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קיודנגה QDENGA (DENGUE VIRUS SEROTYPE 1 (LIVE, ATTENUATED), DENGUE VIRUS SEROTYPE 3 (LIVE, ATTENUATED), DENGUE VIRUS SEROTYPE 4 (LIVE, ATTENUATED), DENGUE VIRUS, SEROTYPE 2, LIVE, ATTENUATED))

תרופה במרשם תרופה בסל נרקוטיקה ציטוטוקסיקה

צורת מתן:

תת-עורי : S.C

צורת מינון:

אבקה וממס להכנת תמיסה להזרקה : POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Summary of the safety profile
In clinical studies, the most frequently reported reactions in subjects 4 to 60 years of age were injection site pain (50%), headache (35%), myalgia (31%), injection site erythema (27%), malaise (24%), asthenia (20%) and fever (11%).

These adverse reactions usually occurred within 2 days after the injection, were mild to moderate in severity, had a short duration (1 to 3 days) and were less frequent after the second injection of Qdenga than after the first injection.

Vaccine viraemia

In clinical study DEN-205, transient vaccine viraemia was observed after vaccination with Qdenga in 49% of study participants who had not been infected with dengue before and in 16% of study participants who had been infected with dengue before. Vaccine viraemia usually started in the second week after the first injection and had a mean duration of 4 days. Vaccine viraemia was associated with transient, mild to moderate symptoms, such as headache, arthralgia, myalgia and rash in some subjects. Vaccine viraemia was rarely detected after the second dose.
Dengue diagnostic tests may be positive during vaccine viraemia and cannot be used to distinguish vaccine viraemia from wild type dengue infection.

Tabulated list of adverse reactions

Adverse reactions associated with Qdenga obtained from clinical studies and post-authorisation experience are tabulated below (Table 1).

The safety profile presented below is based on data generated in placebo-controlled clinical studies and post-authorisation experience. Pooled analysis of clinical studies included data from 14,627 study participants aged 4 to 60 years (13,839 children and 788 adults) who have been vaccinated with Qdenga. This included a reactogenicity subset of 3,830 participants (3,042 children and 788 adults).

Adverse reactions are listed according to the following frequency categories: 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


Table 1: Adverse reactions from clinical studies (age 4 to 60 years) and post-authorisation experience (age 4 years and older)

MedDRA System Organ Class            Frequency               Adverse Reactions Infections and infestations          Very common             Upper respiratory tract infectiona Common                  Nasopharyngitis
Pharyngotonsillitisb
Uncommon                Bronchitis
Rhinitis
Immune system disorders              Not known               Anaphylactic reaction, including anaphylactic shockc
Metabolism and nutrition             Very common             Decreased appetited disorders
Psychiatric disorders                Very common             Irritabilityd Nervous system disorders             Very common             Headache Somnolenced
Uncommon                Dizziness
Gastrointestinal disorders           Uncommon                Diarrhoea Nausea
Abdominal pain
Vomiting
Skin and subcutaneous tissue         Uncommon                Rashe disorders                                                    Pruritusf Urticaria
Very rare               Angioedema
Musculoskeletal and connective       Very common             Myalgia tissue disorders                     Common                  Arthralgia 
MedDRA System Organ Class                Frequency                  Adverse Reactions General disorders and                    Very common                Injection site pain administration site conditions                                      Injection site erythema Malaise
Asthenia
Fever
Common                     Injection site swelling
Injection site bruisingf
Injection site pruritusf
Influenza like illness
Uncommon                   Injection site haemorrhagef
Fatiguef
Injection site discolourationf a
Includes upper respiratory tract infection and viral upper respiratory tract infection b
Includes pharyngotonsillitis and tonsillitis c
Adverse reaction observed post-authorisation d
Collected in children below 6 years of age in clinical studies e
Includes rash, viral rash, rash maculopapular, rash pruritic f
Reported in adults in clinical studies

Paediatric population

Paediatric data in subjects 4 to 17 years of age
Pooled safety data from clinical trials are available for 13839 children (9210 aged 4 to 11 years and 4629 aged 12 to 17 years). This includes reactogenicity data collected in 3042 children (1865 aged 4 to
11 years and 1177 aged 12 to 17 years).

Frequency, type and severity of adverse reactions in children were largely consistent with those in adults. Adverse reactions reported more commonly in children than in adults were fever (11% versus 3%), upper respiratory tract infection (11% versus 3%), nasopharyngitis (6% versus 0.6%), pharyngotonsillitis (2% versus 0.3%), and influenza like illness (1% versus 0.1%). Adverse reactions reported less commonly in children than adults were injection site erythema (2% versus 27%), nausea (0.03% versus 0.8%) and arthralgia (0.03% versus 1%).

The following reactions were collected in 357 children below 6 years of age vaccinated with Qdenga: decreased appetite (17%), somnolence (13%) and irritability (12%).


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: https://sideeffects.health.gov.il

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TAKEDA ISRAEL LTD

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176 51 37674 00

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