
• if you have a very slow heart rate (sinus bradycardia) (less than 50 beats per minute)
• if you have a fast heartbeat or a fast-slow alternating heartbeat (sinoatrial node dysfunction)
• if you suffer from a condition called “severe heart block”. Heart block is a problem with the electrical impulses that control the heartbeat (second or third degree atrioventricular block)
• if your heart function is depressed (cardiogenic shock)
• if you suffer from very low blood pressure (severe hypotension)
• if you have a weak heart (decompensated heart failure)
• if you are taking or have recently taken medicines to treat high blood pressure such as medicines belonging to the group called “calcium channel blockers” (verapamil, diltiazem). Brevibloc will not be given to you within 48 hours of stopping verapamil
• if you have a tumor of the adrenal gland, glands located above the kidneys, which causes an increase in blood pressure (pheochromocytoma) that has not been treated
• if you suffer from increased blood pressure in the lungs (pulmonary hypertension)
• if you suffer from acute asthma (respiratory disease) that is rapidly worsening
• if you have increased levels of acids in the blood (metabolic acidosis)

Warnings and precautions
Talk to your doctor, nurse or pharmacist before you are given Brevibloc.
Your doctor will be particularly careful with this medicine if:

• you have been treated for certain heart rhythm disorders called supraventricular arrhythmia and suffer from a heart condition or are taking other medicines for heart disease. The use of Brevibloc in these cases can lead to serious reactions that can lead to death (see section 4 Possible side effects)
• during therapy you have low blood pressure (hypotension). Signs of this may be a feeling of dizziness or lightheadedness, especially when standing up. This condition usually improves within 30 minutes of stopping treatment with Brevibloc
• you suffer from a slow heartbeat (bradycardia). If your heart rate drops to 50-55 beats per minute, your doctor will give you a lower dose or stop treatment with Brevibloc
• you have a weak heart
• you suffer from problems with the electrical impulses that control your heartbeat (heart block)
• you have a tumor of the adrenal gland, glands located above the kidneys, which causes an increase in blood pressure (pheochromocytoma) that has been treated with medicines called alpha-receptor blockers
• you are taking medicines to treat high blood pressure (hypertension) that has been caused by low body temperature (hypothermia)
• you suffer from or have suffered from a lung disease that causes narrowing of the airways or wheezing, such as asthma. In case of severe difficulty breathing (bronchospasm), your doctor will stop therapy with Brevibloc and, if necessary, give you another medicine
• you have diabetes (high blood sugar levels) or low blood sugar levels (hypoglycemia). Brevibloc can increase the effects of diabetes medicines
• you have skin problems near the injection site. These may be caused by leakage of solution around the injection site. If this happens, your doctor will use a different vein for the injection
• you suffer from chest pain called “Prinzmetal’s angina”
• you have a low amount of blood circulating in the body (hypovolemia)
• you suffer from disorders of blood circulation, such as pale fingers (Raynaud’s syndrome) or difficulty walking
• you suffer from a kidney disease or are undergoing dialysis, a blood filtration system
• you have any allergies or are at risk of severe allergic reactions. Brevibloc can make allergies more severe and more difficult to treat
• you or someone in your family suffers from or has suffered from a skin disease called psoriasis
• your thyroid gland, a gland in the neck, is overactive (hyperthyroidism)

If any of the above conditions apply to you (or if you are not sure), consult your doctor or nurse
before you are given this medicine. You may need careful examination and the
treatment may be modified.
The use of medicines such as Brevibloc for a long time can cause a reduction in the strength
of your heartbeat.
Since Brevibloc is used only for a limited time, it is unlikely to happen to you. During the
treatment you will be carefully monitored and treatment with Brevibloc will be reduced or stopped if the
strength of your heartbeat is reduced. In addition, your doctor will constantly check your blood
pressure and ECG during treatment with Brevibloc.

Children and adolescents
The safety and efficacy of Brevibloc in children and adolescents up to 18 years of age has not yet been
demonstrated. Therefore, no recommendation can be made on the dosage.

For athletes
The use of the drug without therapeutic need constitutes doping and may still
result in a positive doping test.

Other medicines and BREVIBLOC
Tell your doctor or nurse if you are taking, have recently taken or might take
any other medicines.
In particular, tell your doctor or nurse if you are taking:

• medicines that can lower blood pressure or slow down the heartbeat
• medicines used to treat heart rhythm problems (such as verapamil and diltiazem). Brevibloc will not be given to you within 48 hours of stopping verapamil;
• quinidine, disopyramide, amiodarone
• medicines used to treat high blood pressure such as nifedipine, monoxidine
• medicines used to treat a weak heart (such as digoxin, digitoxin, digitalis)
• medicines used to treat diabetes (antidiabetics), including insulin and medicines to be taken orally
• medicines known as ganglion blocking agents
• medicines used as painkillers (such as non-steroidal anti-inflammatory drugs known as NSAIDs, floctafenine, morphine)
• medicines used to treat mental disorders (amisulpride, chlorpromazine, clozapine, reserpine)
• medicines used to treat depression (“tricyclic” antidepressants such as imipramine and amitriptyline)
• medicines used to treat epilepsy, a disease characterized by uncontrolled body movements and loss of consciousness (such as phenobarbital)
• medicines used to treat allergies (epinephrine)
• medicines belonging to the group called “alpha-2 agonists” (such as clonidine, used to treat high blood pressure and migraine)
• medicines mainly used to treat Parkinson’s disease, a central nervous system disease that prevents control of movement, which manifests, for example, with tremor,

feeling of stiffness, slowing of movements, difficulty maintaining balance (ergot derivatives)

• medicines used to treat low blood sugar levels (glucagon)
• medicines used to treat a disease characterized by severe muscle weakness (myasthenia gravis)
• medicines that increase heart contraction and blood pressure (with a “positive inotropic” effect)
• medicines used to make the blood more fluid (warfarin)
• medicines used in anesthesia, such as suxamethonium chloride or mivacurium

Pregnancy, breastfeeding and fertility
You will not be given Brevibloc if you are pregnant or think you might be, as
Brevibloc is not recommended in pregnancy.
Tell your doctor if you are breastfeeding. Brevibloc can pass into breast milk so do notbe
given Brevibloc if you are breastfeeding, as Brevibloc is not recommended in
breastfeeding.

BREVIBLOC contains sodium
Brevibloc contains approximately 0.28 mg of sodium per vial. This should be taken into consideration in people with
impaired kidney function or who are following a low-sodium diet.

3. How BREVIBLOC will be administered to you

This medicine will be administered to you always following the doctor's instructions exactly. If you have
any doubts, consult your doctor.
The dose will be established by the doctor based on your weight and health condition.
Brevibloc has not been studied for therapies lasting longer than 24 hours..
Brevibloc is ready for use. Brevibloc will be administered to you through a needle inserted into a vein in your
arm.

Use in children and adolescents
The safety and efficacy of Brevibloc in children and adolescents up to 18 years of age have not yet been
demonstrated. Currently available data do not allow any recommendation on
dosage.

If you are given too much BREVIBLOC
It is very unlikely that you will be given more infusion solution than necessary, as the doctor or
nurse will monitor you during treatment.
However, if this happens, the doctor will stop the therapy with Brevibloc and administer
additional treatment, if necessary.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most of the adverse reactions observed are mild and transient.
Tell your doctor or nurse immediately if you notice any of the following side effects,
which can be serious:

• decrease in blood pressure (hypotension) The dose of Brevibloc will be reduced or administration will be stopped. Your doctor will monitor your blood pressure during treatment.

In addition, you may experience the following side effects:

very common (may affect more than 1 in 10 people)

• excessive sweating

common (may affect up to 1 in 10 people)

• loss of appetite (anorexia)
• depression
• anxiety
• drowsiness
• headache
• tingling
• difficulty concentrating
• feeling confused or agitated
• dizziness
• nausea and vomiting
• feeling weak
• feeling tired
• irritation, inflammation and hardening of the skin at the site where Brevibloc was injected

uncommon (may affect up to 1 in 100 people)

• abnormal thoughts
• irritability
• sudden loss of consciousness (syncope)
• uncontrolled body movements (convulsions)
• speech problems
• vision problems
• chest pain
• slowed heartbeat (bradycardia)
• problems with the electrical impulses that control the heartbeat (atrioventricular block)
• increased blood pressure in the lungs
• cessation of heart activity (cardiac arrest)
• a heart rhythm disorder (ventricular extrasystoles)
• a heart rhythm disorder (nodal rhythm)
• chest pain caused by a heart problem (angina pectoris)
• poor blood circulation in the arms and legs (peripheral ischemia)
• paleness
• redness
• shortness of breath or tightness in the chest making it difficult to breathe (dyspnea)
• fluid in the lungs (pulmonary edema)
• difficulty breathing (bronchospasm)
• lung disease that makes it difficult to breathe (asthma)
• stuffy nose (nasal congestion)
• wheezing or abnormal rattling during breathing
• changes in the sense of taste (dysgeusia)
• difficulty digesting (dyspepsia)
• constipation
• dry mouth
• pain in the stomach area (abdominal pain)
• skin discoloration
• skin flushing
• muscle or bone pain, including around the shoulder blades and ribs (musculoskeletal pain)
• difficulty urinating
• chills
• high temperature (fever)
• pain and swelling (edema) or a burning or bruising sensation at the site where Brevibloc was injected

very rare (may affect up to 1 in 10,000 people)

• severe decrease in heart rate (sinus arrest)
• absence of electrical activity in the heart (asystole)
• inflammation of blood vessels (thrombophlebitis)
• degeneration of skin tissue (skin necrosis) caused by leakage of solution around the injection site

not known (frequency cannot be estimated from the available data)

• increased levels of potassium in the blood (hyperkalemia)
• increased levels of acids in the body (metabolic acidosis)
• increased heart rate (accelerated idioventricular rhythm)
• spasm of the heart arteries (coronary artery spasm)
• interruption of normal blood circulation (cardiac arrest)
• appearance or worsening of psoriasis (a skin condition that produces scaly patches)
• swelling of the skin of the face, limbs, tongue or throat (angioedema)
• hives
• muscle weakness
• inflammation of a vein (phlebitis) or blistering at the infusion site

Other side effects that have been reported with other medicines containing the same active ingredients as
Brevibloc (esmolol), and which therefore may be potential side effects of Brevibloc,
are:

effects involving the nervous system

• seeing or hearing things that are not there (hallucinations)
• vivid dreams
• sleep disorders
• memory problems
• depression leading to immobility and lack of expressiveness (catatonia) effects involving the blood and circulation
• cold hands and feet
• decreased number of platelets in the blood (thrombocytopenia)
• increased concentration in the blood of antinuclear antibodies, which the body produces against itself
• high concentration in the blood of eosinophils, a type of white blood cell
• red spots on the skin due to the destruction of platelets in the blood (thrombocytopenic purpura)
• red spots on the skin due to inflammation of blood vessels (non-thrombocytopenic purpura)

effects involving the muscles and bones

• joint pain (arthralgia) effects involving the immune system, the body's defense system
• disease involving several organs of the body (systemic lupus erythematosus) allergies
• worsening of allergic reactions effects involving the eye
• decreased tearing effects involving the lungs
• lung infection (pneumonia)
• infection of the pleura, the membrane that surrounds the lungs (pleuritis)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly
through the website http://www.agenziafarmco.gov.it/it/responsabili. By reporting side effects you
can help provide more information on the safety of this medicine.

5. How to store BREVIBLOC

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 25°C. Do not refrigerate or freeze.
From a microbiological point of view, the opened product must be used immediately. If not
used immediately, the in-use storage times and conditions prior to use are the responsibility
of the user and should normally not exceed 24 hours at 2 to 8°C, unless
the opening took place under controlled and validated aseptic conditions.
Do not use this medicine after the expiry date which is stated on the packaging after Exp. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What BREVIBLOC contains

• The active ingredient is esmolol hydrochloride
• The other ingredients are: sodium chloride, sodium acetate, glacial acetic acid, sodium hydroxide or hydrochloric acid (added to ensure the correct pH), water for injections.

Description of the appearance of BREVIBLOC and package contents
Brevibloc is presented as a sterile solution for infusion.
It is available in packs of 5 vials of 10 ml.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
BAXTER S.p.A.
Piazzale dell’Industria 20
00144 ROMA

Manufacturer
Baxter Healthcare Ltd
Caxton Way
Thetford Norfolk IP24 3SE
United Kingdom
---------------------------------------------------------------------------------------------------------------------------
The following information is intended exclusively for doctors or healthcare professionals:
This section contains practical information relating to administration. Read the SmPC for
complete information on dosage, method of administration, contraindications,
warnings etc.

Dosage and administration
Brevibloc 10 mg/ml is an iso-osmotic ready-to-use solution recommended for intravenous
administration.
This dosage scheme is used for administering the correct loading dose or bolus
injected via syringe.
The dosage is summarized in the following table.

Incompatibilities
This medicine must not be mixed with other medicines or sodium bicarbonate solutions.

Special precautions for disposal and handling

• Each bag is for single use and does not contain preservatives. Once the seal on the access port has been broken and the drug has been withdrawn, the bag must be used within 24 hours. Do not reconnect partially used bags.
• Do not use plastic containers for series connections. Such use may cause an embolism due to residual air from the primary container before administration of the liquid from the secondary container is completed.
• Do not use if the outer packaging has previously been opened or damaged.
• The solution must be visually inspected before use to detect any particles or colour change. Do not use if the solution is not clear, colourless to light yellow.
• Dispose of unused content in accordance with local regulations.

BREVIBLOC 10 mg/ml Solution for Infusion

Esmolol hydrochloride
Read this leaflet carefully before you are given this medicine
because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If any side effect occurs, including any not listed in this leaflet, ask your doctor or nurse. See section 4.

Contents of this leaflet:

• 1. What BREVIBLOC is and what it is used for
• 2. What you need to know before BREVIBLOC is given to you
• 3. How BREVIBLOC will be given to you
• 4. Possible side effects
• 5. How to store BREVIBLOC
• 6. Contents of the pack and other information

1. What is BREVIBLOC and what is it used for

BREVIBLOC contains the active ingredient esmolol which belongs to the group of medicines called
“beta-blockers”. This medicine works by controlling the strength and frequency of your
heartbeat.
Brevibloc is used in adultsto treat:

• heart rhythm disturbances, when your heartbeat is too fast (tachycardia)
• heart rhythm disturbances (tachycardia) and increased blood pressure (hypertension), even when this happens during or immediately after surgery.

2. What you need to know before you are given BREVIBLOC

Your doctor will not give you BREVIBLOC

• if you are allergic to esmolol, to other beta-blocker medicines, or to any of the other ingredients of this medicine (listed in section 6)
• if you have a very slow heart rate (sinus bradycardia) (less than 50 beats per minute)
• if you have a fast heartbeat or an alternating fast-slow heartbeat (sinoatrial node dysfunction)
• if you suffer from a condition called “severe heart block”. Heart block is a problem with the electrical impulses that control the heartbeat (second or third degree atrioventricular block)
• if your heart function is depressed (cardiogenic shock)
• if you suffer from very low blood pressure (severe hypotension)
• if you have a weak heart (decompensated heart failure)
• if you are taking or have recently taken medicines to treat high blood pressure such as medicines belonging to the group called “calcium channel blockers” (verapamil, diltiazem). Brevibloc will not be given to you within 48 hours of stopping verapamil
• if you have a tumor of the adrenal gland, glands located above the kidneys, which causes an increase in blood pressure (pheochromocytoma) that has not been treated
• if you suffer from increased blood pressure in the lungs (pulmonary hypertension)
• if you suffer from acute asthma (respiratory disease) that is rapidly worsening
• if you have increased levels of acids in the blood (metabolic acidosis)

Warnings and precautions
Talk to your doctor, nurse or pharmacist before you are given Brevibloc.
Your doctor will be particularly careful with this medicine if:

• you have been treated for certain heart rhythm disorders called supraventricular arrhythmia and suffer from a heart condition or are taking other medicines for heart conditions
• The use of Brevibloc in these cases can lead to serious reactions that can lead to death (see section 4 Possible side effects)
• during therapy you have low blood pressure (hypotension). The signs of this may be a feeling of dizziness or lightheadedness, especially when standing up. This condition usually improves within 30 minutes of stopping treatment with Brevibloc
• you suffer from a slow heartbeat (bradycardia). If your heart rate drops to 50-55 beats per minute, your doctor will give you a lower dose or stop treatment with Brevibloc
• you have a weak heart
• you suffer from problems with the electrical impulses that control your heartbeat (heart block)
• if you have a tumor of the adrenal gland, glands located above the kidneys, which causes an increase in blood pressure (pheochromocytoma) that has been treated with medicines called alpha-receptor blockers
• you are taking medicines to treat high blood pressure (hypertension) that has been caused by low body temperature (hypothermia)
• you suffer from or have suffered from a lung disease that causes narrowing of the airways or wheezing, such as asthma. In case of severe difficulty breathing (bronchospasm), your doctor will stop therapy with Brevibloc and, if necessary, give you another medicine
• you have diabetes (high blood sugar levels) or low blood sugar levels (hypoglycemia). Brevibloc can increase the effects of diabetes medicines
• you have skin problems near the injection site. These may be caused by leakage of solution around the injection site. If this happens, your doctor will use a different vein for the injection
• you suffer from chest pain called “Prinzmetal's angina”
• you have a low amount of blood circulating in your body (hypovolemia)
• you suffer from disorders of blood circulation, such as pale fingers (Raynaud's syndrome) or difficulty walking
• you suffer from a kidney disease or are undergoing dialysis, a blood filtration system
• you have any allergies or are at risk of severe allergic reactions. Brevibloc can make allergies more severe and more difficult to treat
• you or someone in your family suffers from or has suffered from a skin disease called psoriasis
• your thyroid gland, a gland in the neck, is working too much (hyperthyroidism)

If any of the above conditions apply to you (or if you are not sure) consult your doctor or nurse
before you are given this medicine. You may need careful examination and the
treatment may be modified.
The use of medicines such as Brevibloc for a long period of time can cause a reduction in the strength
of your heartbeat.
Since Brevibloc is only used for a limited time, this is unlikely to happen to you. During the
treatment you will be carefully monitored and treatment with Brevibloc will be reduced or stopped if the
strength of your heartbeat is reduced. In addition, the doctor will constantly check your blood
pressure and ECG during treatment with Brevibloc.

Children and adolescents
The safety and efficacy of Brevibloc in children and adolescents up to 18 years of age has not yet been
demonstrated. Therefore, no recommendation can be made on the dosage.

For athletes
The use of the medicine without a therapeutic need constitutes doping and may still
result in a positive doping test.

Other medicines and BREVIBLOC
Tell your doctor or nurse if you are taking, have recently taken or might take
any other medicines.
In particular, tell your doctor or nurse if you are taking:

• medicines that can lower blood pressure or slow the heartbeat
• medicines used to treat heart rhythm problems (such as verapamil and diltiazem). Brevibloc will not be given to you within 48 hours of stopping verapamil; quinidine, disopyramide
• medicines used to treat high blood pressure such as nifedipine, monoxidina
• medicines used to treat a weak heart (such as digoxin, digitoxin, digitalis)
• medicines used to treat diabetes (antidiabetics), including insulin and medicines to be taken orally
• medicines known as ganglion blocking agents (ganglioplegics)
• medicines used as painkillers (such as non-steroidal anti-inflammatory drugs known as NSAIDs, floctafenine, morphine)
• medicines used to treat mental disorders (amisulpride, chlorpromazine, clozapine, reserpine)
• medicines used to treat depression (“tricyclic” antidepressants such as imipramine and amitriptyline)
• medicines used to treat epilepsy, a disease characterized by uncontrolled body movements and loss of consciousness (such as phenobarbital)
• medicines used to treat allergies (epinephrine)
• medicines belonging to the group called “alpha-2 agonists” (such as clonidine, used to treat high blood pressure and migraine)
• medicines mainly used to treat Parkinson's disease, a disease of the central nervous system that prevents control of movement, which manifests, for example, with tremor, feeling of stiffness, slowing of movements, difficulty maintaining balance (ergot derivatives)
• medicines used to treat low blood sugar levels (glucagon)
• medicines used to treat a disease characterized by severe muscle weakness (myasthenia gravis)
• medicines that increase heart contraction and blood pressure (with a so-called “positive inotropic” effect)
• medicines used to make the blood more fluid (warfarin)
• medicines used in anesthesia, such as suxamethonium chloride or mivacurium

Pregnancy, breastfeeding and fertility
You will not be given Brevibloc if you are pregnant or think you might be, as
Brevibloc is not recommended in pregnancy.
Tell your doctor if you are breastfeeding. Brevibloc can pass into breast milk so you will not be
given Brevibloc if you are breastfeeding, as Brevibloc is not recommended in
breastfeeding.

BREVIBLOC contains sodium
This medicine contains 700 mg of sodium per bag. This should be taken into consideration in people with
impaired kidney function or who are following a low-sodium diet.

3. How BREVIBLOC will be administered to you

This medicine will be administered to you always following the doctor's instructions exactly. If you have
any doubts, consult your doctor.
The dose will be established by the doctor based on your weight and your state of health.
Brevibloc has not been studied for therapies lasting longer than 24 hours..
Brevibloc is ready for use. Brevibloc will be administered to you through a needle inserted into a vein in your
arm.

Use in children and adolescents
The safety and efficacy of Brevibloc in children and adolescents up to 18 years of age has not yet been
demonstrated. Currently available data do not allow for any recommendation on
dosage.

If you are given more BREVIBLOC than you should
It is very unlikely that you will be given more infusion solution than you should, as the doctor or
nurse will monitor you during treatment.
However, if this happens, the doctor will stop the therapy with Brevibloc and administer
additional treatment, if necessary.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most of the adverse reactions observed are mild and transient.
Tell your doctor or nurse immediately if you notice any of the following side effects,
which can be serious:

• decrease in blood pressure (hypotension) The dose of Brevibloc will be reduced or administration will be stopped. Your doctor will monitor your blood pressure during treatment.

In addition, you may experience the following side effects:

very common (may affect more than 1 in 10 people),

• excessive sweating

common (may affect up to 1 in 10 people)

• loss of appetite (anorexia)
• depression
• anxiety
• drowsiness
• headache
• tingling
• difficulty concentrating
• feeling confused or agitated
• dizziness
• nausea and vomiting
• feeling weak
• feeling tired
• irritation, inflammation and hardening of the skin at the site where Brevibloc was injected

uncommon (may affect up to 1 in 100 people)

• abnormal thoughts
• irritability
• sudden loss of consciousness (syncope)
• uncontrollable body movements (convulsions)
• problems with speech
• vision problems
• chest pain
• slowed heartbeat (bradycardia)
• problems with the electrical impulses that control the heartbeat (atrioventricular block) - increased blood pressure in the lungs
• stopping of heart activity (cardiac block)
• a heart rhythm disorder (ventricular extrasystoles)
• a heartbeat disorder (nodal rhythm)
• chest pain caused by a heart problem (angina pectoris)
• poor blood circulation in the arms and legs (peripheral ischemia)
• paleness
• redness
• shortness of breath or tightness in the chest making it difficult to breathe (dyspnea)
• fluid in the lungs (pulmonary edema)
• difficulty breathing (bronchospasm)
• lung disease that makes it difficult to breathe (asthma)
• blocked nose (nasal congestion)
• wheezing or abnormal crackling sounds during breathing
• changes in the sense of taste (dysgeusia)
• difficulty digesting (dyspepsia)
• constipation
• dry mouth
• pain in the stomach area (abdominal pain)
• skin discoloration
• skin flushing
• muscle or bone pain, including around the shoulder blades and ribs (musculoskeletal pain)
• difficulty urinating
• chills
• high temperature (fever)
• pain and swelling (edema) or a burning or bruising sensation at the site where Brevibloc was injected

very rare (may affect up to 1 in 10,000 people),

• severe decrease in heart rate (sinus arrest)
• absence of electrical activity in the heart (asystole)
• inflammation of blood vessels (thrombophlebitis)
• degeneration of skin tissue (skin necrosis) caused by leakage of solution around the injection site

not known (frequency cannot be estimated from the available data)

• increased levels of potassium in the blood (hyperkalemia)
• increased levels of acids in the body (metabolic acidosis)
• increased heart rate (accelerated idioventricular rhythm)
• spasm of the heart arteries (coronary artery spasm)
• interruption of normal blood circulation (cardiac arrest)
• appearance or worsening of psoriasis (skin disease that produces scaly patches)
• swelling of the skin of the face, limbs, tongue or throat (angioedema)
• hives
• muscle weakness
• inflammation of a vein (phlebitis) or blister formation at the infusion site

Other side effects that have been reported with other medicines containing the same active ingredients as
Brevibloc (esmolol), and which therefore may be potential side effects of Brevibloc as well,
are:

effects involving the nervous system

• seeing or hearing things that do not exist (hallucinations)
• vivid dreams
• sleep disorders
• memory problems
• depression leading to immobility and lack of expressiveness (catatonia) effects involving the blood and circulation
• cold hands and feet
• decrease in the number of platelets in the blood (thrombocytopenia)
• increased concentration in the blood of antinuclear antibodies, which the body produces against itself
• high concentration in the blood of eosinophils, a type of white blood cell
• red spots on the skin due to the destruction of platelets in the blood (thrombocytopenic purpura)
• red spots on the skin due to inflammation of the blood vessels (non-thrombocytopenic purpura) effects involving the muscles and bones
• joint pain (arthralgia) effects involving the immune system, the body's defense system
• disease involving several organs of the body (systemic lupus erythematosus) allergies
• worsening of allergic reactions effects involving the eye
• decreased tear production effects involving the lungs
• lung infection (pneumonia)
• infection of the pleura, the membrane that surrounds the lungs (pleuritis)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly
through the website http://www.agenziafarmco.gov.it/it/responsabili .By reporting side effects you
can help provide more information on the safety of this medicine.

5. How to store BREVIBLOC

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 25°C. Do not refrigerate or freeze.
From a microbiological point of view, the opened product must be used immediately. If not
used immediately, the in-use storage times and conditions prior to use are the responsibility
of the user and should normally not exceed 24 hours at 2 to 8°C, unless
the opening took place under controlled and validated aseptic conditions.
Do not use this medicine after the expiry date which is stated on the pack after Exp. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What BREVIBLOC contains

• The active ingredient is esmolol hydrochloride
• The other ingredients are: sodium chloride, sodium acetate, glacial acetic acid, sodium hydroxide or hydrochloric acid (added to ensure the correct pH), water for injections.

Description of the appearance of BREVIBLOC and contents of the pack
Brevibloc is presented as a sterile solution for infusion.
It is available in packs containing a plastic bag of 250 ml.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
BAXTER S.p.A.
Piazzale dell’Industria 20
00144 ROME

Manufacturer
Baxter S.A.
Boulevard René Branquart 80,
7860 Lessines, Belgium
-------------------------------------------------------------------------------------------------------------------------

• - The following information is intended exclusively for doctors or healthcare professionals:

This section contains practical information relating to administration. Read the SmPC for
complete information on dosage, method of administration, contraindications,
warnings etc.

Dosage and method of administration
Brevibloc 10 mg/ml is an iso-osmotic ready-to-use solution recommended for intravenous
administration.
This dosage scheme is used for administering the correct loading dose or bolus
injected via syringe.
The dosage is outlined in the following table.

Table 1: Dosage table for the administration of loading and maintenance doses
Volume and amount
ofesmolol
required for an
INITIAL
LOADING
DOSE of
500
micrograms/kg
in 1 minute
Volume of esmolol required to provide different MAINTENANCE DOSES
for infusions between 25 and 300 micrograms/kg/minute
(volume in ml per hour)
Patient
weight
(kg)
Volume
(ml)
Amount
(mg)
DOSES
25
mcg/kg/min
50
mcg/kg/min
100
mcg/kg/min
150
mcg/kg/min
200
mcg/kg/min
300
mcg/kg/
min
AMOUNT TO BE ADMINISTERED PER HOUR
40 2 20 6 ml/hr 12 ml/hr 24 ml/hr 36 ml/hr 48 ml/hr 72 ml/hr
50 2.5 25 7.5 ml/hr 15 ml/hr
30 ml/hr 45 ml/hr 60 ml/hr 90 ml/hr
60 3 30 9 ml/hr 18 ml/hr 36 ml/hr 54 ml/hr 72 ml/hr 108 ml/hr
70 3.5 35 10.5 ml/hr 21 ml/hr 42 ml/hr 63 ml/hr 84 ml/hr 126 ml/hr
80 4 40 12 ml/hr 24 ml/hr 48 ml/hr 72 ml/hr 96 ml/hr 144 ml/hr
90 4.5 45 13.5 ml/hr 27 ml/hr 54 ml/hr 81 ml/hr 108 ml/hr 162 ml/hr
100 5 50 15 ml/hr 30 ml/hr 60 ml/hr 90 ml/hr 120 ml/hr 180 ml/hr
110 5.5 55 16.5 ml/hr 33 ml/hr 66 ml/hr 99 ml/hr 132 ml/hr 198 ml/hr
120 6 60 18 ml/hr 36 ml/hr 72 ml/hr 108 ml/hr 144 ml/hr 216 ml/hr
* ml corresponding to Brevibloc (10 mg/ml)
* As soon as the desired heart rate is reached or safe physiological conditions for the
patient (e.g. lowering of blood pressure), OMIT the loading dose and reduce the
maintenance dose in the infusion from 50 micrograms/kg/min to 25 micrograms/kg/min or less. If
necessary, the interval between each step can be increased from 5 to 10 minutes.
NOTE: It has not been demonstrated that administering maintenance doses greater than 200
micrograms/kg/min leads to significant benefits, and the safety of doses greater than 300
micrograms/kg/min has not been studied.
Tachycardia and increases in peri-operative pressure
For peri-operative tachycardia and hypertension, the dosage regimen may vary as follows:

For intra-operative treatment– during anaesthesia when immediate control is required:
Inject a dose in the form of a bolus of 80 mg in 15-30 seconds, followed by an infusion of 150
micrograms/kg/min. Adjust the infusion rate as required up to 300
micrograms/kg/min. The infusion volume required depending on the different patient weights is
indicated in Table 1

Upon awakening from anaesthesia
Inject 500 micrograms/kg/min for 4 minutes and continue with an infusion of 300 micrograms/kg/min.
The infusion volume required depending on the different patient weights is indicated in Table 1

In post-operative situations when titration is possible
Inject a loading dose of 500 micrograms/kg/min for 1 minute before each titration step to produce a rapid response. Use titration steps of 50, 100, 150, 200, 250 and 300
micrograms/kg/min for 4 minutes and stop when the desired therapeutic effect is reached. The
infusion volume required depending on the different patient weights is indicated in Table 1

Potential effects to consider during treatment with Brevibloc
If side effects occur, the dosage of Brevibloc may be reduced or its
administration stopped. Adverse effects should resolve within 30 minutes.
If a local reaction occurs at the infusion site, an alternative infusion site should be used and
care should be taken to prevent extravasation.
The administration of Brevibloc for periods longer than 24 hours has not been fully evaluated.
Infusions for more than 24 hours should be carried out with caution.
It is recommended to terminate the infusion gradually to avoid the risk of a rebound tachycardia and
hypertension. As with all beta-blockers, given that withdrawal effects cannot be excluded, care should be taken in the abrupt cessation of Brevibloc infusion in
patients with coronary heart disease.

Replacement of Brevibloc therapy with alternative drugs
After patients achieve adequate heart rate control and a stable
clinical condition, they can be switched to therapy with alternative drugs (such as antiarrhythmics or calcium-
antagonists).

Dosage reduction:
When Brevibloc is replaced with alternative drugs, the doctor must carefully consider the
instructions of the chosen alternative drug and reduce the dosage of Brevibloc as follows:

• Within the first hour from the first dose of the alternative drug, reduce the infusion rate of BREVIBLOC by half (50%).
• After administering the second dose of the alternative drug, monitor the patient's response and if satisfactory control is maintained for the first hour, discontinue the Brevibloc infusion

Further information on dosage
When the desired therapeutic effect is achieved or safe physiological conditions for the patient (for
example, lowering of blood pressure) are reached, omit the bolus and reduce the maintenance dose
in the infusion from 50 micrograms/kg/min to 25 or 12.5 micrograms/kg/min.
In addition, the interval between each step can be increased from 5 to 10 minutes.
The administration of Brevibloc should be stopped when the heart rate or blood
pressure rapidly reaches or exceeds a safety limit. When the heart rate or
blood pressure has returned to an acceptable level, restart administration, without
bolus and at a lower dose.

Special populations
Elderly
Elderly patients should be treated with caution, starting with a lower dosage.
No special studies have been conducted in the elderly. However, analysis of data in 252 patients over 65
years of age did not indicate variations in pharmacodynamic effects compared to those collected in patients
under 65 years of age.

Patients with renal impairment
Caution is required when administering Brevibloc to patients with renal impairment,
as the acidic metabolite of Brevibloc is eliminated unchanged by the kidneys. Elimination of the acidic metabolite is significantly reduced in patients with end-stage renal disease; the elimination half-life
increases by approximately 10 times compared to normal, and plasma levels are considerably
elevated.

Patients with hepatic impairment
No special precautions are necessary in case of hepatic impairment as red blood cell esterases play a major role in the metabolism of Brevibloc.

Paediatric population
The safety and efficacy of Brevibloc in children and adolescents up to 18 years of age have not yet
been demonstrated. The available data are described in sections 5.1 and 5.2 but no
recommendations can be made on dosage.

Incompatibilities
This medicine must not be mixed with other medicines or sodium bicarbonate solutions.

Special precautions for disposal and handling

• Each bag is for single use and does not contain preservatives. Once the seal on the access is broken and the drug has been withdrawn, the bag must be used within 24 hours. Do not reconnect partially used bags.
• Do not use plastic containers for series connections. Such use may cause air embolism due to residual air from the primary container before the administration of the liquid from the secondary container is completed.
• Do not use if the outer packaging has previously been opened or damaged.
• The solution must be visually inspected before use for the presence of any particles and colour change. Do not use if the solution is not clear, colourless to pale yellow.
• Dispose of unused contents in accordance with local regulations.