Label: Information for the User

Cefazolina 1 g Powder for Injection EFG

Cefazolina

Read this label carefully before starting to use this medication, as it contains important information for you

• Keep this label. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Cefazolina is an antibiotic belonging to the cefalosporins group.

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

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

Do not use Cefazolina Sala

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

Warnings and precautions

Be especially careful with Cefazolina Sala

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

• If you receive prolonged treatment with cefazolina, you may develop superinfections.

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

• If you are undergoing blood tests, you must inform the healthcare staff that you are being treated with this medication, as cefazolina may interfere with the results.

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

Bleeding disorders may occur rarely during treatment with cefazolina. 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.These patients will have their blood coagulation monitored..

Other medications and Cefazolina Sala

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

Cefazolina 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)
• Renal toxins

Pregnancy and lactation

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

Driving and operating machinery

Cefazolina generally does not affect the ability to drive vehicles and operate machinery.

Cefazolina Sala contains sodium

Patients with low-sodium diets should note that this medication contains 51 mg (2.2 mmoles) of sodium per gram of cefazolina.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

Recommended Dose

Adults and children over 12 years old : 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 1.500 mg every 6 hours.

Children (under 12 years and over 1 year) : a total daily dose of 25 to 50 mg per kg of weight, divided into three or four equal doses, is effective for most mild to moderate infections. The total daily dose should not exceed 100 mg/kg even in cases of severe infections.

Prophylactic Treatment

a) 1-2 g administered intravenously 30 minutes to 1 hour before starting surgery.

b) for prolonged surgical procedures (e.g. two hours or more) 500 mg to 1 g administered intravenously during surgery (the administration will be adjusted according to the duration of the procedure).

c) 500 mg to 1 g administered intravenously every six to eight hours for 24 postoperative hours.

Patients with renal and/or hepatic insufficiency

A dose reduction may be necessary if you have any renal or hepatic impairment. Inform your doctor, who will adjust the dose accordingly.

If you use more Cefazolina 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 insert with you.

If you forget to use Cefazolina Sala

Do not take a double dose to make up for the missed dose.

If you interrupt the treatment with Cefazolina Sala

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

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

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

The incidence of adverse reactions associated with treatment with Cefazolin Sodium 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.

The possible symptoms include:

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

• Sudden swelling of the hands, feet, and ankles.

Other possible side effects

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

• Skin rash.

• Nausea and vomiting.

• Diarrhea.

• Pain or induration (hardened skin) at the injection site.

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

• Oral fungal infection.

• Fever.

• Seizures.

• Phlebitis (inflammation of the veins).

• Pruritus and erythema 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.

• Increase or decrease in the number of blood cells.

• Hyperglycemia (high blood sugar), hypoglycemia (low blood sugar)

• Dizziness.

• Respiratory disorders (respiration).

• Kidney and urinary tract disorders.

• Cough.

• Rhinorrhea.

• Loss of appetite.

• Hepatic insufficiency (detectable in blood tests), jaundice.

• Severe skin eruption (with blisters on the skin and skin peeling, and possible blisters in the mouth).

• Intense fatigue and weakness.

• Chest pain.

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

• Blood coagulation disorders.

• Colitis (inflammation of the colon). The symptoms consist of diarrhea, usually with blood and mucus, abdominal pain, and fever.

• Genital pruritus.

Reporting of side effects

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

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

Do not use this medication after the expiration date that appears 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 is stable for 8 hours at a temperature not exceeding25ºCand for 24 hours if stored in a refrigerator (2-8ºC).

Do not use this medication if you observe visible signs of deterioration.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at theSIGRE Collection Pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Cefazolina Solution Composition

The active ingredient is cefazolin. Each vial contains1 gof cefazolin (D.O.E.) (as cefazolin sodium).

Product Appearance and Packaging Contents

Cefazolina Solution1 gpowder for intravenous injectable solution EFG, is presented in a glass vial.

Each package contains 1 vial and the clinical package contains 100 vials.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Reig Jofre, S.A.

Gran Capitán, 10 – 08970

Sant Joan Despí (Barcelona)

Spain

Responsible Manufacturer:

Reig Jofre, S.A.

C/Jarama 11, Industrial Polygon-45007

Toledo-Spain

Last review date of this leaflet: December 2024

The detailed and updated information of this medicine is available on the webpage of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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This information is intended solely for healthcare professionals

Instructions for correct product administration

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

1. Continuous or intermittent intravenous infusion:cefazolin can be administered through the main liquid infusion systems, controlling the infusion speed, or in a second intravenous infusion bottle. The reconstitution of 500 mg or 1 g of cefazolin can be done with 4 ml of injection water (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 injection water

1. Direct intravenous injection (bolus):

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

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

The solution is injected slowly over 3 to 5 minutes (do not administer in less than three minutes)