PNEUMOVAX 23

Kraj: Izrael

Język: angielski

Źródło: Ministry of Health

Składnik aktywny:

PNEUMOCOCCAL VACCINE POLYVALENT

Dostępny od:

MERCK SHARP & DOHME (ISRAEL - 1996) COMPANY LTD, ISRAEL

Kod ATC:

J07AL01

Forma farmaceutyczna:

SOLUTION FOR INJECTION

Skład:

PNEUMOCOCCAL VACCINE POLYVALENT 25 MCG / 0.5 ML

Droga podania:

I.M, S.C

Typ recepty:

Required

Wyprodukowano przez:

MERCK SHARP & DOHME, NETHERLANDS

Grupa terapeutyczna:

PNEUMOCOCCUS, PURIFIED POLYSACCHARIDES ANTIGEN

Dziedzina terapeutyczna:

PNEUMOCOCCUS, PURIFIED POLYSACCHARIDES ANTIGEN

Wskazania:

For vaccination against pneumococcal disease caused by those pneumococcal types included in the vaccine.

Data autoryzacji:

2022-03-31

Ulotka dla pacjenta

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
.

Charakterystyka produktu

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