Adverse reactions : תופעות לוואי

4.8.    Undesirable effects

Summary of the safety profile
The most frequently reported adverse reactions are nausea and vomiting.
Less frequent, but more severe adverse reactions have been reported shortly after injection, in particular angioedema, respiratory disorders (bronchospasm, laryngeal oedema, respiratory disorders), anaphylactic shock, hypotension, loss of consciousness, respiratory arrestand cardiac arrest.
Tabulated list of adverse reactions
The following adverse drug reactions have been described in connection with the use of fluorescein sodium. Frequencies are defined as: 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), or not known (cannot be estimated from the available data).
MedDRA                              MedDRA                               Frequency System Organ Class                  Preferred Term (PT)

Blood and lymphatic system          Thrombocytopenia                     Very rare disorders
MedDRA                           MedDRA                              Frequency System Organ Class               Preferred Term (PT)

Immune system disorders1         Anaphylactic shock,                 Uncommon Anaphylactic reaction,
Hypersensitivity

Anaphylactoid reaction              Rare

Nervous system disorders         Loss of consciousness               Uncommon 
Coma, syncope, seizure,             Rare headache, dizziness,
paraesthesia, dysgeusia, tremor

Hypoaesthesia                       Very rare
Cerebrovascular accident,           Not known aphasia

Cardiac disorders                Cardiac arrest, acute myocardial    Rare infarction, circulatory collapse,
bradycardia, tachycardia

Vascular disorders               Hypotension                         Uncommon 
Shock, pallor, hot flush            Rare

Thrombophlebitis, hypertension      Not known
Respiratory, thoracic    and     Laryngeal oedema, asthma,           Rare mediastinal disorders            dyspnoea, cough, throat irritation, sneezing,
bronchospasm

Respiratory arrest, pulmonary       Very rare oedema

Respiratory disorder, throat        Not known tightness

Gastrointestinal disorders       Vomiting, nausea                    Uncommon 
Abdominal pain                      Rare

Salivary hypersecretion             Very rare
Retching                            Not known

Skin and subcutaneous tissue     Rash, erythema, urticaria,          Uncommon disorders                        pruritus

Dermatitis, hyperhidrosis, skin     Rare discolouration2

Cold sweat                          Very rare
Renal and      urinary   tract   Chromaturia3                        Rare disorders
MedDRA                                  MedDRA                                    Frequency System Organ Class                      Preferred Term (PT)


General     disorders      and          Extravasation4, malaise                   Uncommon administration site conditions
Chest pain, oedema, asthenia,             Rare feeling hot, chills

Infusion site thrombosis, pain            Not known
1
Hypersensitivity reactions, including rare cases of anaphylactic/anaphylactoid shock, which may have fatal outcome.
2
A yellowish discoloration of the skin may appear following administration, but usually disappears within 6 to 12 hours.
3
Urine, which may also exhibit a bright yellow colouration, returns to its normal colour after 24 to 36 hours.
4
Extravasation of the solution which causes intense pain and may be followed by tissue necrosis (see section 4.4 Special warnings and precautions for use).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization 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