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(powder for solution for injection): 10 X 10 ml
The dosage depends on pathogen sensitivity and the severity of the disease.
Mild infections (caused by Gram-positive pathogens): 500mg- 1g, every 8 hours/every 12 hours, total daily dose: 1.5g-2g.
Uncomplicated urinary tract infections: 1g every 12 hours, total daily dose: 2g.
Moderately severe to severe infections (caused by Gram- negative pathogens): 1g every 6 – 8 hours, total daily dose: 3g-4g.
Life-threatening infections: 1g-1.5g every 6 hour, total daily dose: 4g-6g.
For patients with renal impairment, pediatric patients: Please see prescribing information.
Serious infections: Treatment of serious infections caused by susceptible organisms and also perioperatively for prophylaxis.
Treatment Respiratory tract: Respiratory tract infections due to streptococcus pneumoniae (formerly diplococcus pneumoniae) klebsiella species haemophilus influenzae staphylococcus aureus (penicillin-sensitive and penicillin-resistant) and group A B – hemolytic streptococci.
Cefazolin is effective in the eradication of streptococci from the nasopharynx. However data establishing the efficacy of cefazolin in the subsequent prevention of rheumatic fever are not available at present.
Urinary tract: Infections due to escherichia coli klebsiella species proteus mirabilis and some strains of Enterobacter and enterococci.
Skin and skin structure: -hemolytic beta Infections due to Staphylococcus aureus (penicillin-sensitive and penicillin-resistant) group A streptococci and other strains of streptococci.
Biliary tract: Infections due to escherichia coli various strains of streptococci proteus mirabilis klebsiella species and staphylococcus aureus.
Bone and joint: Infections due to staphylococcus aureus.
Genital infections (i.e. prostatitis epididymitis) due to escherichia coli proteus mirabilis klebsiella species and some strains of enterococci.
Septicemia due to streptococcus pneumoniae (formerly diplococcus pneumoniae) staphylococcus aureus (penicillin-sensitive and penicillin-resistant) proteus mirabilis escherichia coli and klebsiella species.
Endocarditis caused by staphylococcus aureus: (penicillin-sensitive and penicillin-resistant) and group A beta-hemolytic streptococci. Appropriate culture and susceptibility studies should be performed to determine the susceptibility of the causative organism to cefazolin.
Perioperative prophylaxis: The prophylactic administration of cefazolin peri-operatively (preoperatively intra-operatively and postoperatively) may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures (e.g. hysterectomy gastrointestinal surgery and transurethral prostatectomy) that are classified as contaminated or potentially contaminated. The perioperative use of cefazolin may also be effective in surgical patients in whom infection at the operative site would present a serious risk (e.g. open-heart surgery and prosthetic arthroplasty).
Known hypersensitivity to cefazolin or other cephalosporins.
Patients who have previously shown immediate and/or severe hypersensitivity reactions to penicillin or to any other beta-lactam antibiotic.
Particular caution is required in patients with an allergic diathesis, with bronchial asthma or hay fever. Prior to administering Cefazolin-VIT, previous hypersensitivity reactions to other beta-lactams (penicillins or cephalosporins)
must be investigated.
In patients exhibiting allergic reactions, the product must be discontinued and appropriate symptomatic therapy instituted. Serious acute hypersensitivity reactions may require adrenaline (epinephrine) and other emergency measures, including oxygen, i.v. fluids, i.v. antihistamines, corticosteroids, pressor amines and airway management, as clinically indicated.
Cross-allergy with other cephalosporins and occasional cross-allergies with penicillins must be borne in mind. In cases of known hypersensitivity to penicillin, cross-allergy with other beta- lactams, e.g. cephalosporins, must be taken into account. cross-hypersensitivity among beta- lactam antibiotics has been clearly documented and may occur in up to 10% of patients with a history of penicillin allergy.
Severe hypersensitivity reactions (anaphylaxis) with occasional fatal outcomes have been reported in patients undergoing treatment with beta-lactam antibiotics. These reactions are more likely to occur in persons with a history of known hypersensitivity to beta- lactam antibiotics.
In patients with impaired renal function, the dosage and/or dosing frequency
must be adjusted to the degree of renal dysfunction. As with other β-lactam antibiotics, seizures may occur if inappropriately high doses are administered to patients with impaired renal function.
While cefazolin only rarely causes renal impairment, monitoring of renal function is nonetheless recommended, especially ·in severely ill patients receiving maximum doses and patients under concomitant treatment with other potentially diuretics (e.g. furosemide).
As with all cephalosporins, Cefazolin should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
Coagulation disorders may rarely occur during treatment with cefazolin. At risk are patients with risk factors leading to vitamin K deficiency or affecting other coagulation mechanisms (parenteral nutrition, malnutrition, impaired hepatic and renal function, thrombocytopenia). The same applies to comorbidities (e.g. haemophilia, gastrointestinal ulcers) that can trigger or aggravate haemorrhages. Prothrombin values should therefore be monitored in such cases. If these values are reduced, vitamin K replacement should be given (10 mg/week).
In the event of severe and persistent diarrhoea, antibiotic-associated pseudomembranous colitis should be considered, which can be life-threatening.
Cefazolin should therefore be discontinued immediately in such cases and appropriate therapy instituted. Antiperistaltic agents are contraindicated.
During long-term use of cefazolin, non-sensitive pathogens may proliferate.
Patients should therefore be carefully monitored. If superinfection occurs, appropriate measures should be taken. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of “antibiotic-associated colitis.”
In patients with hypertension or heart failure, the sodium content of the solution for injection must be taken into account (50.6 mg per 1g cefazolin).
Children and adolescents: Cefazolin-VIT should not be administered to premature and newborn infants of less than one month of age, as no experience is available and the safety of such use has not been demonstrated.
Not for intrathecal use.
Prescribing Cefazolin-VIT in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Common (≥ 1/100 to < 1/10): Allergic skin reactions such as erythema, generalized exanthema, Urticaria and pruritus, Diarrhoea, nausea, loss of appetite, flatulence, abdominal pain.
See prescribing information for full details.
Concomitant administration contraindicated
Antibiotics: Cefazolin-VIT must not be administered together with antibiotics with bacteriostatic activity (e.g. tetracyclines, sulphonamides, erythromycin, chloramphenicol), as antagonistic effects have been observed during in vitro tests.
Concomitant administration not recommended
Probenecid: Renal clearance of Cefazolin-VIT is reduced when probenecid is co-administered.
Vitamin K1: Some cephalosporins such as cefamandole, cefazolin and cefotetan may interfere with the metabolisation of vitamin K1, particularly in cases of vitamin K1 deficiency. Substitution of vitamin K1 may therefore be necessary.
Anticoagulants: Cephalosporins may, in very rare cases, lead to coagulation disorders. If oral anticoagulants or high heparin doses are adjuvantly administered, coagulation values must be monitored.
Nephrotoxic substances: It cannot be ruled out that the nephrotoxic effect of antibiotics (e.g. aminoglycosides, colistin, polymyxin B) and diuretics (e.g. furosemide) may be aggravated.
If co-administered with cefazolin, renal function tests should be carefully monitored.
Laboratory tests: Laboratory tests may give a false-positive response for urine glucose if Benedict’s solution, Fehling’s solution or Clinitest® tablets are used, but not when enzyme-based detection methods are applied.
The indirect and direct Coombs’ test can also give false-positive results.
This may also apply to newborn infants whose mothers have been receiving cephalosporins.
Oral contraceptives: Cefazolin may influence the efficacy of hormonal contraceptives. For this reason, use of additional birth control methods besides hormonal contraceptives is recommended during a course of treatment with Cefazolin-VIT.
Pregnancy and Lactation
Pregnancy: To date, there is insufficient experience for the use of Cefazolin-VIT during human pregnancy. Hence, Cefazolin-VIT should only be used during pregnancy after careful benefit/risk assessment. This applies particularly to the first trimester. Cefazolin-VIT crosses the placenta.
Lactation: Cefazolin-VIT is excreted in human milk at low concentrations. In breast-fed infants, sensitisation and changes in the intestinal flora and Candida infections may occur. In these cases, breast- feeding should be suspended during treatment.
Symptoms: An overdose can cause pain, inflammatory reactions and phlebitis at the injection site. Administration of very high parenteral cephalosporin doses can result in vertigo, paraesthesia and headache. Particularly in patients with renal disease, seizures may occur following an overdose with cephalosporins.
The following abnormal laboratory test results may occur after an overdose: elevated creatinine values, BUN, liver enzyme values and bilirubin; positive Coombs’ test; thrombocytosis and thrombocytopenia, eosinophilia, leukopenia and prolongation of the prothrombin time.
Treatment: If seizures occur, the product must be discontinued immediately. Treatment with anticonvulsants may be indicated. Vital body functions and relevant laboratory parameters must be very carefully monitored. In the event of a severe overdose, a combination of haemodialysis and haemoperfusion may be beneficial if other treatments are unsuccessful, although supportive data to this are lacking. Peritoneal dialysis is ineffective.