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