Land: Israel
Språk: engelska
Källa: Ministry of Health
PNEUMOCOCCAL VACCINE POLYVALENT
MERCK SHARP & DOHME (ISRAEL - 1996) COMPANY LTD, ISRAEL
J07AL01
SOLUTION FOR INJECTION
PNEUMOCOCCAL VACCINE POLYVALENT 25 MCG / 0.5 ML
I.M, S.C
Required
MERCK SHARP & DOHME, NETHERLANDS
PNEUMOCOCCUS, PURIFIED POLYSACCHARIDES ANTIGEN
PNEUMOCOCCUS, PURIFIED POLYSACCHARIDES ANTIGEN
For vaccination against pneumococcal disease caused by those pneumococcal types included in the vaccine.
2022-03-31
אפורל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה ןכדועמ( 05.2013 ) __ ךיראת . 10.1310 ___________ םושירה רפסמו תילגנאב רישכת םש PNEUMOVAX 23 )136.52.23874.00( םושירה לעב םש MERCK, SHARP & DOHME (ISRAEL-1996) LTD . __________ ! דבלב תורמחהה טורפל דעוימ הז ספוט תושקובמה תורמחהה ןולעב קרפ יחכונ טסקט שדח טסקט ADVERSE EVENTS :תואבה יאוולה תועפות ופסונ TENDERNESS, ECCHYMOSIS, PRURITUS, DIARRHEA, DYSPEPSIA, BACK PAIN, NECK PAIN, UPPER RESPIRATORY INFECTION, PHARYNGITIS, ERYTHEMA MULTIFORME CONCOMITANT ADMINISTRATION WITH OTHER VACCINES In a double-blind, controlled clinical trial, 473 adults, 60 years of age or older, were randomized to receive ZOSTAVAX and PNEUMOVAX 23 concomitantly (N=237), or PNEUMOVAX 23 alone followed 4 weeks later by ZOSTAVAX alone (N=236). At four weeks postvaccination, the varicella-zoster virus (VZV) antibody levels following concomitant use were significantly lower than the VZV antibody levels following nonconcomitant administration (GMTs of 338 vs. 484 gp ELISA units/mL, respectively; GMT ratio = 0.70 (95% CI: [0.61, 0.80]). Limited safety and immunogenicity data from clinical trials are available on the concurrent administration of PNEUMOVAX 23 and vaccines other than ZOSTAVAX . Läs hela dokumentet
PNEUMOVAX ® 23 PNEUMOCOCCAL VACCINE POLYVALENT SOLUTION FOR S.C OR I.M INJECTION Each 0.5-mL dose of vaccine contains 25 micrograms of each of the following pneumococcal polysaccharide types: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F. 1 THERAPEUTIC INDICATIONS PNEUMOVAX 23 is indicated for vaccination against pneumococcal disease caused by those pneumococcal types included in the vaccine. Effectiveness of the vaccine in the prevention of pneumococcal pneumonia and pneumococcal bacteremia has been demonstrated in controlled trials in South Africa, France and in case-control studies. PNEUMOVAX 23 will not prevent disease caused by capsular types of pneumococcus other than those contained in the vaccine. Vaccination with PNEUMOVAX 23 is recommended for selected individuals as follows:_ _ − routine vaccination for persons 50 years of age or older − persons aged ≥ 2 years with certain chronic conditions or in special environments or social settings. SPECIFIC RECOMMENDATIONS FOR THE PREVENTION OF PNEUMOCOCCAL DISEASE CAN BE FOUND AT THE FOLLOWING ADDRESS: HTTPS://WWW.HEALTH.GOV.IL/UNITSOFFICE/HD/PH/EPIDEMIOLOGY/TD/DOCS/TADRICH_CHISUNIM.PDF 2 DOSAGE AND ADMINISTRATION For intramuscular or subcutaneous injection only. 2.1 PREPARATION • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. If either of these two conditions exists, the vaccine should not be administered. • Do not mix PNEUMOVAX 23 with other vaccines in the same syringe or vial. • Use a separate sterile syringe and needle for each individual patient to prevent transmission of infectious agents from one person to another. _ _ _Single-Dose Vial_ Withdraw 0.5 mL from the vial using a sterile needle and syringe free of preservatives, antiseptics, and detergents. _Single-Dose, Prefilled Syringe_ The package contains 2 needles. Attach the sterile needle to the prefilled syringe by twisting in a clockwise direction until the need Läs hela dokumentet