Cefazolin Normon 1 g powder and solvent for intramuscular injection solution EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Cefazolina Normon 1 g powder and solvent for intramuscular injectable solution EFG
Read all of this 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 must not be given to others, even if they have the same symptoms as you. It could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Cefazolina Normon is and what it is used for
- What you need to know before using Cefazolina Normon
- How to use Cefazolina Normon
- Possible adverse effects
- How to store Cefazolina Normon
- Contents of the pack and other information
1. What Cefazolina Normon is and what it is used for
Cefazolin 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 medicine. If you have any antibiotic left over after completing the treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of down the drain or in household waste. |
Cefazolin Normon is indicated in 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 and postoperative period.
2. What you need to know before using Cefazolina Normon
Do not use Cefazolina Normon
If you are allergic to cefazolin or any of the other ingredients of this medicine (listed in section 6).
If you have ever had a severe allergic reaction to penicillin or a similar antibiotic.
If you are allergic to lidocaine and Cefazolina Normon is to be administered by intramuscular injection.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Cefazolina Normon:
- If you have previously experienced a mild allergic reaction to penicillin or other similar antibiotics, for example, skin rashes that may cause itching.
- If you are allergic to any substance not mentioned in this leaflet.
- If you have had intestinal disorders, especially colitis (inflammation of the intestine).
- If you have kidney problems.
- If you are on a low-sodium diet.
Risk factors that may lead to vitamin K deficiency or risk factors affecting other mechanisms of blood coagulation.
Rarely, blood coagulation disorders may occur during treatment with cefazolin. Additionally, changes in blood coagulation may occur in patients with diseases that may cause or worsen bleeding, such as hemophilia or stomach or intestinal ulcers. In such cases, your blood coagulation will be monitored.
This medicine must not be injected near the spinal cord (intrathecal route), as cases of central nervous system toxicity (including seizures) have been reported.
Prolonged use of cefazolin may lead to superinfections. Your doctor will monitor you closely for their occurrence and treat them if necessary.
Signs of allergic reactions, including breathing difficulties and chest pain, have been reported with the use of cefazolin. Immediately discontinue use of cefazolin and contact your doctor immediately or go to the emergency room if you experience any of these symptoms.
Children
Cefazolina Normon must not be used in premature infants or infants during the first month of life.
Use of Cefazolina Normon with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This also includes over-the-counter medicines and herbal remedies, as Cefazolina Normon may affect how other medicines work. Likewise, other medicines may affect how Cefazolina Normon works.
It is very important that you consult your doctor or nurse, especially if you are taking any of the following medicines:
- Aminoglycosides or other antibiotics (used to treat infections).
- Probenecid (used to treat gout).
- Vitamin K.
- Anticoagulants (blood-thinning medicines).
- Furosemide (a diuretic medicine).
You should also inform your doctor or nurse if you need blood tests to measure glucose levels or other blood tests.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and use of machines
In general, cefazolin does not affect the ability to drive or operate machinery. However, adverse reactions (see also section “Possible side effects”) may occur that could affect your ability to drive or operate machinery.
Cefazolina Normon contains sodium
This medicine contains 48 mg of sodium (main component of table/cooking salt) per vial. This corresponds to 2.4% of the maximum recommended daily sodium intake for an adult, which should be taken into account when treating patients on low-sodium diets.
3. How to use Cefazolin Normon
Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Cefazolin should only be administered by appropriately qualified personnel (physicians or other healthcare professionals).
Remember to use your medicine.
Your doctor will inform you of the duration of your treatment with Cefazolin Normon.
The selected dose must be established according to the type of infection, the patient's condition, and the susceptibility of the causative agent to cefazolin.
The recommended dose is:
Adults and children over 12 years of age: in mild infections, 500 mg every 8 hours (total daily dose 1.5 g); in moderate to severe infections, 500 mg to 1 g every 6 or 8 hours (total daily dose 3 g–4 g); in severe infections, 1 to 1.5 g every 6 hours (total daily dose 4 g–6 g).
Children (under 12 years of age and over 1 month): 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.
Prevention of surgical/postoperative infections in adults To prevent postoperative infection in surgery, the recommended doses are as follows:
-
1–2 g intramuscularly administered 1/2 to 1 hour before starting surgery.
-
for prolonged surgical procedures (e.g., 2 hours or more), 500 mg to 1 g intramuscularly during surgery (dosing will be adjusted depending on the duration of the procedure).
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500 mg to 1 g intramuscularly every 6 to 8 hours during the first 24 postoperative hours.
Prevention of surgical/postoperative infections in children
- 25–30 mg/kg for children up to a maximum of 50 mg/kg (maximum dose must not exceed 2 g)
It is important that the preoperative dose be administered just before (1/2 to 1 hour) the start of surgery. Likewise, cefazolin should be administered, if necessary, at appropriate intervals during surgery.
In patients for whom infection at the surgical site may pose a serious risk (e.g., open-heart surgery and prosthetic arthroplasties), 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 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.
Duration of treatment
The duration of treatment depends on the course of the disease. According to general principles of antibiotic therapy, cefazolin should be continued for at least 2 to 3 days after fever has subsided or until evidence of eradication of the causative agent is obtained.
Method of administration
Cefazolin is administered by deep intramuscular injection.
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, the drug should be discontinued 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 name of the medicine and the amount taken.
If you forget to use Cefazolin Normon
Do not take a double dose to make up for missed doses.
If you stop treatment with Cefazolin Normon
Stopping treatment too early may compromise the outcome of therapy or lead to a relapse, which may be more difficult to treat. Follow your doctor's instructions.
If you have any doubts about using this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Cefazolin Normon can cause adverse effects, although not everyone experiences them.
Severe allergic reactions (very rare, may affect up to 1 in 10,000 people).
If you experience a severe allergic reaction, tell your doctor immediately.
Possible symptoms include:
- Sudden swelling of the face, throat, mouth or lips, which may cause difficulty breathing or swallowing.
- Sudden swelling of hands, feet and ankles.
Other possible adverse effects
Common (may affect up to 1 in 10 people):
- Skin rash.
- Nausea and vomiting.
- Diarrhea.
- Pain or induration (hardened skin) at the injection site.
Uncommon (may affect up to 1 in 100 people):
- Fungal mouth infection.
- Fever.
- Seizures (attacks).
- Inflammation of the veins.
- Itching and redness of the skin, joint pain, skin lesions, generalized rash and urticaria.
Rare (may affect up to 1 in 1,000 people):
- Genital infection, vaginal candidiasis — vaginal pain and itching or vaginal discharge.
- Prolonged use may lead to overgrowth of non-susceptible bacteria.
- Increased or decreased number of blood cells.
- Hyperglycemia (high blood sugar level), hypoglycemia (low blood sugar level).
- Dizziness.
- Respiratory disorders (breathing).
- Disorders of the kidneys and urinary tract.
- Cough.
- Rhinorrhea.
- Loss of appetite.
- Liver failure (detectable in blood tests), jaundice.
- Severe rapidly progressing skin rash (with blisters and skin peeling, and possible mouth blisters).
- ?Severe fatigue and weakness.
- Chest pain.
Very rare (may affect up to 1 in 10,000 people):
- Disorders of blood coagulation.
- Inflammation of the colon. Symptoms include diarrhea, usually with blood and mucus, abdominal pain and fever.
- Genital itching.
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.
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 can 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 it 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 refrigerated (2–8 °C).
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Do not use this medicine if you notice any visible signs of deterioration.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a pharmacy’s SIGRE Point. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.
From a microbiological standpoint, unless the method of opening/reconstitution/dilution excludes the risk of microbial contamination, the product should be used immediately. If not used immediately, the responsibility for storage times and conditions during use lies with the user and must not exceed the previously stated times for chemical and physical stability during use.
6. Contents of the pack and other information
Composition of Cefazolin Normon
The active substance is cefazolin (as cefazolin sodium).
Each vial of Cefazolin Normon contains 1 g of cefazolin (as cefazolin sodium).
The other components are:
Solvent ampoule: lidocaine hydrochloride and water for injections.
Appearance of the product and contents of the pack
Each pack of Cefazolin Normon 1 g contains one vial with a white or almost white powder presented in a transparent soda-lime glass vial of type II, closed with a bromobutyl rubber stopper and sealed with a silver aluminium cap, and one 4 ml glass ampoule (type I) of solvent containing a clear, colourless or slightly yellowish solution (lidocaine).
Pack sizes:
- 1 vial and 1 ampoule
- 100 vials and 100 ampoules
Other presentations: Cefazolin Normon 1 g powder and solvent for solution for intravenous injection.
Information for healthcare professionals
Instructions for correct administration of the product:
Intramuscular route: reconstitute the powder with the solvent from the ampoule (lidocaine). Shake until dissolved. Cefazolin should be injected into a large muscle mass. Pain at the injection site is not common, as the solvent ampoules contain lidocaine.
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: April 2026
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/