750 mg and 1.5 g powder for solution for injection or infusion.
Cefuroxime
1. What Cefuroxime Stragen is and what it is used for
Cefuroxime Stragen is an antibiotic used in adults and children. It works by killing bacteria that cause infection. It belongs to a group of drugs called cephalosporin you.
Cefuroxime Stragen is used to treat infections in:
- the lungs or chest
- the urinary tract
- the skin and the soft parts
- buken
Cefuroxime Stragen is also used:
- to prevent infection during surgery.
What you need to know before you are given Cefuroxime Stragen
You must not be given Cefuroxime Stragen
- if you are allergic to any antibiotic-containing cephalosporins or any of the other ingredients of this medicine (listed in section 6).
- if you have ever had an allergic reaction to any other type of beta-lactam antibiotic ( penicillins , monobactams and carbapenems).
Talk to your doctor before starting Cefuroxim Stragen if you think this is true for you. You must not be given Cefuroxime Stragen.
Take special care with Cefuroxim Stragen:
You need to be aware of certain symptoms such as allergic reactions or disorders of the gastrointestinal tract such as diarrhea when you are given Cefuroxime Stragen. 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 Stragen.
If you need to have a blood or urine test
Cefuroxime Stragen may affect the results of urine or blood tests for sugar and a blood test called the Coombs test.
If you are going to undergo tests, tell the person taking the test that you have received Cefuroxim Stragen.
Other medicines and Cefuroxime Stragen
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Some medicines can affect Cefuroxim Stragen 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 Stragen.
Pregnancy, breastfeeding and fertility
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. Your doctor will consider the benefit of treating you with Cefuroxim Stragen 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.
Important information about some of the ingredients of Cefuroxime Stragen
Cefuroxime Stragen 750 mg powder for solution for injection contains 41 mg sodium(the main ingredient in table salt/table salt) per vial. This corresponds to 2% of the highest recommended daily intake of sodium for adults.
Cefuroxime Stragen 1.5 g powder for solution for injection contains 81 mg sodium(the main ingredient in table salt / table salt) per vial . This corresponds to 4% of the highest recommended daily intake of sodium for adults.
3. How Cefuroxime Stragen is given
Cefuroxime Stragen 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 Stragen 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 baby weighs, 30 to 100 mg of Cefuroxime Stragen is given per day divided into two or three doses .
Infants (over 3 weeks) and children
For every kg the baby weighs, 30 to 100 mg of Cefuroxime Stragen is given per day divided into three or four doses.
Adults and adolescents
750 mg to 1.5 g Cefuroxime Stragen per day divided into two, three, or four doses. Maximum dose: 6 g per day.
Patients with kidney problems
If you have kidney problems, your doctor may change your dose .
If you take more Cefuroxime Stragen than you should
Contact your doctor or healthcare professional if you think you have received too much Cefuroxim Stragen
If a dose of Cefuroxime Stragen has been missed
Ask your doctor or healthcare professional if you think a dose has been missed.
If you have any further questions on the use of this product, ask your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects , although not everybody gets them.
Conditions you need to be aware of
A small number of people taking Cefuroxim Stragen 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 ).
- fungal infections. In rare cases, medicines such as Cefuroxim Stragen can cause an overgrowth of yeast ( Candida ) in the body which can lead to a fungal infection (eg cod). This side effect is more likely if you take Cefuroxime Stragen for a long time.
Contact a doctor or nurse immediately if you experience any of these symptoms.
Common side effects are ( may affect up to 1 in 10 people)
- injection site pain, swelling and redness along a vein
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 ).
Less common side effects are (may affect up to 1 in 100 people)
- skin rash, itchy raised rash ( hives )
- diarrhea, nausea, abdominal pain
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.
No known frequency (cannot be calculated from the available data)
- fungal infection
- 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 ).
Side effects that may occur 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.
If you get any side effects, talk to your doctor or nurse. This also applies to any side effects not mentioned in this information.
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 Stragen
Do not store above 25 ° C.
Keep the vials in the outer carton, as the medicine is sensitive to light.
Prepared solution: Chemical and physical in-use stability has been demonstrated for 24 hours at 2-8 ° C.
From a microbiological point of view, the product should be used immediately.
If not used immediately, in-use storage times and conditions prior to administration are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 ºC, unless the solution is prepared under controlled and validated aseptic conditions.
Do not use this medicine after the expiry date which is stated on the carton after EXP. That. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The doctor or nurse discards any drug residues. These measures help to protect the environment.
6. Contents of the packaging and other information
Content declaration
The active substance is cefuroxime (as cefuroxime sodium)
Other ingredients are missing
What the medicine looks like and contents of the pack
Cefuroxime Stragen is a white to off-white powder.
Cefuroxime Stragen is packaged in cartons of vials. Each carton contains 10 vials.
Marketing Authorization Holder and Manufacturer
Stragen Nordic A / S
Helsingørsgade 8C, 3400 Hillerød
Denmark
Tel .: +45 48 10 88 10
E-mail: info@stragen.dk
Manufacturer:
MITIM, SRL
Via Cacciamali 34- 38, I-23125 Brescia, Italy
This medicinal product is authorized under the European Economic Area under the names:
| Denmark, Finland, : | Cefuroxime Stragen |