Cefuroxime Sala 750 mg powder for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Cefuroxime Sala 750 mg powder for injectable solution 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 adverse reactions, talk to your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Leaflet contents:

1. What Cefuroxime Sala is and what it is used for
2. What you need to know before using Cefuroxime Sala
3. How to use Cefuroxime Sala
4. Possible side effects
5. How to store Cefuroxime Sala
6. 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.

Cefuroxime Sandoz is used to treat infections of:

• the lungs or chest,
• the urinary tract,
• the skin and soft tissues,
• the abdomen.

Cefuroxime Sandoz is also used to:

• prevent infections during surgical procedures.

2. What you need to know before starting to use Cefuroxime Sal

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 a severe skin rash or peeling of the 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 Sal 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 potential 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 Sal.

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 your sample that you are receiving cefuroxime.

Using Cefuroxime Sal with other medicines

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

Some medicines may affect how cefuroxime works, or make it more likely that you may have adverse effects. These include:

• aminoglycoside antibiotics,
• "medicines used to increase urination" (diuretics), such as furosemide,
• probenecid,
• oral anticoagulants.

Talk to 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 weigh the benefits of treatment with cefuroxime against the potential risks to your child.

Driving and using machines

Do not drive or operate machinery if you do not feel well.

Cefuroxime Sal contains sodium:

One vial contains 42 mg (1.77 mmol) of sodium, which should be taken into account in patients on low-sodium diets.

3. How to use Cefuroxime Sodium

Cefuroxime is normally administered by a doctor or nurse. It can be given by injection directly into a vein or into a muscle.

Normal dose

Your doctor will decide the optimal dose of cefuroxime for you, based 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 given, 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 given, 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 may cause adverse effects, although not everyone experiences 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, possibly causing blisters, which look 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 may 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 a heart attack triggered by allergy (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 of the kidneys and blood vessels,
• Rapid destruction of red blood cells (hemolytic anemia),
• Skin rash, possibly causing blisters, which look 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 it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: 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 powder, see "INFORMATION FOR HEALTHCARE PROFESSIONALS" at the end of the leaflet.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cefuroxima Sala:

The active substance is cefuroxime sodium. It does not contain excipients.

Each 750 mg vial contains 802.13 mg of cefuroxime sodium equivalent to 750 mg of cefuroxime.

Appearance of Cefuroxima Sala and contents of the pack

Cefuroxime sodium is a white or pale yellow powder.

It is supplied in 10 ml clear type II glass vials, closed with a grey bromobutyl or chlorobutyl rubber stopper and sealed with a "flip-off" cap.

Pack size: 1 vial and hospital pack of 100 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 Jofré, 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 of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

INFORMATION FOR HEALTHCARE PROFESSIONALS

Reconstitution instructions

For single use only. Any unused solution should be discarded.

Intramuscular use

Add 3 ml of Water for Injections to 750 mg cefuroxime powder for injectable solution (see Table “Volumes to be added and concentrations of the solution, which may be useful when fractional doses are required”).

Gently shake to obtain an opaque suspension.

Intravenous use

Dissolve in Water for Injections using at least 6 ml for 750 mg cefuroxime. Gently shake to obtain a clear solution.

Table: Volumes to be added and concentrations of the solution, which may be useful when fractional doses are required.

** The resulting volume of the cefuroxime solution in the reconstitution medium increases by the drug displacement factor resulting in 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's 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% 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 normally should not exceed 5 hours below 25°C and 24 hours under refrigeration (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% p/v sodium bicarbonate injection considerably affects the color of solutions and therefore this solution is not recommended for 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.