0.5 g, 1 g, and 2 g powder for injection and infusion solution
Cefotaxime (as cefotaximnatrium)
1. What Cefotaxim Stragen is and what it is used for
Cefotaxime Stragen is an antibiotic that belongs to the group of drugs cephalosporins. Cefotaxime Stragen has a bactericidal effect. You use Cefotaxime Stragen for severe infections caused by bacteria that are sensitive to cefotaxime such as:
- Bacterial pneumonia
- Severe kidney and upper urinary tract infections
- Severe infection in the skin and soft tissues
- Infection is in the abdomen (including the peritoneum)
- Acute bacterial meningitis
- Blood poisoning
Cefotaxime Stragen may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
2. What you need to know before using Cefotaxim Stragen
Do not use Cefotaxim Stragen
- if you are allergic to cefotaxime or cephalosporins.
Warnings and cautions
Talk to your doctor or nurse before using Cefotaxim Stragen:
- if you have previously reacted with a severe allergic reaction to treatment with penicillin. If you have any other allergies, tell your doctor or nurse before using this medicine.
- if you have a predisposition to allergies or asthma. If you have a predisposition to allergies or asthma, tell your doctor before using this medicine.
- if you get skin and/or mucous membrane reactions after treatment. If you have such reactions, tell your doctor or nurse before continuing treatment.
- It is especially important that you inform your doctor if you suffer from severe persistent diarrhea during or shortly after treatment with Cefotaxime Stragen, as this can be a serious, even life-threatening complication that requires immediate treatment. Do not take any medicine to treat diarrhea without first contacting your doctor.
- if you are treated for more than 7 days, your blood counts should be checked
- If you have impaired kidney function, the dosage must be adjusted and caution should be exercised if you are using aminoglycosides , probenecid (medicines for gout ), or other medicines that impair kidney function.
- if your consciousness is affected, abnormal movements and/or cramps, inform your doctor before continuing treatment
- If you have been prescribed a diet low in salt, you should be aware that the product contains sodium:
- Cefotaxime Stragen 0.5 g powder for solution for injection: This medicine contains 25.3 mg sodium (the main ingredient in table salt/table salt) in each vial. This corresponds to 1.3% of the highest recommended daily intake of sodium for adults.
- Cefotaxime Stragen 1 g powder for solution for injection and infusion: This medicine contains 50.6 mg of sodium (the main ingredient in common salt/table salt) in each vial. This corresponds to 2.5% of the highest recommended daily intake of sodium for adults.
- Cefotaxime Stragen 2 g powder for solution for injection and infusion: This medicine contains 101.2 mg sodium (the main ingredient in common salt/table salt) in each vial. This corresponds to 5.1% of the highest recommended daily intake of sodium for adults.
Blood tests
Always tell Cefotaxim Stragen during your blood test and urine test. This can have an effect on the test results.
Other medicines and Cefotaxim Stragen
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, medicines bought abroad, herbal medicines, strong vitamins, and minerals as well as dietary supplements.
If you are taking any of the following medicines at the same time, take special care:
- high dose er Cefotaxim Stragen and drugs such as aminoglycosides or diuretics such as furosemide.
- Cefotaxime Stragen and antibacterial drugs such as tetracyclines, erythromycin, or chloramphenicol.
- Cefotaxime Stragen and probenecid (medicines for gout ), if you have impaired kidney function
Pregnancy and breastfeeding
Pregnancy:
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 taking this medicine.
Normally you will not be treated with Cefotaxim Stragen if you are pregnant. Your doctor will make an individual assessment.
Breast-feeding:
Your doctor will assess whether you can breast-feed.
Driving and using machines
High doses of Cefotaxime Stragen may cause side effects (eg dizziness, cramps, and fatigue). Do not drive or use machines unless you are sure you are unaffected.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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.
How to use Cefotaxime Stragen
Your doctor or nurse will inform you about how the medicine is dosed and when you should receive it. The recommended dose is determined by your doctor.
Usual dose
Dose one is determined individually for each patient and depends on your illness.
Cefotaxime Stragen is given as an injection. It will normally be a doctor or nurse who gives the injection one.
If you forget to use Cefotaxime Stragen
Ask your doctor or pharmacist if you think you may have missed a dose.
If the treatment lasts for more than 7 days
Your blood counts should be checked.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common side effect is (may affect more than 1 in 10):
- Injection site pain (after muscle injection )
Common side effects are (may affect up to 1 in 10):
- Cod
- Fever
- Stomach problems such as nausea, vomiting, abdominal pain, and diarrhea. Talk to your doctor immediately.
- Change in certain laboratory values (increase in kidney values) that normalize when treatment is stopped
- Inflammation at the injection site, including phlebitis/thrombophlebitis
Less common side effects are (may affect up to 1 in 100):
- Changes in the blood, including decreases in white blood cell count ( leukopenia ), increase in certain white blood cells ( eosinophilia ), decreased platelet count ( thrombocytopenia )
- Reactions such as chills, fever, malaise, muscle pain, and worsening of skin problems may occur with syphilis treatment (Jarisch-Herxheimer reaction)
- Cramps
- Loss of appetite
- Change in certain laboratory values (increase in liver values) that normalize when treatment is stopped
- Rash, itching, and hives
Rare side effects are (may affect up to 1 in 1000 users)
- Long-term treatment can result in the strong growth of resistant bacteria
- Alteration of certain blood levels, including a severe decrease in certain white blood cells ( agranulocytosis ), and a decrease in red blood cells (hemolytic anemia ).
- Brain problems can occur at high doses. The symptoms can affect consciousness and cause abnormal movements. Talk to your doctor.
- Dizziness and fatigue after administration of high doses.
Very rare side effects are (may affect up to 1 in 10 000 users)
- Colon infection (pseudomembranous colitis )
- Acute nephritis
No known frequency (cannot be calculated from the available data);
- Severe allergic reactions that cause difficulty breathing, wheezing or dizziness, swelling of the face or throat, rash with blisters, and shock. Talk to your doctor immediately.
- Headache
- Irregular heartbeats
- Hepatitis (sometimes with yellowing of the skin (jaundice))
- Severe skin reactions such as rash with blistering.
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 Cefotaxim Stragen
Keep this medicine out of the sight and reach of children.
Store in the original package. Sensitive to light.
Do not use this medicine after the expiry date which is stated on the carton after EX. The expiration date is the last day of the specified month.
Prepared solution: For storage instructions for a prepared solution, see “The following information is intended for medical or healthcare professionals only”.
6. Contents of the packaging and other information
Content declaration
- The active substance is 0.5 g, 1 g, and 2 g cefotaxime respectively (as cefotaxime sodium) per vial
There are no other ingredients
What the medicine looks like and the contents of the pack
Cefotaxime Stragen is a crystalline, white to pale yellow powder.
- 0.5 g: Carton of 10 vials
- 1 g: Carton of 10 vials
- 2 g: Carton of 10 vials
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Stragen Nordic A / S
Helsingørsgade 8C, 3400 Hillerød, Denmark
Tel 48 10 8810
e-mail: info@stragen.dk
Manufacturer
MITIM SRL
Via Cacciamali 34-38, I-25125 Brescia, Italy