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, pain and/or inflammation following intramuscular injection 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          Common               Uncommon             Very rare    Unknown Organ Class
Infections                           Candidiasis and                                  (including infestations                         vaginitis and oral
Blood and       Eosinophilia         Neutropenia                       Agranulocytosis lymphatic       Thrombocytosis       Leucopenia                        Haemolytic system                               Thrombocytopenia                  anaemia disorders                                                              Lymphocytosis Immune                                                                 Anaphylaxis system                                                                 (including disorders                                                              bronchospasm and/or hypotension)
(see section 4.4)
Nervous                              Headache                          Neurological system                               Dizziness                         sequelae1 disorders                                                              Paraesthesia Vascular        Phlebitis or disorders       thrombophlebitis with intravenous administration
Gastrointest    Diarrhoea            Antibacterial                     Bad taste inal                                 agent-associated disorders                            diarrhoea and colitis2 (see section 4.4)
Abdominal pain Nausea
Vomiting
Hepatobiliary   Transient                                              Jaundice disorders       elevations in one or more hepatic enzymes3

Skin and              Maculopapul         Pruritus                                  Toxic epidermal subcutaneous          ar or                                                         necrolysis tissue disorders      urticarial                                                    Stevens-Johnson rash                                                          syndrome Erythema multiforme
Angioedema
Drug Reaction with
Eosinophilia and
Systemic
Symptoms
(DRESS)4
Renal and                                 Transient                 Interstitial urinary disorders                         elevations of blood       nephritis urea, blood urea          Acute nitrogen and/or           renal serum creatinine          failure
General               Pain and/or         Fever disorders and         inflammation administration        after site conditions       intramuscular injection

Investigations        Positive
Coombs’ test5
1
There 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 has not been appropriately reduced.
2
Diarrhoea and colitis may be associated with Clostridium difficile and may present as pseudomembranous colitis.
3
ALT (SGPT), AST (SOGT), LHD, GGT, alkaline phosphatase.
4
There have been rare reports where DRESS has been associated with ceftazidime.
5
A 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