Label: information for the user

INTRAZOLINA 1.000 mg powder and solvent for injectable solution and for infusion

Cefazolina

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label.

INTRAZOLINA 1.000 mg is used for the treatment of the following bacterial infections:

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

Do not use INTRAZOLINA 1.000 mg

• If you are allergic (hypersensitive) to Cefazolina, to other cephalosporins, or to any of the other components of INTRAZOLINA 1.000 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 serious. In this case, your doctor will discontinue the administration of cefazolina and initiate appropriate treatment.
• If you are receiving prolonged treatment with INTRAZOLINA, other infections (superinfections) may occur due to overgrowth of certain organisms such as Candida.
• If you have renal insufficiency, your doctor may need to adjust the dose of cefazolina you should receive.
• If you are to undergo blood tests, inform the healthcare staff that you are being treated with this medication, as cefazolina may interfere with the results.

Use of INTRAZOLINA with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

INTRAZOLINA should not be administered simultaneously with:

• Other antibiotics with a similar mechanism of action, such as tetracyclines, sulfonamides, erythromycin, and chloramphenicol.
• Blood thinners (anticoagulants)
• Probenecid
• Renal toxic medications

Pregnancy, breastfeeding, and fertility

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

Your doctor will decide whether to use this medication during pregnancy.

Consult your doctor or pharmacist before taking any medication.

Your doctor will decide whether to use this medication during breastfeeding.

Consult your doctor or pharmacist before taking any medication.

Driving and operating machinery

Cefazolina generally does not affect the ability to drive vehicles and operate machinery.

INTRAZOLINA 1.000 mg contains sodium.

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubts, consult your doctor or pharmacist again.

This medication can be administered by intramuscular injection or by intravenous injection.

Remember that administration must be performed by medical personnel.

Remember to request administration of your medication.

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 renal or hepatic impairment. In this case, inform your doctor so that they can adjust the dose accordingly.

The recommended dose is:

Adults and adolescents (12 to 18 years):in the case of mild infections, 500 mg every 8 hours; in moderate to severe infections, 500 mg to 1g every 6 or 8 hours; in more severe infections, 1 to 1.5g 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 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 1.000 mg than you should

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

If you forgot to use INTRAZOLINA 1.000 mg

Do not use a double dose to compensate for the missed doses.

If you interrupt treatment with INTRAZOLINA 1.000 mg

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

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

Like all medications, INTRAZOLINA 1,000 mg may produce adverse effects, although not all people will experience them.

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

Frequent: may affect up to 1 in 10 patients

Infrequent: 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

Unknown frequency: cannot be estimated from available data

Infections and infestations:

Genital infections.

Blood and lymphatic system disorders:

Decreased white blood cell, red blood cell, and platelet count.

Immune system disorders:

The most common is the appearance of skin lesions that may have a varied appearance. Other possible reactions are itching, facial swelling, difficulty breathing

Nervous system disorders:

May cause dizziness, discomfort, fatigue, difficulty falling asleep, nightmares, weakness, and seizures.

Gastrointestinal disorders:

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

Hepatobiliary disorders:

Transient elevation of some enzymes (transaminases), rarely hepatitis, and yellow skin discoloration.

Skin and subcutaneous tissue disorders:

Genital itching

Renal and urinary disorders:

Increased urea in the blood that may indicate kidney malfunction, rarely kidney inflammation

General disorders and administration site conditions:

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

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

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

Store in the original packaging to protect it from light.

Do not store at a temperature above 25°C.

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

Do not use INTRAZOLINA 1.000 mg after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of INTRAZOLINA 1.000 mg

The active ingredient is cefazolin.

Each vial contains 1.000 mg of cefazolin (as cefazolin sodium). The other components are: water for injection preparations.

Appearance of the product and contents of the package

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

Other presentations

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

Only some package sizes may be marketed.

Marketing authorization holder

LDP-LABORATORIOS TORLAN, S.A.

Ctra. de Barcelona, 135-B

08290 Cerdanyola del Vallès

Barcelona

Responsible for manufacturing

LDP-LABORATORIOS TORLAN, S.A.

Ctra. de Barcelona, 135-B

08290 Cerdanyola del Vallès

Barcelona

or

B. BRAUN MEDICAL, S.A.

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

or

LABORATORIOS INIBSA, S.A

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

Last review date of this leaflet:November 2011

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Warning: Use exclusively by a healthcare professional

This information is intended solely for doctors or healthcare professionals:

• Stability of the Intrazolina reconstituted 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°.

The slightly yellowish color of the solution does not indicate alteration of the antibiotic's efficacy, nor 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 medication

INTRAZOLINA 1.000 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: 1.000 mg reconstituted diluted in 10 ml of water for injection. The solution is injected slowly over 3 to 5 minutes (do not administer in less than three minutes).

For continuous or intermittent intravenous perfusion:

Intrazolina can be administered through the main infusion systems for liquids, controlling the infusion rate, or in a second intravenous infusion bottle. The reconstitution of 1.000 mg of cefazolin can be done in 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 from the ampoule that comes with it (4 ml of water for injection preparations). Shake well until dissolved. Cefazolin should be injected into a large muscle mass area.

Intramuscular cefazolin causes pain at the injection site.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/