Indications : התוויות

Therapeutic indications                                                                                                                                                                                                                             Concomitant administration contraindicated 18.1              150 mg                  115 mg                            4.3 Contraindications Cefazolin is indicated for the treatment of infections due to susceptible                                                                                                                                                                               Antibiotics organisms and also perioperatively for prophylaxis.                                      22.7              190 mg                  140 mg                            This medicinal product must not be used in cases of known hypersensitivity to cefazolin or other cephalosporins and in patients who have previously           Cefazolin must not be administered together with antibiotics with Treatment includes:                                                                   Weight in kg 50 mg/kg/day divided in 50 mg/kg/day divided in                                                                                                      bacteriostatic activity (e.g., tetracyclines, sulphonamides, erythromycin, Respiratory tract infections due to streptococcus pneumoniae (formerly                             3 doses (approx. single 4 doses (approx. single                   shown immediate and/or severe hypersensitivity reactions to penicillin or to any other beta-lactam antibiotic.                                            chloramphenicol), as antagonistic effects have been observed during Diplococcus pneumoniae), Klebsiella species, Haemophilus influenza,                                  dose: mg/every 8 h)     dose: mg/every 6 h)                                                                                                        in vitro tests.
Staphylococcus aureus (penicillin-sensitive and penicillin-resistant)                                                                                                For use in children of less than 30 months of age, cefazolin must not be 4.5               75 mg                  55 mg                             dissolved in lidocaine solutions.                                                  Concomitant administration not recommended group A beta-haemolytic streptococci, streptococci of the nasopharynx.
Urinary tract infections due to Escherichia coli, Klebsiella species, Proteus             9.0              150 mg                  110 mg                            - Hypersensitivity to lidocaine (I.M. administration).                             Probenecid mirabilis and some strains of enterobacter and enterococci.                              13.6              225 mg                  170 mg                            4.4 Special warnings and precautions for use                                       Renal clearance of cefazolin is reduced when probenecid is co- administered.
Skin and skin structure infections due to Staphylococcus aureus (penicillin-             18.1              300 mg                  225 mg                            Particular caution is required in patients with an allergic diathesis, sensitive and penicillin-resistant), group A beta-haemolytic streptococci                                                                                            with bronchial asthma or hay fever. Prior to administering cefazolin,              Precautions 22.7              375 mg                  285 mg                                                                                                               Vitamin K1 and other strains of streptococci.                                                                                                                                   previous hypersensitivity reactions to other beta-lactams (penicillins or Biliary tract infections due to Escherichia coli, various strains of streptococci,   Dosage adjustment in children with renal failure (guidelines):                  cephalosporins) must be investigated.                                              Some cephalosporins, such as cefamandole, cefazolin and cefotetan, Proteus mirabilis, Klebsiella species and Staphylococcus aureus.                     In children with mild to moderate renal impairment (creatinine clearance        In patients exhibiting allergic reactions, the product must be discontinued and    may interfere with the metabolisation of vitamin K1, particularly in cases Bone and joint infections due to Staphylococcus aureus.                              of 70 to 40 ml/min), 60% of the normal daily dose given in equally divided      appropriate symptomatic therapy instituted. Serious acute hypersensitivity         of vitamin K1 deficiency. Substitution of vitamin K1 may therefore be Genital infections due to Escherichia coli, Proteus mirabilis, Klebsiella            doses every 12 hours should be sufficient.                                      reactions may require adrenaline (epinephrine) and other emergency                 necessary.
species and some strains of streptococci.                                            In children with moderate impairment (creatinine clearance of 40 to 20          measures, including oxygen, I.V. fluids, I.V. antihistamines, corticosteroids,     Anticoagulants Septicemia due to streptococcus pneumoniae (formerly Diplococcus                     ml/min), 25% of the normal daily dose given in equally divided doses            pressor amines and airway management, as clinically indicated.                     Cephalosporins may, in very rare cases, lead to coagulation disorders (see pneumoniae), Proteus mirabilis, Escherichia coli and Klebsiella species.             every 12 hours should be sufficient.                                            Cross-allergy with other cephalosporins and occasional cross-allergies             section 4.4). If oral anticoagulants or high heparin doses are adjuvantly Endocarditis due to Staphylococcus aureus (penicillin-sensitive and                  In children with severe impairment (creatinine clearance of 20 to 5 ml/min),    with penicillins must be borne in mind. In cases of known hypersensitivity         administered, coagulation values must be monitored.
penicillin-resistant) and group A beta-haemolytic streptococci.                      10% of the normal daily dose given every 24 hours should be adequate.           to penicillin, cross-allergy with other beta-lactams, e.g., cephalosporins,        Nephrotoxic substances All dose recommendations apply after an initial loading dose is administered.   must be taken into account. Cross-hypersensitivity among beta-lactam Perioperative prophylaxis:                                                                                                                                                                                                                              It cannot be ruled out that the nephrotoxic effect of antibiotics (e.g., antibiotics has been clearly documented and may occur in up to 10%
The prophylactic administration of cefazolin perioperatively (preoperatively,        Perioperative prophylactic use:                                                 of patients with a history of penicillin allergy.                                  aminoglycosides, colistin, polymyxin B) and diuretics (e.g., furosemide) intraoperatively and postoperatively) may reduce the incidence of certain            To prevent postoperative infection in contaminated or potentially                                                                                                  may be aggravated. If co-administered with cefazolin, renal function tests Severe hypersensitivity reactions (anaphylaxis) with occasional fatal              should be carefully monitored.
postoperative infections in patients undergoing surgical procedures                  contaminated surgery the recommend doses are:                                   outcomes have been reported in patients undergoing treatment with (hysterectomy, gastrointestinal surgery) that are classified as contaminated         - 1 g I.V. or I.M. administered half an hour to one hour prior to initiation                                                                                       Laboratory tests beta-lactam antibiotics (see section 4.8). These reactions are more
or potentially contaminated.                                                            of surgery.                                                                                                                                                     Laboratory tests may give a false-positive response for urine glucose if likely to occur in persons with a history of known hypersensitivity to
The perioperative use of cefazolin may also be effective in surgical                 - for lengthy operative procedures (2 hours or longer) 0.5-1.0 g I.V. or        beta-lactam antibiotics.                                                           Benedict’s solution, Fehling’s solution or Clinitest® tablets are used, but patients in whom infection at the operative site would present a serious                I.M. during surgery (administration modified according to the duration                                                                                          not when enzyme-based detection methods are applied.
In patients with impaired renal function, the dosage and/or dosing frequency risk (open-heart surgery and prosthetic arthroplasty).                                  of the operative procedure).                                                                                                                                    The indirect and direct Coombs’ test can also give false-positive results.
must be adjusted to the degree of renal dysfunction (see section 4.2). As