Intrazolina 500 mg powder and solvent for solution for injection and for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

INTRAZOLINA 500 mg powder and solvent for injection and infusion solution

Cefazolin

Read the entire leaflet carefully before you start using this medicine, because 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 and you should not give it 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.

Leaflet contents:

1. What INTRAZOLINA 500 mg powder and solvent for injection and infusion solution is and what it is used for
2. What you need to know before using INTRAZOLINA 500 mg powder and solvent for injection and infusion solution
3. How to use INTRAZOLINA 500 mg powder and solvent for injection and infusion solution
4. Possible side effects
5. How to store INTRAZOLINA 500 mg powder and solvent for injection and infusion solution
6. Contents of the pack and other information

1. What Intrazolina 500 mg powder and solvent for injectable solution and for infusion is and what it is used for

Intrazolina 500 mg is a medicine that contains the active substance Acidum ascorbicum (also known as vitamin C). It is supplied as a powder and solvent to prepare a solution for intravenous injection or infusion.

This medicine is used to treat vitamin C deficiency (hypovitaminosis C or scurvy) and conditions where increased requirements for vitamin C exist, such as during infections, convalescence, or periods of stress. It may also be used as an antioxidant in certain clinical situations.

The preparation is intended for intravenous administration only, either as a slow injection or as an infusion, depending on the prescribed dose and medical indication.

INTRAZOLINE 500 mg is used for the treatment of the following bacterial infections:

• Respiratory tract infections
• Urinary tract infections
• Skin and soft tissue infections
• Gallbladder and biliary tract infections
• Bone and joint infections
• Heart infections
• Infection caused by bacteria entering the bloodstream (septicemia)
• Prevention of infections in surgery

2. Before using Intrazolina 500 mg powder and solvent for injectable and perfusion solution

Do not use INTRAZOLINA 500 mg

• If you are allergic (hypersensitive) to cefazolin, to other cephalosporins, or to any of the other components of INTRAZOLINA 500 mg.

Warnings and precautions

• If you develop severe and persistent diarrhoea, it may be due to a special type of colitis called pseudomembranous colitis, which can be serious. In this case, your doctor will stop cefazolin treatment and initiate appropriate therapy.
• If you are undergoing prolonged treatment with INTRAZOLINA, other infections (superinfections) may occur due to overgrowth of certain organisms such as Candida.
• If you have renal impairment, your doctor may need to adjust the dose of cefazolin you receive.
• If you need to undergo blood tests, you must inform healthcare personnel that you are being treated with this medicine, as cefazolin may interfere with test results.
• Signs of allergic reactions, including respiratory problems and chest pain, have been reported with the use of cefazolin. Immediately discontinue use of cefazolin and contact your doctor immediately or go to the emergency department if you notice any of these signs.

Use of INTRAZOLINA with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

INTRAZOLINA must not be administered simultaneously with:

• Other antibiotics with a similar mechanism of action such as tetracyclines, sulfonamides, erythromycin, and chloramphenicol
• Medicines that help make the blood less prone to clotting (anticoagulants)
• Probenecid
• Medicines that are toxic to the kidneys

Pregnancy, breastfeeding, 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.

During pregnancy, your doctor will decide whether it is appropriate to use this medicine.

Consult your doctor or pharmacist before taking any medicine.

If you are breastfeeding, your doctor will decide whether it is appropriate to use this medicine.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Cefazolin generally does not affect the ability to drive or operate machinery.

INTRAZOLINA 500 mg contains sodium.

Patients on sodium-restricted diets should be aware that this medicine contains 51 mg (2.22 mmol) of sodium per dose.

3. How to use Intrazolina 500 mg powder and solvent for injectable solution and for infusion

Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

This medicine can be administered by intramuscular injection or by intravenous injection slowly.

Remember that administration must be performed by medical personnel.

Remember to request administration of your medicine.

Your doctor will indicate the appropriate dose and determine the duration of your treatment; do not stop or extend it prematurely.

A dose reduction may be necessary if you have any renal or hepatic impairment. In such case, inform your doctor so that your dose can be properly adjusted.

The recommended dose is:

Adults and adolescents (12 to 18 years of age): in 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.

Paediatric population (over 1 year and under 12 years of age) and infants (over 1 month and under 12 months 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 must not exceed 100 mg/kg, even in cases of severe infection.

If you use more INTRAZOLINA 500 mg than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount used.

If you forget to use INTRAZOLINA 500 mg

Do not use a double dose to make up for missed doses.

If you interrupt treatment with INTRAZOLINA 500 mg

Do not stop treatment before completion, as the desired effect will not be achieved. It is very important to treat infections for the recommended duration; otherwise, the condition could worsen.

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

4. Possible adverse effects

Like all medicines, INTRAZOLINA 500 mg may cause adverse effects, although not everyone experiences them.

The following adverse effects have been reported according to the frequencies detailed below:

Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Frequency not known: cannot be estimated from available data

Infections and infestations:
Genital infections.

Blood and lymphatic system disorders:
Decrease in the number of white blood cells, red blood cells, and platelets.

Immune system disorders:
The most frequent are skin lesions, which may vary in appearance. Other possible reactions include itching, facial swelling, and difficulty breathing.

Nervous system disorders:
Dizziness, malaise, fatigue, difficulty sleeping, nightmares, weakness, and seizures.

Gastrointestinal disorders:
Nausea, loss of appetite, vomiting, diarrhea, mouth ulcers, and anal itching.

Hepatobiliary disorders:
Transient increase in certain liver enzymes (transaminases), rarely hepatitis and yellowing of the skin (jaundice).

Skin and subcutaneous tissue disorders:
Itching of the genitals.

Renal and urinary disorders:
Increased blood urea, which may indicate impaired kidney function; rarely, inflammation of the kidneys.

General disorders and administration site conditions:
Pain at the site of intramuscular injection and inflammation of the vein at the injection site.

Other possible adverse effects

Cardiac disorders:
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.

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

5. Storage of Intrazolina 500 mg powder and solvent for injectable and infusion solution

Keep this medicine out of the sight and reach of children.

Store in the original packaging to protect from light.

Do not store above 25°C.

The reconstituted solution with the solvent is stable for 8 hours at a temperature not exceeding 25°C and for 24 hours if stored in a refrigerator (2-8°C).

Do not use INTRAZOLINA 500 mg after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and empty containers at the SIGRE point located at your pharmacy. If you are 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 pack and other information

Composition of INTRAZOLINA 500 mg

The active substance is cefazolin.

Each vial contains 500 mg of cefazolin (as sodium cefazolin). The other component is: water for injections.

Appearance of the product and contents of the pack

INTRAZOLINA 500 mg is presented as a white or almost white, or slightly yellowish, powder and solvent for injectable solution. It is supplied in packs containing 1 vial with 500 mg of cefazolin powder and 1 ampoule of 2 ml of water for injections as solvent, and clinical packs containing 100 vials and 100 solvent ampoules.

Other presentations

INTRAZOLINA 1,000 mg powder and solvent for injectable solution and for perfusion: pack containing 1 vial + 1 ampoule of 4 ml of water for injections. Clinical pack containing 100 vials + 100 ampoules.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder

LDP-LABORATORIOS TORLAN, S.A.

Ctra. de Barcelona, 135-B

08290 Cerdanyola del Vallès

Barcelona

Manufacturer

LDP-LABORATORIOS TORLAN, S.A.

Ctra. de Barcelona, 135-B

08290 Cerdanyola del Vallès

Barcelona

or

• BRAUN MEDICAL, S.A.

Huelma, 5. Poligono Industrial Los Olivares. (Jaen) - 23009 - Spain

or

LABORATORIOS INIBSA, S.A

Ctra Sabadell-Granollers, km 14,5. (Llissa de Vall) - 08185 - Spain

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

Warning: For use by healthcare professionals only

This information is intended solely for physicians or healthcare professionals:

• Stability of reconstituted Intrazolina solution:

After reconstitution, Intrazolina may be stored for up to 3 hours at temperatures below +25°C and for up to 6 hours between +2°C and +8°C.

A slightly yellowish coloration of the solution does not indicate any loss of antibiotic efficacy or reduced tolerability. Solutions with a brownish-yellow or brown color must not be administered.

The stability of Intrazolina solution at concentrations of 5 mg/ml to 10 mg/ml is satisfactory in the following infusion fluids:

• Sodium chloride 0.9%

• Glucose 5% or 10%

• Glucose 5% in Ringer lactate

• Sodium chloride 0.9% and Glucose 5%

• Sodium chloride 0.45% and Glucose 5%

• Ringer lactate

• Fructose 5% or 10% in water for injection

• How to prepare this medicine

INTRAZOLINA 500 mg should be administered according to the following instructions:

Intravenous administration

Intrazolina may be administered by direct intravenous injection or by continuous or intermittent infusion.

For direct intravenous injection (bolus):

Intravenous injection: 500 mg reconstituted and diluted in 10 ml of water for injection. The solution should be injected slowly over 3 to 5 minutes (must not be administered in less than three minutes).

For continuous or intermittent intravenous infusion:

Intrazolina may be administered through standard intravenous infusion systems, with control of infusion rate, or via a secondary intravenous infusion bag. The 500 mg cefazolin should be reconstituted with its solvent and then diluted in 50 to 100 ml of one of the following intravenous solutions:

• Sodium chloride 0.9%
• Glucose 5% or 10%
• Glucose 5% in Ringer lactate
• Sodium chloride 0.9% and Glucose 5%
• Sodium chloride 0.45% and Glucose 5%
• Ringer lactate
• Fructose 5% or 10% in water for injection

Intramuscular administration

For intramuscular injection, INTRAZOLINA 500 mg is reconstituted with the solvent provided in the accompanying ampoule (4 ml of water for injections). Shake well until dissolved. Cefazolin should be injected into a large muscle mass.

Intramuscular cefazolin may cause pain at the injection site.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/