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                      paresthesia
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
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


Table 1
System Organ Class               Frequency                    Event
General disorders and             Common                       inflammation, pain administration site conditions


Uncommon                     thrombophlebitis, pain at the injection site


Paediatric population
Meropenem/ANFARM is licensed for children over 3 months of age. There is no evidence of an increasedrisk 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/