Package Insert: Information for the Patient

Cefazolin Normon 2 g Powder for Injection, for Intravenous Use EFG

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

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

This medication is an antibiotic belonging to the cephalosporin group.

Cefazolina Normon is indicated for the treatment of the following severe infections caused by susceptible microorganisms:

• Respiratory tract infections.
• Genitourinary tract infections.
• Soft tissue and skin infections.
• Biliary tract infections.
• Osteoarticular infections.
• Septicaemia (blood infection caused by bacteria).
• Endocarditis (heart lining infection).
• Prevention of infections in surgery.

No use Cefazolina Normon

If you are allergic to cefazolin, other cephalosporins, or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Cefazolina Normon.

• If you are allergic to penicillins, as there is some evidence of partial cross-reactivity between penicillins and cephalosporins.
• If you have had any type of allergy, especially to medications.
• 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 cefazolin administration and initiate appropriate treatment.
• If you are receiving prolonged treatment with cefazolin, you may develop superinfections.
• If you have renal insufficiency, your doctor may need to adjust the dose of cefazolin you should receive.
• If you are undergoing blood tests, inform the healthcare staff that you are being treated with this medication, as cefazolin may interfere with the results.

Other medications and Cefazolina Normon

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Cefazolin should not be administered with:

• Other antibiotics with a similar mechanism of action, such as tetracyclines, sulfonamides, erythromycin, and chloramphenicol.
• Probenecid.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

In the case of pregnancy, your doctor will decide whether to use this medication.

Breastfeeding

In the case of breastfeeding, your doctor will decide whether to use this medication.

Driving and operating machinery

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

Cefazolina Normon contains sodium

This medication contains 96 mg of sodium (main component of table salt/for cooking) in each 2g vial of cefazolin. This is equivalent to 4.8% of the maximum daily sodium intake recommended for an adult.

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

Remember to use your medication.

Your doctor will indicate the duration of your treatment with Cefazolina Normon 2 g Injectable.

The normal dose is:

Adults and children over 12 years: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 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 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

To prevent postoperative infection in surgery, the recommended doses are as follows:

a) 1 g i.v. administered 1/2 to 1 hour before starting surgery.

b) for prolonged surgical procedures (e.g., 2 hours or more) 0.5 to 1 g i.v. during surgery (dosage will be adjusted depending on the duration of the intervention).

c) 500 mg to 1 g i.v. every 6 to 8 hours for 24 postoperative hours.

It is essential that the preoperative dose be administered just before (1/2 to 1 hour) starting the intervention. Additionally, cefazolina will be administered, if necessary, at appropriate intervals during the intervention.

In surgical operations where the presence of infection can be especially devastating (e.g., open-heart surgery and prosthetic arthroplasty) the prophylactic administration of cefazolina may be continued for 3 to 5 days after surgery. If there are signs of infection, samples should be obtained for culture, in order to identify the causal germ, in order to establish the appropriate therapy.

Patients with renal insufficiency

Cefazolina can be used in patients with renal insufficiency once the dose has been adjusted according to the prescriber's recommendations.

If you use more Cefazolina Normon than you should

Consult your doctor or pharmacist. The administration of large inappropriate doses of parenteral cephalosporins can cause convulsions, especially in patients with renal insufficiency. It is necessary to reduce the dose when renal function is altered (see section 3. How to use Cefazolina Normon). If convulsions occur, discontinue administration of the medication immediately; anticonvulsant treatment may be administered if clinically indicated. Hemodialysis may be considered in cases of massive overdose.

In case of overdose, or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20 indicating the medication and the amount used.

If you forgot to use Cefazolina Normon

Do not take a double dose to compensate for the missed doses.

Like all medications, Cefazolina Normon may produce adverse effects, although not everyone will experience them.

The incidence of adverse reactions associated with treatment with Cefazolina Normon is classified as follows:

Blood and lymphatic system disorders: neutropenia, leucopenia, thrombocytopenia, and direct or indirect positive Coombs test (test that looks for antibodies against red blood cells).

Gastrointestinal disorders:nausea, loss of appetite, vomiting, diarrhea, and mouth ulcers (candidiasis) in some cases. During treatment, symptoms of pseudomembranous colitis may appear.

Renal and urinary disorders:increased urea in the blood, which may indicate kidney malfunction.

General disorders: pain at the site of intramuscular injection.

Immune system disorders: drug fever, skin rash (cutaneous eruption), vulvar pruritus, eosinophilia (increased eosinophils in the blood), and anaphylaxis (severe allergic reaction throughout the body). Hepatobiliary disorders: transient elevation of transaminases (liver enzyme).

If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospectus.

Reporting 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 for Pharmacovigilance of Medicinal Products 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.

Store in the original packaging to protect it from light.

The reconstituted solution with the solvent is stable for a maximum of 8 hours at 25 °C and for a maximum of 24 hours if stored in a refrigerator (2-8 °C).

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

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 the SIGRE collection point of the pharmacy. In this way, you will help protect the environment.

Cefazolina Normon Composition

The active ingredient is cefazolina sodium. Each vial contains 2 g of cefazolina (sodium).

Appearance of the product and content of the container

Cefazolina Normon 2 g is presented in the form of a powder for injectable solution. Each container contains a vial of cefazolina powder.

Holder of the marketing authorization and responsible manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)

Information for healthcare professionals

Instructions for correct administration of the product:

Before administration, medications administered intravenously must be visually inspected to see if there is discoloration, if the solution and container allow it.

Continuous or intermittent intravenous infusion:It can be administered through the main liquid infusion systems, controlling the infusion speed or in a second intravenous infusion bottle. The reconstitution of 2 g of cefazolina can be done in 10 ml of water for injectable preparations and then diluted in 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 and levulose 5% or 10% in water for injectable preparations.

Direct intravenous injection:Dilute 2 g reconstituted in a minimum of 20 ml of sterile water. Inject the solution slowly over 3 to 5 minutes.

Last review date of this leaflet:October 2022

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