Prospecto: information for the patient

Cefazolina LDP-Laboratorios TORLAN 2 g powder for injectable solution and for infusion EFG.

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

• Keep this prospect, as you may have to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you and should not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Content of the prospect:

This medication contains the active ingredientcefazolina (in the form of cefazolina sodium).

Cefazolina belongs to a group of antibiotics calledcephalosporinsthat act byeliminating bacteria.

Cefazolina is used when it is known that an infection has been caused or is likely to be caused by a bacterium that is sensitive to cefazolina. It is used in the treatment ofthe followinginfections:

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

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No use cefazolina LPD-Laboratorios TORLAN

If you are allergic to cefazoline sodium.

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

If you are allergic to lidocaine and will be receiving Cefazolina by intramuscular injection.

Advertencias y precauciones

Consult your doctor, pharmacist, or nurse before starting to use Cefazolina LDP-Laboratorios TORLAN.

• If you have had a mild allergic reaction to penicillin or other similar antibiotics, for example, skin eruptions that may cause itching.
• If you are allergic to something that is not mentioned in this prospectus.
• 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.

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

Bleeding disorders may occur occasionally during treatment with cefazolina. Additionally, changes in blood coagulation may occur in patients with diseases that may cause or worsen bleeding, such ashemophilia or stomach or intestinal ulcers. In these cases, your coagulation will be monitored.

This medication should not be injected near the spinal cord (intrathecal), 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 any signs of overinfections and treat you if necessary.

Children

Cefazolinashould notbe used in premature babies or infants in the first month of life

Other medications and Cefazolina LDP-Laboratorios TORLAN

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 may affect the way other medications work. Additionally, other medications may affect the way Cefazolina 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, lactation, 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.

Driving and operating machinery

The influence of Cefazolina on the ability to drive and operate machinery is negligible. However, adverse reactions may occur (see also the section “Possible side effects”) that may affect the ability to drive and operate machinery.

Cefazolina LDP-Laboratorios TORLAN contains sodium

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

Follow exactly the administration instructions for Cefazolina LDP-Laboratorios Torlan as indicated by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

Cefazolina will be administered by a doctor or a nurse. It will be administered in one of the following ways:

• By slow injection into a vein (which may take 3-5 minutes).
• Through a small tube in a vein (this method is called "intravenous perfusion").

Remember to use your medication.

Your doctor will determine the dose of Cefazolina based on your age, weight, the severity of the infection, and the state of your kidneys. The doctor will explain it to you.

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 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 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 / postoperative infections in adults:

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

a) 1-2 g administered 30 minutes to 60 minutes before starting surgery.

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

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

Prevention of surgical / postoperative infections in children

In patients for whom the infection at the surgical site may pose a grave risk (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 to identify the causal germ, in order to initiate the appropriate therapy.

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Adults and children with reduced renal function

If you have kidney problems, you may receive a lower dose. It may be necessary to have a blood test to ensure that you have received a sufficient dose.

Treatment duration

The duration of treatment depends on the course of the disease. In accordance with the 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.

If you use more Cefazolina LDP-Laboratorios Torlan than you should

Inform your doctor or nurse if you think you have received an excessive amount of Cefazolina.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 915 620 420, indicating the medication and the amount ingested.

If you have any other doubts about the use of this medication, ask your doctor or nurse.

Like all medicines, this medicine 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:

• Swelling of the face, throat, mouth, or lips, which may cause difficulty breathing or swallowing.
• Swelling of the 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 hardening) at the injection site.

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

• Oral fungal infection.
• Fever.
• Seizures.
• Phlebitis.
• Pruritus and erythema of the skin, joint pain, skin lesions, generalized rash, and urticaria.

Rare(may affect up to 1in 1,000people):

• 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), hypoglycemia (low blood sugar)
• Dizziness.
• Respiratory disorders (respiration).
• Renal and urinary tract disorders.
• Cough.
• Rhinorrhea.
• Loss of appetite.
• Liver 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 10,000people):

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

Communication 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 prospectus. 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 the sight and reach of children.

This medication does not require special storage conditions.

The reconstituted solution with sterile water 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 that appears on the vial label and the outer 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. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Cefazolina LDP-Laboratorios Torlan Composition

The active ingredient is cefazoline. Each vial of cefazolina LDP-Laboratorios Torlan contains 2 g of cefazoline (in the form of cefazoline sodium).

Product Appearance and Packaging Contents

Each package of Cefazolina LDP-Laboratorios Torlan contains a vial with a white or almost white powder.

Marketing Authorization Holder and Responsible Manufacturer

LDP-Laboratorios Torlan S.A

Ctra de Barcelona, 135 B

08290 Cerdanyola del Vallès,Barcelona

Spain

Local Representative

LAPHYSAN, SAU

C/ Anabel Segura nº11. Edificio A. Planta 4. Puerta D

28108 Alcobendas, Madrid

Spain

Last Review Date of this Leaflet: September 2023

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

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This information is intended solely for healthcare professionals:

Validity Period after Reconstitution/Dilution:

After reconstitution:the reconstituted solution with sterile water or 1% lidocaine solution is stable for up to 8 hours at 25 °C and up to 24 hours if stored in the refrigerator (2-8 °C).From a microbiological point of view, the product should be used immediately. If not used immediately, storage times and usage conditions are the responsibility of the user, which should not exceed 8 hours at 25 °C and 24 hours between 2-8 °C

Instructions for Correct Product Administration:

-Intravenous Administration:Cefazoline 2g can be administered by direct intravenous injection or by continuous or intermittent infusion (never dissolved in lidocaine). Two forms of administration are distinguished:

a)Continuous or Intermittent Intravenous Infusion:cefazoline can be administered through the main liquid infusion systems, controlling the infusion rate or in a second intravenous infusion bottle.

The reconstitution of 2 g of cefazoline should be done initially in 10 ml of sterile water to then be diluted in 100 ml of one of the following intravenous solutions:

Sodium chloride 0.9%.

Glucose 10%.

Glucose 5% in Ringer lactate.

Sodium chloride 0.9% and glucose 5%.

Ringer.

Ringer lactate.

b)Direct Intravenous Injection (Bolus):dilute 2 g reconstituted in a minimum of 20 ml of sterile water. Inject the solution slowly over 3 to 5 minutes (do not administer in less than three minutes).

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