Cefuroxime Sala 1,500 mg powder for solution for injection and for infusion EFG
SpainTable of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Cefuroxime Sala 1500 mg powder for injectable solution and for infusion EFG
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor, pharmacist, or nurse.
- If you experience any side effects, consult your doctor or nurse, even if they are side effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Cefuroxime Sala is and what it is used for
- What you need to know before using Cefuroxime Sala
- How to use Cefuroxime Sala
- Possible side effects
- How to store Cefuroxime Sala
- Contents of the pack and other information
1. What Cefuroxime Sandoz is and what it is used for
Cefuroxime Sandoz is an antibiotic used in both adults and children. It works by killing the bacteria that cause infections. It belongs to the group of medicines known as cephalosporins.
Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza or the common cold. It is important that you follow your doctor's instructions regarding dosage, administration, and duration of treatment. Do not store or reuse this medicine. If you have any leftover antibiotic after completing the treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste. |
Cefuroxime Sala is used to treat infections of:
- the lungs or chest,
- the urinary tract,
- the skin and soft tissues,
- the abdomen.
Cefuroxime Sala is also used to:
- prevent infections during surgical procedures.
2. What you need to know before starting to use Cefuroxime Sodium
Do not use Cefuroxime:
- if you are allergic (hypersensitive) to cephalosporins or to any of the other components of this medicine (listed in section 6).
- if you have ever had a severe allergic reaction (hypersensitivity) to any other type of beta-lactam antibiotic (penicillins, monobactams, and carbapenems).
- if you have ever developed severe skin rash or peeling skin, blisters and/or mouth ulcers after treatment with cefuroxime or any other cephalosporin antibiotic.
Talk to your doctor before starting treatment with cefuroxime; if you think this may affect you, Cefuroxime Sodium should not be administered.
Warnings and precautions
You should be aware of certain symptoms such as allergic reactions and gastrointestinal disorders, such as diarrhoea, while receiving cefuroxime. This will reduce the risk of possible complications. See (“Symptoms to which you should pay attention”) in section 4. If you have previously had an allergic reaction to other antibiotics, such as penicillin, you may also be allergic to Cefuroxime Sodium.
Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with cefuroxime treatment. Seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.
If you need blood or urine tests
Cefuroxime may affect test results for glucose in blood and urine (Coombs test). If you are having tests:
Inform the person taking the sample that you are receiving cefuroxime.
Using Cefuroxime Sodium with other medicines
Tell your doctor or pharmacist if you are taking any other medicine, if you have recently taken any, or if you might need to take any other medicines.
Some medicines may affect how cefuroxime works, or make it more likely that you will experience adverse effects. These include:
- aminoglycoside antibiotics,
- “medicines used to urinate” (diuretics), such as furosemide,
- probenecid,
- oral anticoagulants.
Consult your doctor if you think this may affect you. You may need additional monitoring to assess kidney function while taking cefuroxime.
Oral contraceptives
Cefuroxime may reduce the effectiveness of oral contraceptives. If you are taking oral contraceptives while being treated with cefuroxime, you should also use barrier contraceptive methods (such as condoms). Ask your doctor for advice.
Pregnancy, breastfeeding and fertility
Inform your doctor before being treated with cefuroxime:
- if you are pregnant, think you may be pregnant, or plan to become pregnant,
- if you are breastfeeding.
Your doctor will assess the benefit of treating you with cefuroxime against the risk to your child.
Driving and use of machines
Do not drive or operate machinery if you do not feel well.
Cefuroxime Sodium contains sodium:
One vial contains 83 mg (3.54 mmol) of sodium, which should be taken into consideration for patients on low-sodium diets.
3. How to use Cefuroxime Salaa
Cefuroxime is normally administered by a doctor or nurse. It may be given by intravenous infusion (drip) or by direct injection into a vein or into a muscle.
Normal dosage
Your doctor will decide the optimal dose of cefuroxime for you, depending on: the severity and type of infection, whether you are being treated with other antibiotics, your weight and age, and how well your kidneys are functioning.
Newborns (0 – 3 weeks)
Per kg of the newborn's body weight, 30 to 100 mg of cefuroxime per day will be administered, divided into two or three doses.
Infants (over 3 weeks) and children
Per kg of the infant's or child's body weight, 30 to 100 mg of cefuroxime per day will be administered, divided into three or four doses.
Adults and adolescents
750 mg to 1,500 mg of cefuroxime per day, divided into two, three, or four doses. The maximum daily dose is 6 g.
Patients with kidney problems
If you have kidney problems, your doctor may adjust your dose. Consult your doctor if you are affected by this condition.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Symptoms to watch for
A small number of people who received cefuroxime have experienced an allergic reaction or a potentially serious skin reaction. Symptoms of these reactions include:
- Severe allergic reaction. Signs include skin rash with itching, swelling, sometimes of the face or mouth, causing difficulty breathing,
- Skin rash, which may cause blisters, appearing like small targets (a dark spot in the center surrounded by a lighter area, with a dark ring around the edge),
- Widespread skin rash, with blisters and peeling skin (These may be symptoms of Stevens-Johnson syndrome or toxic epidermal necrolysis),
- Fungal infections. Rarely, medicines such as cefuroxime can cause overgrowth of fungi (Candida) in the body, leading to fungal infections (such as thrush). This side effect is more likely if you have been treated with cefuroxime for a prolonged period.
- Generalized rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
- Chest pain in the context of allergic reactions, which may be a symptom of an allergic-triggered heart attack (Kounis syndrome).
Contact a doctor or nurse immediately if you experience any of these symptoms.
Frequent adverse effects
May affect up to 1 in 10 people:
- Pain at the injection site, swelling and redness along the vein.
Contact your doctor if you experience any of these symptoms.
Frequent adverse effects that may appear in blood tests:
- Increase in certain substances (enzymes) produced by the liver,
- Changes in white blood cell count (neutropenia or eosinophilia),
- Low levels of red blood cells (anemia).
Uncommon adverse effects
May affect up to 1 in 100 people:
- Skin rash, itching, hives (wheals),
- Diarrhea, nausea, stomach pain.
Contact your doctor if you experience any of these symptoms.
Uncommon adverse effects that may appear in blood tests:
- Low levels of white blood cells (leukopenia),
- Increased bilirubin (a substance produced by the liver),
- Positive Coombs test.
Other adverse effects
Other adverse effects have occurred in a very small number of people, but their exact frequency is unknown:
- Fungal infections,
- High temperature (fever),
- Allergic reactions,
- Inflammation of the colon (large intestine), causing diarrhea, usually with blood and mucus,
- Stomach pain,
- Inflammation in the kidneys and blood vessels,
- Rapid destruction of red blood cells (hemolytic anemia),
- Skin rash, which may cause blisters, appearing like small targets (a dark spot in the center surrounded by a lighter area, with a dark ring around the edge) erythema multiforme.
Contact your doctor if you experience any of these symptoms.
Adverse effects that may appear in blood tests:
- Decrease in the number of blood platelets (cells that help blood to clot – thrombocytopenia),
- Increased levels of blood urea nitrogen and serum creatinine in the blood.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Cefuroxime Sandoz
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.
The expiry date refers to the last day of the month indicated.
Store below 25°C.
Keep the vial in the outer packaging to protect from light.
For storage conditions of the reconstituted/diluted powder, see “INFORMATION FOR HEALTHCARE PROFESSIONALS” at the end of the leaflet.
Medicines should not be disposed of via wastewater or household waste. The doctor or nurse will dispose of any unused medicine. This helps to protect the environment.
6. Contents of the pack and other information
Composition of Cefuroxima Sala:
The active substance is cefuroxime sodium. It contains no excipients.
Each 1500 mg vial contains 1604.27 mg of cefuroxime sodium equivalent to 1500 mg of cefuroxime.
Appearance of Cefuroxima Sala and contents of the container
Cefuroxime sodium is a white or almost white powder.
It is presented in 20 ml transparent type II glass vials, closed with a grey bromobutyl or chlorobutyl rubber stopper and sealed with a "flip-off" cap.
Packaging: 1 vial and clinical pack of 50 vials.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Laboratorio Reig Jofré, S.A.
Gran Capitán 10, 08970 Sant Joan Despí
Barcelona (Spain)
Manufacturer
Laboratorio Reig Jofre, S.A.
C/ Jarama 111
Toledo 45007 Spain
Date of the most recent review of this summary: April 2025
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/
INFORMATION FOR HEALTHCARE PROFESSIONALS
Reconstitution instructions
For single use only. Any unused solution must be discarded.
Intravenous use
Dissolve in Water for Injections using at least 15 ml for 1,500 mg cefuroxime. Gently shake to obtain a clear solution. For short intravenous infusions (e.g., up to 30 minutes), 1,500 mg cefuroxime may be dissolved in 15 ml of Water for Injections, and the reconstituted cefuroxime sodium solution added to 50 or 100 ml of any compatible infusion solution (see "Compatibility" below).
Table: Volumes of diluent and concentrations of solution, which may be useful when fractional doses are required
Volume of diluent and concentrations of the solution, which may be useful when fractionated doses are required | |||
Vial size | Amount of water for injection to be added (ml) | Approximate concentration of cefuroxime (mg/ml)** | |
1,500 mg powder for injectable solution and for infusion | |||
1,500 mg | intravenous bolus intravenous infusion | at least 15 ml 15 ml* | 94 94 |
- Reconstituted solution to be added to 50 or 100 ml of compatible infusion fluid (see “Compatibility”)
** The resulting volume of the cefuroxime solution in the reconstitution medium is increased by the displacement factor of the drug at the concentrations listed in mg/ml.
Compatibility
Sodium cefuroxime is compatible with the following infusion fluids:
Sodium chloride 9 mg/ml (0.9%) solution for injection
Glucose 50 mg/ml (5%) solution for injection
0.18% Sodium chloride plus 4% Glucose solution for injection
5% Glucose and 0.9% Sodium chloride solution for injection
5% Glucose and 0.45% Sodium chloride solution for injection
5% Glucose and 0.225% Sodium chloride solution for injection
10% Glucose solution for injection
10% Invert sugar in Water for Injections
Ringer's injection
Ringer lactate injection
Sodium lactate 1/6 molar solution for injection
Compound sodium lactate solution for injection (Hartmann's solution)
Sodium cefuroxime is compatible with aqueous solutions containing up to 1% lidocaine hydrochloride.
The stability of sodium cefuroxime in 0.9% w/v sodium chloride solution for injection and in 5% glucose solution for injection is not affected by the presence of sodium phosphate hydrocortisone.
Sodium cefuroxime has also been found to be compatible for 24 hours at room temperature when mixed for intravenous infusion with:
Heparin (10 and 50 units/ml) in 0.9% injectable sodium chloride; potassium chloride (10 and 40 mEq/L) in sodium chloride 9 mg/ml (0.9%) solution for injection.
Storage of injectable cefuroxime:
Store below 25°C.
Keep the vial in the outer packaging to protect from light.
Reconstituted solution: From a microbiological standpoint, once opened, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should normally not exceed 8 hours below 25°C and 48 hours in a refrigerator (between 2°C and 8°C), unless reconstitution has been carried out under controlled and validated conditions.
Incompatibilities
Solutions containing cefuroxime must not be mixed with or added to solutions containing other products not previously mentioned (see “Compatibility”).
Cefuroxime powder for injectable solution must not be mixed in the same syringe with aminoglycoside antibiotics.
The pH of 2.74% w/v sodium bicarbonate injection considerably affects the colour of solutions and therefore this solution is not recommended for the dilution of cefuroxime powder for injectable solution. However, if necessary, in patients receiving intravenous sodium bicarbonate infusion, cefuroxime powder for injectable solution may be administered via the administration set side port.