Label: Information for the User

Cefazolina 2 g powder for injectable solution 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)
• 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 to undergo blood tests, you must inform the healthcare staff that you are being treated with this medication, as cefazolina may interfere with the results.

Factors that may cause vitamin K deficiency or factors that influence 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 may cause or worsen bleeding, such ashemophilia or stomach or intestinal ulcers. In these cases, your coagulation will be 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 the event 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 101 mg (4.4 mmol) 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 1.5 g every 6 hours.

Children (under 12 years and over 1 year):A total daily dose of25 to50 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 surgery begins.

b) for prolonged surgical procedures (e.g. 2 hours or more), 500 mg to 1 g administered intravenously during surgery (administration will be adjusted according to the duration of the procedure).

c) 500 mg to 1 g administered intravenously every 6 to 8 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 take 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 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, as otherwise they may worsen.

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

Like other medications, this medication may cause the following adverse effects, although not all people may experience them.

The incidence of adverse reactions associated with treatment with Cefazolina Sala 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 adverse effects

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

• Skin rash.
• Nausea and vomiting.
• Diarrhea.
• Pain or induration (skin hardening) 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 and itching or vaginal discharge.
• Prolonged use may cause the proliferation of non-susceptible bacteria.
• Increased or decreased number of blood cells.
• Hyperglycemia (high blood sugar level), hypoglycemia (low blood sugar level)
• Dizziness.
• Respiratory disorders (respiration).
• Renal 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.

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 that does not appear in this prospectus.You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use (https://www.notificaram.es).By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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 Drop-off Pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Cefazolina Sala Composition

The active ingredient is cefazoline. Each vial contains 2 g of cefazoline (D.O.E.) (as cefazoline sodium).

Appearance of the product and contents of the package

Cefazolina Sala 2 g powder for injectable solution EFG, is presented in a glass vial.

Each package contains 1 vial and the clinical package contains 50 vials.

Holder of the Marketing Authorization and Responsible for Manufacturing

Holder of the Marketing Authorization

Reig Jofre, S.A. Laboratory

Gran Capitán, 10 – 08970

Sant Joan Despí (Barcelona)

Spain

Responsible for Manufacturing:

Reig Jofre, S.A. Laboratory

C/Jarama 11, Industrial Polygon-45007

Toledo-Spain

This leaflet has been approved in: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

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

1. Continuous or intermittent intravenous infusion:Cefazolina can be administered through the main liquid infusion systems, controlling the infusion speed, or in a second intravenous infusion vial. The reconstitution of 500 mg or 1 g of cefazolina can be performed in its solvent (not in lidocaine) and then diluted in50 to100 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 over3 to5 minutes (do not administer in less than three minutes)