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: (≥1/1000 to <1/100)
Rare: (≥1/10000 to <1/1000)
Very rare: (< 1/10000)
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 lymphatic     Eosinophilia            Neutropenia                                 Agranulocytosis system disorders        Thrombocytosis          Leucopenia                                  Haemolytic Thrombocytopenia                            anaemia
Lymphocytosis
Immune system                                                                               Anaphylaxis (including disorders                                                                                   bronchospasm and/or hypotension) (see section 4.4)
Nervous system                                  Headache                                    Neurological sequelae1 disorders                                       Dizziness                                   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 disorders Transient elevations in                                             Jaundice one or more hepatic enzymes3
Skin and subcutaneous Maculopapular or          Pruritus                                    Toxic epidermal tissue disorders        urticarial rash                                                     necrolysis Stevens-johnson syndrome
Erythema multiforme
Angioedema
Drug Reaction with
Eosinophilia and
Systemic Symptoms
(DRESS)4
Renal and urinary                               Transient elevations of      Interstitial disorders                                       blood urea, blood urea       nephritis nitrogen and/or serum        Acute renal creatinine                   failure
General disorders           Pain and/or             Fever and administration          inflammation 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 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 event 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