Adverse reactions : תופעות לוואי

4.8 Undesirable effects
The most commonly reported adverse reactions is diarrhoea (occurring in 1 patient out of 10) Among the most serious adverse reactions pseudo-membranous colitis and toxic epidermal necrolysis occur in 1 to 10 patients in 10,000. The frequencies for pancytopenia, anaphylactic shock and Stevens-Johnson syndrome cannot be estimated from the currently available data.

In the following table, adverse reactions are listed by system organ class and MedDRA- preferred term. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.


System Organ          Very           Common             Uncommon               Rare        Frequency not known Class               common          (≥ 1/100 to        (≥ 1/1,000 to <    (≥ 1/10,000 to   (cannot be estimated (≥ 1/10)          < 1/10)              1/100)           < 1/1,000)     from available data) 
Infections and                  candida infection *                       pseudo- infestations                                                              membranous colitis
Blood and                       thrombocytopenia,      leukopenia                          Pancytopenia*, lymphatic                       anaemia*                                  agranulocytos    neutropenia, haemolytic system disorders                                                          is               anaemia*, eosinophilia*,
thrombocytosis*



Immune system                                                                              anaphylactoid reaction*, disorders                                                                                  anaphylactic reaction*, anaphylactoid shock*,
anaphylactic shock*,
hypersensitivity*
Metabolism and                                         hypokalaemia nutrition disorders



Psychiatric                     insomnia                                                   delirium* disorders
Nervous system                headache               seizure* disorders
Vascular                                             hypotension,
disorders                                            thrombophlebiti s, phlebitis,
flushing
Respiratory,                                                            epistaxis     eosinophilic pneumonia thoracic and mediastinal disorders
Gastrointestinal   diarrhea    abdominal pain,                          stomatitis disorders                     vomiting, nausea,
constipation,
dyspepsia
Hepatobiliary                                                                         Hepatitis*, jaundice, disorders



Skin and                      rash, pruritus         erythema           toxic         Stevens-Johnson subcutaneous                                         multiforme*,       epidermal     syndrome*, dermatitis tissue disorders                                     urticaria, rash    necrolysis*   exfoliative, drug maculopapular*                   reaction with eosinophilia and systemic symptoms
(DRESS)*, acute generalised exanthematous pustulosis (AGEP)*,
dermatitis bullous,
purpura
Musculoskeletal                                      arthralgia,
and connective                                       myalgia tissue disorders
Renal and                                                                             renal failure, urinary                                                                               tubulointerstitial disorders                                                                             nephritis* General                       pyrexia, injection-    chills disorders and                 site reaction administration site conditions
Investigations                alanine                blood glucose                    bleeding time aminotransferase       decreased, blood                 prolonged, gamma- increased, aspartate   bilirubin                        glutamyltransferase aminotransferase       increased,                       increased increased, protein     prothrombin total decreased,       time prolonged blood albumin
decreased, Coombs direct test positive,
blood creatinine increased, blood alkaline phosphatase increased, blood urea increased,
activated partial thromboplastin time prolonged


*ADR identified post marketing
Piperacillin therapy has been associated with an increased incidence of fever and rash in cystic fibrosis patients.
Beta -lactam antibiotics class effects
Beta -lactam antibiotics, including piperacillin tazobactam, may lead to manifestations of encephalopathy and convulsions (see section 4.4)
Reporting of suspected adverse reactions
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.