powder for injection, solution 
cefotaxime

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, pharmacist, or nurse.
  • This medicine has been prescribed for you. Do not give it to others. It may harm them, even if they show symptoms similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Cefotaxim Villerton is and what it is used for 
2. What you need to know before you use Cefotaxim Villerton 
3. How to use Cefotaxime Villerton 
4. Possible side effects 
5. How to store Cefotaxime Villerton 6. Contents of the pack 
and other information 

1. What Cefotaxime Villerton is and what it is used for

Cefotaxime Villerton is an antibiotic, ie a medicine that works against bacterial infections.

Cefotaxime Villerton is used to treat serious infections caused by bacteria that are sensitive to cefotaxime;

  • the infection you proceeded from the lungs, urinary tract, or intestines
  • pneumonia caused by bacteria
  • upper urinary tract infections
  • meningitis ( acute bacterial meningitis )
  • infection is in the abdomen
  • infection in the skin and soft tissues
  • some infection is in the abdomen
  • prevention in certain operations of the colon and rectum.

What you need to know before you use Cefotaxim Villerton

Do not use Cefotaxim Villerton

  • if you are hypersensitive (allergic) to cefotaxime or any other cephalosporin you
  • if you have previously reacted with a severe allergic reaction (type I reaction) to a penicillin (a type of antibiotic ).

Take special care with Cefotaxim Villerton

  • if you have impaired kidney function
  • if you have or have had a penicillin allergy or other allergy
  • if treated for more than 10 days, a blood cell count is required. If the number of white blood cells ( leukocytes ) has decreased, treatment should be stopped. Your doctor will take care of this.
  • if you have previously had stomach or intestinal problems, such as colitis, which causes diarrhea that contains blood.

Other medicines and Cefotaxim Villerton

Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

If any of the following medicines are used at the same time as cefotaxime, the dose of one of Cefotaxime Villerton or the other medicine may need to be changed:

  • probenecid (used for gout )
  • aminoglycoside is ( antibiotics ).

Pregnancy, breastfeeding, and fertility

There is only limited experience with the use of cefotaxime during pregnancy. Therefore, consult your doctor before using Cefotaxim Villerton if you are pregnant.

Cefotaxime passes into breast milk. There is a risk that children who are breastfed may be affected. Therefore, consult your doctor before using Cefotaxim Villerton during breast-feeding.

Driving and using machines

If you have been given high doses of cefotaxime, you may feel dizzy/drowsy or may fall asleep, or have cramps or abnormal body movements. If this happens, do not drive or use machines.

Important information about some of the ingredients of Cefotaxim Villerton

If you have been prescribed a low-salt diet, you should be aware that this medicine contains sodium (2.09 mmol / g cefotaxime).

How to use Cefotaxime Villerton

Cefotaxime Villerton is given by healthcare professionals. Your doctor will decide on the dosage and adjust it for you.

Cefotaxime should be given as an injection or as a drip ( infusion ), but can also be injected into a muscle.

If you have any further questions, ask your doctor or pharmacist.

If you use more Cefotaxim Villerton than you should 

Because you are receiving this medicine in a hospital, you are unlikely to receive too much. However, talk to your doctor if you are worried about anything.

4. Possible side effects

Like all medicines, Cefotaxim Villerton can cause side effects, although not everybody gets them.

Like other antibiotics, it can cause allergies in some people. Tell your doctor immediately if you experience any of the following rare symptoms:

  • sudden wheezing and a feeling of tightness in the chest
  • swelling of the eyelids, face, lips, or throat
  • skin nodules or ‘hives’ ( hives )
  • severe skin rash with itching
  • loss of consciousness, abnormal movements, or cramps

Antibiotic treatment can affect the normal intestinal bacteria and cause a new infection ( colitis ). You should tell your doctor immediately if you get diarrhea.

The following side effects may occur in some patients treated by injection of cefotaxime. Tell your doctor if any of the side effects gets serious.

The very common side effect is (occurring in more than 1 in 10)

  • injection site pain

Less common side effects are (by less than 1 in 100)

  • decreased platelet count, which increases the risk of bruising or bleeding
  • decreased number of white blood cells, which increases the risk of infection s
  • increased white blood cell count
  • fever
  • elevated levels of liver enzymes and/or bilirubin
  • kidney problems
  • skin rash, itching, “hives” ( hives )
  • difficulty breathing
  • cramps
  • diarrhea
  • redness and swelling at the injection site

Not known of adverse s

  • secondary infection er
  • severe allergic reactions that may cause difficulty breathing or dizziness
  • severe allergic reaction that causes swelling of the face or throat
  • difficulty breathing or wheezing
  • headache
  • dizziness
  • loss of consciousness, abnormal movements
  • nausea
  • vomiting
  • abdominal pain
  • diarrhea containing blood
  • liver inflammation ( hepatitis )
  • skin and whites of the eyes turn yellow (jaundice)
  • joint pain
  • irregular heartbeat
  • kidney inflammation that can cause dark discoloration of the urine, cloudy/bloody urine, or altered urine output
  • certain types of severe skin reactions (eg Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis ) with symptoms such as blistering, flaky skin, sores.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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 Cefotaxime Villerton

Keep out of sight and reach of children.

Do not store above 25 ° C.

Store in the outer carton. Sensitive to light.

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

The medicine 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 cefotaxime sodium
  • No other ingredients

What the medicine looks like and the contents of the pack

Cefotaxime Villerton is a white or pale yellow powder.

It is supplied in glass vials with rubber stoppers and aluminum seals containing 0.5 g, 1 g, or 2 g of powder.

The packs contain 10 vials.

Marketing Authorisation Holder

Villerton Invest SA 
Rue Edward Steichen 14

2540 Luxembourg

Manufacturer

ANFARM GREECE, Schimatari Viotia 320 09, Greece

or

ACS DOBFAR SPA, 64100 Teramo, Italy

For any information about this medicinal product, please contact the local representative of the Marketing Authorization Holder.

Mylan Hospital AS

PO Box 194 
1371 Asker 
Norway

Muhammad Nadeem

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