Label: Information for the Patient

Cefazolina Normon 1g Powder and Diluent for Injectable Solution Intramuscular 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 only for you 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 in surgery and postoperative periods.

Do not use Cefazolina Normon

If you are allergic to cefazolin, or any of its components listed in section 6.

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

If you are allergic to lidocaine and Cefazolina Normon will be administered as an injection into a muscle.

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 leaflet.

•If you have had gastrointestinal disorders, especially colitis (inflammation of the intestine).

•If you have kidney problems.

•If you are on a low-sodium diet.

Risk factors that may cause vitamin K deficiency or risk factors that affect other mechanisms of blood coagulation.

In rare cases, blood coagulation disorders may occur during treatment with cefazolin. 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 blood coagulation will be monitored.

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

Prolonged use of cefazolin may cause overinfections. Your doctor will closely monitor you for any signs of overinfections 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 to 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, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

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

Cefazolina Normon contains sodium

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

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

Cefazolin 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 should be established according to the infection, the patient's condition, and the sensitivity of the causal agent to cefazolin.

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 intramuscular administered 1/2 to 1 hour before starting surgery.

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

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

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 cannot exceed 2 g)

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

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

Patients with renal insufficiency

Cefazolin 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, cefazolin 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

Cefazolin is administered by deep intramuscular injection.

If you use more Cefazolina Normon than you should

Consult your doctor or pharmacist. The administration of inappropriate large doses of parenteral cephalosporins can cause convulsions, 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 convulsions 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 the 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 (skin hardening) at the injection site.

Uncommon(may affect up to 1 in 100 people):

• Oral thrush infection.
• Fever.
• Seizures.
• Phlebitis (inflammation of the veins).
• 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 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 (breathing).
• 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). Symptoms include diarrhea, often 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, pharmacist, or nurse, 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 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 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. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacisthow to disposeofthepackaging and of themedications that you no longerneed. 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 in the vial is cefazolin (as cefazolin sodium).

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

The other components are:

Diluent ampoule: lidocaine hydrochloride and water for injection preparations.

Product appearance and packaging contents

Each Cefazolina Normon 1 g package contains a vial with a white or almost white powder presented in a transparent type II soda lime glass vial closed with a bromobutyl stopper and sealed with an aluminum cap colored silver, and a type I glass ampoule of 4ml of diluent with a transparent, colorless, or slightly yellowish solution (lidocaine).

Box sizes:

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

Other presentations: Cefazolin Normon 1 g powder and diluent for intravenous injection solution.

Information for healthcare professionals

Instructions for correct product administration:

Intramuscular route: reconstitute the powder with the diluent ampoule (lidocaine). Stir until dissolved. Cefazolin must be injected into a large muscle mass. Pain at the injection site is not common, as the diluent ampoules contain lidocaine.

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