Cefazolin LDP Laboratorios Torlan 2 g powder for injection and for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

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

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Package leaflet:

1. What Cefazolin LDP-Laboratorios TORLAN is and what it is used for
2. What you need to know before using Cefazolin LDP-Laboratorios TORLAN
3. How to use Cefazolin LDP-Laboratorios TORLAN
4. Possible side effects
5. How to store Cefazolin LDP-Laboratorios TORLAN
6. Contents of the pack and other information

1. What Cefazolina LDP-Laboratorios TORLAN is and what it is used for

This medicine contains the active substance cefazolin (in the form of cefazolin sodium).

Cefazolin belongs to a group of antibiotics called cephalosporins, which work by killing bacteria.

Cefazolin 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 cefazolin. It is used to treat the following infections:

• 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 the postoperative period

2. What you need to know before starting to use Cefazolin LDP-Laboratorios TORLAN

Do not use cefazolin LPD-Laboratorios TORLAN

If you are allergic to sodium cefazolin.

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

If you are allergic to lidocaine and will receive Cefazolin by intramuscular injection.

Warnings and precautions

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

• If you have previously experienced 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.
• Signs of allergic reaction, including breathing difficulties and chest pain, have been reported with the use of cefazolin. Immediately discontinue use of cefazolin and contact your doctor or go to the emergency room if you notice any of these signs.

Risk factors that may lead to vitamin K deficiency or risk factors affecting other mechanisms of blood coagulation.

Rarely, blood coagulation disorders may occur during treatment with cefazolin. Additionally, changes in blood coagulation may occur in patients with conditions that may cause or worsen bleeding, such as hemophilia or stomach or intestinal ulcers. In these cases, your blood coagulation will be monitored.

This medicine must 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 lead to superinfections. Your doctor will monitor you closely for their occurrence and treat them if necessary.

Children

Cefazolin must not be used in premature infants or infants during the first month of life.

Other medicines and Cefazolin LDP-Laboratorios TORLAN

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This also applies to over-the-counter medicines and herbal remedies, as cefazolin may affect how other medicines work. In addition, other medicines may affect how cefazolin works.

It is very important that you 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 diuretic medicine).

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, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery

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

Cefazolin LDP-Laboratorios TORLAN contains sodium

This medicine contains 96 mg of sodium (the main component of table/cooking salt) in a two-gram dose. This corresponds to 4.8% of the maximum daily sodium intake recommended for an adult.

3. How to use Cefazolin LDP-Laboratorios TORLAN

Follow exactly the administration instructions for Cefazolin LDP-Laboratorios Torlan as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

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

• By slow injection into a vein (may last 3–5 minutes).
• Through a small tube into a vein (this method is called "intravenous infusion").

Remember to use your medicine as prescribed.

Your doctor will determine the dose of Cefazolin based on your age, weight, severity of infection, and kidney function. The doctor will explain this to you.

Adults and children over 12 years of age:
For mild infections: 500 mg every 8 hours.
For moderate to severe infections: 500 mg to 1 g every 6 or 8 hours.
For 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 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 infection.

Prevention of surgical/postoperative infections in adults:

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

• 1–2 g administered 30 to 60 minutes before starting surgery.

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

• 500 mg to 1 g every 6 to 8 hours during the first 24 hours postoperatively.

Prevention of surgical/postoperative infections in children:

1. 25–30 mg/kg for children, up to a maximum of 50 mg/kg (the maximum dose must not exceed 2 g). It is important that the preoperative dose is administered just before (30 to 60 minutes prior to) the start of surgery. Additionally, cefazolin should 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 arthroplasties), prophylactic administration of cefazolin may be continued for 3 to 5 days after surgery. If signs of infection occur, samples should be taken for culture in order to identify the causative organism and initiate appropriate therapy.

Adults and children with reduced kidney function

If you have kidney problems, you may receive a lower dose. A blood test may be necessary to ensure you have received an adequate dose.

Duration of treatment

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 fever has subsided or after confirmation of eradication of the causative agent.

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 Cefazolin.

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

If you have any further questions about the use of this medicine, ask your doctor or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Severe allergic reactions (very rare, may affect up to 1 in 10,000 people).

If you experience a severe allergic reaction, tell 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 adverse effects

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

• Skin rash.
• Nausea and vomiting.
• Diarrhea.
• Pain or hardening (hardened skin) at the injection site.

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

• Fungal mouth infection.
• Fever.
• Seizures (attacks).
• Inflammation of the veins.
• Itching and redness of the skin, joint pain, skin lesions, generalized rash and hives.

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

• Genital infection, vaginal candidiasis — vaginal pain and itching or vaginal discharge.
• Prolonged use may lead to overgrowth of non-sensitive bacteria.
• Increase or decrease in blood cell counts.
• Hyperglycaemia (high blood sugar level), hypoglycaemia (low blood sugar level).
• Dizziness.
• Respiratory disorders (breathing).
• Disorders of the kidneys and urinary tract.
• Cough.
• Rhinorrhea.
• Loss of appetite.
• Liver failure (detectable in blood tests), jaundice.
• Severe rapidly progressing rash (with blisters on the skin and skin peeling, and possible blisters in the mouth).
• Severe fatigue and weakness.
• Chest pain.

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

• Blood coagulation disorders.
• Inflammation of the colon. Symptoms include diarrhoea, usually with blood and mucus, abdominal pain and fever.
• Genital itching.

Frequency not known (cannot be estimated from available data):

• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Cefazolin LDP-Laboratorios TORLAN

Keep out of the sight and reach of children.

This medicine does not require special storage conditions.

The reconstituted solution with sterile water is stable for up to 8 hours at 25 °C and for up to 24 hours if stored in the refrigerator (2-8 °C).

Do not use this medicine after the expiry date stated on the vial label and outer packaging following «EXP». The expiry date refers to the last day of the month indicated.

Do not use this medicine if visible signs of deterioration are observed.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the package and other information of Cefazolina LDP-Laboratorios TORLAN

Composition of cefazolin ldp-laboratorios torlan

The active substance is cefazolin. Each cefazolin vial from ldp-laboratorios torlan contains 2 g of cefazolin (as cefazolin sodium).

Appearance of the product and contents of the container

Each container of Cefazolina LDP-Laboratorios TORLAN contains a vial with a white or almost white powder.

Marketing Authorization Holder and Manufacturing Responsible

LDP-Laboratorios TORLAN S.A.

Ctra de Barcelona, 135 B

08290 Cerdanyola del Vallès, Barcelona

Spain

Local Representative

LAPHYSAN, SAU

C/ Anabel Segura nº11. Building A. 4th Floor. Door D

28108 Alcobendas, Madrid

Spain

Date of the most recent review of this leaflet: March 2026

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/

This information is intended exclusively for healthcare professionals:

Shelf-life 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 refrigerated (2–8 °C). From a microbiological standpoint, the product should be used immediately. If not used immediately, storage times and conditions prior to use are the user's responsibility and should not exceed 8 hours at 25 °C or 24 hours at 2–8 °C.

Instructions for correct administration of the product:

• Intravenous administration: Cefazolin 2 g may be administered by direct intravenous injection or by continuous or intermittent infusion (never dissolved in lidocaine). Two administration methods are distinguished:

a) Continuous or intermittent intravenous infusion: cefazolin can be administered through standard intravenous fluid delivery systems, controlling the infusion rate, or via a secondary intravenous infusion bag.

Reconstitution of 2 g of cefazolin should initially be performed with 10 ml of sterile water, followed by dilution in 100 ml of one of the following intravenous solutions:

Sodium chloride 0.9%.

Dextrose 10%.

Dextrose 5% in lactated Ringer's.

Sodium chloride 0.9% and dextrose 5%.

Ringer's solution.

Lactated Ringer's solution.

b) Direct intravenous injection (bolus): dilute the reconstituted 2 g in a minimum of 20 ml of sterile water. Inject the solution slowly over 3 to 5 minutes (should not be administered in less than three minutes).