Background pattern

Cefazolin Noridem

About the medicine

How to use 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 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 allergy to Cefazolin Noridem.
  • The patient has kidney or liver dysfunction.
  • 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, decreased 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 1 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 special caution if the patient is taking any of the following medicines:

  • Anticoagulant medications (medications that prevent blood clotting):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 enhance 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 passes through 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 operating machinery

Cefazolin Noridem has no influence or has a negligible influence on the ability to drive and operate machinery.

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

Use in children and adolescents

Preterm infants and infants under 1 month of age:

The safety of use in infants under 1 month of age has not been established.

Children over 1 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.

Elderly patients

In elderly 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.
Continued 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
For patients undergoing hemodialysis, the treatment schedule depends on the dialysis conditions.

Guidelines for dosing in adults

Table for reconstitution for intramuscular injection

Content in the vialVolume of diluent to be addedApproximate concentration
1 g2.5 ml330 mg/ml

Table for reconstitution for intravenous injection

Content in the vialMinimum volume of diluent to be addedApproximate concentration
1 g4 ml220 mg/ml

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 1 month of age

Since the safety of use in preterm infants and infants under 1 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 given 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 given 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

Body weightDose5 kg10 kg15 kg20 kg25 kg
Dose divided every 12 hours at 25 mg/kg body weight per dayVial 1 g63 mg;125 mg;188 mg;250 mg;313 mg;
0.29 ml0.57 ml0.85 ml1.14 ml1.42 ml
Dose divided every 8 hours at 25 mg/kg body weight per dayVial 1 g42 mg;85 mg;125 mg;167 mg;208 mg;
0.19 ml0.439 ml0.57 ml0.76 ml0.94 ml
Dose divided every 6 hours at 25 mg/kg body weight per dayVial 1 g31 mg;62 mg;94 mg;125 mg;156 mg;
0.14 ml0.28 ml0.43 ml0.57 ml0.71 ml
Dose divided every 12 hours at 50 mg/kg body weight per dayVial 1 g125 mg250 mg;375 mg;500 mg;625 mg;
0.57 ml1.14 ml1.7 ml2.27 ml*2.84 ml*
Dose divided every 8 hours at 50 mg/kg body weight per dayVial 1 g83 mg;166 mg;250 mg;333 mg;417 mg;
0.438 ml0.75 ml1.14 ml1.51 ml1.89 ml
Dose divided every 6 hours at 50 mg/kg body weight per dayVial 1 g63 mg;125 mg;188 mg;250 mg;313 mg;
0.29 ml0.57 ml0.85 ml1.14 ml1.42 ml
Dose divided every 8 hours at 100 mg/kg body weight per dayVial 1 g167 mg;333 mg;500 mg;667 mg;833 mg;
0.76 ml1.51 ml2.27 ml*3.03 ml*3.79 ml*
Dose divided every 6 hours at 100 mg/kg body weight per dayVial 1 g125 mg;250 mg;375 mg;500 mg;625 mg;
0.57 ml1.14 ml1.7 ml2.27 ml*2.84 ml*

* In the case of intramuscular administration, when the calculated dose per injection exceeds 2 ml, it is preferable to choose a dosing schedule 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

Body weightDose5 kg10 kg15 kg20 kg25 kg
Dose divided every 12 hours at 25 mg/kg body weight per dayVial 2 g63 mg;125 mg;188 mg;250 mg;313 mg;
0.35 ml0.69 ml1.04 ml1.39 ml1.74 ml
Dose divided every 8 hours at 25 mg/kg body weight per dayVial 2 g42 mg;85 mg;125 mg;167 mg;208 mg;
0.23 ml0.47 ml0.69 ml0.93 ml1.15 ml
Dose divided every 6 hours at 25 mg/kg body weight per dayVial 2 g31 mg;62 mg;94 mg;125 mg;156 mg;
body weight per day0.17 ml0.34 ml0.52 ml0.69 ml0.87 ml
Dose divided every 12 hours at 50 mg/kg body weight per dayVial 2 g125 mg250 mg;375 mg;500 mg;625 mg;
0.69 ml1.39 ml2.08 ml2.78 ml3.47 ml
Dose divided every 8 hours at 50 mg/kg body weight per dayVial 2 g83 mg;166 mg;250 mg;333 mg;417 mg;
0.46 ml0.92 ml1.39 ml1.85 ml2.32 ml
Dose divided every 6 hours at 50 mg/kg body weight per dayVial 2 g63 mg;125 mg;188 mg;250 mg;313 mg;
0.35 ml0.69 ml1.04 ml1.39 ml1.74 ml
Dose divided every 8 hours at 100 mg/kg body weight per dayVial 2 g167 mg;333 mg;500 mg;667 mg;833 mg;
0.93 ml1.85 ml2.78 ml3.7 ml4.63 ml
Dose divided every 6 hours at 100 mg/kg body weight per dayVial 2 g125 mg;250 mg;375 mg;500 mg;625 mg;
0.69 ml1.39 ml2.08 ml2.78 ml3.47 ml

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 taken and 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.
U 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.
U 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.
Elderly patients:
In elderly 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

Duration of treatment

The duration of treatment depends on the severity of the infection and the patient's clinical and bacteriological progress.

Disposal

Any unused medicinal product or waste material should be disposed of in accordance with local regulations.

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.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In case of observation of any of the following symptoms, the medicine should be discontinued and the doctor consulted:

Uncommon: may occur in up to 1 in 100 patients

  • redness of the skin (rash), widespread skin rash (erythema multiforme or exanthema), hives (red, itchy, uneven skin rash) on the skin surface, fever, swelling under the skin (angioedema) and (or) swelling of lung tissue potentially with cough and breathing difficulties (interstitial pneumonia or non-infectious pneumonia), as these side effects may indicate an allergic reaction to this medicine.

Rare: may occur in up to 1 in 1000 patients

  • jaundice (yellowing of the skin and whites of the eyes)
  • severe skin rash with redness, fever, blisters, or ulcers (Stevens-Johnson syndrome) or severe skin rash with redness, peeling, and swelling of the skin resembling a burn (toxic epidermal necrolysis).

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

  • severe allergic reaction (anaphylactic shock) with difficulty breathing, swelling of the throat, face, eyelids, or lips, rapid heartbeat, and blood pressure drop. This reaction may start shortly after the first administration of the medicine or appear later.

Frequency not known: frequency cannot be estimated from the available data

  • prolonged or repeated treatment with cefazolin may lead to further infection with fungi or bacteria resistant to cefazolin (superinfection).

Reporting of side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the
Department for Monitoring of Adverse Reactions to Medicinal Products,
Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C
02-222 Warsaw,
Phone: +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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Cefazolin Noridem

The medicine should be stored out of sight and reach of children.
Cefazolin Noridem should not be used after the expiry date stated on the vial and carton after EXP. The expiry date refers to the last day of the month.
Store at a temperature below 30°C.
Store the vials in the outer packaging to protect from light.
After reconstitution/dilution
Chemical and physical stability has been demonstrated for 12 hours at 25°C and up to 24 hours at 2–8°C.
From a microbiological point of view, unless the method of opening/reconstitution/dilution excludes the risk of microbial contamination, the product should be used immediately. If the product is not used immediately, the user is responsible for the storage time and conditions before use, which is usually not longer than the above-mentioned stability times.

Disposal of unused medicinal products

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Cefazolin Noridem contains

  • The active substance of the medicine is cefazolin. Vial 1 g: One vial contains 1 g of cefazolin (in the form of cefazolin sodium). Vial 2 g: One vial contains 2 g of cefazolin (in the form of cefazolin sodium).

What Cefazolin Noridem looks like and contents of the pack

Cefazolin Noridem is a white or almost white powder for solution for injection/infusion. The product is available in glass vials in packs containing 10 and 50 vials.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:Noridem Enterprises Ltd, Makariou & Evagorou 1, Mitsi Building 3,
Office 115, 1065 Nicosia, Cyprus.
Manufacturer:DEMO S.A., PHARMACEUTICAL INDUSTRY, 21st km National Road Athens-Lamia,
14568 Krioneri, Attiki, Greece. T.: +302108161802, F.: +302108161587

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

United Kingdom: Cefazolin 1g Powder for solution for injection/infusion
Cefazolin 2g Powder for solution for injection/infusion
Cyprus:
Cefazolin/Noridem 1g Πούδρα για ενέσιμο διάλυμα/διάλυμα προς έγχυση
Cefazolin/Noridem 2 g Πούδρα για ενέσιμο διάλυμα/διάλυμα προς έγχυση
Germany:
Cefazolin Noridem 1g Pulver zur Herstellung einer Injektions-/Infusionslösung
Cefazolin Noridem 2g Pulver zur Herstellung einer Injektions-/Infusionslösung
France:
Cefazoline Noridem 1 g poudre pour solution injectable/pour perfusion
Cefazoline Noridem 2 g poudre pour solution injectable/ pour perfusion
Belgium:
Cefazoline Noridem 1 g poudre pour solution injectable/pour perfusion - poeder
voor oplossing voor injectie/infusie - Pulver zur Herstellung einer Injektions-
/Infusionslösung
Cefazoline Noridem 2 g poudre pour solution injectable/pour perfusion - poeder
voor oplossing voor injectie/infusie - Pulver zur Herstellung einer Injektions-
/Infusionslösung
Poland:
Cefazolin Noridem
Slovakia:
Cefazolin Noridem 1 g prášok na injekčný/infúzny roztok
Cefazolin Noridem 2 g prášok na injekčný /infúzny roztok
Czech Republic: Cefazolin Noridem

Date of last revision of the leaflet: ---------------------------------------------------------------------------

Information intended for healthcare professionals only:

Preparation of the medicinal product for use and handling

Preparation of the solution

In the case of any administration route, the patient should familiarize themselves with the table where the volumes to be added and the concentrations of the solution can be found, which may be useful in the event that small doses are required.

Dosing guidelines for adults

Intramuscular injection
Cefazolin Noridem, 1 g:
The medicinal product Cefazolin Noridem should be dissolved in one of the following compatible diluents, in accordance with the table of dilutions:

  • water for injections
  • 10% glucose solution
  • 0.9% sodium chloride solution
  • 0.5% lidocaine hydrochloride solution

Shake well until the contents of the vial are completely dissolved and inject deeply into the muscle.
Table regarding reconstitution for intramuscular injection

Content in the vialVolume of diluent to be addedApproximate concentration
1 g2.5 ml330 mg/ml

Table regarding reconstitution for intravenous injection

Content in the vialMinimum volume of diluent to be addedApproximate concentration
1 g4 ml220 mg/ml

Cefazolin is intended for slow injection over a period of three to five minutes. In no case should the solution be injected in less than 3 minutes. The injection should be administered directly into a vein or into a line through which the patient is receiving an intravenous solution.
Singe doses greater than 1 g should be administered by intravenous infusion lasting 30 to 60 minutes.

Dosing guidelines for children and adolescents

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 given 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 given in Table 2.
Information on the volume of diluent to be added in the case of the pediatric and adolescent population, see the section "Dosing guidelines for children and adolescents". In the case of volumes less than 1 ml, a 0.5 ml syringe should be used to increase dosing accuracy.
Intravenous infusion
The medicinal product Cefazolin Noridem should first be dissolved in one of the listed compatible diluents intended for intravenous injection.
Further dilutions should be performed using one of the following compatible diluents, in accordance with the table of dilutions:

  • 0.9% sodium chloride solution
  • 5% glucose solution
  • Ringer's solution
  • Ringer's solution with lactate
  • water for injections

Table of dilutions for intravenous infusion

Content in the vialReconstitutionDilutionApproximate concentration
Minimum volume of diluent to be addedVolume of diluent to be added
1 g4 ml50 ml – 100 ml20 mg/ml – 10 mg/ml
2 g8 ml50 ml – 100 ml40 mg/ml – 20 mg/ml

In the case of Cefazolin Noridem, 2 g, if smaller doses are required, it is recommended to use half of the reconstituted solution (approximately 4 ml in the case of cefazolin 1 g; i.e., half of the vial contents) and add a compatible diluent to the final volume of 100 ml (which will result in a concentration of approximately 10 mg/ml). The required volume of the diluted solution can then be administered to the patient over the recommended time.
Solutions of Cefazolin Noridem containing lidocaine should never be administered intravenously.
Similarly, as with all parenterally administered medicinal products, the solution after reconstitution should be inspected for particulate matter and discoloration prior to administration. The solution should only be administered if it is clear and practically free of particulate matter.
The reconstituted product is intended for single use only.
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.

Incompatibilities

Cefazolin has been shown to be incompatible with amikacin sulfate, amobarbital sodium, ascorbic acid, bleomycin sulfate, calcium gluheptonate, calcium gluconate, cimetidine hydrochloride, colistin methanesulfonate, erythromycin gluheptonate, kanamycin sulfate, oxytetracycline hydrochloride, pentobarbital sodium, polymyxin B sulfate, and tetracycline hydrochloride.

Dosage and administration

The dose and method of administration depend on the location and severity of the infection, as well as the patient's clinical and bacteriological progress. Local therapeutic guidelines should be taken into account.

Adults and adolescents (over 12 years of age and weighing ≥ 40 kg)

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

In the case of severe infections, doses of up to 6 g per day can be administered in three or four equal divided doses (one dose every 6 or 8 hours).

Special dosage recommendations

Prevention of infections during the perioperative period

  • Recommended doses for the prevention of infections during the perioperative period in the case of contaminated or potentially contaminated procedures are: 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.
  • Continued use after the completion of the surgical procedure should be justified by national guidelines.

It is essential that (1) the preoperative dose is administered directly before (30 minutes to 1 hour) the start of the procedure, so that appropriate antibiotic concentrations are present in the blood serum and tissues at the time of the first surgical incision; and (2) cefazolin is administered at appropriate intervals during the procedure to ensure adequate antibiotic concentrations at the expected times of greatest exposure to infectious microorganisms.

Adult 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
For patients undergoing hemodialysis, the treatment schedule depends on the dialysis conditions.

Dosing guidelines for adults

Table for reconstitution for intramuscular injection

Content in the vialVolume of diluent to be addedApproximate concentration
1 g2.5 ml330 mg/ml

Table for reconstitution for intravenous injection

Content in the vialMinimum volume of diluent to be addedApproximate concentration
1 g4 ml220 mg/ml

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 1 month of age

Since the safety of use in preterm infants and infants under 1 month of age has not been established, Cefazolin Noridem is not recommended for these patients.

Dosing guidelines for 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 given 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 given 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

Body weightDose5 kg10 kg15 kg20 kg25 kg
Dose divided every 12 hours at 25 mg/kg body weight per dayVial 1 g63 mg;125 mg;188 mg;250 mg;313 mg;
0.29 ml0.57 ml0.85 ml1.14 ml1.42 ml
Dose divided every 8 hours at 25 mg/kg body weight per dayVial 1 g42 mg;85 mg;125 mg;167 mg;208 mg;
0.19 ml0.439 ml0.57 ml0.76 ml0.94 ml
Dose divided every 6 hours at 25 mg/kg body weight per dayVial 1 g31 mg;62 mg;94 mg;125 mg;156 mg;
0.14 ml0.28 ml0.43 ml0.57 ml0.71 ml
Dose divided every 12 hours at 50 mg/kg body weight per dayVial 1 g125 mg250 mg;375 mg;500 mg;625 mg;
0.57 ml1.14 ml1.7 ml2.27 ml*2.84 ml*
Dose divided every 8 hours at 50 mg/kg body weight per dayVial 1 g83 mg;166 mg;250 mg;333 mg;417 mg;
0.438 ml0.75 ml1.14 ml1.51 ml1.89 ml
Dose divided every 6 hours at 50 mg/kg body weight per dayVial 1 g63 mg;125 mg;188 mg;250 mg;313 mg;
0.29 ml0.57 ml0.85 ml1.14 ml1.42 ml
Dose divided every 8 hours at 100 mg/kg body weight per dayVial 1 g167 mg;333 mg;500 mg;667 mg;833 mg;
0.76 ml1.51 ml2.27 ml*3.03 ml*3.79 ml*
Dose divided every 6 hours at 100 mg/kg body weight per dayVial 1 g125 mg;250 mg;375 mg;500 mg;625 mg;
0.57 ml1.14 ml1.7 ml2.27 ml*2.84 ml*

* In the case of intramuscular administration, when the calculated dose per injection exceeds 2 ml, it is preferable to choose a dosing schedule 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

Body weightDose5 kg10 kg15 kg20 kg25 kg
Dose divided every 12 hours at 25 mg/kg body weight per dayVial 2 g63 mg;125 mg;188 mg;250 mg;313 mg;
0.35 ml0.69 ml1.04 ml1.39 ml1.74 ml
Dose divided every 8 hours at 25 mg/kg body weight per dayVial 2 g42 mg;85 mg;125 mg;167 mg;208 mg;
0.23 ml0.47 ml0.69 ml0.93 ml1.15 ml
Dose divided every 6 hours at 25 mg/kg body weight per dayVial 2 g31 mg;62 mg;94 mg;125 mg;156 mg;
body weight per day0.17 ml0.34 ml0.52 ml0.69 ml0.87 ml
Dose divided every 12 hours at 50 mg/kg body weight per dayVial 2 g125 mg250 mg;375 mg;500 mg;625 mg;
0.69 ml1.39 ml2.08 ml2.78 ml3.47 ml
Dose divided every 8 hours at 50 mg/kg body weight per dayVial 2 g83 mg;166 mg;250 mg;333 mg;417 mg;
0.46 ml0.92 ml1.39 ml1.85 ml2.32 ml
Dose divided every 6 hours at 50 mg/kg body weight per dayVial 2 g63 mg;125 mg;188 mg;250 mg;313 mg;
0.35 ml0.69 ml1.04 ml1.39 ml1.74 ml
Dose divided every 8 hours at 100 mg/kg body weight per dayVial 2 g167 mg;333 mg;500 mg;667 mg;833 mg;
0.93 ml1.85 ml2.78 ml3.7 ml4.63 ml
Dose divided every 6 hours at 100 mg/kg body weight per dayVial 2 g125 mg;250 mg;375 mg;500 mg;625 mg;
0.69 ml1.39 ml2.08 ml2.78 ml3.47 ml

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 taken and 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 Dosing guidelines for 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.
U 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.
U 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.
Elderly patients:
In elderly 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

Duration of treatment

The duration of treatment depends on the severity of the infection and the patient's clinical and bacteriological progress.

Disposal

Any unused medicinal product or waste material should be disposed of in accordance with local regulations.

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.

  • Country of registration
  • Active substance
  • Prescription required
    Yes
  • Manufacturer
  • Importer
    DEMO S.A. Pharmaceutical Industry

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