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 Candida overgrowth, overgrowth
Infections and infestations                                                          of Clostridioides difficile Blood and Lymphatic                                             leukopenia, positive thrombocytopenia, haemolytic anaemia system disorders            neutropenia, eosinophilia,          Coomb’s test decreased haemoglobin concentration
Drug    fever,     interstitial   nephritis,
Immune system disorders                                                                anaphylaxis, cutaneous vasculitis Gastrointestinal                                                gastrointestinal disorders                                                       disturbance             pseudomembranous colitis (see section 4.4) Hepatobiliary           transient rise in liver                 transient rise in disorders               enzymes                                 bilirubin Skin and subcutaneous                                          skin rash, urticaria and tissue disorders                                               pruritus                 erythema multiforme, toxic epidermal necrolysis and Stevens- Johnson syndrome,
angioneurotic oedema
Renal and urinary disorders                                                             elevations in serum creatinine, elevations in blood urea nitrogen and decreased creatinine clearance (see section 4.4)
General disorders and         injection site reactions which administration site           may      include    pain   and conditions                    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 / and emailed to the Registration Holder’s Patient Safety Unit at: drugsafety@neopharmgroup.com.