CEFAZOLIN Powder for solution for injection/infusion Ref.[6592] Active ingredients: Cefazolin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2015  Publisher: MIP Pharma GmbH, Kirkeler Str. 41, 66440, Blieskastel, Germany

Therapeutic indications

Cefazolin is indicated for the treatment of the following infections caused by cefazolin-susceptible micro-organisms:

  • Skin and soft tissue infections
  • Bone and joint infections

Perioperative prophylaxis. For surgical operations with increased risk of infections with anaerobic pathogens, e.g. colorectal surgery, a combination with an appropriate drug with activity against anaerobes is recommended.

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 as well as the method of administration are dependent on the location and severity of the infection and on the clinical and bacteriological progress.

Adults and adolescents (above 12 years of age and ≥40 kg bodyweight)

  • Infections caused by sensitive micro-organisms: 1 g-2 g cefazolin per day divided into 2-3 equal doses.
  • Infections caused by moderately sensitive micro-organisms: 3 g-4 g cefazolin per day divided into 3-4 equal doses.

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

Special dosage recommendations

Peri-operative prophylaxis:

  • To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are: 1 g cefazolin 30-60 minutes before surgery
  • In case of long surgical interventions (2 hours or more) additional 0.5 – 1 g 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 of creatinine clearance can be established.

Cefazolin maintenance therapy in patients with renal impairment:

Creatinine clearance [ml/min] Serum creatinine [mg/dl] Dosage
≥55≤1.5Normal dose and normal dosage interval
33-541.6-3.0Normal dose, every 8 hours
11-343.1-4.5Half of the normal dose every 12 hours
≤10≥4.6Half of the normal dose every 18-24 hours

In haemodialysis patients, the treatment schedule depends on the dialysis conditions.

Paediatric population

Infections caused by sensitive microorganisms: A dose of 25-50 mg/kg body weight divided into two to four 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 100 mg/kg body weight divided in three or four equal doses is recommended (one dose every 6 or 8 hours).

Prematures and infants below the age of 1 month

Since safety of use in prematures and infants below the age of one month has not been determined, the use of Cefazolin in these patients is not recommended. See also section 4.4.

Guidelines for paediatric dosage

The content of 1 vial (2000 mg cefazolin) is dissolved in 10 ml of a compatible solvent (i.e. concentration approx. 200 mg/ml). The respective volume of this solution to be used is indicated in the following table in addition to the dose in mg.

Alternatively, the dosage can be given as intravenous infusion, using the diluted solution (10 mg/ml) described in section 6.6.

Body weight5 kg10 kg15 kg20 kg25 kg
Divided dose every 12 hours at 25 mg/kg body weight per day63 mg; 0.3 ml125 mg; 0.65 ml188 mg; 0.95 ml250 mg; 1.3 ml313 mg; 1.55 ml
Divided dose every 8 hours at 25 mg/kg body weight per day42 mg; 0.2 ml85 mg; 0.4 ml125 mg; 0.65 ml167 mg; 0.85 ml208 mg; 1.05 ml
Divided dose every 6 hours at 25 mg/kg body weight per day31 mg; 0.15 ml62 mg; 0.3 ml94 mg; 0.45 ml125 mg; 0.65 ml156 mg; 0.8 ml
Divided dose every 12 hours at 50 mg/kg body weight per day125 mg; 0.65 ml250 mg; 1.3 ml375 mg; 1.9 ml500 mg; 2.5 ml625 mg; 3.15 ml
Divided dose every 8 hours at 50 mg/kg body weight per day83 mg; 0.4 ml166 mg; 0.85 ml250 mg; 1.3 ml333 mg; 1.65 ml417 mg; 2.1 ml
Divided dose every 6 hours at 50 mg/kg body weight per day63 mg; 0.3 ml125 mg; 0.65 ml188 mg; 0.95 ml250 mg; 1.3 ml313 mg; 1.55 ml
Divided dose every 8 hours at 100 mg/kg body weight per day167 mg; 0.85 ml333 mg; 1.7 ml500 mg; 2.5 ml667 mg; 3.5 ml833 mg; 4.15 ml
Divided dose every 6 hours at 100 mg/kg body weight per day125 mg; 0.65 ml250 mg; 1.3 ml375 mg; 1.9 ml500 mg; 2.5 ml625 mg; 3.15 ml

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. If not possible, the dosage of creatinine clearance may be determined according to the following guidelines.

In children with moderate impairment (creatinine clearance 40-20 ml/min), 25% of the normal daily dose, divided into doses every 12 hours are sufficient.

In children with severe impairment (creatinine 20-5 ml/min) will be 10% of normal daily dose, given every 24 hours are sufficient.

All these guidelines are valid after an initial starting dose.

See also section 4.4.

Elderly patients

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

Method of administration

Cefazolin 2 g may be administered by slow intravenous injection or by intravenous infusion after dilution.

The volume of diluent to be used for the reconstitution is dependent upon the method of administration.

For instructions on the reconstitution of the medicinal product before administration, please see section 6.6.

Duration of treatment

The duration of the treatment depends on the severity of the infection as well as on the clinical and bacteriological progress.

Overdose

Symptoms of an overdose are headache, vertigo, paraesthesia, central nervous states of agitation, myoclonia and convulsions.

In case of poisoning, elimination accelerating measures are indicated. A specific antidote does not exist. Cefazolin can be haemodialysed.

Shelf life

Shelf life: 3 years.

Shelf-life of the reconstituted solution for injection/infusion The chemical and physical stability of the prepared solution is 12 hours at 25°C and 24 hours at 2-8°C. From a microbiological point of view, the prepared solution should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

Special precautions for storage

Do not store above 30°C. Keep the vial in the outer carton in order to protect from light.

For storage conditions after reconstitution, see section 6.3.

Nature and contents of container

The product is supplied in 15 ml (type I) and 100 ml colourless glass vials (type II) closed with a chlorobutyl rubber stopper which is sealed with an aluminium flip-off cap, containing a white or almost white powder.

Packages with 1, 5 and 10 vials.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Preparation of the solution

For each route of administration see the table for addition volumes and solution concentrations, which may be useful when fractional doses are required.

Intravenous injection

The dry powder is dissolved in at least 10 ml water for injections, physiological sodium chloride solution (0.9%) or 5% glucose solution.

Reconstitution table for intravenous injection:

Content per vialMinimum amount of diluent to be addedApproximate concentration
2 g10 ml200 mg/ml

Cefazolin is to be injected slowly over three to five minutes. In no case should the solution be injected in less than 3 minutes. This should be done directly into the vein or into the tube from which the patient receives intravenous solution.

Single doses exceeding 1 g should be given as intravenous infusion over 30 to 60 minutes.

Intravenous infusion

The dry powder is dissolved in 8 ml water for injections and diluted to 50-100 ml with a compatible diluent. For infusion, the powder can be reconstituted with the solvent directly in the vial.

Dilution table for intravenous infusion:

Content per vialReconstitutionDilutionApproximate concentration
 Minimum amount of diluent to be addedAmount of diluent to be added 
2 g8 ml50 ml-100 ml34 mg/ml-19 mg/ml

If smaller doses are needed, it is recommended to use half of the reconstituted solution (about 4 ml with 1 g cefazolin; i.e. half of the vial content) and to add a compatible diluent to a final volume of 100 ml (resulting concentration about 10 mg/ml). The required amount of this diluted solution can then be administered to the patient over the prescribed time.

Compatibility with intravenous liquids

The following solvents are suitable for the preparation of the solution:

  • water for injections
  • 50 mg/ml (5%) glucose solution
  • 9 mg/ml (0.9 %) sodium chloride solution.

The reconstituted solution is clear, pale yellow and should be protected from light.

As for all parenteral medicinal products, inspect the reconstituted solution visually for particulate matter and discoloration prior to administration. The solution should only be used if the solution is clear and practically free from particles.

The reconstituted product is for single use only. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.