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אינפנריקס הקסא INFANRIX HEXA (DIPHTHERIA TOXOID, FILAMENTOUS HAEMAGGLUTININ (FHA), HAEMOPHILUS B, HEPATITIS B VACCINES, PERTACTIN, PERTUSSIS TOXOID (PT), POLIOVIRUS TYPE 1 INACTIVATED, POLIOVIRUS TYPE 2 INACTIVATED, POLIOVIRUS TYPE 3 INACTIVATED, TETANUS TOXOID)

תרופה במרשם תרופה בסל נרקוטיקה ציטוטוקסיקה

צורת מתן:

תוך-שרירי : I.M

צורת מינון:

אבקה ותרחיף להכנת תרחיף להזרקה : POWDER AND SUSPENSION FOR SUSPENSION FOR INJECTION

Interactions : אינטראקציות

4.5   Interaction with other medicinal products and other forms of interaction

Infanrix hexa can be given concomitantly with pneumococcal conjugate vaccines (PCV7, PCV10 and PCV13), meningococcal serogroup C conjugate vaccine (CRM197 and TT conjugates), meningococcal serogroups A, C, W-135 and Y conjugate vaccine (TT conjugate), meningococcal serogroup B vaccine (MenB), oral rotavirus vaccine and measles- mumps-rubella-varicella (MMRV) vaccine.
Data have shown no clinically relevant interference in the antibody response to each of the individual antigens, although inconsistent antibody response to poliovirus type 2 in co- administration with Synflorix was observed (seroprotection ranging from 78% to 100%) and the immune response rates to the PRP (Hib) antigen of Infanrix hexa after 2 doses given at 2 and 4 months of age were higher if co-administered with a tetanus toxoid conjugate pneumococcal or meningococcal vaccine (see section 5.1). The clinical relevance of these observations remains unknown.
When Infanrix hexa was co-administered with MenB and pneumococcal conjugate vaccines, inconsistent results were seen across studies for responses to inactivated poliovirus type 2, pneumococcal conjugate serotype 6B antigen and to the pertussis pertactin antigen but these data do not suggest clinically significant interference. Data from clinical studies indicate that, when Infanrix hexa is co-administered with pneumococcal conjugate vaccines, the rate of febrile reactions is higher compared to that occurring following the administration of Infanrix hexa alone. Data from one clinical study indicate that when Infanrix hexa is co-administered with MMRV vaccine, the rate of febrile reactions is higher compared to that occurring following the administration of Infanrix hexa alone and similar to that occurring following the administration of MMRV vaccine alone (see sections 4.4 and 4.8). The immune responses were unaffected.
Due to an increased risk of fever, pain at the injection site, appetite lost and irritability when Infanrix hexa was co-administered with MenB vaccine and 7-valent pneumococcal conjugate vaccine, separate vaccinations can be considered when possible.

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


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בעל רישום

GLAXOSMITHKLINE (ISRAEL) LTD

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133 20 30676 00

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