CEFAZOLINE SALA 1 g POWDER FOR INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Cefazoline Sala 1 g Powder for Solution for Injection EFG

Cefazoline

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

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

1. What is Cefazoline Sala and what is it used for

Cefazoline is an antibiotic belonging to the group of cephalosporins.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or common cold.

It is important that you follow the instructions regarding dosage, administration interval, and treatment duration as indicated by your doctor.

Do not store or reuse this medication. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medications through the drain or in the trash.

This medication is used for the treatment of the following bacterial infections caused by susceptible pathogens localized in:

• respiratory system
• urinary system
• skin and soft tissues
• joints
• heart
• blood (septicemia)
• prevention of infections in surgery

2. What you need to know before you use Cefazoline Sala 1 g Powder for Solution for Injection EFG

Do not use Cefazoline Sala

• If you are allergic (hypersensitive) to cefazoline, other cephalosporins, or any of its components.

Warnings and precautions

Be careful with Cefazoline Sala

• If you experience severe and prolonged diarrhea, it may be due to a special type of colitis called pseudomembranous colitis, which can be severe. In these cases, your doctor will decide whether to suspend cefazoline administration and initiate appropriate treatment.

• If you undergo prolonged treatment with cefazoline, superinfections may occur.

• If you have renal insufficiency, your doctor may need to adjust the dose of cefazoline you receive.

• If you are to undergo any blood tests, inform the healthcare staff that you are being treated with this medication, as cefazoline may interfere with test results.

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

On rare occasions, blood coagulation disorders may occur during treatment with cefazoline. 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 medications and Cefazoline Sala

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

Cefazoline should not be administered 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

In case of pregnancy or breastfeeding, your doctor will decide whether to use this medication. Consult your doctor or pharmacist before taking any medication.

Driving and using machines

Cefazoline generally does not affect the ability to drive vehicles or operate machinery.

Cefazoline Sala contains sodium

Patients on low-sodium diets should note that this medication contains 51 mg (2.2 mmol) of sodium per gram of cefazoline.

3. How to use Cefazoline Sala

Follow your doctor's instructions for administering this medication exactly. If in doubt, consult your doctor or pharmacist again.

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

Recommended dose

Adults and children over 12 years: for mild infections, 500 mg every 8 hours; for moderate to severe infections, 500 mg to 1 g every 6 or 8 hours; for more severe infections, 1 g to 1.5 g every 6 hours.

Children (under 12 years and over 1 year): 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 severe infections.

Prophylactic treatment

• 1-2 g intravenously administered 30 minutes to 1 hour before surgery.

• For prolonged surgical procedures (e.g., 2 hours or more), 500 mg to 1 g intravenously during surgery (administration will be adjusted depending on the duration of the procedure).

• 500 mg to 1 g intravenously every 6 to 8 hours for 24 hours postoperatively.

Patients with renal and/or hepatic insufficiency

A dose reduction may be necessary if you have any renal or hepatic impairment. In such cases, inform your doctor so that they can adjust the dose accordingly.

If you use more Cefazoline Sala than you should

In case of accidental overdose, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount taken. Bring the package leaflet with you.

If you forget to use Cefazoline Sala

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

If you stop treatment with Cefazoline Sala

Do not stop treatment before completing it, as the desired effect will not be achieved. It is very important to treat infections for the recommended time; otherwise, they may worsen.

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

4. Possible side effects

Like all medicines, this medicine can cause the following side effects, although not everybody gets them.

The incidence of adverse reactions associated with Cefazoline Sala treatment is classified as follows:

Severe allergic reactions(very rare, may affect up to 1 in 10,000 people).

If you have a severe allergic reaction, inform your doctor immediately.

Possible symptoms include:

• Sudden swelling of the face, throat, mouth, or lips, which can cause difficulty breathing or swallowing.

• Sudden swelling of hands, feet, and ankles.

Other possible side effects

Common(may affect up to 1 in 10 people):

• Rash.
• Nausea and vomiting.
• Diarrhea.
• Pain or induration (hardened skin) at the injection site.

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

• Oral thrush.
• Fever.
• Seizures.
• Phlebitis.
• 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 or itching or vaginal discharge.
• Prolonged use may cause the proliferation of non-susceptible bacteria.
• Increased or decreased blood cell count.
• Hyperglycemia (high blood sugar), hypoglycemia (low blood sugar)
• Dizziness.
• Respiratory disorders (breathing).
• Kidney and urinary disorders.
• Cough.
• Rhinorrhea.
• Lack of appetite.
• Liver failure (detectable in blood tests), jaundice.
• Severe rash with rapid progression (with blisters on the skin and skin peeling, 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.
• Colitis. Symptoms include diarrhea, usually with blood and mucus, abdominal pain, and fever.

• Genital itching.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines (https://www.notificaram.es). By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Cefazoline Sala

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

Do not use this medication after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

Store in the outer packaging to protect from light.

The reconstituted solution 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 medication if you observe visible signs of deterioration.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and further information

Composition of Cefazoline Sala

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

Appearance of the product and pack contents

Cefazoline Sala 1 g Powder for Solution for Injection EFG is presented in a glass vial.

Each pack contains 1 vial, and the clinical pack contains 100 vials.

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

Date of the last revision of this leaflet: December 2024

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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This information is intended only for healthcare professionals

Instructions for the correct administration of the product

Intravenous administration:cefazoline can be administered by direct intravenous injection or by continuous or intermittent infusion (never dissolved in lidocaine).

1. Continuous or intermittent intravenous infusion:cefazoline can be administered through the main infusion systems for liquids, controlling the infusion rate, or in a second infusion bottle. The reconstitution of 500 mg or 1 g of cefazoline can be performed with 4 ml of water for injection (not in lidocaine) and then diluted in 50 to 100 ml of one of the following intravenous solutions:

Sodium chloride 0.9%

Glucose 5% or 10%

Glucose 5% in Ringer lactate

Sodium chloride 0.9% and glucose 5%

Sodium chloride 0.45% and glucose 5%

Ringer lactate

Fructose 5% or 10% in water for injection

1. Direct intravenous injection (bolus):

500 mg or 1 g reconstituted: diluted in 10 ml of water for injection.

2 g reconstituted: diluted in a minimum of 20 ml of water for injection.

The solution is injected slowly over 3 to 5 minutes (it should not be administered in less than three minutes)