Adverse reactions : תופעות לוואי

4.8. Undesirable effects
a. Summary of the safety profile
The safety of Influvac Tetra was assessed in three clinical trials.
In two clinical studies, healthy adults 18 years of age and older, and healthy children 3 to 17 years of age were administered Influvac Tetra or trivalent influenza vaccine Influvac.
In a third study, the safety of Influvac Tetra was assessed in healthy children from 6 months to 35 months of age administered Influvac Tetra or a non-influenza vaccine control.
In both children studies, children from 6 months to 8 years of age received one or two doses of Influvac Tetra depending on their influenza vaccination history.
Most reactions usually occurred within the first 3 days following vaccination and resolved spontaneously within 1 to 3 days after onset. The intensity of these reactions was generally mild.
In all age groups, the most frequently reported local adverse reaction after vaccination observed in the clinical studies for Influvac Tetra was vaccination site pain.
The most frequently reported general adverse reactions after vaccination observed in the clinical studies for Influvac Tetra in adults and children from 6 to 17 years of age were fatigue and headache, and for children from 3 to 5 years of age drowsiness, irritability and loss of appetite.
The most frequently reported general adverse reactions after vaccination observed in the clinical studies for Influvac Tetra in children from 6 months to 35 months of age were irritability/fussiness.
Similar rates of solicited adverse reactions were observed in recipients of Influvac Tetra and trivalent influenza vaccine Influvac.
The rates of solicited systemic adverse reactions were similar in recipients of Influvac Tetra and the non-influenza vaccine, whereby the rates of solicited local adverse reactions were lower in recipients of Influvac Tetra.
b. Tabulated summary of adverse reactions
The following undesirable effects are considered at least possibly related to Influvac Tetra and have 
either been observed during the clinical trials with Influvac Tetra or are resulting from post-marketing experience with Influvac Tetra and/or the trivalent influenza vaccine Influvac.

The following frequencies apply:
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).
Adults and elderly
Adverse Reactions Reported with Influvac Tetra
Not Knowna
MedDRA System         Very common        Common            Uncommon
(cannot be estimated
Organ Class           ≥ 1/10             ≥ 1/100 to < 1/10 ≥ 1/1,000 to < 1/100 from the available data)
Blood and lymphatic                                                                  Transient system                                                                               thrombocytopenia, 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 rare cases with
Vascular disorders
transient renal
involvement
Skin and                                 Sweating                                    Generalised skin reactions subcutaneous tissue                                                                  including pruritus, disorders                                                                            urticaria or non-specific rash
Musculoskeletal and                      Myalgia,
connective tissue                        arthralgia
disorders

General disorders     Fatigue            Malaise, shivering Fever
and administration    Local reaction:    Local reactions:
site conditions       pain               redness, swelling,
ecchymosis,
induration
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
In elderly adults (≥ 61 years) reported as common



    Paediatric population
Children (6 months to 17 years of age) Adverse Reactions Reported with Influvac Tetra Uncommon          Not Knowna
MedDRA System          Very common              Common
≥ 1/1,000 to      (cannot be estimated
Organ Class            ≥ 1/10                   ≥ 1/100 to < 1/10 < 1/100           from the available data)
Blood and lymphatic                                                                    Transient system                                                                                 thrombocytopenia, transient lymphadenopathy
Allergic reactions, in rare
Immune system
cases leading to shock,
disorders
angioedema
Nervous system         Headachec                                                       Neuralgia, paraesthesia, disorders              Drowsinessb                                                     febrile convulsions, neurological disorders,
such as encephalomyelitis,
neuritis and Guillain Barré
syndrome
Vasculitis associated in
very rare cases with
Vascular disorders
transient renal
involvement
Skin and            Sweatingf                                                          Generalised skin reactions subcutaneous tissue                                                                    including pruritus, disorders                                                                              urticaria or non-specific rash
Metabolism and         Appetite lossb
nutrition disorders
Gastrointestinal       Nauseac, abdominal
disorders              painc, diarrhoeae,
vomitinge
Psychiatric disorders Irritability/fussinessb

Musculoskeletal and Myalgiac                    Arthralgiac
connective tissue
disorders
General disorders      Fatiguec, feverf       Shiveringc
c
and administration     malaise                Local reaction:
site conditions        Local reactions: pain, ecchymosis
redness, swellingd,
indurationd
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
Reported in children 6 months to 5 years of age
c
Reported in children 6 to 17 years of age
d
Reported as common in children 6 to 35 months of age
e
Reported as common in children 3 to 5 years of age
f
Reported as common in children 3 to 17 years of age

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://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@moh.g ov.il