Adverse reactions : תופעות לוואי

4.8   Undesirable effects

The most common adverse reactions are neutropenia, eosinophilia, transient rise in liver enzymes or bilirubin, particularly in patients with pre-existing liver disease, but there is no evidence of harm to the liver and injection site reactions.

The frequency categories assigned to the adverse reactions below are estimates, as for most reactions suitable data for calculating incidence are not available. In addition, the incidence of adverse reactions associated with cefuroxime sodium may vary according to the indication.

Data from clinical trials were used to determine the frequency of very common to rare adverse reactions.
The frequencies assigned to all other adverse reactions (i.e. those occurring at <1/10,000) were mainly determined using post-marketing data and refer to a reporting rate rather than a true frequency.

Treatment related adverse reactions, all grades, are listed below by MedDRA body system organ class, frequency and grade of severity. The following convention has been utilised for the classification of 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 and not known (cannot be estimated from the available data).

System organ class Common                          Uncommon              Not known Infections       and                                                     Candida overgrowth, overgrowth infestations                                                             of Clostridioides difficile Blood and lymphatic neutropenia,                   leukopenia,      thrombocytopenia,            haemolytic system disorders     eosinophilia, decreased       positive Coomb’s anaemia haemoglobin                   test concentration
Immune        system                                                     drug fever, interstitial nephritis, disorders                                                                anaphylaxis, cutaneous vasculitis Gastrointestinal                                   gastrointestinal      pseudomembranous      colitis   (see disorders                                          disturbance           section 4.4) Hepatobiliary        transient rise in liver       transient rise in disorders            enzymes                       bilirubin
Skin             and                               skin          rash,   erythema     multiforme,     toxic subcutaneous tissue                                urticaria      and    epidermal necrolysis and Stevens- disorders                                          pruritus              Johnson syndrome, angioneurotic oedema
Renal and urinary                                                        elevations in serum creatinine, disorders                                                                elevations in blood urea nitrogen and      decreased      creatinine

System organ class      Common                      Uncommon             Not known clearance (see section 4.4)
General disorders       injection site reactions and administration      which may include pain site conditions         and thrombophlebitis
Description of selected adverse reactions
Cephalosporins as a class tend to be absorbed onto the surface of red cell membranes and react with antibodies directed against the drug to produce a positive Coomb’s test (which can interfere with cross matching of blood) and very rarely haemolytic anaemia.

Transient rises in serum liver enzymes or bilirubin have been observed which are usually reversible.

Pain at the intramuscular injection site is more likely at higher doses. However, it is unlikely to be a cause for discontinuation of treatment.

Paediatric population
The safety profile for cefuroxime sodium in children is consistent with the profile in adults.

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
Additionally, you may also report to GSK Israel (il.safety@gsk.com).