Cefazolin Noridem

Leaflet attached to the packaging: patient information

Cefazolin Noridem, 1 g, powder for solution for injection/infusion

Cefazolin Noridem, 2 g, powder for solution for injection/infusion

Cefazolin

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

The medicine is called Cefazolin Noridem, 1 g, powder for solution for injection/infusion Cefazolin Noridem, 2 g, powder for solution for injection/infusion.
In the rest of this leaflet, the medicine will be called Cefazolin Noridem.

Table of contents of the leaflet

• 1. What is Cefazolin Noridem and what is it used for
• 2. Important information before using Cefazolin Noridem
• 3. How to use Cefazolin Noridem
• 4. Possible side effects
• 5. How to store Cefazolin Noridem
• 6. Contents of the packaging and other information

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

This medicine contains the active substance cefazolin, which is an antibiotic. Cefazolin Noridem is used to treat bacterial infections caused by bacteria sensitive to cefazolin, such as:

• skin and soft tissue infections,
• bone and joint infections.

Cefazolin can also be used during surgical procedures, before and after their completion, to prevent possible infections.

2. Important information before using Cefazolin Noridem

When not to use Cefazolin Noridem:

• if the patient is allergic to cefazolin or any of the other ingredients of this medicine (listed in section 6).
• if the patient is allergic (hypersensitive) to cephalosporin antibiotics.
• if the patient has ever had a severe allergic reaction (hypersensitivity) to any other beta-lactam antibiotic (penicillins, monobactams, and carbapenems).

Warnings and precautions

Before starting to use Cefazolin Noridem, the patient should discuss it with their doctor or pharmacist if:

• The patient has a tendency to allergic reactions (e.g., hay fever or bronchial asthma), as there is then an increased risk of a severe allergic reaction to Cefazolin Noridem.
• The patient has ever had an allergic reaction to other beta-lactam antibiotics (e.g., penicillins), as there is then an increased risk of being allergic to Cefazolin Noridem as well.
• The patient has kidney or liver function disorders.
• The patient has bleeding disorders (e.g., hemophilia) or their current condition may lead to such disorders, e.g., parenteral nutrition, malnutrition, liver or kidney disease, reduced platelet count leading to an increased risk of bleeding or bruising (thrombocytopenia), or the use of anticoagulant medications (e.g., heparin).
• The patient has diseases that may lead to bleeding (e.g., gastrointestinal ulcers).
• The patient has severe, persistent diarrhea during treatment with Cefazolin Noridem or after its completion. In such a situation, the patient should contact their doctor immediately.

Without consulting a doctor, the patient should not take any anti-diarrheal medications.

Children

• Cefazolin should not be used in newborns and infants under one month of age, as its safety in this age group has not been established.

Cefazolin Noridem and other medicines

The patient should tell their doctor or pharmacist about all the medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The doctor will exercise particular caution if the patient is taking any of the following medicines:

• Anticoagulant medications (blood thinners):Cefazolin can very rarely lead to bleeding disorders. In connection with this, if the patient is taking cefazolin and anticoagulant medications (e.g., heparin) at the same time, careful and regular monitoring of blood clotting factors is necessary.
• Probenecid(a medicine used to treat joint diseases and gout).
• Medicines with potential harmful effects on the kidneys:Cefazolin may exacerbate the harmful effects of some antibiotics (aminoglycosides) and diuretic medications (e.g., furosemide) on the kidneys. Concurrent use of Cefazolin Noridem and one of these medicines requires regular monitoring of kidney function, especially in patients with kidney disease.

Pregnancy and breastfeeding

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

Pregnancy

Cefazolin crosses the placenta and may affect the unborn child. In connection with this, if the patient is pregnant, the doctor should prescribe cefazolin only if it is absolutely necessary and after careful consideration of the benefits and risks.

Breastfeeding

Cefazolin passes into human milk in small amounts. Therefore, during treatment with Cefazolin Noridem, breastfeeding should be discontinued.

Driving and using machines

Cefazolin Noridem has no influence or negligible influence on the ability to drive and use machines.

Cefazolin Noridem contains sodium.

Vial 1 g: This medicine contains 50.6 mg of sodium (the main component of table salt) per vial.
This corresponds to 2.5% of the maximum recommended daily sodium intake in the diet for adults.
Vial 2 g: This medicine contains 101.2 mg of sodium (the main component of table salt) per vial.
This corresponds to 5% of the maximum recommended daily sodium intake in the diet for adults.

3. How to use Cefazolin Noridem

Administration:

Cefazolin Noridem is always administered by medical personnel. It is administered by injection or infusion (into a vein) after dissolution or into a muscle (intramuscularly) in the form of a deep intramuscular injection. The doctor will inform the patient about the necessary duration and frequency of administration of Cefazolin Noridem.

Recommended doses are:

Adult patients with normal kidney function

• Infections caused by susceptible bacteria: 1-2 g per day in 2-3 divided doses.
• Infections caused by moderately susceptible bacteria: 3-4 g per day in 3-4 divided doses.

There is a possibility of increasing the daily dose to 6 g in three or four equal divided doses (one dose every 6 or 8 hours).

Use in children and adolescents

Preterm infants and infants under one month of age:

The safety of use in infants under one month of age has not been established.

Children over one month of age:

• Infections caused by susceptible bacteria: 25-50 mg/kg body weight per day in 2-4 divided doses every 6, 8, or 12 hours.
• Infections caused by moderately susceptible bacteria: up to 100 mg/kg body weight per day in 3-4 divided doses every 6-8 hours.

The medicine is not recommended for children who have not completed 1 month of age.

Geriatric patients

In geriatric patients with normal kidney function, there is no need to modify the dose.

Special dosage recommendations

Prevention of infections during surgical procedures
1 g of cefazolin 30-60 minutes before the procedure.
In the case of long surgical procedures (lasting at least 2 hours), an additional dose of 0.5-1 g of cefazolin during the procedure.
Prolonged use after the completion of the surgical procedure should be justified by national guidelines.

Patients with renal impairment

Adult patients with renal impairment may require a lower dose to avoid exacerbation of the effect.
A lower dose can be determined based on blood concentrations. If this is not possible, the dose can be determined based on creatinine clearance.

Maintenance treatment with cefazolin in patients with renal impairment

Creatinine clearance (ml/min) Serum creatinine concentration (mg/dl)

Dose

≤ 1.5
usual dose and usual interval
≥ 55
between doses
35–54
1.6–3.0
usual dose, every 8 hours
11–34
3.1–4.5
half the usual dose every 12
hours
≤ 10
≥ 4.6
half the usual dose every
18–24 hours
In patients undergoing hemodialysis, the treatment regimen depends on the dialysis conditions.

Guidelines for dosing in adults

Table for reconstitution for intramuscular injection

Table for reconstitution for intravenous injection

Children and adolescents:

Infections caused by susceptible bacteria

The recommended dose is 25–50 mg/kg body weight per day in two to four divided doses (one dose every 6, 8, or 12 hours).

Infections caused by moderately susceptible bacteria

The recommended dose is up to 100 mg/kg body weight per day in three or four divided doses (one dose every 6 or 8 hours).

Preterm infants and infants under one month of age

Since the safety of use in preterm infants and infants under one month of age has not been established, Cefazolin Noridem is not recommended for these patients.

Guidelines for dosing in children and adolescents

Intravenous injection
Vial containing 1 g: The content of 1 vial (1000 mg of cefazolin) is dissolved in 4 ml of a compatible diluent (resulting in a concentration of approximately 220 mg/ml). The appropriate volume of the solution to be used, along with the dose in mg, is indicated in Table 1.
Vial containing 2 g: The content of 1 vial (2000 mg of cefazolin) is dissolved in 10 ml of a compatible diluent (resulting in a concentration of approximately 180 mg/ml). The appropriate volume of the solution to be used, along with the dose in mg, is indicated in Table 2.
It is strongly recommended to avoid intravenous administration of lidocaine solutions.
Table 1: Appropriate volumes of Cefazolin Noridem, 1 g, powder for solution for injection/infusion for intravenous and intramuscular injections in children and adolescents

* In the case of intramuscular administration, when the calculated dose for a single administration exceeds 2 ml, it is preferable to choose a dosing regimen with a greater number of divided doses per day (3 or 4) or to divide the administered volume into equal parts in two different injection sites.
Table 2: Appropriate volumes of Cefazolin Noridem, 2 g, powder for solution for injection/infusion for intravenous injections in children and adolescents

In the case of volumes less than 1 ml, a 0.5 ml syringe should be used to increase dosing accuracy.
Intramuscular injection
The content of 1 vial (1000 mg of cefazolin) is dissolved in 4 ml of a compatible diluent (resulting in a concentration of approximately 220 mg/ml), and then the appropriate volume (indicated in Table 1) of the reconstituted solution is administered intramuscularly.
In the case of administration to children under 30 months of age, cefazolin should not be dissolved in a lidocaine solution.
Intravenous infusion
The dose can be administered as an intravenous infusion using the reconstituted and further diluted (10 mg/ml) solution, as described in the subsection Intravenous infusionin Guidelines for dosing in adults.

Children and adolescents with renal impairment

Children with renal impairment (like adults) may require a lower dose to avoid exacerbation of the effect.
A lower dose can be determined based on blood concentrations. If this is not possible, the dose can be determined based on creatinine clearance according to the following guidelines.
In children with moderate renal impairment (creatinine clearance 40 – 20 ml/min), 25% of the usual daily dose is sufficient, divided into doses administered every 12 hours.
In children with severe renal impairment (creatinine clearance 20 – 5 ml/min), 10% of the usual daily dose is sufficient, administered every 24 hours.
All these guidelines apply after the initial dose has been administered.
Geriatric patients:
In geriatric patients with normal kidney function, there is no need to modify the dose.

Method of administration

Cefazolin Noridem, 1 g can be administered by deep intramuscular injection or by slow intravenous injection or intravenous infusion after dissolution.
Cefazolin Noridem, 2 g can be administered by slow intravenous injection or intravenous infusion after dissolution. Single doses greater than 1 g should be administered by intravenous infusion.
The volume and type of diluent used for reconstitution depend on the method of administration.
Instructions for reconstituting the medicinal product before administration, see the section Preparation of the medicinal product for use and handling

Overdose

Symptoms of overdose include: headache, dizziness, paresthesia, central nervous system disorders, such as excitement, myoclonus, and seizures.
In case of poisoning, measures to accelerate elimination are recommended. There is no specific antidote. Cefazolin can be removed by hemodialysis.