Label: Information for the Patient

Cefazolina Normon 1 g Powder and Diluent for Injectable Solution for Intravenous Use EFG

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

- Keep this label, as you may need to read it again.

- If you have any questions, consult your doctor or pharmacist.

- This medication has been prescribed to you alone and should not be given 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 label. See section 4.

Cefazolina is an antibiotic belonging to the cefalosporins group.

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

• 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 (heart lining infection)
• Prevention of infections during and after surgery

Do not use Cefazolina Normon

If you are allergic to cefazolina or any of the other components of this medication (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 to use Cefazolina 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 prospectus.
• 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.

• Factors that may cause vitamin K deficiency or factors that affect other mechanisms of blood coagulation.
• In rare cases, blood coagulation disorders may occur during treatment with cefazolina. Additionally, changes in blood coagulation may occur in patients with diseases that may cause or worsen bleeding, such as hemophilia or stomach or intestinal ulcers. In these cases, your coagulation will be monitored.

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

• Prolonged use of cefazolina may cause overinfections. Your doctor will closely monitor you for this and treat you if necessary.

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

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

• It is very important that you consult your doctor or nurse, especially if you are taking any of the following medications:
• Aminoglycosides or other antibiotics (used to treat infections).
• Probenecid (used to treat gout).
• Vitamin K.
• Anticoagulants (blood thinners).
• Furosemide (diuretic).

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

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

Driving and operating machinery

Cefazolina generally has no influence on the ability to drive vehicles or operate machinery. However, adverse reactions (see also the section “Possible side effects”) may occur that may affect the ability to drive and operate machinery.

Cefazolina Normon contains sodium

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

Follow exactly the administration instructions of Cefazolina Normon indicated by your doctor or pharmacist. In case of doubts, ask your doctor or pharmacist.

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

Remember to use your medication.

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

The selected dose must be established according to the infection, the patient's condition, and the sensitivity of the causal agent to cefazolina.

The recommended dose is:

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

Surgical site infection prevention / postoperative in adultsThe recommended doses for preventing postoperative infection in surgery are as follows:

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

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

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

Surgical site infection prevention / postoperative in children

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

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

In patients for whom the infection at the surgical site may present a severe risk (e.g., open-heart surgery and prosthetic joint arthroplasty) the prophylactic administration of cefazolina may be continued for 3 to 5 days after surgery. If signs of infection appear, samples should be obtained for culture to identify the causal germ, in order to initiate 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.

Treatment duration

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

Method of administration

Cefazolina is administered intravenously.

If you use more Cefazolina Normon than you should

Consult your doctor or pharmacist immediately. The administration of inappropriate large doses of parenteral cephalosporins can cause seizures, especially in patients with renal insufficiency. The dose should be reduced when renal function is altered (see section 3. How to use Cefazolina Normon). If seizures occur, discontinue 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 dose.

If you interrupt treatment withCefazolina Normon

Stopping treatment too soon may compromise the outcome of the therapy or cause 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.

Like all medicines, Cefazolina Normon may cause side effects, although not everyone will experience 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.

The 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

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

•Skin rash.

•Nausea and vomiting.

•Diarrhea.

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

Not very frequent (may affect up to 1 in 100 people):

•Oral fungal infection.

•Fever.

•Seizures.

•Phlebitis.

•Pruritus and skin redness, 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. 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 of 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 out of 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 the 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.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

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

Cefazolina Normon Composition

The active ingredient is cefazolin (sodium). Each vial contains 1 g of cefazolin (sodium).

Each vial of Cefazolina Normon contains 1g of cefazolin (as cefazolin sodium)

The other components are:

Injection vial: water for injection preparations

Appearance of the product and contents of the package

Each package of Cefazolina Normon 1 g contains a vial with a white or almost white powder, presented in a transparent type II soda glass vial closed with a bromobutyl stopper and sealed with an aluminum capsule colored silver and a vial with type I glass of 4ml of solvent, a transparent and colorless solution. (water for injection)

Packaging 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 correct administration of the product:

Before administration, drugs 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 rate or in a second intravenous infusion bottle. Reconstitute 1 g of cefazolin 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 injection preparations. Inject the solution slowly over 3 to 5 minutes.

Marketing authorization holder and responsible manufacturer

LABORATORIOS NORMON, S.A.

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

Last review date of this leaflet:November 2021

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