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 colonization
with resistant bacteria or yeasts (oral thrush,
monoliasis vaginalis)
Blood and                       Thrombocytopenia,     Coagulation lymphatic                       neutropenia,          disorders,
system                          leucopenia,           haemorrhages* disorders                       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                                               dizziness                          convulsions § system 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                          angioedema            Stevens- disorders                                             Johnson syndrome
Hepatobiliary                   Slight,   transient   Temporary           Reversible disorders                       elevation of AST,     increase in GGT,    hepatitis ALT and alkaline      bilirubin and/or    and phosphatase           LDH                 cholestatic 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/ and emailed to the Registration Holder’s Patient Safety Unit at: drugsafety@neopharmgroup.com.