Quest for the right Drug
פרבנאר 13 PREVENAR 13 (PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19 F, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V)
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
Interactions : אינטראקציות
4.5 Interaction with other medicinal products and other forms of interaction Infants and children aged 6 weeks to 5 years Prevenar 13 can be given concomitantly with any of the following vaccine antigens, either as monovalent or combination vaccines: diphtheria, tetanus, acellular or whole cell pertussis, Haemophilus influenzae type b, inactivated poliomyelitis, hepatitis B (see section 4.4 for guidance on Infanrix hexa), meningococcal serogroup C, measles, mumps, rubella, varicella and rotavirus vaccine. Prevenar 13 can also be given concomitantly between 12-23 months with the tetanus toxoid conjugated meningococcal polysaccharide serogroups A, C, W and Y vaccine to children who have been adequately primed with Prevenar 13 (as per local recommendations). Data from a postmarketing clinical study evaluating the impact of prophylactic use of antipyretics (ibuprofen and paracetamol) on the immune response to Prevenar 13 suggest that administration of paracetamol concomitantly or within the same day of vaccination may reduce the immune response to Prevenar 13 after the infant series. Responses to the booster dose administered at 12 months were unaffected. The clinical significance of this observation is unknown. Children and adolescents 6 to 17 years of age No data are currently available regarding concomitant use with other vaccines. Adults 18 to 49 years of age No data are available regarding concomitant use with other vaccines. Adults aged 50 years and older Prevenar 13 may be administered concomitantly with the seasonal trivalent inactivated influenza vaccine (TIV). In two studies conducted in adults aged 50-59 and 65 years and older, it was demonstrated that Prevenar 13 may be given concomitantly with trivalent inactivated influenza vaccine (TIV). The responses to all three TIV antigens were comparable when TIV was given alone or concomitantly with Prevenar 13. When Prevenar 13 was given concomitantly with TIV, the immune responses to Prevenar 13 were lower compared to when Prevenar 13 was given alone, however, there was no long-term impact on circulating antibody levels. In a third study in adults aged 50-93 years, it was demonstrated that Prevenar 13 may be given concomitantly with the seasonal quadrivalent inactivated influenza vaccine (QIV). The immune responses to all four QIV strains were noninferior when Prevenar 13 was given concomitantly with QIV compared to when QIV was given alone. The immune responses to Prevenar 13 were noninferior when Prevenar 13 was given concomitantly with QIV compared to when Prevenar 13 was given alone. As with concomitant administration with trivalent vaccines, immune responses to some pneumococcal serotypes were lower when both vaccines were given concomitantly. Concomitant use with other vaccines has not been investigated. Different injectable vaccines should always be given at different vaccination sites. Concomitant administration of Prevenar 13 and 23-valent pneumococcal polysaccharide vaccine has not been studied. In clinical studies when Prevenar 13 was given 1 year after 23-valent pneumococcal polysaccharide vaccine the immune responses were lower for all serotypes compared to when Prevenar 13 was given to subjects not previously immunised with 23-valent pneumococcal polysaccharide vaccine. The clinical significance of this is unknown.
פרטי מסגרת הכללה בסל
התרופה תינתן לילדים החל מגיל 8 שבועות ועד לגיל 59 חודשים, אשר משתייכים לקבוצות הסיכון האלה: 1. הפרעות בפעילות הטחול (אנטומיות או תפקודיות), כגון כריתת טחול, חוסר טחול מולד, אנמיה חרמשית (SCD) וכדומה. 2. ליקויים אימונולוגיים עקב: א. מחלות ממאירות, כגון לוקמיה ולימפומה. ב. טיפול מדכא חסינות (כגון הקרנות, חומרים ציטוטוקסיים). ג. זיהום HIV. ד. כל מצב רפואי אחר, המלווה בליקויים של מערכת החיסון. 3. השתלת איברים, שתל קוכליארי ומח עצם. 4. דליפות נוזל חוט שדרה עם סיכון לדלקת עוצבה חוזרת. 5. אי ספיקת כליות כרונית, תסמונת נפרוטית, טיפול בדיאליזה. 6. חולי Ataxia Telangiectasia.
שימוש לפי פנקס קופ''ח כללית 1994
Vaccination should be considered for the following high risk groups: after splenectomy or splenic dysfunction (sickle cell anaemia), nephrotic syndrome, persons with chronic illness who may be at a greater risk of pneumococcal infections
תאריך הכללה מקורי בסל
15/05/2006
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