Cefazolin Sala 1 g powder and solvent for solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Cefazolina Sala 1 g powder and solvent for injectable solution EFG

Cefazolin

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally and must not be given to other people, even if they have the same symptoms, as it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

1. What Cefazolina Sala is and what it is used for.
2. What you need to know before using Cefazolina Sala.
3. How to use Cefazolina Sala.
4. Possible side effects.
5. How to store Cefazolina Sala.
6. Contents of the pack and other information.

1. What Cefazolin Sandoz 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 that you follow the instructions regarding dosage, dosing interval, and duration of treatment as directed by your doctor.

Do not store or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

This medicine is used to treat the following bacterial infections caused by susceptible pathogens located in:

• respiratory tract
• urinary tract
• skin and soft tissues
• joints
• heart
• blood (septicemia)
• surgical prophylaxis of infections

2. What you need to know before using Cefazolin Sala

Do not use Cefazolin Sala:

• If you are allergic (hypersensitive) to cefazolin, to other cephalosporins, or to any of the components of this medicine.

Warnings and precautions

Take special care with Cefazolin Sala:

• If you develop severe and persistent diarrhoea, this may be due to a specific type of colitis called pseudomembranous colitis, which can be serious. In such cases, your doctor will decide whether cefazolin treatment should be discontinued 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 require 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 reactions, including breathing difficulties and chest pain, have been reported with the use of cefazolin. Immediately discontinue the use of cefazolin and contact your doctor immediately or go to the emergency room if you experience any of these symptoms.

Risk factors that may cause vitamin K deficiency or risk factors affecting other blood coagulation mechanisms.

Rarely, disorders of blood coagulation may occur during treatment with cefazolin. Additionally, changes in blood coagulation may occur in patients with diseases that can cause or worsen bleeding, such as hemophilia or stomach or intestinal ulcers. In these cases, your blood coagulation will be monitored.

Other medicines and Cefazolina Sala

Inform your doctor or pharmacist if you are currently using or have recently used any other medicines, including those obtained without a prescription.

Cefazolin must not be administered together with:

• Other antibiotics with a similar mechanism of action, such as tetracyclines, sulfonamides, erythromycin, and chloramphenicol
• Anticoagulants
• Probenecid (used to treat gout)
• Nephrotoxic agents

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, your doctor will decide whether it is advisable to use this medicine. Consult your doctor or pharmacist before taking any medication.

Driving and use of machines

Cefazolin generally does not impair the ability to drive vehicles or operate machinery.

Cefazolina Sala contains sodium

Patients on sodium-restricted diets should be aware that this medicine contains 51 mg (2.2 mmol) of sodium per gram of cefazolin.

Cefazolina Sala contains lidocaine hydrochloride

This medicinal product contains lidocaine hydrochloride to improve local tolerance during intramuscular administration. Therefore, it must not be used intravenously or in patients with a history of hypersensitivity to lidocaine.

Lidocaine hydrochloride may produce a positive result in doping controls.

3. How to use Cefazolin Sala

Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine the appropriate dose and duration of your treatment; do not stop or extend it prematurely.

Recommended dose

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 g to 1,500 mg 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 infections.

Prophylactic treatment

• 1-2 g administered intramuscularly, given from 30 minutes to one hour before starting surgery.

• For prolonged surgical procedures (e.g., two hours or longer), 500 mg to 1 g administered intramuscularly during surgery (administration will be adjusted depending on the duration of the procedure).

• 500 mg to 1 g administered intramuscularly every six to eight hours for 24 hours postoperatively.

Patients with renal and/or hepatic impairment

Dose reduction may be necessary if you have renal or hepatic impairment. In such cases, inform your doctor so that your dose can be appropriately adjusted.

If you use more Cefazolin Sala than you should

In case of accidental overdose, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested. Take the package leaflet with you.

If you forget to use Cefazolin Sala

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

If you interrupt treatment with Cefazolin Sala

Do not stop treatment before completion, as the desired effect may not be achieved. It is very important to treat infections for the recommended duration; otherwise, the condition could worsen.

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

4. Possible adverse effects

Like all medicines, this medicine may cause the following adverse effects, although not everyone will experience them.

The frequencies of adverse reactions associated with treatment with Cefazoina Sala are classified as follows:

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 in
  breathing or swallowing.

• Sudden swelling of hands, feet and ankles.

Other possible adverse effects

Frequent (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 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.

• Increase or decrease in blood cell counts.

• 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 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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products (https://www.notificaram.es). By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of CEFAZOLINA SALA

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

Store in the outer packaging to protect from light.

The reconstituted solution with the solvent is stable for 8 hours at a temperature not exceeding 25°C and for 24 hours if stored in the refrigerator (2–8°C).

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 SIGRE Point at your pharmacy. If in doubt, 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 Cefazolin Sala 1 g powder and solvent for injectable solution EFG

The active substance is cefazolin. Each vial contains 1 g of cefazolin (D.O.E.) (as sodium cefazolin).

Each solvent ampoule contains 4 ml of 0.5% lidocaine hydrochloride solution (20 mg).

Appearance of the product and contents of the pack

Cefazolin Sala 1 g powder and solvent for injectable solution EFG is supplied as a glass vial accompanied by a glass ampoule containing the solvent.

Each pack contains 1 vial and 1 ampoule; the clinical pack contains 100 vials and 100 ampoules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorio Reig Jofre S.A.

Gran Capitán, 10 - 08970

Sant Joan Despí (Barcelona)

Spain

Manufacturer:

Laboratorio Reig Jofre, S.A.

C/Jarama 11, Polígono industrial - 45007

Toledo - Spain

This leaflet was approved in: March 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/

This information is intended for healthcare professionals only

Intramuscular administration: reconstitute with the solvent from the ampoule. Shake well until dissolved. Cefazolin should be injected into a large muscle mass. Pain at the injection site is uncommon, as the solvent ampoule contains lidocaine.