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רביפור RABIPUR (RABIES, INACTIVATED, WHOLE VIRUS)

תרופה במרשם תרופה בסל נרקוטיקה ציטוטוקסיקה

צורת מתן:

תוך-שרירי : I.M

צורת מינון:

אבקה וממס להכנת תמיסה להזרקה : POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Interactions : אינטראקציות

4.5   Interaction with other medicinal products and other forms of interaction

Immunosuppressive agents can interfere with the development of an adequate response to the rabies vaccine. Therefore, it is recommended that serological responses should be monitored in such subjects, and additional doses administered as necessary (see section 4.2).
The vaccine must not be mixed in the same syringe with other medicinal products. If rabies immunoglobulin is indicated in addition to Rabipur vaccine, then it must be administered at an anatomical site distant to the vaccination.
Available clinical data support concomitant administration of Rabipur with inactivated Japanese encephalitis (JE) vaccine and conjugated MenACWY meningococcal vaccine in adult subjects; limited data are available in the paediatric population.


Almost all adult subjects achieved an adequate immune response (Rabies Viral Neutralizing Antibodies (RVNAs) ≥ 0.5 IU/ml) within 7 days after the end of a primary series of three injections of Rabipur when given concomitantly with inactivated JE vaccine according to to either a rapid or the conventional PrEP schedule by the intramuscular route. From day 57 after vaccination a faster decline in immune response to rabies was observed in individuals vaccinated concomitantly with JE vaccine according to the rapid PrEP schedule compared with the concomitant conventional PrEP schedule and the rabies only conventional PrEP schedule. At day 366, percentages of subjects with RVNA concentration ≥0.5 IU/mL were 68%, 76%, and 80% for vaccine groups rabies/JE accelerated, rabies/JE conventional, and rabies conventional, respectively.
All adult subjects achieved an adequate immune response (RVNAs ≥ 0.5 IU/ml) within 28 days after the end of a primary series of three injections of Rabipur when given concomitantly with conjugated MenACWY vaccine according to the recommended conventional schedule by the intramuscular route.
Rabipur_Vial_PFS_SPC_V4.1_Update_09-2019                Page 5 of 12
Concomitant vaccines should always be administrated at separate injection sites and preferably contralateral limbs.


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בעל רישום

GLAXO SMITH KLINE (ISRAEL) LTD

רישום

114 03 29537 00

מחיר

0 ₪

מידע נוסף

עלון מידע לרופא

03.10.19 - עלון לרופא 03.10.19 - עלון לרופא

עלון מידע לצרכן

03.10.19 - עלון לצרכן

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