CEFAZOLINE SALA 1 g POWDER AND SOLVENT FOR INJECTABLE SOLUTION

Introduction

Leaflet: Information for the user

Cefazoline Sala 1 g powder and solvent for injectable solution EFG

Cefazoline

Read the entire leaflet carefully before starting to use this medicine, as it contains important information for you

• Keep this leaflet. You may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you personally and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Cefazoline Sala is and what it is used for.
2. What you need to know before starting to use Cefazoline Sala.
3. How to use Cefazoline Sala.
4. Possible side effects.
5. Storage of Cefazoline Sala.
6. Package contents and additional information.

1. What Cefazoline Sala is and what it is 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 the flu or the common cold.

It is essential to follow the instructions regarding dosage, administration interval, and treatment duration as indicated by your doctor.

Do not store or reuse this medicine. If you have any leftover antibiotic after completing the treatment, return it to the pharmacy for proper disposal. Do not throw away medicines down the drain or in the trash.

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

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

2. What you need to know before starting to use Cefazoline Sala

Do not use Cefazoline Sala:

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

Warnings and precautions

Be particularly careful with Cefazoline Sala

• If you experience intense 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 kidney failure, 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 medicine, as cefazoline may interfere with the 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 medicines and Cefazoline Sala

Inform your doctor or pharmacist if you are using or have recently used any other medicine, including those purchased 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 medicine. Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

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

Cefazoline Sala contains sodium

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

Cefazoline Sala contains lidocaine hydrochloride

This specialty contains lidocaine hydrochloride to increase local tolerance in intramuscular administration. Consequently, it should not be used intravenously or in patients with a history of hypersensitivity to lidocaine.

Lidocaine hydrochloride may produce a positive result in doping tests.

3. How to use Cefazoline Sala

Follow your doctor's instructions for administering this medicine 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 before completing it or prolong it.

Recommended dose

Adults and children over 12 years old: in the case of 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 1.5 g every 6 hours.

Children (under 12 years old and over 1 year old): 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 intramuscularly administered 30 minutes to 1 hour before starting surgery.

• for prolonged surgical procedures (e.g., 2 hours or more) 500 mg to 1 g intramuscularly during surgery (administration will be modified depending on the duration of the intervention).

• 500 mg to 1 g intramuscularly every 6 to 8 hours for 24 hours post-operatively.

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 medicine and the amount taken. Bring the leaflet with you.

If you forget to use Cefazoline Sala

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

If you interrupt 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 other doubts about using this product, ask your doctor or pharmacist.

4. Possible side effects

Like other medicines, this medicine can cause the following side effects, although not all people will experience 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.

Other possible side effects

Frequent(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 tract 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.
• Colon inflammation. Symptoms include diarrhea, usually with blood and mucus, abdominal pain, and fever.

• Genital itching.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines (https://www.notificaram.es). By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Cefazoline Sala

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

Do not use this medicine 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 it 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 visible signs of deterioration.

Medicines should not be thrown away down the drain or in the trash. Deposit the packaging and unused medicines in a SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Cefazoline Sala 1 g powder and solvent for injectable solution EFG

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

Each ampoule of solvent includes 4 ml of lidocaine hydrochloride solution at 0.5% (20 mg)

Appearance of the product and package contents

Cefazoline Sala 1 g powder and solvent for injectable solution EFG is presented in a glass vial accompanied by a glass ampoule with the solvent.

Each package contains 1 vial with 1 ampoule, and the clinical package 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:December 2024

Detailed and updated information on this medicine 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

Intramuscular administration:reconstitute with the solvent from the ampoule. Shake well until dissolved. Cefazoline should be injected into a area of large muscle mass. It is infrequent to experience pain at the injection site, as the solvent ampoule contains lidocaine.