Adverse reactions : תופעות לוואי

4.8     Undesirable effects

The safety profile presented below is based on data from more than 5300 subjects that participated in clinical trials, plus reactions observed through post-marketing surveillance. It should be noted that it was not possible to calculate the frequency of reactions from the post-marketing data, therefore the frequency is noted as “Not known”.
The most frequently reported reactions are pain and redness at site of injection (Havrix 1440 has reports in over 50% of doses, Havrix 720 Junior has reports in 18.2% of doses overall). Swelling at the site of injection was the next most frequently reported reactions.

Frequencies per dose are defined as follows:
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 data available 
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness 
* refers to adverse reaction reported only for Havrix 1440 (1mL adult dose) ** refers to adverse reactions reported only for Havrix 720 Junior (0.5mL children’s dose) # this adverse reaction was identified through post-marketing surveillance but was not observed in randomised controlled clinical trials. The frequency category of rare was estimated from a statistical calculation based on the total number of paediatric patients exposed to Havrix in randomised controlled clinical trials (n=4574).


System Organ              Frequency        Adverse reaction
Classes
Infections and            Uncommon         Upper respiratory tract infection* infestations                               Rhinitis*

Immune system             Not known        Anaphylaxis disorders                                  Allergic reactions including anaphylactoid reactions and mimicking serum sickness

Metabolism and            Common           Appetite lost nutrition disorders

Psychiatric disorders     Very             Irritability** common
Nervous system            Very             Headache (common with Havrix 720 Junior disorders                 common           formulation)
Common           Drowsiness**
Uncommon         Dizziness*
Rare             Hypoaesthesia
Paraesthesia
Not known        Convulsions
Guillain Barre Syndrome
Transverse myelitis
Neuralgic amyotrophy

Vascular disorders      Not known     Vasculitis

Gastrointestinal        Common        Gastrointestinal symptoms*(rare with Havrix 720 disorders                             Junior formulation#)
Nausea
Diarrhoea (uncommon with Havrix 720 Junior formulation)
Uncommon      Vomiting
Hepatobiliary           Not known     Transient increase in liver function tests disorders
Skin and subcutaneous   Uncommon      Rash** tissue disorders
Rare          Pruritus
Not known     Angioneurotic oedema
Erythema multiforme
Urticaria
Musculoskeletal and     Uncommon      Myalgia* connective tissue                     Musculoskeletal stiffness* disorders
Not known     Arthralgia

General disorders and   Very          Pain and redness at the injection site administration site     common        Fatigue* (rare with Havrix 720 Junior conditions                            formulation#)
Common        Fever (37.5°C)
Injection site reaction, such as swelling or induration (uncommon with Havrix 720 Junior formulation)
Malaise
Uncommon      Influenza like illness*
Rare          Chills

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).