Adverse reactions : תופעות לוואי

4.8          Undesirable effects
Summary of the safety profile
In a review of 4,872 patients with 5,026 meropenem treatment exposures, meropenem-related
adverse reactions most frequently reported were diarrhoea (2.3%), rash (1.4%),
nausea/vomiting (1.4%) and injection site inflammation (1.1%). The most commonly reported



meropenem-related laboratory adverse events were thrombocytosis (1.6%) and increased
hepatic enzymes (1.5-4.3%).

Tabulated risk of adverse reactions
In the table below all adverse reactions are listed by system organ class and frequency: very
common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥ 1/1,000 to <1/100); rare
(≥ 1/10,000 to <1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the
available data). Within each frequency grouping, undesirable effects are presented in order of
decreasing seriousness.

Table 1
System Organ Class                        Frequency                             Event
Infections and infestations               Uncommon                              oral and vaginal candidiasis Blood and lymphatic system                Common                                thrombocythaemia
disorders
Uncommon                              agranulocytosis, haemolytic
anaemia, thrombocytopenia,
neutropenia, leukopenia,
eosinophilia

Immune system disorders                   Uncommon                              , anaphylaxis (see sections 4.3 and 4.4), angioedema
Psychiatric disorders                     Rare                                   delirium



Nervous system disorders                  Common                                headache
Uncommon                              paraesthesia
Rare                                  convulsions (see section 4.4)
Gastrointestinal disorders                Common                                diarrhoea, abdominal pain vomiting, nausea
Uncommon                              antibiotic-associated colitis (see
section 4.4)
Hepatobiliary disorders                   Common                                transaminases increased, blood alkaline phosphatase increased,
blood lactate dehydrogenase
increased.
Uncommon                              blood bilirubin increased
Skin and subcutaneous tissue              Common                                rash, pruritus
disorders
Uncommon                              toxic epidermal necrolysis, Stevens
Johnson syndrome, erythema
multiforme. (see section 4.4),
urticaria


Table 1
System Organ Class                        Frequency                             Event
Not known                             drug reaction with eosinophilia and
systemic symptoms , acute
generalised exanthematous
pustulosis (see section 4.4)

Renal and urinary disorders               Uncommon                              blood creatinine increased, blood urea increased
General disorders and                     Common                                inflammation, pain administration site conditions
Uncommon                              thrombophlebitis, pain at the
injection site


Paediatric population
Meronem is licensed for children over 3 months of age. There is no evidence of an increased
risk of any adverse drug reaction in children based on the limited available data. All reports
received were consistent with events observed in the adult population.

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/