Adverse reactions : תופעות לוואי

4.8    Undesirable effects

Summary of the safety profile
Zerbaxa was evaluated in Phase 3 comparator-controlled clinical trials of complicated intra-abdominal infections and complicated urinary tract infections (including pyelonephritis), which included a total of 1,015 patients, treated with Zerbaxa (1 g / 0.5 g intravenously every 8 hours, adjusted to match renal function where appropriate) for up to 14 days.

The most common adverse reactions (≥ 3% in pooled Phase 3 trials) occurring in patients receiving Zerbaxa were nausea, headache, constipation, diarrhoea, and pyrexia and were generally mild or moderate in severity.

Tabulated list of adverse reactions

The following adverse reactions have been identified during clinical trials with Zerbaxa. Adverse reactions are classified according to MedDRA System Organ Class and frequency. Frequency categories are derived according to the following conventions: common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) (see Table 3).

Table 3: Adverse reactions identified during clinical trials with ceftolozane/tazobactam (N=1,015) Common                              Uncommon
System organ class
(≥ 1/100 to < 1/10)                 (≥ 1/1,000 to < 1/100)


Common                             Uncommon
System organ class
(≥ 1/100 to < 1/10)                (≥ 1/1,000 to < 1/100)
Candidiasis including oropharyngeal and
Infections and infestations                                      vulvovaginal, Clostridium difficile colitis, fungal urinary tract infection
Blood and the lymphatic
Thrombocytosis                     Anaemia system disorders
Metabolism and nutrition                                         Hyperglycaemia, hypomagnesaemia, Hypokalemia disorders                                                        hypophosphataemia Psychiatric disorders         Insomnia, anxiety
Nervous system disorders      Headache, dizziness                Ischemic stroke Cardiac disorders                                                Atrial fibrillation, tachycardia, angina pectoris Vascular disorders            Hypotension                        Phlebitis, venous thrombosis Respiratory, thoracic, and
Dyspnoea mediastinal disorders
Nausea, diarrhoea, constipation,   Gastritis, abdominal distension, dyspepsia, Gastrointestinal disorders vomiting, abdominal pain           flatulence, ileus paralytic
Skin and subcutaneous
Rash                               Urticaria tissue disorders
Renal and urinary
Renal impairment, renal failure disorders
General disorders and administration site           Pyrexia, infusion site reactions conditions
Alanine aminotransferase           Coombs test positive, increased serum gamma- Investigations                increased, Aspartate               glutamyl transpeptidase (GGT), increased serum aminotransferase increased         alkaline phosphatase

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 http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@moh.gov.il