Quest for the right Drug
סיי-בי-ואק 2.5 מק"ג/0.5 מ"ל SCI-B-VAC 2.5 MCG/0.5 ML (HEPATITIS B VACCINES)
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 safety profile Pediatric Use: Sci-B-Vac has been shown to be well tolerated and highly immunogenic in infants and children of all ages. Newborns also respond well; maternally transferred antibodies do not interfere with the active immune response to the vaccine. The clinical trial safety profile of Sci-B-Vac is based on two Phase 3 controlled clinical trials (Sci-B-Vac-001 and Sci-B-Vac-002) in which 2 920 adults received at least one dose of Hepatitis B vaccine (recombinant, adsorbed) 10µg/1 ml. Local and systemic post-injection reactions were monitored using diary cards for a 7-day period starting on the day of each vaccination (solicited adverse events). The most common solicited local reactions were injection-site pain (72.2%), tenderness (71.2%) and local pruritus/itching (12.2%). Most common solicited systemic reactions were myalgia (41.7%), fatigue (37.5%), and headache (36.3%). The frequency and severity of solicited adverse events generally declined or remained similar with successive vaccinations. Tabulated list of adverse reactions The information in the table below is taken from data from the two pivotal studies and includes both solicited and spontaneously reported adverse reactions. The frequency of adverse reactions is defined as follows: Very common: (≥1/10) Common: (≥1/100 to <1/10) Uncommon: (≥1/1000 to <1/100) Rare: (≥1/10,000 to <1/1000) Very rare: (<1/10,000) Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Table 1: Adverse Reactions by System Organ Class and Frequency System Organ Class Adverse Reaction Frequency Blood and Lymphatic System Lymphadenopathy Uncommon Disorders Diarrhoea1, nausea/vomiting1 Common Gastrointestinal Disorders Abdominal pain Common Injection site pain1, injection site tenderness1, Very Common injection site pruritus1, fatigue1, General Disorders and Injection site swelling1, injection site redness1 Common Administration Site Conditions Injection site bruising Common Fever1 Common Headache1 Very Common Nervous System Disorders Dizziness Common Musculoskeletal and Connective Myalgia1 Very Common Tissue Disorder Arthralgia Common Skin and Subcutaneous Tissue Urticaria, pruritus Uncommon Disorders Rash Common Vascular disorders Flushing, hot flush Uncommon 1 Local and systemic adverse reactions collected using diary cards. Adverse events collected on the diary cards included local (pain, tenderness, erythema/redness, pruritus/itchiness and oedema/swelling) and systemic (nausea/vomiting, diarrhoea, headache, fever, fatigue and myalgia) solicited adverse events. In a series of studies, 2313 doses of Sci-B-Vac were administered to 771 healthy adults who were monitored for 5 days after each dose. The following adverse reactions were reported: Incidence Equal to or Greater Than 1% of Injections: Local Reaction (Injection Site): Injection site reactions consist of soreness and include pain, tenderness, pruritus, erythema, ecchymosis, swelling, warmth and nodule formation. These reactions were mild and resolved within two days after vaccination. Additional complaints included fatigue/weakness, headache, fever (37.8ºC), malaise, nausea, diarrhoea pharyngitis and upper respiratory infection. Incidence Less Than 1% of Injections: Sweating, aching, sensation of warmth, light-headedness, chills, flushing, vomiting, abdominal pains/cramps, dyspepsia, diminished appetite, rhinitis, influenza, cough, vertigo/dizziness, paresthesia, pruritus, rash (non-specified), angioedema, urticaria, arthralgia including monarticular, myalgia, back pain, neck pain, shoulder pain, neck stiffness, lymphadenopathy, insomnia/disturbed sleep, earache, dysuria and hypotension. Additional information in special populations Safety data are limited in immunocompromised adults, in adults previously vaccinated for hepatitis B and in adults with chronic renal failure, including patients on haemodialysis. 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
Prevention of hepatitis b infection in those who are at increased risk such as health care personnel, patients in hemodialysis units, infants born to HBsAg positive mothers, sexual and household contacts of HBsAg positive persons
תאריך הכללה מקורי בסל
01/01/1995
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