Adverse reactions : תופעות לוואי

4.8. Undesirable effects
a. Summary of safety profile
The most frequently reported adverse drug reactions following use of Influvac are local and/or systemic reactions such as injection site pain or fatigue and headache. Most of these adverse reactions are of mild to moderate intensity.
These reactions usually disappear within 1-2 days without treatment.

In rare cases, allergic reactions may evolve to shock, angioedema (see section 4.4).

b. Tabulated summary of adverse reactions
The following undesirable effects have been observed during clinical trials or are resulting from post- marketing experience with the following frequencies:
very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); and not known (adverse reactions from post-marketing experience; cannot be estimated from the available data).


Adverse Reactions Reported with Influvac
Uncommon          Not Knowna
MedDRA System           Very common Common
≥ 1/1,000 to      (cannot be estimated from
Organ Class             ≥ 1/10      ≥ 1/100 to < 1/10
< 1/100           the available data)
Blood and lymphatic                                                                   Transient thrombocytopenia, system                                                                                transient lymphadenopathy Allergic reactions, in rare
Immune system                                                                         cases leading to shock, disorders                                                                             angioedema Nervous system                           Headacheb                                    Neuralgia, paraesthesia, disorders                                                                             febrile convulsions, neurological disorders, such
as encephalomyelitis, neuritis
and Guillain Barré syndrome
Vasculitis associated in very
Vascular disorders                                                                    rare cases with transient renal involvement
Skin and                                 Sweatingb                                    Generalised skin reactions subcutaneous tissue                                                                   including pruritus, urticaria or disorders                                                                             non-specific rash 
Musculoskeletal and                      Myalgia, arthralgiab
connective tissue
disorders

General disorders and                    Fever, malaise,
administration site                      shivering, fatigue
conditions                               Local reactions:
redness, swelling, pain,
ecchymosis,
indurationb
a
Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure b
These reactions usually disappeared spontaneously within 1-2 days without treatment.


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