INTRAZOLINA 500 mg POWDER AND SOLVENT FOR INJECTABLE SOLUTION AND FOR INFUSION

Introduction

Package Leaflet: Information for the User

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

Cefazolin

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.

Contents of the pack and other information:

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

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

INTRAZOLINA 500 mg is used to treat the following bacterial infections:

• Respiratory infections
• Urinary infections
• Infections of the skin and soft tissues
• Infections of the gallbladder and bile ducts
• Infections of bones and joints
• Heart infections
• Infection caused by the passage of bacteria into the blood (septicemia)
• In the prevention of infections in surgery

2. Before using Intrazolina 500 mg powder and solvent for solution for injection and infusion

Do not use INTRAZOLINA 500 mg

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

Warnings and precautions

• If you experience intense and prolonged diarrhea, it may be due to a special type of colitis called pseudomembranous colitis, which can be severe. In this case, your doctor will suspend the administration of cefazolin and initiate appropriate treatment.
• If you undergo prolonged treatment with INTRAZOLINA, other infections (superinfections) may appear due to the overgrowth of certain organisms such as Candida.
• If you have kidney failure, your doctor may need to adjust the dose of cefazolin you receive.
• If you are going to have a blood test, inform the healthcare staff that you are being treated with this medicinal product, as cefazolin may interfere with the results.

Using INTRAZOLINA with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

INTRAZOLINA should not be administered simultaneously with:

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medicinal product.

In case of pregnancy, your doctor will decide whether to use this medicinal product.

Consult your doctor or pharmacist before taking any medicine.

In case of breastfeeding, your doctor will decide whether to use this medicinal product.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

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

INTRAZOLINA 500 mg contains sodium.

Patients on low-sodium diets should note that this medicinal product contains 51 mg (2.22 mmol) of sodium per dose.

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

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

This medicinal product can be administered by intramuscular injection or by slow intravenous injection.

Remember that administration must be carried out 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 suspend it before or prolong it.

A dose reduction may be necessary if you have any kidney or liver impairment. In such cases, inform your doctor so that they can adjust the dose accordingly.

The recommended dose is:

Adults and adolescents (12 to 18 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.

Pediatric population (over 1 year and under 12 years) and infants (over 1 month and under 12 months):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 infections.

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 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 forgotten doses.

If you interrupt treatment with INTRAZOLINA 500 mg

Do not suspend treatment before finishing it, as the desired effect will not be achieved. It is very important to treat infections for the recommended time; otherwise, they may worsen.

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

4. Possible side effects

Like all medicines, INTRAZOLINA 500 mg can cause side effects, although not everybody gets them.

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

Frequent: may affect up to 1 in 10 patients

Uncommon: may affect up to 1 in 100 patients

Rare: may affect up to 1 in 1,000 patients

Very rare: may affect up to 1 in 10,000 patients

Frequency not known: cannot be estimated from the 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, the appearance of skin lesions that can have a varied appearance. Other possible reactions are itching, swelling of the face, difficulty breathing.

Nervous system disorders:

Dizziness, discomfort, fatigue, difficulty falling asleep, nightmares, weakness, and convulsive crises.

Gastrointestinal disorders:

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

Hepatobiliary disorders:

Transient elevation of some enzymes (transaminases), rarely hepatitis, and yellowing of the skin.

Skin and subcutaneous tissue disorders:

Itching in the genital area.

Renal and urinary disorders:

Increased urea in the blood, which may indicate poor kidney function, rarely kidney inflammation.

General disorders and administration site conditions:

Pain at the injection site and inflammation of the vein at the injection site.

If you experience side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet.

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

Keep this medicinal product 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 the refrigerator (2-8°C).

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicinal products in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicinal products. 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 cefazolin sodium). The other components are water for injections.

Appearance of the product and packaging contents

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

Other presentations

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

Not all pack sizes may be marketed.

Marketing authorisation 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 last revision of this leaflet:November 2011

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Warning: For use exclusively by healthcare professionals

This information is intended only for doctors or healthcare professionals:

• Stability of the reconstituted Intrazolina solution:

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

The slightly yellowish color of the solution does not indicate any alteration in the efficacy of the antibiotic or its tolerance. Solutions with a yellowish-brown or brown color should not be administered.

The stability of the Intrazolina solution at a concentration of 5 mg/ml to 10 mg/ml is satisfactory in the following infusion liquids:

• 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 medicinal product

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

Intravenous administration

Intrazolina can 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 is injected slowly over 3 to 5 minutes (it should not be administered in less than three minutes).

For continuous or intermittent intravenous infusion:

Intrazolina can be administered through the main infusion systems for liquids, controlling the infusion rate, or in a second infusion bag. The reconstitution of 500 mg of cefazolin can 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 500 mg is reconstituted with the solvent from the accompanying ampoule (4 ml of water for injections). Shake well until dissolved. Cefazolin should be injected into a area of large muscle mass.

Intramuscular cefazolin causes pain at the injection site.

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