Intrazolina 1000 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 1,000 mg powder and solvent for solution for injection and for infusion

Cefazolin

Read all of this 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 must not be given to other people, even if they have the same symptoms, as it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet.

Leaflet contents:

1. What INTRAZOLINA 1,000 mg powder and solvent for solution for injection and for infusion is and what it is used for
2. What you need to know before using INTRAZOLINA 1,000 mg powder and solvent for solution for injection and for infusion
3. How to use INTRAZOLINA 1,000 mg powder and solvent for solution for injection and for infusion
4. Possible side effects
5. How to store INTRAZOLINA 1,000 mg powder and solvent for solution for injection and for infusion
6. Contents of the pack and other information

1. What Intrazolina 1,000 mg powder and solvent for injection solution and for infusion is and what it is used for

Intrazolina 1,000 mg is a medicine that contains the active substance Acidum ascorbicum (ascorbic acid, also known as vitamin C). It is supplied as a powder and solvent to be reconstituted into a solution for intravenous injection or infusion.

This medicine is used for the treatment of vitamin C deficiency (hypovitaminosis C or scurvy), especially when oral administration is not possible or not sufficient. It may also be used as an antioxidant in certain conditions involving increased oxidative stress, or as an adjunct in the treatment of certain diseases where high-dose vitamin C is indicated.

The solution is administered by healthcare professionals either as a slow intravenous injection or as an intravenous infusion, depending on the dose and clinical condition.

INTRAZOLINA 1,000 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 1,000 mg powder and solvent for injectable solution and for infusion

Do not use INTRAZOLINA 1,000 mg

• If you are allergic (hypersensitive) to Cefazolin, to other cephalosporins, or to any of the other components of INTRAZOLINA 1,000 mg.

Warnings and precautions

• If you develop severe and persistent diarrhoea, this may be due to a specific type of colitis called pseudomembranous colitis, which can be serious. In such case, your doctor will discontinue cefazolin and initiate appropriate treatment.
• 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 are 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 cefazolin and contact your doctor or go to the emergency room if you notice any of these signs.

Use of INTRAZOLINA with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take 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 viscous (anticoagulants)
• Probenecid
• Medicines toxic to the kidneys

Pregnancy, breastfeeding, 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.

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 use of machines

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

INTRAZOLINA 1,000 mg contains sodium.

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

3. How to use Intrazolina 1,000 mg powder and solvent for injectable solution and for infusion

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

This medicine can be administered by intramuscular injection or by intravenous route via slow injection.

Remember that administration must be performed by medical personnel.

Remember to request administration of your medicine.

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

A dose reduction may be necessary if you have renal or hepatic impairment. In such cases, inform your doctor so that your dose can be appropriately 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 should not exceed 100 mg/kg, even in cases of severe infection.

If you use more INTRAZOLINA 1,000 mg than you should

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

If you forget to use INTRAZOLINA 1,000 mg

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

If you stop treatment with INTRAZOLINA 1,000 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, your condition may 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 1,000 mg may cause adverse effects, although not everyone will experience 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:

Most commonly, skin lesions with varying appearance. Other possible reactions include itching, facial swelling, 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 genital area.

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 intramuscular injection site 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 1,000 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 1,000 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 their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of INTRAZOLINA 1.000 mg

The active substance is cefazolin.

Each vial contains 1,000 mg of cefazolin (as cefazolin sodium). The other components are: water for injectable preparations.

Appearance of the product and contents of the pack

INTRAZOLINA 1.000 mg is presented as a white or almost white powder, or slightly yellowish, and solvent for injectable solution. It is supplied in packs containing 1 vial with 1,000 mg of cefazolin powder and 1 ampoule with 4 ml of water for injectable preparations as solvent, and clinical packs containing 100 vials and 100 solvent ampoules.

Other presentations

INTRAZOLINA 500 mg powder and solvent for injectable solution and for perfusion: pack containing 1 vial + 1 ampoule with 2 ml of water for injectable preparations. Clinical pack with 100 vials + 100 solvent ampoules.

Only certain pack sizes may be marketed.

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: Use exclusively by a healthcare professional

This information is intended only for doctors 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 up to 6 hours between +2°C and +8°C.

A slightly yellow coloration of the solution does not indicate a loss of antibiotic efficacy or reduced tolerance. 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 1.000 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: 1,000 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 can be administered through standard intravenous infusion systems, with control of the infusion rate, or into a secondary intravenous infusion bag. Reconstitution of 1,000 mg cefazolin may be performed 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 1.000 mg is reconstituted with the solvent provided in the accompanying ampoule (4 ml of water for injectable preparations). 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 Health Products (AEMPS) http://www.aemps.es/