CEFAZOLINE NORMON 1 g POWDER AND SOLVENT FOR INTRAVENOUS INJECTION SOLUTION

Introduction

Package Leaflet: Information for the Patient

Cefazoline Normon 1 g Powder and Solvent 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 experience 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 Package Leaflet:

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

Cefazoline is an antibiotic belonging to the group of cephalosporins.

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

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

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

Do not use Cefazoline Normon

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

If you have ever had a severe allergic reaction to penicillin or a similar antibiotic

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting treatment with Cefazoline Normon.

• If you have had a mild allergic reaction to penicillin or other similar antibiotics, for example, skin rashes that may cause itching.
• If you are allergic to something not mentioned in this leaflet.
• If you have had intestinal disorders, especially colitis (inflammation of the intestine).
• If you have kidney problems.
• If you are on a low-sodium diet.

• Risk factors that may lead to vitamin K deficiency or risk factors that affect other blood coagulation mechanisms.
• Rarely, 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.

• This medicine should not be injected into the area near the spinal cord (intrathecally), as cases of central nervous system toxicity (including seizures) have been reported.

• Prolonged use of cefazoline may lead to superinfections. Your doctor will closely monitor you for these and treat them if necessary.

• Children
• Cefazoline Normon should not be used in premature babies or infants in the first month of life.

• Use of Cefazoline with other medicines
• Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter medicines and herbal medicines, as Cefazoline Normon may affect how other medicines work. Additionally, other medicines may affect how Cefazoline Normon works.

• It is very important to consult your doctor or nurse, especially if you are taking any of the following medicines:
• Aminoglycosides or other antibiotics (used to treat infections).
• Probenecid (used to treat gout).
• Vitamin K.
• Anticoagulants (blood-thinning medicines).
• Furosemide (a medicine to increase urine production).

• You should also inform your doctor or nurse if you need to undergo tests to measure glucose levels or other blood tests.

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

Driving and using machines

Generally, cefazoline does not affect the ability to drive or use machines. However, side effects may occur (see also section “Possible side effects”) that can affect the ability to drive and use machines.

Cefazoline Normon contains sodium

This medicine contains 48mg of sodium (main component of table salt) per vial. This is equivalent to 2.4% of the maximum recommended daily sodium intake for an adult, which should be taken into account in the treatment of patients on low-sodium diets.

3. How to use Cefazoline Normon

Follow exactly the administration instructions of Cefazoline Normon as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Cefazoline should only be administered by properly qualified personnel (doctors or other healthcare professionals).

Remember to use your medicine.

Your doctor will indicate the duration of your treatment with Cefazoline Normon.

The selected dose should be established according to the infection, the patient's condition, and the sensitivity of the causative agent to cefazoline.

The recommended dose is:

Adults and children over 12 years:for mild infections, 500 mg every 8 hours (total daily dose 1.5g); for moderate to severe infections, 500 mg to 1g every 6 or 8 hours (total daily dose 3g-4g); for severe infections, 1 to 1.5g every 6 hours (total daily dose 4g-6g).

Children (under 12 years and over 1 month):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 cases of mild to moderate infections. The total daily dose should not exceed 100 mg/kg, even in cases of severe infections.

Prevention of surgical infections / postoperative infections in adults

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

• for prolonged surgical procedures (e.g., 2 hours or more) 500 mg to 1 g i.v. during surgery (dosage will be adjusted depending on the duration of the procedure).

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

Prevention of surgical infections / postoperative infections in children

• 25-30 mg/kg for children up to a maximum of 50 mg/kg (the maximum dose cannot exceed 2 g).

It is important that the preoperative dose is administered just before (1/2 to 1 hour) starting the procedure. Similarly, cefazoline will be administered, if necessary, at appropriate intervals during the procedure.

In patients for whom infection at the surgical site may pose a serious risk (e.g., open-heart surgery and prosthetic joint replacement), prophylactic administration of cefazoline may be continued for 3 to 5 days after surgery. If signs of infection appear, samples should be taken for culture to identify the causative agent and initiate appropriate therapy.

Patients with renal insufficiency

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

Duration of treatment

The duration of treatment depends on the course of the disease. According to the general principles of antibiotic therapy, cefazoline should be continued for at least 2 to 3 days after the fever has subsided or the test for eradication of the causative agent has been obtained.

Method of administration

Cefazoline is administered intravenously.

If you use more Cefazoline Normon than you should

Consult your doctor or pharmacist immediately. 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 impaired (see section 3. How to use Cefazoline Normon). If seizures occur, administration of the medicine should be discontinued 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.

If you stop using Cefazoline Normon

Stopping treatment too soon may compromise the outcome of therapy or lead to a relapse, which is more difficult to treat. Follow your doctor's instructions.

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

4. Possible side effects

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

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 may cause difficulty breathing or swallowing.
• Sudden swelling of hands, feet, and ankles.

Other possible side effects

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

• Skin 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 lead to the proliferation of non-susceptible bacteria.
• Increased or decreased blood cell count.
• Hyperglycemia (high blood sugar), hypoglycemia (low blood sugar)
• Dizziness.
• Respiratory disorders (breathing).
• Disorders of the kidneys and urinary tract.
• Cough.
• Runny nose.
• 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).
• Extreme fatigue and weakness.
• Chest pain.

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

• Blood coagulation disorders.
• Colitis. Symptoms include diarrhea, usually with blood and mucus, abdominal pain, and fever.
• Genital itching.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects 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 out of the sight and reach of children.

Store in the original packaging to protect 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. Return the packaging and any unused medicines to the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

From a microbiological point of view, unless the method of opening/reconstitution/dilution excludes the risk of microbial contamination, the product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and should not exceed the times above for chemical and physical stability in use.

6. Contents of the pack and other information

Composition of Cefazoline Normon

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

Each vial of Cefazoline Normon contains 1g of cefazoline (as cefazoline sodium)

The other ingredients are:

Solvent ampoule: water for injections

Appearance of the product and pack contents

Each pack of Cefazoline Normon 1 g contains a vial with a white or almost white powder, presented in a clear type II glass vial closed with a bromobutyl stopper and sealed with a silver-colored aluminum cap and an ampoule with type I glass of 4ml of solvent, a clear and colorless solution. (water for injection)

Pack sizes:

• 1 vial and 1 ampoule
• 100 vials and 100 ampoules

Other presentations: Cefazolin Normon 1 g powder and solvent for solution for intramuscular injection.

Information for healthcare professionals

Instructions for the correct administration of the product:

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

Continuous or intermittent intravenous infusion:can be administered through the main infusion systems of liquids, controlling the infusion rate or in a second infusion bag. Reconstitute 1 g of cefazoline with its own solvent (not with lidocaine) and then dilute the solution (1 g of reconstituted product) with 50-100 ml of one of the following intravenous solutions:

Sodium chloride 0.9%,

glucose 5%,

glucose 10%,

Ringer lactate.

Direct intravenous injection:dilute 1 g of the reconstituted product in a minimum of 10 ml of water for injections. Inject the solution slowly over 3 to 5 minutes.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the last revision of this leaflet:November 2021

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/