CEFAZOLIN LDP LABORATORIOS TORLAN 2g POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION

Introduction

Package Leaflet: Information for the Patient

Cefazoline LDP-Laboratorios TORLAN 2 g powder for solution for injection and infusion EFG.

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

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

This medicine contains the active substance cefazoline (as cefazoline sodium).

Cefazoline belongs to a group of antibiotics called cephalosporins that work by eliminating bacteria.

Cefazoline 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 cefazoline. 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 postoperative period

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

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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 are going to receive Cefazoline by intramuscular injection.

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

• If you have had a mild allergic reaction to penicillin or other similar antibiotics, such as skin rashes that may cause itching.
• If you are allergic to something that is 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.

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

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

This medicine should not be injected into the area near the spinal cord (intrathecally), as cases of central nervous system toxicity (including seizures) have been reported.

Prolonged use of cefazoline may cause superinfections. Your doctor will monitor you closely for these and treat them if necessary.

Children

Cefazoline should notbe used in premature babies or infants in the first month of life.

Other medicines and Cefazoline LDP-Laboratorios TORLAN

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter medicines and herbal medicines, as Cefazoline may affect how other medicines work. Additionally, other medicines may affect how Cefazoline 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 make you urinate).

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

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If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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Cefazoline has no influence on the ability to drive and use machines. However, side effects (see also section “Possible side effects”) may occur that can affect the ability to drive and use machines.

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

3. How to use Cefazoline LDP-Laboratorios TORLAN

Follow exactly the administration instructions of Cefazoline LDP-Laboratorios Torlan indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

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

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

Remember to use your medicine.

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

Adults and children over 12 years:for mild infections 500 mg every 8 hours; for moderate to severe infections 500 mg to 1 g every 6 or 8 hours; for 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 body 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 infections / postoperative in adults:

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

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

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

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

Prevention of surgical infections / postoperative in children

1. 25-30 mg/kg for children up to a maximum of 50 mg/kg (the maximum dose cannot exceed 2 g). It is important that the preoperative dose is administered just before (30 to 60 minutes) starting the procedure. Also, cefazoline will 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 joint replacement), prophylactic administration of cefazoline may continue for 3 to 5 days after surgery. If signs of infection appear, samples should be taken for culture to identify the causal germ and initiate appropriate therapy.

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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 that you have received a sufficient dose.

Duration of treatment

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

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Tell your doctor or nurse if you think you have received too much Cefazoline.

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 medicine and the amount ingested.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

If you have a severe allergic reaction, tell your doctor immediately.

Possible symptoms include:

• Sudden swelling of the face, throat, mouth, or lips, which may cause difficulty in breathing or swallowing.
• Sudden swelling of hands, feet, and ankles.

Other possible side effects

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

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

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

• Oral thrush.
• Fever.
• Seizures.
• Phlebitis.
• 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 blood cell count.
• Hyperglycaemia (high blood sugar), hypoglycaemia (low blood sugar)
• Dizziness.
• Respiratory disorders (breathing).
• Disorders of the kidneys and urinary tract.
• Cough.
• Runny nose.
• Lack of appetite.
• Liver failure (detectable in blood tests), jaundice.
• Severe rash with rapid progression (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.
• Colitis. Symptoms include diarrhoea, usually with blood and mucus, abdominal pain, and fever.
• Genital itching.

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If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cefazoline LDP-Laboratorios TORLAN

Keep out of sight and reach of children.

This medicine does not require any special storage conditions.

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

Do not use this medicine after the expiry date which is stated on the vial label and the outer packaging after ‘EXP’. The expiry date is the last day of the month stated.

Do not use this medicine if you notice visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information of Cefazoline LDP-Laboratorios TORLAN

Composition of cefazoline ldp-laboratorios torlan

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

Appearance and packaging of the product

Each pack of Cefazoline LDP-Laboratorios TORLAN contains a vial with a white or almost white powder.

Marketing authorisation holder and 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

Date of last revision of this leaflet: September 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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This information is intended only 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, the storage times and 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 the correct administration of the product:

• 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 differentiated:
  • Continuous or intermittent intravenous infusion: cefazoline can be administered through the main infusion systems of liquids, controlling the infusion rate or in a second infusion bag.

The reconstitution of 2 g of cefazoline should be done initially in 10 ml of sterile water and then 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.

• 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 (should not be administered in less than three minutes).

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