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עמוד הבית / סינפלוריקס 4 מנות / מידע מעלון לרופא

סינפלוריקס 4 מנות SYNFLORIX 4 DOSE (PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19 F, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5, 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

Interactions : אינטראקציות

4.5    Interaction with other medicinal products and other forms of interaction

Use with other vaccines
Synflorix can be given concomitantly with any of the following monovalent or combination vaccines [including DTPa-HBV-IPV/Hib and DTPw-HBV/Hib]: diphtheria-tetanus-acellular pertussis vaccine (DTPa), hepatitis B vaccine (HBV), inactivated polio vaccine (IPV), Haemophilus influenzae type b vaccine (Hib), diphtheria-tetanus-whole cell pertussis vaccine (DTPw), measles-mumps-rubella vaccine (MMR), varicella vaccine (V), meningococcal serogroup C conjugate vaccine (CRM197 and TT conjugates), meningococcal serogroups A, C, W-135 and Y conjugate vaccine (TT conjugate), oral polio vaccine (OPV) and oral rotavirus vaccine. Different injectable vaccines should always be given at different injection sites.
Synflorix SPC V8.0 June 2020                      Page 4 of 21
Clinical studies demonstrated that the immune responses and the safety profiles of the co-administered vaccines were unaffected, with the exception of the inactivated poliovirus type 2 response, for which inconsistent results were observed across studies (seroprotection ranging from 78% to 100%). In addition when the meningococcal serogroups A, C, W-135 and Y vaccine (TT conjugate) was co- administered with a booster dose of Synflorix during the second year of life in children primed with 3 doses of Synflorix, lower antibody geometric mean concentration (GMC) and opsonophagocytic assay geometric mean titre (OPA GMT) were observed for one pneumococcal serotype (18 C). There was no impact of co-administration on the other nine pneumococcal serotypes. Enhancement of antibody response to Hib-TT conjugate, diphtheria and tetanus antigens was observed. The clinical relevance of the above observations is unknown.

Use with systemic immunosuppressive medicinal products

As with other vaccines, it may be expected that in patients receiving immunosuppressive treatment an adequate response may not be elicited.

Use with prophylactic administration of antipyretics

Clinical data suggest that prophylactic administration of paracetamol, used to reduce the rate of possible post-vaccination febrile reactions, might reduce the immune response to Synflorix. However, the clinical relevance of this observation is not known. See section 4.4.

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מידע נוסף

עלון מידע לרופא

06.07.20 - עלון לרופא

עלון מידע לצרכן

לתרופה במאגר משרד הבריאות

סינפלוריקס 4 מנות

קישורים נוספים

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