Adverse reactions : תופעות לוואי

4.8.     Undesirable effects

The most common adverse reactions are eosinophilia, thrombocytosis, phlebitis or thrombophlebitis with intravenous administration, diarrhoea, transient increases in hepatic enzymes, maculopapular or urticarcial rash and positive Coomb’s test.

Data from sponsored and un-sponsored clinical trials have been used to determine the frequency of common and uncommon undesirable effects. The frequencies assigned to all other undesirable effects were mainly determined using post-marketing data and refer to a reporting rate rather than a true frequency. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. The following convention has been used for the classification of frequency:

Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1,000 to <1/100)
Rare (≥1/10,000 to <1/1000)
Very rare (<1/10,000)
Unknown (cannot be estimated from the available data)

System Organ Class     Common                 Uncommon                Very rare     Unknown 
Infections and                                Candidiasis infestations                                  (including vaginitis and oral thrush)

Blood and              Eosinophilia           Neutropenia                           Agranulocytosis lymphatic system       Thrombocytosis         Leucopenia                            Haemolytic disorders                                     Thrombocytopenia                      anaemia Lymphocytosis
Immune system                                                                       Anaphylaxis disorders                                                                           (including bronchospasm and/or hypotension) (see section 4.4)
Nervous                                       Headache                              Neurological system disorders                              Dizziness                             sequelae1 Paraesthesia
Vascular disorders     Phlebitis or thrombophlebitis with intravenous administration


Gastrointestinal          Diarrhoea                  Antibacterial agent-                          Bad taste disorders                                            associated diarrhoea and colitis2 (see section 4.4)
Abdominal pain
Nausea
Vomiting
Hepatobiliary             Transient                                                                Jaundice disorders                 elevations in one or more hepatic enzymes3
Skin and                  Maculopapular or           Pruritus                                      Toxic epidermal subcutaneous tissue       urticarial rash                                                          necrolysis disorders                                                                                          Stevens-Johnson syndrome
Erythema multiforme
Angioedema
Drug Reaction with Eosinophilia and Systemic
Symptoms
(DRESS)4

Renal and urinary                                    Transient elevations         Interstitial disorders                                            of blood urea, blood         nephritis urea nitrogen and/or         Acute renal serum creatinine             failure
General disorders                                    Fever and administration site conditions


Investigations            Positive Coombs’ test5
1There have been reports of neurological sequelae including tremor, myoclonia, convulsions, encephalopathy and coma in patients with renal impairment in whom the dose of CEFTAZIDIME-VIT 2 G has not been appropriately reduced.
2Diarrhoea and colitis may be associated with Clostridium difficile and may present as pseudomembranous colitis.
3ALT (SGPT), AST (SOGT), LHD, GGT, alkaline phosphatase.
4There have been rare reports where DRESS has been associated with ceftazidime.
5A positive Coombs test develops in about 5% of patients and may interfere with blood cross matching.



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