CEFUROXIME NORMON 1500 mg POWDER FOR INJECTION AND INFUSION SOLUTION

2. What you need to know before you use Cefuroxima Normon

Do not use Cefuroxima Normon:

• If you are allergic (hypersensitive)to cephalosporinsor to any of the other ingredients 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 skin peeling, blisters, and/or ulcers in the mouth after treatment with cefuroxime or any other cephalosporin antibiotic.

Be careful with Cefuroxima Normon

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 medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Consult your doctor beforestarting treatment with cefuroxime; if you think this may affect you, you should not be given this medicine.

Warnings and precautions

You should be aware of certain symptoms such as allergic reactions and gastrointestinal disorders, such as diarrhea, while receiving cefuroxime. This will reduce the risk of possible complications. See (“Symptoms 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 cefuroxime.

If you need a blood or urine test

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

Tell the person taking the samplethat you are taking cefuroxime.

Using Cefuroxima Normon with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

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

• aminoglycoside antibiotics,
• “water pills” (diuretics), such as furosemide,
• probenecid,
• oral anticoagulants.

Consult your doctorif you think this may affect you. You may need additional checks to monitor kidney function while taking cefuroxime.

Contraceptive pill

Cefuroxime may reduce the effectiveness of the contraceptive pill. If you are taking the contraceptive pill while being treated with cefuroxime, you should also use barrier contraceptive methods(such as condoms). Ask your doctor for advice.

Pregnancy, breastfeeding, and fertility

Tell 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 being treated with cefuroxime against the risk to your child.

Driving and using machines

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

Cefuroxima Normon contains sodium:

This medicine contains 84 mg of sodium (main component of cooking/table salt) per vial. This is equivalent to 4.2% of the maximum recommended daily sodium intake for an adult.

3. How to use Cefuroxima Normon

Cefuroxime is usually administered by a doctor or nurse. It can be administered by drip (intravenous infusion) or by injection directly into a vein or muscle.

The normal dose

Your doctor will decide what dose of cefuroxime is best 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 working.

Newborns (0 - 3 weeks)

For every kg of the newborn's weight, they will be given 30 to 100 mg of cefuroxime per day, divided into two or three doses.

Infants (over 3 weeks) and children

For every kg of the baby's or child's weight, they will be given 30 to 100 mg of cefuroxime per day, divided into three or four doses.

Adults and adolescents

750 mg to 1,500 mg of cefuroxime sodium two, three, or four times a day.

Patients with kidney problems

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Symptoms to be aware of

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

• Widespread rash, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).
• Chest pain in the context of allergic reactions, which can be a symptom of allergy-induced heart attack (Kounis syndrome).

• Severe allergic reaction. The signs include skin rash with itching, swelling, sometimes of the face or mouth, causing difficulty breathing,
• Skin rash,which can cause blisters,that look like small targets(dark spot in the center surrounded by a lighter area, with a dark ring around the edge),
• Widespread skin rash,with blisters and skin peeling.(These can be symptoms of Stevens-Johnson syndromeor toxic epidermal necrolysis),
• Fungal infectionsin rare cases, medicines like cefuroxime can cause an overgrowth of fungi (Candida) in the body, which can lead to fungal infections (such as thrush). This side effect is more likely to occur if you have been treated with cefuroxime for a long time.

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

Common side effects

May affect up to 1 in 10 people:

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

Contact your doctorif you suffer from any of these symptoms.

Common side effects that may appear in blood tests:

• increase in some substances (enzymes) produced by the liver,
• changes in white blood cell count (neutropeniaor eosinophilia),
• low levels of red blood cells (anemia).

Uncommon side effects

May affect up to 1 in 100 people:

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

Contact your doctorif you suffer from any of these symptoms.

Uncommon side effects that may appear in blood tests:

• low levels of white blood cells (leukopenia),
• increase in 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,
• 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 can cause blisters, that look 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 suffer from any of these symptoms.

Side effects that may appear in blood tests:

• decrease in the number of platelets in the blood (cells that help blood to clot – thrombocytopenia),
• increase in urea and creatinine levels in the blood.

Reporting of side effects

If you experience 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 via the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https//www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Cefuroxima Normon

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 shown.

Store below 25 ºC.

Keep the vial in the outer packaging to protect it from light.

For the 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. Ask your doctor or nurse to dispose of any unused medicine.

6. Contents of the pack and other information

Composition of Cefuroxima Normon:

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

Each 1.500 mg vial contains 1.626 mg of cefuroxime sodium equivalent to 1.500 mg of cefuroxime.

Appearance of Cefuroxima Normon and contents of the pack

Cefuroxime sodium is a white or almost white powder.

It is presented in 20 ml capacity colorless glass type II vials, closed with a gray chlorobutyl rubber stopper and sealed with a “flip-off” cap.

Pack of 1 vial.

Pack of 50 vials (clinical pack).

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of last revision of this leaflet:July 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Medicines and Healthcare Products Agency (AEMPS) http://www.aemps.gob.es/.

You can access detailed and up-to-date information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone.

You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/62907/P_62907.html.

INFORMATION FOR HEALTHCARE PROFESSIONALS

Instructions for reconstitution

For single use. Discard unused solution.

Intravenous use

Dissolve in water for injections using at least 15 ml for cefuroxime 1,500 mg. Shake gently to obtain a clear solution. For short intravenous infusions (e.g., up to 30 minutes), cefuroxime 1,500 mg may be dissolved with 15 ml of water for injections, adding the reconstituted cefuroxime sodium solution to 50 or 100 ml of any compatible infusion solution (see “Compatibility” below).

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

• 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 drug displacement factor resulting in the listed concentrations in mg/ml.

Compatibility

Cefuroxime sodium 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
• Sodium chloride 0.18% + Glucose 4% solution for injection
• Glucose 5% + Sodium chloride 0.9% solution for injection
• Glucose 5% + Sodium chloride 0.45% solution for injection
• Glucose 5% + Sodium chloride 0.225% solution for injection
• Glucose 10% solution for injection
• Invert sugar 10% in water for injections
• Ringer's injection
• Ringer's lactate injection
• Sodium lactate 1/6 molar solution for injection
• Sodium lactate compound solution for injection (Hartmann's solution)

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

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

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

Conservation of cefuroxime injectable:

Store below 25 ºC.

Keep the vial in the outer packaging to protect it from light.

Reconstituted solution: From a microbiological point of view, the product should be used immediately after opening. If not used immediately, the in-use storage times and conditions are the responsibility of the user and normally should not exceed 25 ºC protected from light, unless the reconstitution has been carried out under controlled and validated conditions.

Incompatibilities

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

Cefuroxime powder for solution 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 therefore, this solution is not recommended for the dilution of cefuroxime powder for solution for injection. However, if necessary, in patients receiving sodium bicarbonate injection by infusion, cefuroxime powder for solution for injection may be introduced into the infusion set.