1 g and 2 g powder for solution for injection/infusion. Cloxacillin sodium is equivalent to 1g or 2g cloxacillin. 

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 nurse.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • 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 Cloxacillin Stragen is and what it is used for 
2. What you need to know before you use Cloxacillin Stragen 
3. How to use Cloxacillin Stragen 
4. Possible side effects 
5. How to store Cloxacillin Stragen 6. Contents of the pack 
and other information 

1. What Cloxacillin Stragen is and what it is used for

Cloxacillin Stragen is an antibiotic that belongs to a type of medicine called penicillinase-stable penicillins.

Cloxacillin Stragen works by preventing the bacterium from forming a normal cell wall. Without a cell wall, the bacterium dies. Cloxacillin Stragen works against gram-positive aerobes and against anaerobes, especially staphylococci.

Cloxacillin Stragen is used to treat infections caused by penicillinase-producing staphylococci:

  • skin and soft tissue infections 
  • inflammation of the heart ( endocarditis )
  • inflammation of the bone marrow (osteomyelitis)
  • blood poisoning ( sepsis )

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

What you need to know before using Cloxacillin Stragen

Do not use Cloxacillin Stragen

  • if you are allergic (hypersensitive) to cloxacillin
  • if you are allergic (hypersensitive) to penicillin
  • if you are allergic (hypersensitive) to cephalosporins.

Warnings and cautions

Talk to your doctor before using Cloxacillin Stragen:

  • if you have impaired kidney function

Other medicines and Cloxacillin Stragen

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

It is especially important to inform your doctor if you have been treated with:

  • Probenecid (medicine for gout ) may affect the secretion of cloxacillin.
  • Methotrexate (a medicine used to treat rheumatoid arthritis ) as concomitant use of methotrexate may increase the effect/side effects of methotrexate due to decreased excretion.
  • Dicumarol medicines (medicines that have a blood-thinning effect) as their effect may be reduced during concomitant treatment with cloxacillin.

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 for advice before using this medicine.

Pregnancy: Long clinical experience shows a small risk of adverse effects on the pregnancy, the fetus, or the newborn. However, you should ask your doctor for advice if you are pregnant or planning to become pregnant.

Breast-feeding: Some of the medicine passes into breast milk. Effects on breastfed infants are unlikely, although some effects on the baby’s gastrointestinal flora cannot be ruled out. Small amounts of the active substance in breast milk may cause an increased risk of hypersensitivity. Talk to your doctor if you are breast-feeding.

Driving and using machines

This medicine is not expected to affect your ability to drive or use 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. Therefore, always read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Cloxacillin Stragen contains sodium

Cloxacillin Stragen 1 g powder for solution for injection/infusion contains 46 mg sodium (the main ingredient in common table salt) per vial. This corresponds to 2.3% of the highest recommended daily intake of sodium for adults.

Cloxacillin Stragen 2 g powder for solution for injection/infusion contains 92 mg sodium (the main ingredient in common table salt) per vial. This corresponds to 4.6% of the highest recommended daily intake of sodium for adults.

How to use Cloxacillin Stragen

This is a medicine that is given to you by healthcare professionals.

The product can be given as an intramuscular injection or as an intravenous infusion. Infusion is used when the patient can not take the medication in tablet form and in cases where there is a need for a rapid onset of treatment.

The recommended dose is

The doctor adjusts the dose individually.

4. Possible side effects

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

Common side effects are (may affect up to 1 in 10):

  • Nausea, loose stools
  • Rash
  • Phlebitis ( inflammation of a vein after intravenous injection )

Less common side effects are (may affect up to 1 in 100):

  • Increased number of white blood cells of a special type in the blood ( eosinophilia)
  • Hives ( urticaria )

Rare side effects are (may affect up to 1 in 1000 people):

  • Decreased number of granulocyte cells in the blood ( agranulocytosis )
  • Decreased white blood cell count ( leukopenia )
  • Acute inflammation of the colon (pseudomembranous colitis )
  • Liver damage
  • Kidney damage
  • Severe allergic reactions (difficulty breathing or shock )

Local pain may occur with intramuscular injection.

Cloxacillin Stragen can cause a decrease in the number of white blood cells and your resistance to infection can thus decrease. If you experience an infection with symptoms such as fever and severe effects on the general condition or fever with local infection symptoms such as sore throat/throat/mouth or urinary tract, contact your doctor immediately. A blood test will be done to check for any reduction in white blood cell count ( agranulocytosis ). It is important to inform your doctor about your medicine.

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. Postal address

5. How to store Cloxacillin Stragen

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 label and carton after EXP. The expiration date is the last day of the specified month.

6. Contents of the packaging and other information

Content declaration

  • The active substance is cloxacillin sodium equivalent to 1 g or 2 g cloxacillin
  • The product does not contain any excipients

What the medicine looks like and the contents of the pack

Cloxacillin Stragen is a powder for solution for injection/infusion. The powder is white to almost white. The powder is packaged in a single-use vial that is packaged in an outer carton.

Each carton contains 10 vials.

Marketing Authorisation Holder

Stragen Nordic A / S

Helsingørsgade 8C

3400 Hillerød

Denmark

Tel: +45 48 10 88 10

Email: info@stragen.dk

Manufacturer

MITIM SRL

I-25125 Brescia, Italy

Muhammad Nadeem

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