Cefazolin Sandoz

Package Leaflet: Information for the Patient

Cefazolin Sandoz, 1 g, Powder for Solution for Injection and Infusion

Cefazolin

Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.

Package Leaflet Contents

• 1. What Cefazolin Sandoz is and what it is used for
• 2. Important information before using Cefazolin Sandoz
• 3. How to use Cefazolin Sandoz
• 4. Possible side effects
• 5. How to store Cefazolin Sandoz
• 6. Package contents and other information

1. What Cefazolin Sandoz is and what it is used for

Cefazolin Sandoz is an antibiotic containing cefazolin as the active substance, a semi-synthetic cephalosporin for intravenous or intramuscular administration. Like other beta-lactam antibiotics, cefazolin works bactericidally by inhibiting the synthesis of the bacterial cell wall.

Cefazolin Sandoz is used to treat infections caused by bacteria susceptible to cefazolin:

• lower respiratory tract infections (exacerbation of chronic bronchitis, pneumonia),
• urinary tract infections (acute pyelonephritis),
• skin and soft tissue infections,
• endocarditis,
• septicemia; in the prevention of postoperative infections (infections after surgical procedures with a high risk of such infections).

2. Important information before using Cefazolin Sandoz

When not to use Cefazolin Sandoz

If the patient is allergic to cefazolin, any of the other ingredients of this medication (listed in section 6), or other cephalosporins.

If the patient has experienced a severe allergic reaction to penicillin or any beta-lactam antibiotic (penicillins, monobactams, carbapenems) in the past.

Children under one year of age should not be given cefazolin dissolved in a lidocaine solution.

If any of the above situations apply to the patient, they should consult a doctor or pharmacist.

Warnings and precautions

Before starting treatment with Cefazolin Sandoz, the patient should discuss the following with their doctor:

• if the patient has a tendency to allergies (e.g., asthma or hay fever);
• if the patient has been found to be hypersensitive to penicillins or cephalosporins, as they may also be allergic to other beta-lactam antibiotics, including cefazolin;
• if the patient has kidney function disorders, as dose modification may be necessary;
• if the patient has factors that may cause vitamin K deficiency or blood coagulation disorders for other reasons (such as parenteral nutrition, liver and kidney dysfunction, hemophilia, thrombocytopenia).

If any of the following symptoms occur during treatment, the patient should immediately inform their doctor.

• Severe or persistent diarrhea. It may be a sign of antibiotic-associated, life-threatening pseudomembranous colitis (see section 4). If diarrhea occurs, the patient should stop taking the medication and contact their doctor. They should not take medications that suppress intestinal movements.
• Symptoms of a new infection. It may develop due to the growth of bacteria resistant to cefazolin. The doctor will provide appropriate treatment.

During treatment with Cefazolin Sandoz, the patient should be particularly cautious.

Severe skin reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during treatment with Cefazolin Sandoz.

Prolonged treatment or the use of high doses

During prolonged treatment or the use of high doses of the medication, elevated liver enzyme activity and changes in blood cells (see section 4) may occur.

Information for athletes

During treatment with cefazolin in a lidocaine solution, positive doping test results may occur.

Effect on laboratory test results

Cefazolin Sandoz may alter the results of glucose (sugar) tests in urine. If the patient performs urine tests to detect sugar, they should inform their doctor about taking this medication. Other tests may be necessary.

Indirect and direct Coombs test results may be falsely positive, e.g., in newborns whose mothers received cephalosporins.

Children

The medication should not be used in premature infants or newborns in the first month of life.

Cefazolin Sandoz and other medications

The patient should inform their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.

This is especially important for:

such antibiotics as tetracyclines, sulfonamides, erythromycin, chloramphenicol, as they may interfere with the effectiveness of cefazolin when used concurrently; their use with cefazolin is contraindicated;

probenecid, as it may interfere with the excretion of cefazolin;

vitamin K, as Cefazolin Sandoz may disrupt its conversion in the body;

anticoagulant medications or heparin in high doses, as cefazolin may rarely cause blood coagulation disorders;

medications that may harm the kidneys, such as certain antibiotics (e.g., aminoglycosides, colistin, polymyxin B) and diuretics (e.g., furosemide), as cefazolin may increase their nephrotoxic effects when used concurrently.

In case of doubts about the medications being used, the patient should consult their doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, or thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medication.

Pregnancy

The use of this medication in pregnant women should be avoided unless, in the doctor's opinion, it is absolutely necessary.

Breastfeeding

A small amount of cefazolin passes into breast milk. In breastfed infants, hypersensitivity, disruption of the intestinal flora, and fungal superinfections may occur. If the breastfed child experiences diarrhea or a fungal infection (e.g., thrush), breastfeeding should be discontinued.

Fertility

There is no data on the effect of cefazolin on human fertility.

Driving and using machines

The effect of Cefazolin Sandoz on the ability to drive and use machines has not been studied. However, during treatment, side effects (e.g., allergic reactions, dizziness) may occur that can impair the performance of these activities (see section 4).

Cefazolin Sandoz contains sodium

Cefazolin Sandoz contains 50.6 mg of sodium (the main component of common salt) per vial. This corresponds to 2.5% of the maximum recommended daily intake of sodium in the diet for adults.

The medication may be diluted in a 0.9% NaCl solution. The sodium content from the diluent should be taken into account when calculating the total sodium content in the prepared dilution of the medication.

To obtain accurate information about the sodium content in the solution used to dilute the medication, the patient should read the package leaflet of the diluent used.

This should be considered in patients with hypertension and those with heart failure.

3. How to use Cefazolin Sandoz

The dose and duration of treatment are determined by the doctor. The medication should always be used as directed by the doctor. The patient should not reduce the dose or stop treatment without first consulting their doctor.

The dose of the medication depends on the susceptibility of the microorganisms that caused the disease and the severity of the infection.

Adults

Adults with renal impairment

In patients undergoing hemodialysis, the dosing schedule of the medication depends on the dialysis conditions.

In the prevention of postoperative infections

The dosage depends on the type and duration of the surgical procedure.

Cefazolin Sandoz in an initial dose of 1 g to 2 g is administered intravenously or intramuscularly 30 minutes to 1 hour before the start of surgery.

If the procedure lasts longer (at least 2 hours), an additional dose of 500 mg to 1 g is administered intravenously or intramuscularly during the procedure.

After surgery, within 24 hours, a dose of 500 mg to 1 g is administered intravenously or intramuscularly every 6 to 8 hours.

In the treatment of infections that may pose a significant threat to the patient (e.g., after heart surgery or major orthopedic procedures, such as total joint replacement), it is recommended to continue administering the medication for 24 to 48 hours, in doses usually used after surgical procedures.

Elderly patients

In elderly patients with normal kidney function, dose modification is not necessary.

Newborns under 1 month of age

The safety of using the medication in newborns under 1 month of age has not been established.

Children and adolescents

In most mild and moderate infections, the effective total daily dose is 25 to 50 mg/kg body weight, divided into 3 or 4 equal doses.

In severe infections, the total daily dose can be increased to a maximum recommended dose of 100 mg/kg body weight.

Recommendations for dose determination in infants and younger and older children

Children with renal impairment

In children undergoing hemodialysis, an initial dose of 7 mg/kg body weight is administered, and between dialyses, a dose of 3 to 4 mg/kg body weight (with a dialysis interval of 72 hours) is administered.

Duration of treatment

The duration of treatment depends on the course of the disease. Cefazolin Sandoz should be used for at least 2 to 3 days after the fever has subsided or the infection has been eliminated.

In the treatment of infections caused by beta-hemolytic streptococci, the administration of the medication should last for at least 10 days.

Method of administration

The prepared solution of Cefazolin Sandoz is administered intravenously or intramuscularly by a doctor or nurse.

Detailed information can be found at the end of the package leaflet, in the section intended for healthcare professionals.

Administration of a higher dose of Cefazolin Sandoz than recommended

In case of administration of a higher dose of the medication than recommended, the patient should immediately contact their doctor.

Overdose may cause pain, inflammation, and phlebitis at the injection site.

Administration of very high doses of the medication may cause dizziness, tingling, and headache.

In patients with kidney disease, overdose may cause seizures.

It may also increase the levels of creatinine, bilirubin, urea, liver enzymes, and the prothrombin time in the blood, and cause a positive Coombs test result, thrombocytosis or thrombocytopenia (increase or decrease in platelet count), eosinophilia, leukopenia, and other changes in blood cells.

Treatment of overdose

In case of seizures, the medication should be discontinued immediately.

It may be necessary to administer anticonvulsant medications.

The doctor will monitor vital functions and laboratory parameters.

After significant overdose, especially in patients with kidney damage, if there is no response to other treatments, simultaneous hemodialysis with hemoperfusion may be beneficial, although there is no additional data.

Peritoneal dialysis is not effective.

Missing a dose of Cefazolin Sandoz

Cefazolin Sandoz should be used as directed by the doctor.

In case of missing a dose, the patient should take it as soon as possible and then return to the recommended dosing schedule.

The patient should not take two doses of the medication at the same time.

Stopping treatment with Cefazolin Sandoz

The medication should be used until the end of the treatment cycle, even if the patient's condition improves.

Stopping the medication too early may cause the infection to recur.

It may also cause the bacteria to become resistant to the medication.

In case of doubts about using this medication, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medications, Cefazolin Sandoz can cause side effects, although not everybody gets them.

In case of the following symptoms, the patient should immediately stop treatment and consult their doctor

and seek medical attention: facial swelling, tongue swelling, laryngeal edema with airway obstruction, rapid heart rate, shortness of breath, sudden decrease in blood pressure, blisters and peeling of the skin and mucous membranes, anaphylactic shock, toxic epidermal necrolysis, Stevens-Johnson syndrome, pseudomembranous colitis, jaundice, hepatitis, severe and persistent diarrhea, angioedema, drug fever.

These are severe side effects that may indicate hypersensitivity to cefazolin.

In such cases, immediate medical attention or hospital treatment is necessary.

Frequent side effects (occurring in no more than 1 in 10 people):

• allergic skin reactions, such as rash, urticaria, and itching;
• nausea, vomiting, diarrhea, loss of appetite;
• rash;
• pain at the intramuscular injection site, sometimes with tissue hardening.

Uncommon side effects (occurring in no more than 1 in 100 people):

• decreased or increased white blood cell count (leukopenia or leukocytosis), increased granulocyte count (granulocytosis), decreased granulocyte count (agranulocytosis), decreased neutrophil count (neutropenia), decreased platelet count (thrombocytopenia), increased monocyte count (monocytosis), decreased lymphocyte count (lymphocytopenia), increased basophil count (basophilia) and eosinophil count (eosinophilia), decreased hemoglobin level, decreased hematocrit value, anemia, including aplastic and hemolytic anemia (caused by the breakdown of red blood cells), pancytopenia (decrease in the number of red, white blood cells, and platelets);
• severe allergic reactions, such as angioedema and drug fever;
• mild, transient elevation of liver enzymes AspAT, AlAT, and alkaline phosphatase;
• erythema multiforme, angioedema;
• phlebitis, thrombophlebitis.

Rare side effects (occurring in less than 1 in 1000 people):

• rhinitis;
• coagulation and bleeding disorders;
• increased or decreased blood sugar levels (hyperglycemia or hypoglycemia);
• dizziness;
• pleural effusion, shortness of breath, or respiratory failure, cough;
• transient elevation of gamma-GT and (or) LDH enzyme activity, increased bilirubin levels;
• very severe skin reactions with blistering and peeling of the skin (toxic epidermal necrolysis, Stevens-Johnson syndrome);
• interstitial pneumonia or pneumonitis;
• interstitial nephritis and other kidney diseases;
• malaise, fatigue, chest pain, pneumonitis.

Very rare side effects (occurring in less than 1 in 10,000 people):

• life-threatening anaphylactic shock;
• transient hepatitis and cholestatic jaundice;
• vulvar and vaginal itching.

Other:

• phlebitis at the injection site after intravenous administration;
• a reaction similar to hypersensitivity to light after previous exposure to UV radiation (a "dose memory" effect).

During treatment with some cephalosporins, the following have also been reported:

• nightmares, dizziness of peripheral origin, excessive restlessness, nervousness or anxiety, insomnia, somnolence, weakness, hot flashes, color vision disturbances, confusion, and increased seizure threshold.

Reporting side effects

If side effects occur, including any not listed in this package leaflet, the patient should inform their doctor or pharmacist.

Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Al. Jerozolimskie 181C, 02-222 Warsaw

Tel.: +48 22 49 21 301

Fax: +48 22 49 21 309

website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, more information can be collected on the safety of the medication.

5. How to store Cefazolin Sandoz

Store the medication out of sight and reach of children.

Do not use this medication after the expiry date stated on the outer packaging and on the vial.

The expiry date refers to the last day of the month stated.

Vials of powder for solution for injection and infusion: store in the outer packaging to protect from light, at a temperature below 25°C.

Prepared solution: store for no more than 24 hours at a temperature of 2°C to 8°C.

Medications should not be disposed of via wastewater or household waste.

The patient should ask their pharmacist how to dispose of medications that are no longer needed.

This will help protect the environment.

6. Package contents and other information

What Cefazolin Sandoz contains

1 vial contains 1000 mg of cefazolin in the form of sodium salt (1048 mg).

The medication does not contain excipients.

What Cefazolin Sandoz looks like and what the package contains

Cefazolin Sandoz is available in 15 ml glass vials type III with a rubber stopper made of chlorobutyl rubber and an aluminum cap with a plastic flip-off cap, in a cardboard box.

The package contains 1 vial or 10 vials.

Marketing authorization holder and manufacturer

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl, Austria

For more information about the medication, please contact:

Sandoz Polska Sp. z o.o.

ul. Domaniewska 50 C

02-672 Warsaw

tel. +48 22 209 70 00

Date of last revision of the package leaflet:10/2024

(marketing authorization holder's logo)

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Information intended for healthcare professionals only:

Method and route of administration of Cefazolin Sandoz

Method of administration

The prepared solution is administered deep intramuscularly or intravenously.

The medication should not be administered intrathecally.

Only freshly prepared, clear, and colorless solutions should be administered.

Only one dose should be drawn up.

Unused solution should be discarded.

Intramuscular administration

The medication can be administered intramuscularly only in uncomplicated infections.

Before intramuscular administration, the medication should be dissolved in a 0.5% lidocaine solution.

Intramuscular doses (up to 1 g) should be injected into muscles with a large mass.

The solvent may also be a 0.9% sodium chloride solution.

1 g of powder should be dissolved in 4 ml of solvent.

Intravenous administration

Solutions for intravenous injection and infusion are prepared by dissolving the dry substance in water for injection or 0.9% NaCl solution.

A minimum of 4 ml of solvent should be used for each gram of powder.

To prepare solutions for intravenous infusion, the infusion bottle should be filled with 50-100 ml of 0.9% NaCl solution, and the powder should be allowed to dissolve, then administered in slow intravenous infusion.

Cefazolin dissolved in a lidocaine solution should not be administered intravenously.

Intravenous infusion

Larger daily doses (4 to 6 g in 2 or 3 divided doses) are administered in intravenous infusion (over 20 to 30 minutes).

Cefazolin can be administered with other intravenous fluids or in a separate infusion bottle.

Direct intravenous injection

Up to a dose of 1 g, cefazolin can be administered in slow intravenous injection (3 to 5 minutes), directly into a vein or through a catheter.