10 mg / mL infusion solution 
esmolol hydrochloride

1. What Brevibloc is and what it is used for

Brevibloc contains a substance called esmolol, which belongs to a group of medicines called “beta-blockers”. Brevibloc works by controlling the speed and force of your heartbeat and can help lower your blood pressure.

Brevibloc is used to treat:

• Problems with heart rate one, when your heart beats too fast

• Pulse problems and increased blood pressure if this occurs during or immediately after surgery

Esmolol contained in Brevibloc may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.

2. What you need to know before you receive Brevibloc

Your doctor will not give you Brevibloc if:

  • you are allergic (hypersensitive) to esmolol, to any other beta-blocker, or to any of the other ingredients of this medicine (listed in section 6). Signs of allergic reactions may include shortness of breath, wheezing, rash, itching, or swelling of the face and lips
  • you have a very slow heart rate (less than 50 beats per minute)
  • you have a fast or alternating fast and slow pulse
  • you have something called “severe heart block”. Heart block is a problem with the electrical signals that control your heart rate
  • you have low blood pressure
  • you have problems with the blood supply to the heart
  • you have severe symptoms of heart failure
  • you are receiving or have recently received a medicine containing verapamil. You must not be given Brevibloc within 48 hours of stopping receiving verapamil.
  • you have a glandular disease called pheochromocytoma, which is untreated. Pheochromocytoma comes from the adrenal gland and can cause a sudden increase in blood pressure, severe headaches, sweating, and increased heart rate
  • you have high blood pressure in the lungs ( pulmonary hypertension )
  • you have asthma symptoms that get worse quickly
  • you have elevated acid levels in your body (metabolic acidosis )

You will not receive Brevibloc if any of the above apply to you. Consult your doctor, nurse, or pharmacist before receiving Brevibloc if you are not sure if you have any of these conditions.

Warnings and cautions

Talk to your doctor, nurse, or pharmacist before receiving Brevibloc. Your doctor will be careful to ensure the following when you receive this medicine if:

  • you are being treated for certain heart rhythm diseases called supraventricular arrhythmias and you:
    • have other heart problems or
    • taking other medicines for heart disease. Use of Brevibloc on these occasions can lead to serious reactions that can be fatal including:
    • unconsciousness
    • shock (when the heart is not pumping enough blood)
    • heart attack (cardiac arrest)
  • you get low blood pressure ( hypotension ). Signs of this can be that you get dizzy or dizzy, especially when you get up. Low blood pressure usually improves within 30 minutes after stopping treatment with Brevibloc.
  • you have a low heart rate before starting treatment
  • your heart rate drops to less than 50 to 55 beats per minute. If this happens, your doctor may give you a lower dose or stop taking Brevibloc.
  • you have heart failure
  • you have problems with the electrical signals that control your heart rate (heart block)
  • you have a glandular disease called pheochromocytoma, which has been treated with a drug called alpha-receptor blocker
  • you are being treated for high blood pressure ( hypertension ) which has been caused by low body temperature ( hypothermia )
  • you have narrowing of the airways or hissing, as in asthma
  • you have diabetes or low blood sugar. Brevibloc may increase the effects of diabetes medicines
  • you get skin problems. They can be caused by solution leaking around the injection site. If this happens, your doctor will use another vein to inject one.
  • you have a special type of angina (chest pain) called “Prinzemetals angina”
  • you have low blood volume (with low blood pressure ), you can more easily develop circulatory collapse.
  • you have circulatory problems, such as paleness of the fingers ( Raynaud’s disease) or aching, tired, and sometimes burning pain in the legs.
  • you have kidney problems. If you have kidney disease or need dialysis, you may have high levels of potassium in your blood (hyperkalemia). This can cause serious heart problems.
  • you have any allergies or are at risk of having anaphylactic reactions (severe allergic reactions). Brevibloc can make allergies worse and make them harder to treat.
  • you or someone in your family has psoriasis (when there are flaky spots on the skin).
  • you have a disease called hyperthyroidism (an overactive thyroid gland ).

Change of dose one is usually not necessary if you have liver problems

If any of the above apply to you (or you are not sure), ask your doctor, nurse, or pharmacist for advice before taking this medicine. You may need careful checks and the treatment may change.

Other medicines and Brevibloc

Tell your doctor, nurse, or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription, including herbal remedies and herbal remedies. Your doctor will check that any other medicines you are taking do not change the way Breviblock works.

In particular, tell your doctor or pharmacist if you are taking any of the following:

  • Drugs that can lower blood pressure or heart rate.
  • Drugs used to treat heart rhythm problems or chest pain (angina), such as verapamil and diltiazem. You should not be given Brevibloc within 48 hours of stopping verapamil.
  • Nifedipine used to treat chest pain ( angina pectoris ), high blood pressure, and Raynaud’s disease.
  • Drugs used to treat heart rhythm problems (eg quinidine, disopyramide, or amiodarone ) and heart failure (eg digoxin, digitoxin, and digitalis ).
  • Medicines used to treat diabetes, including insulin and medicines are taken orally
  • Drugs called ganglion blockers (eg trimethaphan)
  • Drugs used as painkillers, for example, non-steroidal anti-inflammatory drugs, so-called NSAIDs
  • Floktafenin, which is a painkiller.
  • Amisulpride, a drug used to treat mental health problems.
  • Tricyclic antidepressants (such as imipramine and amitriptyline) or other medicines for mental health problems.
  • Barbiturates (eg phenobarbital used to treat epilepsy ) or phenothiazines (eg chlorpromazine used to treat mental illness).
  • Clozapine used to treat mental illness.
  • Adrenaline, which is used to treat allergic reactions.
  • Drugs used to treat asthma.
  • Medicines used to treat colds or nasal congestion, so-called mucosal decongestants.
  • Reserpine, which is used to treat high blood pressure
  • Clonidine, which is used to treat high blood pressure and migraines
  • Moxonidine, which is used to treat high blood pressure
  • Diphtheria derivatives (ergot alkaloids), drugs that are mainly used to treat Parkinson’s disease
  • Warfarin, which is used to thin your blood
  • Morphine, which is a strong painkiller
  • Suxamethonium chloride (also known as succinylcholine or choline or mivacurium used to relax muscles, usually during surgery) Your doctor will also be especially careful if Brevibloc is used during surgery when you are given anesthesia or other treatments

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

Tests that can be done while you are being treated with Brevibloc

Using medicines like Brevibloc for a long period of time can reduce the power of your heartbeat.

Because Brevibloc is only used for a limited time, this is unlikely to happen to you. During treatment, you will be closely monitored and treated with Brevibloc will be reduced or discontinued completely if the force of your heartbeat decreases.

Your doctor will also check your blood pressure while you are being treated with Brevibloc.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.

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

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

Brevibloc contains sodium

Brevibloc contains approximately 700 mg of sodium per bag. This can be important if you

controls the amount of sodium in your diet.

3. How to get Brevibloc

Recommended dose

Your doctor will determine how much medicine you need and how long your treatment should last.

Brevibloc is not normally given for more than 24 hours.

How to get Brevibloc

Brevibloc is ready to use and you will get it through a slow injection ( infusion ) via a needle that is 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 steps:

Step one: a large dose is given for one minute. This quickly increases the levels in your blood.

– Step two: then give a smaller dose for four minutes.

– Steps one and two can then be repeated and adjusted according to how your heart responds. As soon as an improvement has occurred, step one (the large dose one) is stopped, and step two (the small dose one) is reduced if necessary.

– Once you have reached a stable state, you may be given another medicine for your heart, while your dose of Brevibloc is gradually reduced.

– If your heart rate or blood pressure increases during an operation or shortly after you recover from it, you can receive a larger dose of Brevibloc for a short time.

Older

Your doctor will start treatment with a lower dose.

Children

Children up to the age of 18 should not be given Brevibloc.

If you take more Brevibloc than you should

Because you are receiving Brevibloc from a trained and qualified person, it is unlikely that you will receive too much. However, should this occur, your doctor will stop giving you Brevibloc and you will receive other treatment if needed.

If you think a dose of Brevibloc has been missed

Because you are receiving Brevibloc from a trained and qualified person, it is unlikely that you will miss a dose. However, if you think you have missed a dose, contact your doctor, nurse, or pharmacist as soon as possible.

If you stop taking Brevibloc

Sudden discontinuation of Brevibloc treatment may cause symptoms such as rapid heartbeat ( tachycardia ) and high blood pressure ( hypertension ) to return. To avoid this, your doctor should discontinue treatment gradually. If it is known that you have coronary heart disease (which may be associated with a history of angina or heart attack), your doctor will need to 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.

4. Possible side effects

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

Contact your doctor, nurse, or pharmacist if you notice any of the following side effects that may be serious. Infusion one may also need to be stopped.

Very common (may affect more than 1 user in 10)

• Drop in blood pressure. This can be quickly corrected by reducing the dose of Brevibloc or stopping treatment completely. Your blood pressure will be measured frequently during treatment

• Abnormal sweating

Common (may affect less than 1 user in 10)

  • Reduced appetite
  • Anxiety or depression
  • Dizziness
  • Somnolence
  • Headache
  • A tingling sensation or numbness
  • Concentration difficulties
  • Confusion or upset
  • Feeling sick (nausea and vomiting)
  • Feeling weak
  • Feeling tired (tiredness)
  • Irritation or hardening of the skin where Brevibloc was injected

Uncommon (may affect less than 1 user in 100)

  • Abnormal thoughts
  • Sudden unconsciousness
  • Feeling weak or fainting
  • Seizures (convulsions or convulsions)
  • Speech problems
  • Vision problems
  • Slow pulse
  • Problems with the electrical signals that control your heart rate
  • Increased pressure in the artery are the lungs
  • The inability of the heart to pump enough blood ( heart failure )
  • A disorder of the heart rhythm sometimes called palpitations (ventricular extrasystoles )
  • Problems with heart rhythm (nodal rhythm)
  • Chest discomfort caused by poor blood flow in the blood vessels of the heart muscle (angina, angina pectoris )
  • Poor circulation in arms and legs
  • Paleness or redness
  • Fluid in the lungs
  • Shortness of breath or pressure over the chest that makes it difficult to breathe
  • Wheezing
  • Nasal congestion
  • Abnormal rustling/scratching sounds when you breathe
  • Changed sense of taste
  • Digestive problems
  • Constipation
  • Dry mouth
  • Pain in the abdominal area
  • Discoloration of the skin
  • Reddening of the skin
  • Pain in muscles or tendons, including around the shoulder blades and ribs
  • Problems urinating ( urinary retention )
  • Freezing or high temperature (fever)
  • Pain and swelling ( edema ) on your vein where Brevibloc was injected
  • A burning sensation at the injection site

Very rare (may affect less than 1 in 10,000 users)

  • Severely reduced heart rate (sinus arrest)
  • No electrical activity in the heart (asystole)
  • Fragile blood vessels with an area of ​​hot, red skin ( thrombophlebitis )
  • Dead skin caused by solution leaking around the injection site

No known frequency (number of persons involved is unknown)

  • Increased potassium levels in the blood ( hyperkalemia )
  • Increased acid levels in the body (metabolic acidosis )
  • Increased rate of contraction of the heart (increasing idioventricular rhythm)
  • Spasm you in the artery are in the heart
  • Inability to circulate blood normally (cardiac arrest)
  • Psoriasis (when there are flaky spots on the skin)
  • Swelling of the skin of the face, body parts, tongue, or throat ( angioedema )
  • Rash ( urticaria )
  • Inflammation of a vein or blistering at the infusion site.

If you get any side effects, talk to your doctor, nurse, or pharmacist. This also applies to side effects that are not mentioned in this information. You can also report side effects directly to (see details below). By reporting side effects, you can help increase drug safety information.

The Medical Products Agency

Box 26

751 03 Uppsala

Website: www.lakemedelsverket.se

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information

5. How to store Brevibloc

• Keep out of sight and reach of children

• Do not use this medicine after the expiry date which is stated on the label after EXP. The expiration date is the last day of the specified month

• Do not remove the outer bag until the product is to be used

• Do not store above 25 ° C.

• Store in a cool place. Do not freeze.

• Opened product is stable for 24 hours at 2 ° C – 8 ° C but should be used immediately after opening.

• Do not use Brevibloc if you notice particles in the solution or if it is discolored.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is esmolol hydrochloride, 10 mg/ml. A 250 ml bag contains 2500 mg of esmolol hydrochloride
  • The other ingredients are sodium acetate, glacial acetic acid, sodium chloride, and sterile water (referred to as “water for injections”). Sodium hydroxide and/or hydrochloric acid may be added to ensure proper pH

What the medicine looks like and the contents of the pack

Brevibloc is a clear, colorless to light yellow, sterile solution for intravenous infusion(slow injection ). Available in 250 ml of plastic bags (latex-free).

Marketing Authorization Holder and Manufacturer

Marketing authorization holders are:

Baxter Medical AB

PO Box 63

164 94 Kista

Manufacturer:

Baxter SA

Boulevard René Branquart, 80

7860 Lessines

BelgiumShow larger

Name of Member State Name of the medicine
Belgium Brevibloc 10 mg / ml, perfusion solution
Denmark Brevibloc
Finland Brevibloc 10 mg / ml infusion test, liuos
Germany Brevibloc 10 mg / ml infusion solution
Ireland Brevibloc Premixed 10mg / ml, Solution for Infusion
Luxembourg Brevibloc 10 mg / ml, perfusion solution
Netherlands Brevibloc 10 mg / ml, solution for infusion
Norway Brevibloc 10 mg / ml, solution for infusion
Poland Brevibloc 10 mg/ml, Roztwór do infusion
Portugal Brevibloc Premixed 10 mg/ml, Perfusion Solution
Spain Brevibloc 10 mg / ml, perfusion solution
UK Brevibloc Premixed 10mg / ml, Solution for Infusion

Muhammad Nadeem

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