Cefuroxime Normon 250 mg powder and solvent for injection solution EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Cefuroxime Normon 250 mg powder and solvent 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, consult your doctor, pharmacist, or nurse.
- If you experience any adverse reactions, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.
Leaflet Contents:
- What Cefuroxime Normon is and what it is used for
- What you need to know before using Cefuroxime Normon
- How to use Cefuroxime Normon
- Possible side effects
- How to store Cefuroxime Normon
- Contents of the pack and other information
1. What Cefuroxime Normon is and what it is used for
Cefuroxime Normon is an antibiotic used in both adults and children. It works by killing the bacteria that cause infections. It belongs to a group of medicines called cephalosporins.
Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.
It is important that you follow your doctor's instructions regarding dose, timing, and duration of treatment.
Do not store or reuse this medicine. If you have any antibiotic left over after completing your treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.
Cefuroxime Normon is used to treat infections of:
- the lungs or chest,
- the urinary tract,
- the skin and soft tissues,
- the abdomen.
Cefuroxime Normon is also used to:
- prevent infections during surgical procedures.
2. What you need to know before using Cefuroxime Normon
Do not use Cefuroxime Normon:
- If you are allergic (hypersensitive) to cephalosporins or 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 severe skin rash or peeling, blisters and/or mouth ulcers after treatment with cefuroxime or any other cephalosporin antibiotic.
Take special care with Cefuroxime Normon
Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with cefuroxime treatment. Seek immediate medical attention if you experience any of the symptoms related to these severe skin reactions described in section 4.
Talk to your doctor before starting treatment with cefuroxime; if you think this may apply to you, this medicine should not be given to you.
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 help 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.
If you need blood or urine tests
Cefuroxime may affect test results for glucose in urine and blood (Coombs test). If you are having tests:
Inform the person taking the sample that you are receiving cefuroxime.
Using Cefuroxime Normon 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 medicine.
Some medicines may affect how cefuroxime works, or increase the likelihood of adverse effects. These include:
- aminoglycoside antibiotics,
- “medicines used to urinate” (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 might be pregnant, or plan to become pregnant,
- if you are breastfeeding.
Your doctor will assess 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 Normon contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per vial; essentially, it is “sodium-free”.
Two vials of this medicine contain 28 mg of sodium (the main component of table/cooking salt). This corresponds to 1.4% of the maximum daily intake of sodium recommended for an adult.
3. How to use Cefuroxime Normon
Cefuroxime is normally administered by a doctor or nurse. It may be given as an injection directly into a vein or into a muscle.
Normal dose
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 sodium two, three, or four times a day.
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:
-
Widespread 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).
-
Severe allergic reaction. Signs include skin rash with itching, swelling, sometimes of the face or mouth, causing difficulty breathing,
-
Skin rash, possibly causing blisters, appearing as small targets (a dark spot in the center surrounded by a lighter area, with a dark ring around the edge),
-
Widespread rash across the skin, with blisters and peeling of the 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.
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, urticaria (hives),
- 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, appearing as 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 may also report them directly via 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 Normon
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date 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 must 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 Cefuroxime Normon
The active substance is cefuroxime sodium.
Each 250 mg vial contains 271 mg of cefuroxime sodium equivalent to 250 mg of cefuroxime.
The solvent ampoule contains water for injection.
Appearance of Cefuroxime Normon and contents of the pack
Cefuroxime sodium is a white or almost white powder.
It is supplied in 8 ml colourless type II glass vials, closed with a grey chlorobutyl rubber stopper and sealed with a "flip-off" cap.
Pack: 1 vial and 1 solvent ampoule.
Marketing Authorisation Holder and Manufacturer
LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)
Date of the most recent review of this leaflet: July 2023
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.
You can access detailed and updated information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging.
You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/62909/P_62909.html
INFORMATION FOR HEALTHCARE PROFESSIONALS
Instructions for reconstitution
For single use only. Discard any unused solution.
Intramuscular use
Add 1 ml of water for injection to cefuroxime 250 mg (see Table "Volumes of solvent 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 injection using at least 2 ml for cefuroxime 250 mg. Gently shake to obtain a clear solution. For short intravenous infusions (e.g., up to 30 minutes), refer to the Table "Volumes of solvent added and concentrations of the solution, which may be useful when fractional doses are required".
Reconstitution volumes and concentrations of the solution, which may be useful when fractional doses are required | |||
Vial size | Amount of Water for Injections to be added (ml) | Approximate cefuroxime concentration (mg/ml)** | |
250 mg powder and solvent for injectable solution | |||
250 mg | intramuscular intravenous bolus | 1 ml at least 2 ml | 216 116 |
** The resulting volume of the cefuroxime solution in the reconstitution medium increases by the drug displacement factor resulting at the concentrations listed in mg/mL.
Compatibility
Cefuroxime sodium is compatible with aqueous solutions containing up to 1% lidocaine hydrochloride.
The stability of cefuroxime sodium in 0.9% sodium chloride injection solution and in 5% glucose injection solution is not affected by the presence of sodium hydrocortisone phosphate.
Storage of injectable cefuroxime
Store below 25 °C.
Keep the vial in the outer packaging to protect it from light.
Reconstituted solution: From a microbiological standpoint, once opened, the product should be used immediately. If not used immediately, the in-use storage times and conditions prior to use are the responsibility of the user and normally should not exceed storage at 25 °C protected from light, 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 markedly affects the color of solutions and, therefore, this solution is not recommended for the dilution of cefuroxime powder for injectable solution.