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 disorders       Common                       thrombocythaemia Uncommon                     agranulocytosis, haemolytic anaemia,
thrombocytopenia, neutropenia, leucopenia,
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, urticaria.
Not known                    Drug Reaction with Eosinophilia and
Systemic Symptoms (DRESS Syndrome), acute generalised exanthematous pustulosis (see section 4.4)
Renal and urinary disorders                Uncommon                     blood creatinine increased, blood urea increased
General disorders and administration       Common                       inflammation, pain site conditions                            Uncommon                     Thrombophlebitis, pain at the injection site Pediatric population
Meropenem Fresenius 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 and emailed to the Registration Holder's Patient Safety Unit at: drugsafety@neopharmgroup.com