0.5 mg / ml injection solution 
bumetanide

1. What Burinex is and what it is used for

Burinex is a diuretic that accelerates the excretion of urine.

Burinex is used in adults to treat the accumulation of fluid in the body ( edema ), which can occur in connection with heart failure , liver cirrhosis or kidney disease.

Bumetanide contained in Burinex may also be approved for the treatment of other conditions not mentioned in this product information. 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 using Burinex

Do not use Burinex

  • if you are allergic to bumetanide, formaldehyde or any of the other ingredients of this medicine (listed in section 6)
  • in severe hepatic impairment (hepatic encephalopathy)
  • if you have kidney failure with little or no urine excretion
  • in conditions of altered fluid and salt balance in the body.

Warnings and cautions

Talk to your doctor or pharmacist before using Burinex.

  • There are very small amounts of formaldehyde in the medicine. Due to the risk of developing a severe allergic reaction ( anaphylactic reaction ), caution should be exercised.
  • In case of severe hepatic impairment, low blood pressure or hypomagnesaemia(low magnesium content in the blood). Regular monitoring of the blood concentration of certain electrolytes will be done because Burinex can change the fluid and salt balance in the body.
  • If you have a narrowing of the urinary tract.
  • If you have severe renal impairment or elevated levels of urea or creatinine in your blood.
  • If you have diabetes, your urine and blood glucose should be checked regularly.
  • If you are hypersensitive to sulphonamides , you may also be hypersensitive to Burinex.

Children

Burinex is not recommended for use in children due to insufficient information on safety, efficacy and dosage .

Other medicines and Burinex

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

The effect of treatment can be affected if this medicine is taken at the same time as certain other medicines.

Caution should be exercised when using Burinex and concomitantly

  • certain types of heart medicine ( digitalis glycosides )
  • antiarrhythmic drugs ( antiarrhythmics )
  • certain medicines are given for manic-depressive illness (lithium)
  • certain painkillers ( NSAIDs )
  • other diuretics ( diuretics )
  • some medicines for high blood pressure
  • certain medicines that can lower blood pressure (eg tricyclic antidepressants )
  • substances that reduce the potassium level in the blood
  • certain medicines for gout (probenecid)
  • certain antibiotics ( aminoglycosides , cephalosporins ).

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Bumetanide should not be used during pregnancy unless your doctor tells you it’s absolutely necessary. It should only be used by pregnant women in heart failure as the benefits of the treatment outweigh the risks to the fetus.

Breast-feeding

Burinex should not be used during breast-feeding.

Driving and using machines

Dizziness may occur and this should be taken into account when driving or using machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and / or side effects . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

3. How to use Burinex

Burinex will be administered by healthcare professionals.

You will receive this medicine as an injection into a vein ( intravenous injection ) or into a muscle ( intramuscular injection ). The dosage one and the way to give the injection one depends on your special needs and your illness and is decided by your doctor.

Use for children and adolescents

Burinex is not recommended for use in children.

Overdose can cause dehydration of the body, very large amounts of urine and electrolyte disturbances. Symptoms of electrolyte disturbances include dry mouth , thirst, weakness, drowsiness, confusion, nausea, vomiting, abdominal pain, restlessness, muscle aches, muscle cramps and seizures.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Burinex can in rare cases affect the white blood cells so that the defense against infection deteriorates. If you get an infection with symptoms such as fever with severe general deterioration or fever with local infection symptoms such as sore throat/throat/mouth or difficulty urinating, you should see a doctor as soon as possible so that blood tests can rule out a lack of white blood cells ( agranulocytosis ). It is important that you then information about your medication.

Common (may affect up to 1 in 10 people):

  • alteration of fluid and salt balance (low levels of potassium , sodium and chlorine or high levels of potassium in the blood)
  • dizziness, fatigue, headache
  • abdominal pain, nausea
  • muscle pain
  • urination problem.

Uncommon (may affect up to 1 in 100 people):

  • elevated blood sugar
  • high level of uric acid in the blood, gout
  • fainting
  • low blood pressure
  • vomiting, diarrhea, constipation
  • skin reactions such as rash, hives , itching , increased sensitivity to light
  • renal impairment (including renal failure )

Has been reported (occurs in an unknown number of users):

  • decreased platelet count, anemia
  • hearing disorders
  • dermatitis, eczema
  • dehydration.

Reporting of side effects ar

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 (see details below). By reporting side effects , you can help increase drug safety information.

The Medical Products Agency

Box 26

751 03 Uppsala


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 Burinex

Keep this medicine out of the sight and reach of children.

Keep the vial are in the outer carton. Sensitive to light.

Do not store above 25 ° C.

Burinex should be used before the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.

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 bumetanide 0.5 mg/ml.
  • The other ingredients are: Disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, xylitol, water for injections.

What the medicine looks like and the contents of the pack

Each ampoule contains 4 ml solution for injection .

Pack size: 5 × 4 ml.

Marketing Authorization Holder and Manufacturer

medinfo@karopharma.com

Manufacturer

Cenexi

52, rue Marcel and Jacques Gaucher

94120 Fontenay-sous-Bois

France

Muhammad Nadeem

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