Quest for the right Drug
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
עלון לרופא
מינוניםPosology התוויות
Indications תופעות לוואי
Adverse reactions התוויות נגד
Contraindications אינטראקציות
Interactions מינון יתר
Overdose הריון/הנקה
Pregnancy & Lactation אוכלוסיות מיוחדות
Special populations תכונות פרמקולוגיות
Pharmacological properties מידע רוקחי
Pharmaceutical particulars אזהרת שימוש
Special Warning עלון לרופא
Physicians Leaflet
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
שימוש לפי פנקס קופ''ח כללית 1994
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תאריך הכללה מקורי בסל
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הגבלות
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מידע נוסף