Adverse reactions : תופעות לוואי

4.8   Undesirable effects
Summary of the safety profile
The most commonly reported adverse reactions during treatment are erythematous skin eruption, ion disbalances (see section 4.4), injection site reactions, dysgeusia and gastrointestinal disturbances. Other important adverse reactions include anaphylactic shock, antibiotic associated colitis and decreases in white blood cell counts (see section 4.4).
Tabulated list of adverse reactions
Undesirable effects are listed by body system and frequency using the following convention: 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
Not known: cannot be estimated from the available data
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
System Organ Class              Frequency                     Adverse reaction Blood and lymphatic             Not known                     Agranulocytosis (transient), system disorders                                              leucopenia, thrombocytopenia,
neutropenia
Immune system disorders         Very rare                     Anaphylactic reactions including anaphylactic shock and hypersensitivity (see section 4.4)
Nervous system disorders        Common                        Dysgeusia, Uncommon                      Headache
Investigations                  Common                        Hypernatremia, hypokalemia* (see section
4.4)
Gastrointestinal disorders      Uncommon                      Nausea, vomiting, diarrhea Not known                     Antibiotic-associated colitis
(see section 4.4)
Hepatobiliary disorders         Uncommon                      Blood alkaline phosphatase increased (transient),
Transaminases increased
(ALAT, ASAT), gamma-GT increased
Not known                     Hepatitis
Skin and subcutaneous           Common                        Erythematous eruption tissue disorders
Uncommon                      Rash

Not known                        Angioedema, pruritus,
urticaria
General disorders and        Common                           Injection site phlebitis administration site
Uncommon                         Asthenia conditions
* see section below (Description of selected adverse reactions)
Description of selected adverse reactions:
Hypokalaemia may result in diffuse symptoms such as weakness, tiredness or oedema and/or muscle twitching. Severe forms may cause hyporeflexia and cardiac arrhythmia.
Hypernatraemia may be associated with thirst, hypertension and signs of fluid overload such as oedema (see section 4.4). Severe forms may cause confusion, hyperreflexia, seizures and coma.
Paediatric population
Limited safety information is available from the paediatric population. Frequency, type and severity of adverse reactions may be expected to be similar to the adult population.
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 http://sideeffects.helath.gov.il