Special Warning : אזהרת שימוש

4.4         Special warnings and precautions for use
-     Special precaution should be exercised in patients with an allergic diathesis, with bronchial asthma or hay fever. Before the administration of cefazolin previous hypersensitivity reactions to other beta-lactams (penicillins or cephalosporins) should be investigated.
-   In patients developing allergic reactions the drug should be discontinued and appropriate symptomatic treatment should be instituted. Cross allergies with other cephalosporins and occasionally occurring cross allergies with penicillins should be considered. In cases of known hypersensitivity to penicillins, a cross-allergy to other beta-lactams such as cephalosporins should be taken into account.
-   Serious and occasionally fatal hypersensitivity reactions (anaphylaxis) have been reported in patients treated with beta-lactam antibiotics (see section 4.8). These reactions are more likely to occur in individuals with a history of beta-lactam hypersensitivity.
-   In the case of severely impaired renal function with a glomerular filtration rate below 55 ml/min, accumulation of cefazolin can be expected; therefore the dose should be reduced accordingly or the dosing interval extended (see section 4.2). Although cefazolin seldom causes renal impairment, it is recommended to monitor the renal function, especially in severely ill patients, who are administered maximum doses and in patients who receive other potentially nephrotoxic drugs concomitantly, such as aminoglycosides or potent diuretics (e.g. furosemide).
-   In rare cases, coagulation disorders may occur during cefazolin treatment. Patients at risk are those with risk factors causing vitamin K deficiency or affecting other coagulation mechanisms (parenteral nutrition, dietary deficiencies, impaired hepatic and renal function, thrombocytopenia). Blood clotting may also be disrupted in case of associated diseases (e.g. haemophilia, gastric and duodenal ulcers) causing or aggravating haemorrhages. Prothrombin time should, therefore, be monitored in patients presenting with these diseases. If these values are reduced, vitamin K (10 mg/week) should be supplemented.
-   Antibiotic-related pseudomembranous colitis
Cases of antibiotic-associated colitis have been reported in almost all antibiotics, the severity of which can range from mild to life threatening (see section 4.8). Therefore it is important to be mindful of this diagnosis in patients who experience diarrhoea during or after using an antibiotic. In the event of antibiotic-associated colitis, cefazolin should be discontinued immediately, a doctor consulted, and appropriate treatment initiated. Anti- peristaltic medicinal products are contraindicated in this situation.
-   With long-term use of cefazolin, non-sensitive pathogens can get out of control. Close monitoring of the patient is therefore essential. If a superinfection occurs during treatment, appropriate measures must be taken.
-   Long-term or high-dose therapy
Regular check of organ system functions, including renal, hepatic and hematopoietic function, is advisable during long-term or high-dose treatment. Elevated liver enzymes and changes in blood cells have been reported (see section 4.8).
-   In patients with hypertension or heart failure the sodium content of the solutions for injection should be taken into account (48 mg per 1 g cefazolin)
-   Paediatric population
Cefazolin should not be administered to premature and newborn infants of less than 1 month of age as no data is available and the safety of use has not been established.

Intrathecal administration

Not for intrathecal administration. Severe central nervous system intoxications (including convulsions) were reported following intrathecal administration of cefazolin.

-     Cefazol contains sodium
This medicinal product contains 50.6 mg sodium per vial, equivalent to 2.5 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.

Effects on Driving

4.7        Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
However, there may be side effects (e.g. allergic reactions, dizziness) which may affect the ability to drive and use machines (see section 4.8).