CEFAZOLIN NORMON 2 g POWDER FOR INTRAVENOUS SOLUTION

Introduction

Package Leaflet: Information for the Patient

Cefazoline Normon 2 g Powder for Solution for Intravenous Injection EFG

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 pack:

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

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

This medicine is an antibiotic of the cephalosporin group.

Cefazoline Normon is indicated for the treatment of the following severe infections caused by sensitive germs:

• Respiratory tract infections.
• Genitourinary tract infections.
• Skin and soft tissue infections.
• Biliary tract infections.
• Bone and joint infections.
• Septicemia (blood infection caused by bacteria).
• Endocarditis (infection of the heart lining).
• Prevention of infections in surgery.

2. What you need to know before you use Cefazoline Normon

Do not use Cefazoline Normon

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

Warnings and precautions

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

• If you are allergic to penicillins, as there is some evidence of partial cross-allergy between penicillins and cephalosporins.
• If you have presented any type of allergy, especially to drugs.
• 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 the administration of cefazoline and initiate appropriate treatment.
• If you are undergoing 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 going to have a blood test, you should inform the healthcare staff that you are being treated with this medicine, as cefazoline can interfere with the results.

Other medicines and Cefazoline Normon

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Cefazoline should not be administered with:

• Other antibiotics that have 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 are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

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

Breastfeeding

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

Driving and using machines

Cefazoline, in general, does not affect the ability to drive vehicles and operate machinery.

Cefazoline Normon contains sodium

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

3. How to use Cefazoline Normon

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

Remember to use your medicine.

Your doctor will indicate the duration of your treatment with Cefazoline 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 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 cases of severe infections.

Prophylactic treatment

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

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

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

• 500 mg to 1 g i.v. every 6 to 8 hours during 24 hours postoperatively.

It is essential that the preoperative dose be administered just before (1/2 to 1 hour) starting the intervention. Similarly, cefazoline 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 joint replacement), the prophylactic administration of cefazoline may continue for 3 to 5 days after surgery. If there are signs of infection, samples should be taken for culture to identify the causal germ and initiate appropriate therapy.

Patients with renal insufficiency

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

If you use more Cefazoline Normon than you should

Consult your doctor or pharmacist. The administration of large, inappropriate doses of parenteral cephalosporins can cause seizures, especially in patients with renal insufficiency. It is necessary to reduce the dose when renal function is altered (see section 3. How to use Cefazoline Normon). If seizures occur, the administration of the medicine should be suspended immediately; anticonvulsant treatment may be administered if clinically indicated. Hemodialysis may be considered in case 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 medicine and the amount used.

If you forget to use Cefazoline Normon

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

4. Possible side effects

Like all medicines, Cefazoline Normon can cause side effects, although not everybody gets them.

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

Blood and lymphatic system disorders: neutropenia, leucopenia, thrombocytopenia, and direct or indirect Coombs test positive.

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

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

General disorders: pain at the injection site.

Immune system disorders: drug fever, skin rash, vulvar pruritus, eosinophilia, and anaphylaxis. Hepatobiliary disorders: transient elevation of transaminases.

If you experience side effects, talk to your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is a possible side effect 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 help provide more information on the safety of this medicine.

5. Storage of Cefazoline Normon

Keep this medicine 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 up to 8 hours at 25°C and up to 24 hours if stored in the refrigerator (2-8°C).

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Do not use this medicine if you notice visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cefazoline Normon

The active substance is cefazoline sodium. Each vial contains 2 g of cefazoline (sodium).

Appearance of the product and contents of the pack

Cefazoline Normon 2 g is presented in the form of powder for solution for injection. Each pack contains one vial of cefazoline powder.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

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

Information for healthcare professionals

Instructions for the correct administration of the product:

Before administration, drugs administered intravenously should be visually inspected for discoloration, if the solution and container allow it.

Continuous or intermittent intravenous infusion:It can be administered through the main infusion systems for liquids, controlling the infusion rate or in a second infusion bag. The reconstitution of 2 g of cefazoline can be performed 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.

Date of the last revision of this leaflet:October 2022

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