750 mg powder for solution for injection / infusion 

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • If you get any side effects, talk to your doctor or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Cefuroxim Fresenius Kabi is and what it is used for 
2. What you need to know before you are given Cefuroxime Fresenius Kabi 
3. How Cefuroxim Fresenius Kabi is given 
4. Possible side effects 
5. How Cefuroxim Fresenius Kabi should be stored 
6. Contents of the packaging and other information 

What Cefuroxime Fresenius Kabi is and what it is used for

Cefuroxime Fresenius Kabi is an antibiotic used in adults and children. It works by killing bacteria that cause infection. It belongs to a class of drugs called cephalosporin.

Cefuroxime Fresenius Kabi is used to treat infections in:

  • the lungs or chest
  • the urinary tract
  • the skin and the soft parts
  • buken

Cefuroxime Fresenius Kabi is also used:

  • to prevent infection during surgery.

Your doctor can test the type of bacteria that is causing your infection and monitor if the bacteria are sensitive to Cefuroxime Fresenius Kabi during treatment.

Cefuroxime contained in Cefuroxime Fresenius Kabi 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.

What you need to know before you are given Cefuroxime Fresenius Kabi

You must not be given Cefuroxime Fresenius Kabi:

  • if you are allergic to any cephalosporin antibiotics or any of the other ingredients of Cefuroxime Fresenius Kabi (listed in section 6).
  • if you have ever had an allergic reaction (hypersensitivity) to any other type of beta-lactam antibiotic ( penicillins, monobactams, carbapenems).

→ Tell your doctor before starting Cefuroxim Fresenius Kabi if you think this is true for you. You must not be given Cefuroxime Fresenius Kabi.

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before using Cefuroxim Fresenius Kabi. You need to be aware of certain symptoms such as allergic reactions, skin rash disorders in the gastrointestinal tract such as. diarrhea or fungal infections when given Cefuroxime Fresenius Kabi. This reduces the risk of possible problems. See “Conditions that you need to be aware of” in section 4. If you have had an allergic reaction to other antibiotics such as penicillin, you may also be allergic to Cefuroxim Fresenius Kabi.

If you need to undergo a blood or urine test

Cefuroxime Fresenius Kabi can affect the results of urine or blood tests for sugar and a blood test called the Coombs test. If you are going to take tests:

→ Tell the person taking the test that you have received Cefuroxim Fresenius Kabi.

Other medicines and Cefuroxime Fresenius Kabi

Tell your doctor if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter medicines.

Some medicines can affect Cefuroxim Fresenius Kabi or make you more likely to get side effects. These include:

  • antibiotics of the aminoglycoside
  • diuretic tablets ( diuretics ), e.g. furosemide
  • probenecid
  • blood-thinning drugs given by mouth

→ Tell your doctor if this is true for you. You may need extra controls to monitor your kidney function while taking Cefuroxime Fresenius Kabi.

Pregnancy, breastfeeding, and fertility

Tell your doctor before giving Cefuroxim Fresenius Kabi:

  • If you are pregnant, think you may be pregnant, or planning to become pregnant
  • if you are breast-feeding

Your doctor will consider the benefit of treating you with Cefuroxim Fresenius Kabi against the risk to your child.

Driving and using machines

Do not drive or use machines unless you are feeling well.

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.

Cefuroxime Fresenius Kabi contains sodium.

This medicine contains 40.63 mg sodium (the main ingredient in table salt/table salt) per vial. This corresponds to 2% of the maximum recommended daily sodium intake for adults.

3. How Cefuroxim Fresenius Kabi is given

Cefuroxime Fresenius Kabi is usually given by a doctor or nurse. It can be given as a drip ( intravenous infusion ) or as an injection directly into a vein or muscle.

Usual dose

The correct dose of Cefuroxime Fresenius Kabi for you is determined by your doctor and depends on: the severity and type of infection, if you are taking any other type of antibiotic, your weight and age, how well your kidneys are working.

Newborn babies (0–3 weeks)

For every kg the child weighs , 30 to 100 mg of Cefuroxime Fresenius Kabi is given per day in two or three doses.

Infants (over 3 weeks) and children

For every kg the infant or baby weighs , 30 to 100 mg of Cefuroxime Fresenius Kabi is given per day in three or four doses.

Adults and young people

750 mg to 1.5 g Cefuroxime Fresenius Kabi two, three or four times daily. Maximum dose: 6 g per day.

Patients with kidney problems

If you have kidney problems, your doctor may change your dose.

→ Tell your doctor if this applies to you.

4. Possible side effects

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

Conditions that you need to be aware of

A small number of people taking Cefuroxim Fresenius Kabi have an allergic reaction or a skin reaction that can be serious. Symptoms of these reactions include:

  • severe allergic reaction. Signs include raised and itchy rashes, swelling, sometimes on the face or mouth that make it difficult to breathe.
  • skin rash that can form blisters and look like small targets (dark dot in the middle surrounded by a lighter area with a dark ring around the edge).
  • a widespread rash with blisters and scaly skin. (These may be signs of Stevens-Johnson syndrome or toxic epidermal necrolysis ).

Other symptoms that you should be aware of when taking Cefuroxim Fresenius Kabi include:

  • Fungal infections In rare cases, medicines such as Cefuroxim Fresenius Kabi can cause an overgrowth of yeast ( Candida ) in the body which can lead to fungal infections (eg cod). This side effect is more likely if you take Cefuroxime Fresenius Kabi for a long time.
  • severe diarrhea (pseudomembranous colitis ) Drugs such as Cefuroxim Fresenius Kabi can cause inflammation of the colon, causing severe diarrhea, usually with blood and mucus, abdominal pain, fever.

→ Contact a doctor, pharmacist, or nurse immediately if you experience any of these symptoms.

Common side effects are

These can affect up to 1 in 10 people :

injection site pain, swelling, and redness along a vein.

→ Tell your doctor if any of these bother you.

Common side effects that may show up in blood tests:

  • increase of substances ( enzyme s ) produced by liver
  • altered white blood cell count ( neutropenia or eosinophilia )
  • low levels of red blood cells ( anemia )

Uncommon side effects are

These can affect up to 1 in 100 people:

  • skin rash, itchy raised rash ( hives )
  • diarrhea, nausea, abdominal pain

→ Tell your doctor if you get any of these side effects.

Uncommon side effects that may show up in blood tests:

  • low levels of white blood cells ( leukopenia )
  • increase in bilirubin (a substance produced by the liver)
  • positive Coombs test.

Other side effects are

Other side effects have affected a very small number of people but it is not known how often they occur:

  • fungal infections
  • elevated temperature ( fever )
  • allergic reactions
  • inflammation of the colon, causing diarrhea, usually with blood and mucus, abdominal pain
  • inflammation of the kidneys and blood vessels
  • red blood cells that break down too quickly ( hemolytic anemia ).
  • skin rash that can form blisters and look like small targets (dark dot in the middle surrounded by a lighter area with a dark ring around the edge) erythema multiforme.

→ Tell your doctor if you get any of these side effects.

Side effects that can show up in blood tests:

  • decreased platelet count (cells that help the blood to clot – thrombocytopenia )
  • elevated levels of urea nitrogen and serum creatinine in the blood.

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 Cefuroxime Fresenius Kabi

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. date ”or“ EXP ”. The expiration date is the last day of the specified month.

Do not store above 25 ° C. Store the vials in the outer carton. Sensitive to light.

When Cefuroxime Fresenius Kabi powder is mixed into a suspension/injection solution, it should be used immediately. If not used immediately, store the reconstituted solution/suspension in a refrigerator (2–8 ° C) and use within 5 hours.

Do not use Cefuroxim Fresenius Kabi if you see signs of deterioration, e.g. that the solution contains particles or is discolored. Any remaining solution/suspension is discarded.

Medicines should not be disposed of via wastewater or household waste. Your doctor or nurse will discard medicines that are no longer used. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is cefuroxime (750 mg) as cefuroxime sodium.

What the medicine looks like and the contents of the pack

Cefuroxime Fresenius Kabi powder is normally mixed with water for injections into a clear solution for injection or infusion into veins ( intravenously ) or muscles ( intramuscularly ). The reconstituted cefuroxime solution may be reconstituted by your physician with other suitable infusion fluids. The color of the solution may be unstained to yellowish depending on the concentration, diluent, and storage conditions.

Cefuroxime Fresenius Kabi 750 mg powder for solution for injection/infusion is available in packs of 1 and 10 vials of powdered glass, closed with a rubber stopper, aluminum seal, and a flip-off cap in blue plastic.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder: 
Fresenius Kabi AB 
SE-751 74 Uppsala

LABESFAL – Laboratórios Almiro SA 
Lagedo, 3465-157 Santiago de Besteiros 

Muhammad Nadeem

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