Cefazolin 1g and 2g Powder for solution for injection/infusion Prescribing Information

Please refer to the Summary of Product Characteristics (SmPC) before prescribing.

Name and active ingredients: Cefazolin 1g and 2g Powder for solution for injection/infusion.

Each 1g vial contains 1g cefazolin (as cefazolin sodium).

One 1g vial of powder contains 2.2mmol (50.6mg) sodium.

Each 2g vial contains 2g cefazolin (as cefazolin sodium).

One 2g vial of powder contains 4.4mmol (101.2mg) sodium.

Indications: Cefazolin 1g and 2g powder for solution for injection/infusion is indicated for the treatment of skin and soft tissue infections and bone and joint infections caused by cefazolin-susceptible micro-organisms.

It may also be used as perioperative prophylaxis.

The use of Cefazolin should be limited to cases where parenteral treatment is needed.

Susceptibility of causative organism to the treatment should be tested (if possible), although therapy may be initiated before the results are available.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Posology and method of administration: The dosage and method of administration are dependent on the location and severity of the infection and on the clinical and bacteriological progress.

Local therapeutic guidance should be taken into consideration.

Adults and adolescents (above 12 years of age and ≥ 40kg of bodyweight): Infections caused by sensitive micro-organisms: 1g - 2g cefazolin per day divided into 2 - 3 equal doses.

Infections caused by moderately sensitive microorganisms: 3g - 4g cefazolin per day divided into 3 - 4 equal doses.

In severe infections, doses of up to 6g per day can be administered in 3 or 4 equal doses (one dose every 6 or 8 hours).

Special dosage recommendations: Perioperative prophylaxis - to prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are: 1g cefazolin 30 - 60 minutes before surgery.

In case of long surgical interventions (2 hours or more) additional 0.5 - 1g cefazolin during the intervention.

Prolonged continuation of administration beyond the surgical intervention should be supported by national official guidance.

It is important that (1) the preoperative dose be given just (30 min to 1 hour) prior to the start of surgery so that adequate antibiotic levels are present in the serum and tissues at the time of initial surgical incision; and (2) cefazolin be administered, if necessary, at appropriate intervals during surgery to provide sufficient levels of the antibiotic at the anticipated moments of greatest exposure to infective organisms.

Adult patients with renal impairment: Adults with renal impairment may need a lower dose to avoid overlapping.

This lower dose may be guided by determining blood levels.

If not possible, the dosage can be established based on creatinine clearance (see SmPC section 4.2).

Paediatric population: Infections caused by sensitive microorganisms - A dose of 25 - 50mg / kg body weight divided into 2 - 4 equal doses per day is recommended (one dose every 6, 8 or 12 hours).

Infections caused by moderately sensitive microorganisms - A dose of up to 100mg / kg body weight divided in 3 or 4 equal doses is recommended (one dose every 6 or 8 hours).

Prematures and infants below the age of 1 month: The use of Cefazolin 1g and 2g Powder for solution for injection/infusion in these patients has not been determined and is therefore, not recommended. (see SmPC section 4.4).

Paediatric patients with renal impairment: Children with renal impairment (like adults) may need a lower dose to avoid overlapping.

This lower dose may be guided by determining blood levels or based on creatinine clearance (see SmPC section 4.2).

Elderly patients: In elderly patients with normal renal function no dosage adjustment is necessary.

Method of administration: Cefazolin 1g Powder for solution for injection/infusion may be administered as a deep IM injection or by slow intravenous injection or intravenous infusion after dilution.

Cefazolin 2g Powder for solution for injection/infusion may be administered by slow intravenous injection or by intravenous infusion after dilution.

Single doses exceeding 1g should be given as intravenous infusion.

Contraindications: Hypersensitivity to cefazolin sodium.

History of severe hypersensitivity (e.g. anaphylactic reaction) to other beta-lactam antibiotics (penicillins, monobactams and carbapenems).

Contraindications to lidocaine must be excluded before intramuscular injection of cefazolin when lidocaine solution is used as a solvent (see SmPC section 4.4).

Cefazolin solutions containing lidocaine should never be administered intravenously.

Special warning and precautions for use: Warnings: Before therapy is initiated, it must be ascertained that the patient has shown no previous hypersensitivity following administration of cephalosporins, penicillins or other medicinal substances.

Cefazolin should be administered with caution in patients with a tendency to allergies.

Cross-allergies between penicillins and cephalosporins have been documented.

As with all beta-lactam antibacterial agents, severe hypersensitivity reactions including fatal outcome have uncommonly been reported.

In the event of severe hypersensitivity reactions, treatment with cefazolin must be discontinued immediately and adequate emergency measures must be initiated.

Prior to administration, it should be determined whether the patient has a past history of severe hypersensitivity reactions to cefazolin, other cephalosporins or any other type of beta-lactam agent.

Cefazolin should be used with caution in patients with a history of hypersensitivity reactions to other beta-lactams categorized as non-serious.

In cases of severe and persistent diarrhoea, considerations should be given to the possibility of antibiotic- related pseudomembranous colitis.

This condition can be life-threatening and therefore, treatment with cefazolin should be stopped immediately and appropriate therapy should be administered; antiperistaltic agents are contraindicated. (see SmPC section 4.8).

In patients with renal impairment, the dose and/or dosing frequency should be adjusted to the degree of renal dysfunction (see SmPC section 4.2).

Not for intrathecal administration.

Severe intoxication of the central nervous system (including convulsions) has been reported following intrathecal administration of cefazolin.

Long-term treatment of cefazolin can result in cefazolin-resistant bacteria.

Patients should be closely monitored for potential superinfections.

If these occur, appropriate measures should be taken.

Treatment with cefazolin may lead to coagulation disorders in exceptional cases.

Risk factors are vitamin K deficiency in patients or the effect of other coagulation mechanisms (parenteral nutrition, malnutrition, impaired hepatic and renal function, thrombocytopenia).

Blood clotting may also be impaired in the case of associated diseases (haemophilia, gastric and duodenal ulcers) that may cause or aggravate bleeding.

Therefore, patients with these conditions should be monitored for their prothrombin time.

If there is a significant reduction, a vitamin K supplement (10 mg / week) should be administered.

In patients with hypertension or heart failure the sodium content of the solution for injection should be taken into account.

In case a lidocaine solution is used as a solvent, cefazolin solutions must only be used for intramuscular injection.

Contraindications to lidocaine, warnings and other relevant information as detailed in the SmPC of lidocaine must be considered before use (see SmPC section 4.3).

The lidocaine solution should never be administered intravenously.

Paediatric population: Cefazolin must not be given to preterm babies and infants below the age of one month, as there has been no adequate relevant experience to date.

This medicinal product contains 50.6 mg sodium per vial (1,000 mg), 101.2 mg sodium per vial (2,000 mg), which is equivalent to 2.5% (1,000 mg) and 5% (2,000 mg) of the WHO recommended maximum daily intake of 2 g sodium for an adult.

To be taken into consideration by patients on a controlled sodium diet.

Interactions: Antibiotics - The potential for antagonistic effects that have been observed in vitro with antibiotics with a bacteriostatic action (e.g. tetracyclines, sulphonamides, erythromycin, chloramphenicol) should be considered when these antibiotics are to be co-administered with cefazolin.

Probenecid - The renal clearance of cefazolin is reduced with concomitant administration of probenecid.

Vitamin K1 - Some cephalosporins such as cefamandole, cefazolin and cefotetan can cause interference in vitamin K1 metabolism, especially in cases of vitamin K1 deficiency.

This may require vitamin K1 replacement.

Anticoagulants - Cephalosporins can, in very rare cases, lead to coagulation cause bleeding disorders (section 4.4).

During concomitant use with oral anticoagulants (e.g. warfarin or heparin) in high doses, coagulation parameters must be monitored.

In a large number of cases, an increase in oral anticoagulant activity has been reported in patients receiving antibiotics.

Infection and inflammation, age and general condition of the patient are likely to constitute risk factors.

Under these circumstances, it is difficult to establish which role the infectious disease and its treatment play when INR imbalance occurs.

However, some classes of antibiotics are more implicated, particularly fluoroquinolones, macrolides, cyclins, cotrimoxazole and some cephalosporins.

Nephrotoxic substances - It cannot be excluded that the nephrotoxic effect of antibiotics (e.g. aminoglycosides, colistin, polymyxin B), iodine-containing contrast agents, organoplatinum compounds, high-dose methotrexate, some antiviral drugs (e.g. aciclovir, foscarnet), pentamidine, ciclosporin, tacrolimus and diuretics (e.g. furosemide) is increased.

When co-administered with cefazolin, kidney function tests must be carefully monitored.

Laboratory tests - In laboratory tests, there may be a false-positive reaction for urinary glucose when using Benedict’s solution or Fehling’s solution in patients treated with cefazolin.

Cefazolin has no effect on enzymatic measurements of glucose in urine.

The indirect and direct Coombs’ test can also give false-positive results.

This may also apply to newborn babies whose mothers have been receiving cephalosporins.

Fertility, pregnancy and lactation: Pregnancy - There is not sufficient experience in the human use of cefazolin.

As a precautionary measure, it is preferable to avoid the use of Cefazolin 1g and 2g Powder for solution for injection/infusion during pregnancy, unless it is absolutely necessary.

Breast feeding: Cefazolin is excreted in maternal milk at very low concentrations and therefore it should only be used after careful benefit/risk assessment.

If diarrhoea or candidiasis should occur in the infant during breastfeeding, the mother should not breastfeed her infant during treatment, or else treatment with cefazolin should be discontinued.

Fertility: Animal studies have shown no effects on fertility.

Effects on ability to drive and use machinery: Cefazolin has no influence on the ability to drive and use machines.

However, adverse reactions may occur (see also section 4.8) which may affect the ability to drive and use machines.

Undesirable Effects: Common (≥1/100 to <1/10).

Nausea, vomiting, diarrhoea, rash, pain at the intramuscular injection site, sometimes with induration.

For uncommon, rare and very rare undesirable effects, see SmPC section 4.8.

Legal category: POM.

Presentations: 10 x 1g – Kent Pharma List Price: £161.83.

10 x 2g – Kent Pharma List Price: £183.90.

Marketing Authorisation Holder: Noridem Enterprises Ltd.

Evagorou & Makariou, Mitsi Building 3, Office 115, 1065 Nicosia, Cyprus.

Marketing Authorisation Number:

1g - PL 24598/0053.

2g – PL 24598/0054.

Distributed by Kent Pharma UK Ltd.

Date of preparation: May 2025.

UK25/002 SmPC September 2024.

Adverse events should be reported: Reporting forms and information can be found at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Kent Pharma UK Ltd on 01233 506574 or medical@kent-athlone.com. For a copy of the SmPC or further medical information, please contact medical@kent-athlone.com. Additional information available on request.