Adverse reactions : תופעות לוואי

4.8      Undesirable effects
The meaning of the named frequencies is as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data): System organ        Common         Uncommon                Rare           Very rare        Not known class
Infections and                                         Rhinitis                            Long-term or infestations                                                                               repeated    use may lead to superinfection or colonisation with resistant bacteria      or yeasts     (oral thrush,
monoliasis vaginalis)
Blood and                        Thrombocytopenia, Coagulation lymphatic                        neutropenia,          disorders,
system disorders                 leucopenia,           haemorrhages* eosinophilia,
agranulocytosis,


haemolytic anaemia,
granulocytosis,
leukocytosis,
monocytosis,
lymphocytopenia,
basophilia
Immune system      Allergic skin Severe                                       Life disorders          reactions     hypersensitivity                             threatening such as       reactions such as                            anaphylactic erythema,     angioedema and                               shock ** urticaria and drug-induced pruritus      fever
Metabolism and                                            Hyperglycaemia, nutrition                                                 hypoglycaemia disorders
Nervous system                                            dizziness                           convulsions § disorders
Respiratory,                                              Pleural effusion, thoracic and                                              dyspnoea or mediastinal                                               respiratory disorders                                                 distress, cough Gastrointestinal   Diarrhoea,                                                                 Pseudomembra disorders          nausea,                                                                    nous colitis + vomiting,
loss of appetite
Skin and           Rash          Erythema                 Toxic epidermal subcutaneous                     multiforme,              necrolysis, tissue disorders                 angioedema               Stevens-
Johnson syndrome
Hepatobiliary                    Slight, transient        Temporary           Reversible disorders                        elevation of AST,        increase in         hepatitis and ALT and alkaline         GGT, bilirubin      cholestatic phosphatase              and/or LDH          jaundice
Renal and                                                 Interstitial urinary                                                   nephritis and disorders                                                 other kidney diseases $
General                          Phlebitis,               Malaise, fatigue, disorders and                    thrombophlebitis         chest pain administration site conditions


* Patients at risk for these effects are those with vitamin K deficiency or other factors leading to coagulation disturbances and patients with diseases that induce or intensify bleedings.
** which may necessitate immediate intensive care.
§ Especially in case of overdosing or unadjusted dosing in renal failure.
# In most cases, the symptoms are only mild and often disappear during or after the treatment.
+ In cases of severe and persistent diarrhoea during or after the treatment with cefazolin a physician should be consulted because this could be the symptom of a serious disease (pseudomembranous colitis) that must be treated immediately (e.g. with oral vancomycin 250 mg qid). The patients should refrain from any self medication with peristalsis-inhibiting drugs.
$ Mostly in severely ill patients receiving additional drugs.

In cases of severe and persistent diarrhoea during or after the treatment with cefazolin, a physician should be consulted because this could be the symptom of a serious disease (pseudomembranous colitis) that must be treated immediately. The patients should refrain from any self-medication with peristalsis inhibiting medicinal products (see section 4.4). Prolonged use of a cephalosporin may result in the overgrowth of cefazolin-resistant bacteria, especially Enterobacter, Citrobacter, Pseudomonas, Enterococci, or Candida.


Studies
Transient increase in SGOT, SGPT, blood urea and alkaline phosphatase without clinical evidence of renal or hepatic damage. Animal data has shown that a potential nephrotoxicity with cefazolin exists. Although not demonstrated in humans, this possibility should nevertheless be considered especially in patients receiving high doses administered over longer periods. Interstitial nephritis and undefined nephropathies have been reported in rare cases. The patients affected were seriously ill and had several medications administered. The role of cefazolin in the development of interstitial nephritis and other nephropathies has not been established.

In rare cases the following have been reported:
Decreased haemoglobin and/or hematocrit, anaemia, aplastic anaemia, pancytopenia and haemolytic anaemia.

The following cases have been reported during treatment with certain cephalosporins: Nightmares, vertigo, hyperactivity, nervousness or anxiety, insomnia, drowsiness, weakness, hot flushes, disturbed colour vision, confusion and epileptogenic activity.


Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal 

product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il/