Adverse reactions : תופעות לוואי

4.8.    Undesirable effects

System organ       Very Common       Uncommon           Rare            Very rare         Not known class              (≥1/10)           (≥1/1,000 to       (≥1/10,000 to   (<1/10,000)       (cannot be <1/100)            <1/1,000)                         estimated from available data)


System organ     Very Common   Uncommon           Rare            Very rare     Not known class            (≥1/10)       (≥1/1,000 to       (≥1/10,000 to   (<1/10,000)   (cannot be <1/100)            <1/1,000)                     estimated from available data)
Infections and                                                                  Superinfection infestations                                                                    (see section 4.9)
Blood and the                  Leukopenia                                       Bone marrow lymphatic                      Eosinophilia                                     failure system                         Thrombocyto                                      Pancytopenia disorders                      penia                                            Neutropenia Agranulocytos is (see section
4.4)
Haemolytic anaemia
Immune system                  Jarisch-                                         Anaphylactic disorders                      Herxheimer                                       reactions reaction                                         Angioedema
Bronchospas m
Anaphylactic shock
Nervous system                 Convulsions                                      Headache disorders                      (see section                                     Dizziness 4.4)                                             Encephalopat hy* (see section 4.4)
Cardiac                                                                         Arrhythmia disorders                                                                       following rapid bolus infusion through central venous catheter

System organ       Very Common   Uncommon            Rare            Very rare     Not known class              (≥1/10)       (≥1/1,000 to        (≥1/10,000 to   (<1/10,000)   (cannot be <1/100)             <1/1,000)                     estimated from available data)
Gastrointestinal                 Diarrhea                                          Nausea disorders                                                                          Vomiting Abdominal pain
Pseudomembr anous colitis
(see section
4.4)
Hepatobiliary                    Increase in                                       Hepatitis** disorders                        liver enzymes                                     (sometimes (ALAT,                                            with jaundice)
ASAT, LDH,
gamma-GT and/or alkaline phosphatase) and/or bilirubin
Skin and                         Rash                                              Erythema subcutaneous                     Pruritus                                          multiforme tissue disorders                 Urticaria                                         Stevens- Johnson syndrome
Toxic epidermal necrolysis (see section 4.4)
Acute generalised exanthematou s pustulosis

System organ      Very Common      Uncommon             Rare            Very rare     Not known class             (≥1/10)          (≥1/1,000 to         (≥1/10,000 to   (<1/10,000)   (cannot be <1/100)              <1/1,000)                     estimated from available data)
(AGEP)
Drug reaction with eosinophilia and systemic symptoms
(DRESS) (see section 4.4)
Renal and                          Decrease in                                        Acute renal Urinary                            renal function/                                    failure (see disorders                          increase of                                        section 4.4) creatinine                                         Interstititial
(particularly                                      nephritis when co- prescribed with aminoglycosid es)
General           For IM           Fever                                              For IM disorders and     formulation      Inflammatory                                       formulations administration    ns:              reactions at                                       (where site conditions   Pain at the      the injection                                      lidocaine is injection site   site, including                                    used for phlebitis/                                         reconstitution) thrombophlebi                                      : tis                                                Systemic reactions to lidocaine
*Beta-lactams, including cefotaxime, predispose the patient to encephalopathy risk (which may include convulsions, confusion, impairment of consciousness, movement disorders), particularly in case of overdose or renal impairment.

**post-marketing experience

Jarisch-Herxheimer reaction
For the treatment of borreliosis, a Jarisch-Herxheimer reaction may develop during the first days of treatment.
The occurrence of one or more of the following symptoms has been reported after several week's treatment of borreliosis: skin rash, itching, fever, leucopenia, increase in liver enzymes, difficulty of breathing, joint discomfort.


Hepatobiliary disorders
Increase in liver enzymes (ALAT, ASAT, LDH, gamma-GT and/or alkaline phosphatase) and/or bilirubin have been reported. These laboratory abnormalities may rarely exceed twice the upper limit of the normal range and elicit a pattern of liver injury, usually cholestatic and most often asymptomatic.


Superinfection:
As with other antibiotics, the use of cefotaxime, especially if prolonged, may result in overgrowth of non-susceptible organisms. Repeated evaluation of the patient's condition is essential. If superinfection occurs during therapy, appropriate measures should be taken.


For IM Formulations
Since the solvent contains lidocaine, systemic reactions to lidocaine may occur, especially in the event of inadvertent intravenous injection or injection into highly vascularised tissue or in the event of an overdose.


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