Cefazolin Normon 2 g powder for intravenous injection solution EFG
Spain
Table of Contents
Package Leaflet: Information for the User
Introduction
Package leaflet: information for the patient
Cefazolin Normon 2 g powder for intravenous 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 or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Cefazolin Normon is and what it is used for
- What you need to know before using Cefazolin Normon
- How to use Cefazolin Normon
- Possible adverse effects
- How to store Cefazolin Normon
- Contents of the pack and other information
1. What Cefazolina Normon is and what it is used for
This medicine is an antibiotic belonging to the cephalosporin group.
Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza or the common cold. It is important to follow your doctor's instructions regarding dosage, administration, and duration of treatment. Do not store or reuse this medication. If you have any antibiotic left over after completing the treatment, return it to the pharmacy for proper disposal. Do not dispose of medications by flushing them down the drain or throwing them in the trash. |
Cefazolina Normon is indicated for the treatment of the following serious infections caused by susceptible microorganisms:
- Respiratory tract infections.
- Genitourinary tract infections.
- Skin and soft tissue infections.
- Biliary tract infections.
- Bone and joint infections.
- Septicemia (blood infection caused by bacteria).
- Endocarditis (infection of the heart lining).
- Prevention of infections in surgery.
2. What you need to know before using Cefazolina Normon
Do not use Cefazolina Normon
If you are allergic to cefazolin, to other cephalosporins, or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before starting to use Cefazolina Normon
- If you are allergic to penicillins, as there is some evidence of partial cross-allergy between penicillins and cephalosporins.
- If you have had any type of allergy, especially to drugs.
- If you develop severe and persistent diarrhea, which may be due to a special type of colitis called pseudomembranous colitis, which can be serious. In such cases, your doctor will decide whether cefazolin treatment should be stopped and appropriate therapy initiated.
- If you are undergoing prolonged treatment with cefazolin, superinfections may occur.
- If you have renal impairment, your doctor may need to adjust the dose of cefazolin you should receive.
- If you are due to have blood tests, you must inform healthcare personnel that you are being treated with this medicine, as cefazolin may interfere with test results.
- Signs of allergic reaction, including breathing difficulties and chest pain, have been reported with the use of cefazolin. Immediately stop using cefazolin and contact your doctor immediately or go to emergency services if you experience any of these symptoms.
Other medicines and Cefazolina Normon
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Cefazolin must not be administered together with:
- Other antibiotics with a similar mechanism of action, such as tetracyclines, sulfonamides, erythromycin, and chloramphenicol.
- Probenecid.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
During pregnancy, your doctor will decide whether it is appropriate to use this medicine.
Breastfeeding
During breastfeeding, your doctor will decide whether it is appropriate to use this medicine.
Driving and using machines
Cefazolin generally does not affect the ability to drive or operate machinery.
Cefazolina Normon contains sodium
This medicine contains 96 mg of sodium (main component of table/cooking salt) in each 2 g vial of cefazolin. This corresponds to 4.8% of the maximum daily recommended sodium intake for an adult.
3. How to use Cefazolin Normon
Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Remember to use your medicine.
Your doctor will determine the duration of your treatment with Cefazolin Normon 2 g for injection.
The usual dose is:
Adults and children over 12 years of age: in mild infections, 500 mg every 8 hours; in moderate to severe infections, 500 mg to 1 g every 6 or 8 hours; in more severe infections, 1 to 1.5 g every 6 hours.
Children (under 12 years and over 1 year of age): a total daily dose of 25 to 50 mg per kg of body weight, divided into three or four equal doses, is effective in most mild to moderate infections. The total daily dose should not exceed 100 mg/kg, even in cases of severe infection.
Prophylactic treatment
To prevent postoperative infection in surgery, the recommended doses are as follows:
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1 g i.v. administered 1/2 to 1 hour before starting surgery.
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for prolonged surgical procedures (e.g., 2 hours or longer), 0.5 to 1 g i.v. during surgery (the dosing will be adjusted depending on the duration of the procedure).
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500 mg to 1 g i.v. every 6 to 8 hours for 24 hours postoperatively.
It is important that the preoperative dose is administered just before (1/2 to 1 hour prior) starting the procedure. Likewise, cefazolin should be administered, if necessary, at appropriate intervals during the procedure.
In surgical procedures where infection may be especially devastating (e.g., open-heart surgery and prosthetic arthroplasty), prophylactic administration of cefazolin may be continued for 3 to 5 days after surgery. If signs of infection occur, samples should be taken for culture in order to identify the causative organism, so that appropriate therapy can be initiated.
Patients with renal impairment
Cefazolin may be used in patients with renal impairment once the dose has been adjusted according to the prescribing physician's recommendations.
If you use more Cefazolin Normon than you should
Consult your doctor or pharmacist. Administration of inappropriately high doses of parenteral cephalosporins may cause seizures, especially in patients with renal impairment. Dose reduction is necessary when renal function is impaired (see section 3. How to use Cefazolin Normon). If seizures occur, administration of the medicine must be stopped immediately; anticonvulsant treatment may be administered if clinically indicated. Hemodialysis may be considered in cases of massive overdose.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.
If you forget to use Cefazolin Normon
Do not take a double dose to make up for forgotten doses.
4. Possible adverse effects
Like all medicines, Cefazolin Normon may produce adverse effects, although not everyone experiences them.
The frequencies of adverse reactions associated with treatment with Cefazolin Normon are classified as follows:
Blood and lymphatic system disorders: neutropenia, leucopenia, thrombocytopenia, and positive direct or indirect Coombs test (a test that detects antibodies against red blood cells).
Gastrointestinal disorders: nausea, loss of appetite, vomiting, diarrhoea, and oral thrush (candidiasis) in some cases. Symptoms of pseudomembranous colitis may appear during treatment.
Renal and urinary disorders: increased blood urea, which may indicate impaired kidney function.
General disorders: pain at the site of intramuscular injection.
Immune system disorders: drug fever, skin rash, vulvar pruritus (itching), eosinophilia (increased eosinophils in blood), and anaphylaxis (severe allergic reaction throughout the body).
Hepatobiliary disorders: transient elevation of transaminases (liver enzyme).
Cardiac disorders
Frequency "not known" (cannot be estimated from available data)
Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.
If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, 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 Cefazolin Normon
Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect from light.
The reconstituted solution with the solvent is stable for up to 8 hours at 25 °C and for up to 24 hours if stored in the refrigerator (2–8 °C).
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Do not use this medicine if visible signs of deterioration are observed.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a pharmacy’s SIGRE collection point. This helps protect the environment.
6. Contents of the pack and other information
Composition of Cefazolina Normon
The active substance is sodium cefazolin. Each vial contains 2 g of cefazolin (sodium).
Appearance of the product and contents of the pack
Cefazolina Normon 2 g is presented as a powder for injectable solution. Each pack contains one vial of cefazolin powder.
Marketing Authorization Holder and Manufacturer
LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)
Information for healthcare professionals
Instructions for correct administration of the product:
Before administration, parenteral drugs administered intravenously should be visually inspected for discoloration, if solution and container permit.
Continuous or intermittent intravenous infusion: May be administered through standard intravenous fluid delivery systems, controlling the infusion rate, or into a secondary intravenous infusion bottle. Reconstitution of 2 g of cefazolin can be performed in 10 ml of water for injections, then diluted in 100 ml of one of the following intravenous solutions: 0.9% sodium chloride, 5% or 10% glucose, 5% glucose in lactated Ringer's, 0.9% sodium chloride and 5% glucose, 0.45% sodium chloride and 5% glucose, lactated Ringer's, or 5% or 10% levulose in water for injections.
Direct intravenous injection: Reconstituted 2 g should be diluted in a minimum of 20 ml of sterile water. Inject the solution slowly over 3 to 5 minutes.
Date of latest revision of this leaflet: March 2026
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/