Cefazolin noridem

Package leaflet: Information for the patient

Cefazolin Noridem, 1 g, powder for solution for injection/infusion
Cefazolin Noridem, 2 g, powder for solution for injection/infusion
Cefazolin
Please read carefully the entire leaflet before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are identical.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

The medicine is called Cefazolin Noridem, 1 g, powder for solution for injection/infusion and
Cefazolin Noridem, 2 g, powder for solution for injection/infusion.
In the remainder of this leaflet, this medicine will be referred to as Cefazolin Noridem.
Table of contents

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

1. What Cefazolin Noridem is and what it is 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, for example:

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

Cefazolin may also be used during surgical procedures, both before and after surgery, to prevent possible infections.

2. Information before using Cefazolin Noridem

When not to use Cefazolin Noridem:

• if the patient is allergic to cefazolin or to 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 experienced a severe allergic reaction (hypersensitivity) to any other beta-lactam antibiotic (penicillins, monobactams, or carbapenems).

Warnings and precautions
Before starting treatment with Cefazolin Noridem, consult a doctor or pharmacist if:

• The patient has a tendency towards allergic reactions (e.g. hay fever or bronchial asthma), as this increases the 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 this increases the risk of hypersensitivity to Cefazolin Noridem.
• The patient has impaired kidney or liver function.
• The patient has blood clotting disorders (e.g. haemophilia) or a condition that may lead to such disorders, such as parenteral nutrition, malnutrition, liver or kidney disease, low platelet count leading to increased risk of bleeding or petechiae (thrombocytopenia), or use of anticoagulant drugs (e.g. heparin).
• The patient has diseases that may lead to bleeding (e.g. gastrointestinal ulcers).
• The patient develops severe, persistent diarrhoea during or after treatment with Cefazolin Noridem. In such a case, contact a doctor immediately.

Do not take any anti-diarrhoeal medicines without first consulting a doctor.
Children

• Cefazolin must not be used in newborns and infants under 1 month of age, as safety has not yet been established in this age group.

Cefazolin Noridem with other medicines
Inform your doctor or pharmacist about any other medicines the patient is currently taking, has recently taken, or plans to take.
The doctor should exercise particular caution if the patient is taking any of the following medicines:

• Anticoagulants (medicines that inhibit blood clotting): Cefazolin may very rarely cause blood clotting disorders. Therefore, if the patient is taking cefazolin together with anticoagulant medicines (e.g. heparin), careful and regular monitoring of blood clotting factors is required.
• Probenecid (a medicine used for joint diseases and gout).
• Medicines with potential harmful effects on the kidneys: Cefazolin may enhance the nephrotoxic effects of certain antibiotics (aminoglycosides) and diuretics (e.g. furosemide). Concurrent use of Cefazolin Noridem with any of these medicines requires regular monitoring of kidney function, especially in patients with pre-existing kidney disease.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Cefazolin crosses the placenta and may affect the unborn child. Therefore, if the patient is pregnant, the doctor should prescribe cefazolin only if absolutely necessary and after careful consideration of the benefits and risks.
Breastfeeding
Cefazolin passes into human milk in small amounts. Therefore, breastfeeding should be discontinued during treatment with Cefazolin Noridem.
Driving and operating machinery
Cefazolin Noridem has no effect or has a negligible effect on the ability to drive and operate machinery.
Cefazolin Noridem contains sodium.
1 g vial: 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 dietary intake of sodium for adults.
2 g vial: 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 dietary intake of sodium for adults.

3. How to use Cefazolin Noridem

Administration:
Cefazolin Noridem is always administered by qualified medical personnel. It is given either as an injection or infusion (into a vein) after reconstitution, or as a deep intramuscular injection (into muscle). Your doctor will inform you about the required duration and frequency of treatment with Cefazolin Noridem.
Recommended doses:
Adult patients with normal renal function

• Infections caused by bacteria sensitive to this medicine: 1–2 g per day in 2–3 divided doses.
• Infections caused by bacteria moderately sensitive to this medicine: 3–4 g per day in 3–4 divided doses.

The daily dose may be increased up to 6 g given in three or four equal divided doses.
Use in children and adolescents
Premature infants and neonates under one month of age:
Safety of use has not been established in infants under one month of age.
Children over one month of age:

• Infections caused by bacteria sensitive to this medicine: 25–50 mg/kg body weight per day in 2–4 divided doses administered every 6, 8 or 12 hours.
• Infections caused by bacteria moderately sensitive to this medicine: Up to 100 mg/kg body weight per day in 3–4 divided doses administered every 6–8 hours.

The medicine is not recommended for children under 1 month of age.
Elderly patients
In elderly patients with normal renal function, dose adjustment is not necessary.
Special dosage recommendations
Prophylaxis of infections during surgical procedures
1 g of cefazolin 30–60 minutes before surgery.
In case of prolonged surgical procedures (lasting at least 2 hours), an additional dose of 0.5–1 g of cefazolin should be administered during surgery.
Patients with impaired renal function
In patients with impaired renal function, elimination of cefazolin is slower. Therefore, the physician will adjust the dose according to the severity of renal impairment by reducing the maintenance dose or by extending the dosing intervals.
Duration of treatment
The duration of treatment depends on the severity of infection and the rate of patient's recovery.
Use of a higher than recommended dose of Cefazolin Noridem
Since the medicine is administered by a doctor or nurse, the risk of overdose is low.
Symptoms of overdose include: headache, vertigo (central origin dizziness), skin prickling or tingling sensation (paresthesia), restlessness, involuntary muscle jerks (myoclonia), and seizures. If any of these symptoms occur, seek immediate medical advice.
In an emergency, the doctor must take appropriate measures to treat the symptoms of overdose.
Missed dose of Cefazolin Noridem
Do not administer a double dose to make up for a missed dose. A missed dose should only be administered before the next scheduled dose if there is a sufficiently long interval until the next dose.
Discontinuation of Cefazolin Noridem
Low doses, irregular administration, or premature discontinuation of treatment may adversely affect treatment efficacy or lead to relapse, which may be more difficult to treat. Follow your doctor's instructions.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the symptoms listed below occur, stop taking the medicine immediately and consult your doctor:

Uncommon: may occur in 1 out of 100 patients

• Skin redness (erythema), widespread skin rash (erythema multiforme or exanthema), urticaria (red, itchy, irregular skin rash), fever, subcutaneous swelling (angioedema), and/or lung tissue swelling potentially causing cough and breathing difficulties (interstitial pneumonia or non-infectious pneumonia), as these adverse reactions may indicate an allergic reaction to this medicine.

Rare: may occur in 1 out of 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 resembling burns (toxic epidermal necrolysis).

Very rare: may occur in 1 out of 10,000 patients

• Severe allergic reaction (anaphylactic shock) with breathing difficulties, swelling of the throat, face, eyelids or lips, rapid heartbeat and drop in blood pressure. This reaction may begin shortly after the first dose of the medicine or appear later.

The following adverse reactions have also been reported, but their frequency is unknown:

• Severe and frequent diarrhoea, sometimes with blood, as this may indicate a serious condition (pseudomembranous colitis).

During treatment with products containing cefazolin, the following adverse reactions may also occur:

Common: may occur in 1 out of 10 patients

• Mild gastrointestinal disturbances (loss of appetite, diarrhoea, nausea, vomiting, severe and frequent diarrhoea). These adverse reactions usually resolve within a few days.
• Intramuscular injection may cause pain at the injection site, sometimes accompanied by hardening of the skin and soft tissue at the site.

Uncommon: may occur in 1 out of 100 patients

• Oral thrush (thick, white or cream-colored deposits in the mouth and on the tongue)
• Seizure attacks in patients with kidney disease
• Vein swelling caused by blood clot formation following intramuscular injection (thrombophlebitis)

Rare: may occur in 1 out of 1000 patients

• Bacterial infection of the genital organs in men or women, with symptoms such as itching, redness, swelling and discharge in women (genital candidiasis, vulvovaginitis)
• Increased or decreased blood glucose levels (hyperglycaemia or hypoglycaemia)
• Reversible blood disorders, including decreased or increased numbers of red and white blood cells (leukopenia, granulocytopenia, neutropenia, thrombocytopenia, leukocytosis, granulocytosis, monocytosis, lymphopenia, basophilia and eosinophilia), which may lead to bleeding, tendency to develop petechiae and/or skin discoloration (confirmed by blood test)
• Dizziness, fatigue and general malaise
• Chest pain, excess fluid in the lungs, shortness of breath, cough, nasal congestion (rhinitis)
• Liver disorders (e.g. transient increase in alkaline phosphatase activity or transient hepatitis), with symptoms such as increased liver enzyme activity [alanine aminotransferase (AlAT), aspartate aminotransferase (AspAT), gamma-glutamyltransferase (gamma-GT) and lactate dehydrogenase (LDH)] and increased bilirubin concentration (a breakdown product of red blood cells) in bile or urine (confirmed by blood test)
• Kidney disorders (nephrotoxicity, interstitial nephritis, unspecified nephropathy, proteinuria), with symptoms such as kidney swelling and increased nitrogen concentration in the body, detectable by urine test; these usually occur in patients receiving cefazolin concurrently with other medicines that may cause kidney disorders

Very rare: may occur in 1 out of 10,000 patients

• Itching of the anus or genital organs
• Blood clotting disorders, which may lead to a tendency to bleed. This can be corrected by increasing vitamin K intake, confirmed by blood test (see section 2)
• Sleep disturbances, including nightmares and insomnia
• Feelings of nervousness or anxiety, drowsiness, weakness, hot flushes, colour vision disturbances, dizziness and epileptic seizures (involuntary, rapid and repetitive contractions and relaxations of muscles)

Frequency unknown: frequency cannot be estimated from available data

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

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to:
Department of Monitoring of Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Cefazolin Noridem

Keep the medicine out of the sight and reach of children.
Do not use Cefazolin Noridem after the expiry date stated on the vial and
carton after EXP. The expiry date refers to the last day of the stated month.
Store below 30°C.
Keep 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 for 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 duration and conditions prior to use, provided
that such time does not usually exceed the chemical and physical stability periods stated above.

Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures will help protect
the environment.

6. Contents of the package and other information

What Cefazolin Noridem contains

• The active substance is cefazolin.
  1 g vial: One vial contains 1 g of cefazolin (as cefazolin sodium).
  2 g vial: One vial contains 2 g of cefazolin (as cefazolin sodium).

What Cefazolin Noridem looks like and contents of the pack
Cefazolin Noridem is a white or almost white powder for the preparation of a solution for
injection/infusion. The product is available in glass vials in pack sizes containing
10 and 50 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 authorised in the European Economic Area countries 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 Κόνις για ενέζιμο διάλυμα/διάλυμα προς έγχυση
Cefazolin/Noridem 2g Κόνις για ενέζιμο 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

Information intended exclusively for healthcare professionals:

Preparation of the medicinal product for administration and handling
Solution preparation
For each route of administration, refer to the table providing the volumes to be added and the resulting concentrations, which may be useful when small doses are required.

Dosing guidelines for adults
Intramuscular injection
Cefazolin Noridem, 1 g:
Reconstitute the medicinal product Cefazolin Noridem with one of the following compatible diluents according to the dilution table:

• Water for injections
• 10% glucose solution
• 0.9% sodium chloride solution
• 0.5% lidocaine HCl solution

Shake well until the entire contents of the vial are completely dissolved and administer by deep intramuscular injection.

Table for reconstitution for intramuscular injection

Information on the volume of diluent to be added for the paediatric and adolescent population, see section: Dosing guidelines for children and adolescents.
Lidocaine use:
When using lidocaine solution as the solvent, cefazolin solutions may only be administered by intramuscular injection. Prior to use, contraindications, warnings and other important information provided in the lidocaine product characteristics must be taken into account.
Lidocaine solution must never be administered intravenously.
Intramuscular injection using lidocaine as the solvent is indicated in children above
30 months of age.

Cefazolin Noridem, 2 g: Do not use for intramuscular administration.
Intravenous injection
Reconstitute the medicinal product Cefazolin Noridem with one of the following compatible diluents according to the reconstitution table:

• Water for injections
• 0.9% sodium chloride solution
• 5% glucose solution
• 10% glucose solution

Reconstitution table for intravenous injection

Cefazolin is intended for slow injection over a period of three to five minutes. Under no circumstances should the solution be administered in less than 3 minutes. The injection should be given directly into a vein or into the intravenous line through which the patient receives intravenous fluids.

Single doses exceeding 1 g should be administered by intravenous infusion lasting 30 to 60 minutes.

Dosing guidelines in children and adolescents

Vial containing 1 g: The contents of 1 vial (1000 mg cefazolin) should be dissolved in 4 ml of a compatible solvent (resulting in a concentration of approximately 220 mg/ml). The appropriate volume of solution to be used, alongside the dose in mg, is given in Table 1.

Vial containing 2 g: The contents of 1 vial (2000 mg cefazolin) should be dissolved in 10 ml of a compatible solvent (resulting in a concentration of approximately 180 mg/ml). The appropriate volume of solution to be used, alongside the dose in mg, is given in Table 2.

Information regarding the volume of diluent to be added for the pediatric and adolescent population is provided in the section "Dosing guidelines in children and adolescents". For 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 solvents intended for intravenous injection.

Further dilution should be performed using one of the following compatible diluents, according to the table of dilutions below:

• 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

In the case of Cefazolin Noridem 2 g, if lower doses are required, it is recommended to use half of the solution after reconstitution (approximately 4 ml in the case of 1 g cefazolin; i.e. half the content of the vial) and add a compatible diluent to a final volume of 100 ml (resulting in a concentration of approximately 10 mg/ml). The required amount of diluted solution can then be administered to the patient within the recommended time.
Solutions of the medicinal product Cefazolin Noridem containing lidocaine must never be administered intravenously.
As with all parenteral medicinal products, the reconstituted solution should be inspected visually for particulate matter and discoloration prior to administration. The solution should be administered only 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.
Pharmaceutical incompatibilities
Cefazolin is incompatible with amikacin disulfate, sodium amobarbital, Acidum ascorbicum, bleomycin sulfate, calcium glucoheptonate, calcium gluconate, cimetidine hydrochloride, sodium colistimethate, erythromycin glucoheptonate, kanamycin sulfate, oxytetracycline hydrochloride, sodium pentobarbital, polymyxin B sulfate, and tetracycline hydrochloride.
Dosage and method of administration
The dose and route of administration depend on the site and severity of infection, as well as on clinical and bacteriological progress. Local therapeutic guidelines should be taken into account.
Adults and adolescents (aged over 12 years and weighing ≥ 40 kg)

• Infections caused by susceptible microorganisms: 1 g – 2 g of cefazolin per day given in 2–3 divided doses.
• Infections caused by moderately susceptible microorganisms: 3 g – 4 g of cefazolin per day given in 3–4 divided doses.

In severe infections, doses up to 6 g per day may be given in three or four equal divided doses (one dose every 6 or 8 hours).
Special dosage recommendations
Prophylaxis of infections in the perioperative period

• Recommended doses for perioperative infection prophylaxis in contaminated or potentially contaminated procedures: 1 g of cefazolin 30–60 minutes before surgery.
• In the case of prolonged surgical procedures (lasting at least 2 hours), an additional dose of 0.5–1 g of cefazolin during the procedure.
• Prolonged use after completion of the surgical procedure should be justified according to national guidelines.

It is important that (1) the preoperative dose is administered immediately before (30 minutes to 1 hour) the start of surgery, so that adequate concentrations of antibiotic are present in blood serum and tissues at the time of the first surgical incision; and (2) if necessary, cefazolin is administered at appropriate intervals during surgery to ensure sufficient antibiotic concentrations at times of expected maximal microbial exposure.
Adult patients with renal impairment
Adults with impaired renal function may require reduced doses to avoid drug accumulation.
The dose may be adjusted based on serum concentrations. If this is not feasible, the dose may be determined based on creatinine clearance.
Maintenance therapy with cefazolin in patients with renal impairment
Creatinine clearance (ml/min) Serum creatinine concentration
Dose
(mg/dl)
normal dose and normal interval
≥ 55 ≤ 1.5
between doses
35–54 1.6–3.0 normal dose every 8 hours
half the normal dose every 12
11–34 3.1–4.5 hours
half the normal dose every
≤ 10 ≥ 4.6
18–24 hours
In patients undergoing hemodialysis, the dosing regimen depends on the dialysis conditions.
Dosage guidelines for adults
Table for reconstitution for intramuscular injection

Table for reconstitution for intravenous injection

Children and adolescents:
Infections caused by susceptible microorganisms
The recommended dose is 25–50 mg/kg body weight per day given in two to four equal divided doses (one dose every 6, 8, or 12 hours).
Infections caused by moderately susceptible microorganisms
The recommended dose is up to 100 mg/kg body weight in three or four equal divided doses (one dose every 6 or 8 hours).
Premature infants and infants under 1 month of age
As the safety of use in premature infants and infants under one month of age has not been established, the use of the medicinal product Cefazolin Noridem is not recommended in these patients.
Dosing guidelines for children and adolescents
Intravenous injection
Vial containing 1 g: The content of 1 vial (1000 mg of cefazolin) should be dissolved in 4 ml of a compatible solvent (resulting in a concentration of approximately 220 mg/ml). The appropriate volume of solution to be used, together with the dose in mg, is given in Table 1.
Vial containing 2 g: The content of 1 vial (2000 mg of cefazolin) should be dissolved in 10 ml of a compatible solvent (resulting in a concentration of approximately 180 mg/ml). The appropriate volume of solution to be used, together with the dose in mg, is given in Table 2.
Intravenous administration of lidocaine solutions should be strictly avoided.
Table 1: Appropriate volumes of the medicinal product Cefazolin Noridem, 1 g, powder for solution for injection/infusion for intravenous and intramuscular injection in children and adolescents

* In the case of intramuscular administration, when the calculated dose per single administration
exceeds 2 ml, a dosing regimen with a higher number of divided doses per day (3 or 4) or dividing the
administered volume into equal parts injected at two different sites is preferred.
Table 2: Appropriate volumes of the medicinal product Cefazolin Noridem, 2 g, powder for
preparation of injection/infusion solution for intravenous injection 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 contents of 1 vial (1000 mg cefazolin) should be dissolved in 4 ml of a compatible diluent (resulting in a concentration of approximately 220 mg/ml). The appropriate volume (as indicated in Table 1) of the reconstituted solution should then be withdrawn and administered by intramuscular injection.
When administering cefazolin to children under 30 months of age, it must not be dissolved in lidocaine solution.
Intravenous infusion
The dose may be given as an intravenous infusion using the reconstituted and further diluted (10 mg/ml) solution described in the subsection Intravenous infusion under Dosage guidelines in adults.
Children and adolescents with renal impairment
Children with renal impairment (similarly to adults) may require reduced doses to avoid accumulation of the drug.
Dose reduction may be based on serum concentrations. If this is not feasible, dosage may be adjusted according to creatinine clearance as per the guidelines below.
In children with moderate renal impairment (creatinine clearance 40–20 ml/min), 25% of the normal daily dose, divided into doses administered every 12 hours, is sufficient.
In children with severe renal impairment (creatinine clearance 20–5 ml/min), 10% of the normal daily dose administered every 24 hours is sufficient.
All these recommendations apply after administration of an initial loading dose.
Elderly patients:
In elderly patients with normal renal function, dosage adjustment is not necessary.
Method of administration
Cefazolin Noridem 1 g medicinal product may be administered by deep intramuscular injection, slow intravenous injection, or intravenous infusion after dilution.
Cefazolin Noridem 2 g medicinal product may be administered by slow intravenous injection or intravenous infusion after dilution. Single doses exceeding 1 g should be administered by intravenous infusion.
The volume and type of diluent used for reconstitution depend on the route of administration.
For instructions on reconstitution of the medicinal product prior to administration, see section Preparation of the medicinal product for use and handling.
If lidocaine is used as the diluent, the resulting solution must never be administered intravenously. The information provided in the lidocaine product characteristics must be taken into account.
Duration of treatment
The duration of treatment depends on the severity of infection as well as clinical and bacteriological response.
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, and central nervous system disturbances such as restlessness, myoclonia, and seizures.
In case of poisoning, measures to enhance elimination are recommended. There is no specific antidote. Cefazolin can be removed by hemodialysis.