Adverse reactions : תופעות לוואי

4.8.    Undesirable effects

The most common adverse reactions are eosinophilia, thrombocytosis, phlebitis or thrombophlebitis with intravenous administration, diarrhoea, transient increases in hepatic enzymes, maculopapular or urticarcial rash, pain and/or inflammation following intramuscular injection and positive Coomb’s test.

Data from sponsored and un-sponsored clinical trials have been used to determine the frequency of common and uncommon undesirable effects. The frequencies assigned to all other undesirable effects were mainly determined using post-marketing data and refer to a reporting rate rather than a true frequency. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. The following convention has been used 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 <1/1000)
Very rare (<1/10,000)
Unknown (cannot be estimated from the available data)

System          Common                 Uncommon                Very rare      Unknown Organ Class
Infections                             Candidiasis and                                    (including vaginitis infestations                           and oral thrush)


Blood and          Eosinophilia               Neutropenia                                   Agranulocytosis lymphatic          Thrombocytosis             Leucopenia                                    Haemolytic system                                        Thrombocytopenia                              anaemia disorders                                                                                   Lymphocytosis Immune                                                                                      Anaphylaxis system                                                                                      (including disorders                                                                                   bronchospasm and/or hypotension) (see section 4.4)
Nervous                                       Headache                                      Neurological system                                        Dizziness                                     sequelae1 disorders                                                                                   Paraesthesia Vascular           Phlebitis or disorders          thrombophlebitis with intravenous administration
Gastrointesti      Diarrhoea                  Antibacterial agent-                          Bad taste nal disorders                                 associated diarrhoea and colitis2 (see section 4.4)
Abdominal pain
Nausea
Vomiting
Hepatobiliar       Transient                                                                Jaundice y disorders        elevations in one or more hepatic enzymes3
Skin and           Maculopapular or           Pruritus                                      Toxic epidermal subcutaneous       urticarial rash                                                          necrolysis tissue                                                                                      Stevens-Johnson disorders                                                                                   syndrome Erythema multiforme
Angioedema
Drug Reaction with Eosinophilia and Systemic
Symptoms
(DRESS)4

Renal and                                     Transient elevations         Interstitial urinary                                       of blood urea, blood         nephritis disorders                                     urea nitrogen and/or         Acute renal serum creatinine             failure
General            Pain and/or                Fever disorders and      inflammation after administratio      intramuscular n site             injection conditions
Investigation      Positive Coombs’ s                  test5
1There have been reports of neurological sequelae including tremor, myoclonia, convulsions, encephalopathy and coma in patients with renal impairment in whom the dose of Fortum has not been appropriately reduced.
2Diarrhoea and colitis may be associated with Clostridium difficile and may present as pseudomembranous colitis.
3ALT (SGPT), AST (SOGT), LHD, GGT, alkaline phosphatase.
4There have been rare reports where DRESS has been associated with ceftazidime.
5A positive Coombs test develops in about 5% of patients and may interfere with blood cross matching.



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 should also report to GSK Israel (il.safety@gsk.com).