Quest for the right Drug
בוסטריקס פוליו BOOSTRIX POLIO (DIPHTHERIA TOXOID, FILAMENTOUS HAEMAGGLUTININ (FHA), INACTIVATED POLIO VIRUS (IPV) TYPE 1, INACTIVATED POLIO VIRUS (IPV) TYPE 2, INACTIVATED POLIO VIRUS (IPV) TYPE 3, PERTACTIN (PRN OR 69 KDA OMP), PERTUSSIS TOXOID VACCINE, TETANUS TOXOID)
תרופה במרשם
תרופה בסל
נרקוטיקה
ציטוטוקסיקה
צורת מתן:
תוך-שרירי : I.M
צורת מינון:
תרחיף להזרקה : SUSPENSION 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 The safety profile presented in Table 1 is based on data from clinical trials where Boostrix Polio was administered to 908 children (from 4 to 8 years of age) and 955 adults, adolescents and children (from 10 to 93 years of age). The most common events occurring after Boostrix Polio administration in both groups were local injection site reactions (pain, redness and swelling) reported by 31.3 – 82.3% of subjects overall. These usually had their onset within the first 48 hours after vaccination. All resolved without sequelae. Tabulated list of adverse reactions Adverse reactions reported are listed according to the following frequency: 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) • Clinical trials Table 1: Adverse reactions reported in clinical trials with Boostrix-Polio Adverse reactions System Organ Class Frequency Subjects aged 4 - 8 years Subjects aged 10 - 93 (N=908) years (N = 955) Infections and Uncommon oral herpes infestations Blood and lymphatic Uncommon lymphadenopathy lymphadenopathy system disorders Metabolism and Common anorexia nutrition disorders Uncommon decreased appetite Psychiatric disorders Common irritability Uncommon sleep disorder, apathy Nervous system disorders Very common somnolence headache Common headache Uncommon paraesthesia, somnolence, dizziness Respiratory, thoracic Uncommon dry throat asthma and mediastinal disorders Gastrointestinal Common gastrointestinal disorders disorders (such as vomiting, abdominal pain, nausea) Uncommon diarrhoea, vomiting, abdominal pain, nausea Skin and subcutaneous Uncommon pruritus tissue disorders Musculoskeletal and Uncommon arthralgia, myalgia connective tissue disorders General disorders and Very common injection site reactions injection site reactions administration site (such as redness and/or (such as redness and/or conditions swelling), injection site swelling), fatigue, pain injection site pain Common pyrexia (fever ≥ 37.5°C, pyrexia (fever 37.5°C), including fever > 39°C), injection site reactions extensive swelling of (such as haematoma, vaccinated limb pruritus, induration and (sometimes involving the warmth numbness) adjacent joint), injection site reactions (such as haemorrhage, pruritus and induration) Uncommon fatigue extensive swelling of vaccinated limb (sometimes involving the adjacent joint), pyrexia (fever > 39.0°C), chills, pain Coadministration with MMR/V vaccines in children aged 3-6 years Boostrix-Polio was coadministered with MMR/V vaccines in 2 clinical studies with 406 children aged 3-6 years. In these studies, upper respiratory tract infection and rash were commonly reported. Fever, irritability, fatigue, loss of appetite and gastrointestinal disorders (including diarrhoea and vomiting) were reported with a higher frequency (very common) when compared to Table 1 while all other adverse reactions occurred at the same or lower frequency. Adverse reactions additionally reported during clinical studies with Boostrix (dTpa component of Boostrix-Polio), administered to 839 children (from 4 to 8 years of age) and 1931 adults, adolescents and children (from 10 to 76 years of age), are listed in Table 2. Table 2: Adverse reactions reported in clinical trials with Boostrix Adverse reactions System Organ Class Frequency Subjects aged 4 - 8 years Subjects aged 10 - 76 (N=839) years (N = 1931) Infections and Uncommon upper respiratory tract infestations infection, pharyngitis Nervous system disorders Uncommon disturbances in attention syncope Eye disorders Uncommon conjunctivitis Respiratory, thoracic Uncommon cough and mediastinal disorders Gastrointestinal Uncommon diarrhoea disorders Skin and subcutaneous Uncommon hyperhidrosis, rash tissue disorders Musculoskeletal and Uncommon joint stiffness, connective tissue musculoskeletal stiffness disorders General disorders and Very malaise administration site common conditions Common injection site reactions (such as injection site mass and injection site abscess sterile) Uncommon pain influenza like illness Reactogenicity after repeat dose Data suggest that in subjects primed with DTP in childhood a second booster dose might give an increase of local reactogenicity. Subjects aged 15 years onwards without recent vaccination for diphtheria, tetanus, pertussis and poliomyelitis, who received a dose of Boostrix-Polio or another reduced-antigen content vaccine, followed by an additional dose of Boostrix-Polio 10 years after, showed no increased reactogenicity after this second dose compared to the first one. • Post-marketing surveillance Because these events were reported spontaneously, it is not possible to reliably estimate their frequency. Table 3: Adverse reactions reported with Boostrix-Polio during post-marketing surveillance System Organ Class Frequency Adverse reactions Immune system disorders unknown allergic reactions, including anaphylactic and anaphylactoid reactions Nervous system disorders unknown hypotonic-hyporesponsiveness episodes, convulsions (with or without fever) Skin and subcutaneous tissue unknown urticaria, angioedema disorders General disorders and unknown asthenia administration site conditions Following administration of tetanus toxoid containing vaccines, there have been very rare reports of adverse reactions on the central or peripheral nervous systems, including ascending paralysis or even respiratory paralysis (e.g. Guillain-Barré syndrome). 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/ Additionally, you should also report to GSK Israel, (il.safety@gsk.com).
שימוש לפי פנקס קופ''ח כללית 1994
לא צוין
תאריך הכללה מקורי בסל
לא צוין
הגבלות
לא צוין
מידע נוסף
עלון מידע לצרכן
14.07.14 - עלון לצרכן 12.09.19 - עלון לצרכן 02.09.21 - עלון לצרכן עברית 11.10.22 - עלון לצרכן אנגלית 11.10.22 - עלון לצרכן עברית 11.10.22 - עלון לצרכן ערבית 13.12.22 - עלון לצרכן אנגלית 13.12.22 - עלון לצרכן עברית 13.12.22 - עלון לצרכן ערבית 24.01.24 - עלון לצרכן עברית 06.03.24 - עלון לצרכן עברית 10.03.24 - עלון לצרכן אנגלית 10.03.24 - עלון לצרכן ערבית 02.04.24 - עלון לצרכן עברית 06.06.24 - עלון לצרכן אנגלית 06.06.24 - עלון לצרכן עברית 06.06.24 - עלון לצרכן ערבית 04.12.11 - החמרה לעלון 02.09.21 - החמרה לעלון 02.04.24 - החמרה לעלון 20.09.24 - החמרה לעלוןלתרופה במאגר משרד הבריאות
בוסטריקס פוליו