Cefazolin Normon 1 g powder and solvent for intravenous injection solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Cefazolin Normon 1 g powder and solvent 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could 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:

1. What Cefazolin Normon is and what it is used for
2. What you need to know before using Cefazolin Normon
3. How to use Cefazolin Normon
4. Possible adverse effects
5. How to store Cefazolin Normon
6. 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.

Cefazolin 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 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 to 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.

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 conditions 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 such infections and treat them if necessary.

• 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 the emergency room if you notice 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 applies to over-the-counter medicines and herbal medicines, 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 medicine to increase urine production).

• You should also inform your doctor or nurse if you need to have 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using 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 the ability to drive and use machines.

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 consideration when treating patients on low-sodium diets.

3. How to use Cefazolina Normon

Follow exactly the administration instructions for Cefazolina Normon as given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Cefazolin must only be administered by appropriately qualified personnel (physicians or other healthcare professionals).

Remember to use your medicine.

Your doctor will determine the duration of your treatment with Cefazolina Normon.

The dose selected should 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 i.v. administered 1/2 to 1 hour before starting surgery.

• for prolonged surgical procedures (e.g., 2 hours or longer), 500 mg to 1 g i.v. during surgery (dosing will be adjusted depending on the duration of the procedure).

• 500 mg to 1 g i.v. 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 is administered just before (1/2 to 1 hour) starting the procedure. 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 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.

Duration of treatment

The duration of treatment depends on the course of the disease. In accordance with 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 intravenous route.

If you use more Cefazolina Normon than you should

Contact your doctor or pharmacist immediately. Inappropriate administration of large doses of parenteral cephalosporins may cause seizures, especially in patients with renal impairment. Dosage reduction is necessary when renal function is impaired (see section 3. How to use Cefazolina 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 91 562 04 20, indicating the medicine and the amount taken.

If you forget to use Cefazolina Normon

Do not take a double dose to make up for forgotten doses.

If you stop using Cefazolina Normon

Stopping treatment too early may compromise the outcome of therapy or lead to relapse, which is more difficult to treat. Follow your doctor's instructions.

If you have any questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Cefazolin Normon may 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, inform 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 (hardening of the skin) at the injection site.

Uncommon (may affect up to 1 in 100 people):

• Fungal mouth infection.
• Fever.
• Seizures (attacks).
• Inflammation of veins.
• Itching and redness of the skin, joint pain, skin lesions, generalized rash and hives.

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.
• Increase or decrease in blood cell counts.
• Hyperglycemia (high blood sugar), hypoglycemia (low blood sugar).
• 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 peeling of the skin, and possible blisters in the mouth).
• ?Severe fatigue and weakness.
• Chest pain.

Very rare (may affect up to 1 in 10,000 people):

• Blood coagulation disorders.
• 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 adverse effects, 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 out of 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 refers to the last day of the month indicated.

Do not use this medicine if there are visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point in the pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help 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 storage times and conditions during use are the responsibility of the user and must not exceed the previously mentioned time limits for chemical and physical stability during use.

6. Contents of the pack and other information

Composition of Cefazolina Normon

The active substance is cefazolin (sodium). Each vial contains 1 g of cefazolin (sodium).

Each vial of Cefazolina Normon contains 1 g of cefazolin (as cefazolin sodium).

The other components are:

Solvent ampoule: water for injections

Appearance of the medicinal product and contents of the container

Each pack of Cefazolina Normon 1 g contains a vial with a white or almost white powder, presented in a transparent soda-lime glass type II vial closed with a bromobutyl stopper and sealed with a silver aluminum cap, and one ampoule containing 4 ml of solvent made of type I glass, a clear and colourless solution (water for injection).

Pack sizes:

• 1 vial and 1 ampoule
• 100 vials and 100 ampoules

Other presentations: Cefazolin Normon 1 g, powder and solvent for solution for intramuscular injection.

Information for healthcare professionals

Instructions for correct administration of the product:

Before administration, parenteral drugs administered intravenously should be inspected visually for discoloration and particulate matter, if the solution and container permit.

Continuous or intermittent intravenous infusion: May be administered through primary intravenous fluid delivery systems by controlling the infusion rate or into a secondary intravenous infusion bottle. Reconstitute 1 g of cefazolin with its own solvent (not with lidocaine), then dilute the resulting solution (1 g of reconstituted product) with 50–100 ml of one of the following intravenous solutions:

Sodium chloride 0.9%,
5% glucose,
10% glucose,
Lactated Ringer's solution.

Direct intravenous injection: Dilute 1 g of the reconstituted product in a minimum of 10 ml of water for injections. Inject the solution slowly over 3 to 5 minutes.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent revision of this leaflet: April 2026

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/