Cefazolin LDP Laboratorios Torlan 1 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 1 g powder for injectable solution and for infusion EFG.

Read all of this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as 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 may 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
• Septicemia (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 Cefazolina LDP-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 Cefazolina by intramuscular injection.

Warnings and precautions

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

• If you have 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 immediately or go to emergency services if you notice any of these signs.

Risk factors that may cause 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 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 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 superinfection. Your doctor will closely monitor you for this and treat it 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 medicines available without a prescription and herbal medicines, as Cefazolin may affect how other medicines work. Likewise, 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 medicine to increase urine production).

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 plan 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 or operate machinery. However, adverse reactions may occur (see also section “Possible side effects”) that could affect the ability to drive and operate machinery.

Cefazolina LDP-Laboratorios TORLAN contains sodium

This medicine contains 48 mg of sodium (the main component of table/cooking salt) per vial. This corresponds to 2.4% of the maximum daily recommended sodium intake 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, consult your doctor or pharmacist.

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

• By intramuscular injection (e.g., into a muscle of the arm).
• By slow injection into a vein (may last 3–5 minutes).
• Through a small tube inserted into a vein (this method is called "intravenous infusion").

Remember to use your medication as prescribed.

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

The recommended dose is:

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

Children (under 12 years of age and over 1 month of age):
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:

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

• For prolonged surgical procedures (e.g., 2 hours or longer), 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:

25–30 mg/kg for children, up to a maximum of 50 mg/kg (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 the procedure. 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 to identify the causative organism, so that appropriate therapy can be initiated.

Adults and children with reduced renal 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 until eradication of the causative agent has been confirmed.

If you have been given more cefazolin LDP-laboratorios TORLAN than you should

Inform your doctor or nurse if you think you have been given too much cefazolin.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, 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, 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 adverse effects

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

• Skin rash.
• Nausea and vomiting.
• Diarrhea.
• Pain or induration (hardening of the 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 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 lead to overgrowth of non-susceptible bacteria.
• Increase or decrease in blood cell counts.
• Hyperglycaemia (high blood sugar), hypoglycaemia (low blood sugar).
• Dizziness.
• Respiratory disorders (breathing).
• Disorders of the kidneys and urinary tract.
• Cough.
• Rhinorrhoea.
• Loss of appetite.
• Hepatic 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 clotting 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 solution reconstituted with sterile water or 1% lidocaine solution 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 after "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. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy or through any other medicine waste collection system. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and additional information for Cefazolina LDP-Laboratorios TORLAN

Composition of cefazolin LDP-Laboratorios Torlan

The active substance is cefazolin. Each vial of Cefazolin LDP-Laboratorios TORLAN contains 1 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:

Before administration, drugs administered intravenously should be visually inspected for discoloration, whenever solution and container permit.

Stability 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 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 responsibility of the user, but in any case should not exceed 8 hours at 25 °C or 24 hours between 2–8 °C.

Instructions for correct administration of the product:

- Intramuscular administration: Cefazolin 1 g should be reconstituted with 10 ml of sterile water or with 4 ml of 1% lidocaine solution. Shake well until dissolved. Cefazolin must be injected into a large muscle mass.

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

a) Continuous or intermittent intravenous infusion: Cefazolin may be administered via the main intravenous fluid infusion systems, controlling the infusion rate, or into a secondary intravenous infusion bag.

Where: Reconstitution of 1 g of cefazolin should initially be performed with 5 ml of sterile water, and then diluted with 50 to 100 ml of one of the following intravenous solutions:

0.9% Sodium chloride.

10% Glucose.

5% Glucose in Ringer's lactate.

0.9% Sodium chloride and 5% Glucose.

Ringer's solution.

Ringer's lactate.

b) Direct intravenous injection (bolus): Dilute 1 g of reconstituted cefazolin in a minimum of 10 ml. Inject the solution slowly over 3 to 5 minutes (must not be administered in less than three minutes).