Label: Information for the User

Cefuroxime Sodium 1500 mg Powder for Injection and for Infusion EFG

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this label. See section 4.

Cefuroxima Sala is an antibiotic used in both adults and children. It works by eliminating the bacteria that cause infections. It belongs to the group of medications known as cephalosporins .

Cefuroxima Sala is used to treat infections of:

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

Cefuroxima Sala is also used to:

• prevent infections during surgical procedures.

Do not use Cefuroxima:

• if you are allergic (hypersensitive) to cephalosporinsor to any of the other components of this medication (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, blisters, and/or mouth ulcers after treatment with cefuroxima or any other cephalosporin antibiotic.

Consult your doctor beforestarting treatment with cefuroxima; if you consider this may affect you, Cefuroxima Tablet should not be administered to you.

Warnings and precautions

You should be aware of certain symptoms such as allergic reactions and gastrointestinal disturbances, such as diarrhea, while receiving cefuroxima. This will reduce the risk of possible complications. See (“Symptoms to be aware of”) in section 4. If you have had any allergic reaction to other antibiotics, such as penicillin, you may also be allergic to Cefuroxima Tablet.

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported associated with cefuroxima treatment. Seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

If you need blood or urine tests

Cefuroxima may affect the results in the determination of sugar in urine and blood tests (Coombs test). If you are undergoing tests:

Inform the person taking the samplethat you are receiving cefuroxima.

Use of Cefuroxima Tablet with other medications

Inform your doctor or pharmacist if you are taking another medication, if you have taken recently or may have to take any other medication.

Some medications may affect the way cefuroxima acts, or make it more likely that you may have adverse effects. These include:

• aminoglycoside antibiotics,
• “urine-voiding” medications (diuretics), such as furosemide,
• probencid,
• oral anticoagulants.

Consult your doctorif you think this may affect you. You may need additional reviews to monitor renal function while taking cefuroxima.

Birth control pill

Cefuroxima may reduce the effectiveness of the birth control pill. If you are taking the birth control pill while being treated with cefuroxima, you should use additional barrier methods (such as condoms). Ask your doctor for advice.

Pregnancy, breastfeeding, and fertility

Inform your doctor before being treated with cefuroxima:

• if you are pregnant, think you may be pregnant, or intend to become pregnant,
• if you are breastfeeding.

Your doctor will assess the benefit of being treated with cefuroxima against the risk to your child.

Driving and operating machinery

Do not drive or operate machinery if you are not feeling well.

Cefuroxima Tablet contains sodium:

A vial contains 83 mg (3.54 mmol) of sodium, which should be taken into account in patients with low-sodium diets.

Cefuroxima is usually administered by a doctor or nurse. It can be administered through infusion (intravenous perfusion) or through direct injection into a vein or muscle.

Normal Dose

Your doctor will decide on the optimal dose of cefuroxima for you, based on: the severity and type of infection, if you are being treated with other antibiotics, your weight and age, and how well your kidneys are functioning.

Newborns (0 - 3 weeks)

For each kilogram of the newborn's weight, 30 to 100 mg of cefuroxima will be administered per day, divided into two or three doses.

Infants (over 3 weeks) and children

For each kilogram of the baby's or child's weight, 30 to 100 mg of cefuroxima will be administered per day, divided into three or four doses.

Adults and adolescents

750 mg to 1,500 mg of cefuroxima per day, divided into two, three, or four doses. The maximum dose is 6 g per day.

Patients with kidney problems

If you have a kidney problem, your doctor may adjust your dose.Consult with your doctorif you are affected by this problem.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Symptoms to be aware of

A small number of people who received cefuroxime presented an allergic reaction or a potentially severe skin reaction. The symptoms of these reactions include:

• Severe allergic reaction. The signs includeskin rash with itching, swelling, sometimes on the face or mouth, causingdifficulty breathing,
• skin rash,which may causeblistering,which appear likesmall targets(dark spot in the center surrounded by a lighter area, with a dark ring around the edge),
• Widespread skin rash,withblistering and skin peeling.(These may be symptoms ofStevens-Johnson Syndromeortoxic epidermal necrolysis),
• Fungal infectionsin rare cases, medicines like cefuroxime can cause an overgrowth of fungi (Candida) in the body that may lead to fungal infections (such as mouth ulcers). This side effect is more likely to occur if you have been treated with cefuroxime for a prolonged period.
• Generalized rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Chest pain in the context of allergic reactions, which may be a symptom of an allergic-induced heart attack (Kounis syndrome).

Contact a doctor or nurse immediately if you experience any of these symptoms.

Common side effects

May affectup to 1 in 10 people:

• Pain, swelling, and redness along the vein at the injection site.

Contact your doctorif you experience any of these symptoms.

Common side effects that may appear in blood tests:

• Increased levels of certain substances (enzymes) produced by the liver,
• Changes in white blood cell count (neutropeniaoreosinophilia),
• Low levels of red blood cells (anemia).

Uncommon side effects

May affectup to 1 in 100 people:

• skin rash, itching, hives (urticaria),
• diarrhea, nausea, stomach pain.

Contact your doctorif you experience any of these symptoms.

Uncommon side effects that may appear in blood tests:

• Low levels of white blood cells (leucopenia),
• Increased levels of bilirubin (a substance produced by the liver),
• Positive Coombs test.

Other side effects

Other side effects have occurred in a very small number of people, but their exact frequency is unknown:

• Fungal infections,
• High temperature (fever),
• Allergic reactions,
• Colitis (inflammation of the 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 blistering, which appear like small targets (dark spot in the center surrounded by a lighter area, with a dark ring around the edge)erythema multiforme.

Contact your doctorif you experience any of these symptoms.

Side effects that may appear in blood tests:

• Decreased platelet count in the blood (cells that help blood to clot –thrombocytopenia),
• Increased levels of urea nitrogen and creatinine in the blood.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https//www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box after CAD.

The expiration date is the last day of the month indicated.

Store below 25°C.

Store the vial in the outer packaging to protect from light.

For storage conditions of the reconstituted/diluted powder see “INFORMATION FOR THE HEALTHCARE PROFESSIONAL” at the end of the leaflet.

Medicines should not be disposed of via the drains or in the waste. The doctor or nurse will dispose of the medication that is no longer needed. This will help protect the environment.

Composition of Cefuroxime Sodium:

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

Each vial of 1500 mg contains 1604.27 mg of cefuroxime sodium equivalent to 1500 mg of cefuroxime.

Appearance of Cefuroxime Sodium and packaging contents

Cefuroxime sodium is a white or almost white powder.

It is presented in transparent type II glass vials of 20ml capacity, closed with a grey bromobutyl rubber stopper and sealed with a "flip-off" capsule.

Packaging of 1 vial and clinical packaging of 50 vials.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Reig Jofré, S.A. Laboratory

Gran Capitán 10, 08970 Sant Joan Despí

Barcelona (Spain)

Responsible manufacturer

Reig Jofré, S.A. Laboratory

C/ Jarama 111

Toledo 45007 Spain

Last review date of this leaflet:May 2023

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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INFORMATION FOR THE HEALTHCARE PROFESSIONAL

Instructions for reconstitution

For single use. Discard unused solution.

Intravenous use

Dissolve in water for injection preparations using at least 15 ml for cefuroxime 1,500 mg. Gently shake to obtain a transparent solution. For intravenous infusions of up to 30 minutes, cefuroxime 1,500 mg may be dissolved with 15 ml of water for injection preparations, adding the reconstituted cefuroxime sodium solution to 50 or 100 ml of any compatible infusion solution (see "Compatibility" below).

Table of volumes of addition and concentrations of the solution, which may be useful when fractional doses are required

* Reconstituted solution to be added to 50 or 100 ml of compatible infusion solution (see "Compatibility")

** The resulting volume of the cefuroxime solution in the reconstitution medium is increased by the displacement factor of the resulting drug in the listed concentrations in mg/ml.

Compatibility

Cefuroxime sodium is compatible with the following infusion solutions:

Sodium chloride 9 mg/ml (0.9%) injection solution

Glucose 50 mg/ml (5%) injection solution

Sodium chloride 0.18% + glucose 4% injection solution

Glucose 5% and sodium chloride 0.9% injection solution

Glucose 5% and sodium chloride 0.45% injection solution

Glucose 5% and sodium chloride 0.225% injection solution

Glucose 10% injection solution

Invert sugar 10% in water for injection

Ringer's injection

Ringer lactate injection

Sodium lactate 1/6 molar injection solution

Sodium lactate compound injection solution (Hartmann's solution)

Cefuroxime sodium is also compatible with aqueous solutions containing up to 1% lidocaine hydrochloride.

The stability of cefuroxime sodium in sodium chloride 0.9% injection solution and glucose 5% injection solution is not affected by the presence of hydrocortisone phosphate sodium.

It has been observed that cefuroxime sodium is also compatible for 24 hours at room temperature when mixed for intravenous infusion with:

Heparin (10 and 50 units/ml) in sodium chloride injection 0.9%; potassium chloride (10 and 40 mEq/L) in sodium chloride 9 mg/ml (0.9%) injection solution.

Storage of cefuroxime injectable:

Store below 25°C.

Store the vial in the outer packaging to protect it from light

Reconstituted solution: From a microbiological point of view, once opened, the product should be used immediately. If not used immediately, the storage times in use and the conditions prior to use are the responsibility of the user and should not normally exceed 8 hours below 25°C and 48 hours in the refrigerator (between 2°C and 8°C), unless the reconstitution was performed in controlled and validated conditions.

Incompatibilities

Solutions containing cefuroxime should not be mixed with or added to solutions containing other products that are not mentioned above (see "Compatibility").

Cefuroxime powder for injection should not be mixed in the same syringe with aminoglycoside antibiotics.

The pH of sodium bicarbonate injection 2.74% p/v significantly affects the color of the solutions and is therefore not recommended for the dilution of cefuroxime powder for injection. However, if necessary, in patients receiving sodium bicarbonate injection, cefuroxime powder for injection may be introduced into the administration equipment's catheter.