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 system                neutropenia,             disorders,
disorders                       leucopenia,              haemorrhages* eosinophilia,
agranulocytosis haemolytic anaemia,
granulocytosis,
leukocytosis,
monocytosis,
lymphocytopenia,
basophilia
Immune system      Allergic     Severe                                     Life disorders          skin         hypersensitivity                           threatening reactions    reactions such as                          anaphylactic such as      angioedema and                             shock ** erythema,    drug-induced fever urticaria and pruritus
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 GGT,    hepatitis and ALT and alkaline         bilirubin and/or    cholestatic phosphatase              LDH                 jaundice
Renal and urinary                                          Interstitial disorders                                                  nephritis and other kidney diseases $
General disorders                 Phlebitis,               Malaise, fatigue, 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