VAQTA 50 UML

Země: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktivní složka:

HEPATITIS A VIRUS ANTIGEN, INACTIVATED

Dostupné s:

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

ATC kód:

J07BC02

Léková forma:

SUSPENSION FOR INJECTION

Složení:

HEPATITIS A VIRUS ANTIGEN, INACTIVATED 50 U/ML

Podání:

I.M

Druh předpisu:

Required

Výrobce:

MERCK SHARP & DOHME B.V, HOLLAND

Terapeutické skupiny:

HEPATITIS A, INACTIVATED, WHOLE VIRUS

Terapeutické oblasti:

HEPATITIS A, INACTIVATED, WHOLE VIRUS

Terapeutické indikace:

Vaqta is indicated for active pre-exposure prophylaxis against disease caused by hepatitis A virus in persons 2 years of age and older.

Datum autorizace:

2021-05-31

Charakteristika produktu

1
VAQTA
® 25 U / 0.5 ML
VAQTA
® 50 U / ML
HEPATITIS A VIRUS ANTIGEN, INACTIVATED
SUSPENSION FOR INTRAMUSCULAR INJECTION ONLY
1
THERAPEUTIC INDICATIONS
1.1
INDICATIONS AND USE
VAQTA
1
[Hepatitis A Vaccine, Inactivated] is indicated for the prevention of
disease caused by
hepatitis A virus (HAV) in persons 12 months of age and older. The
primary dose should be given at least
2 weeks prior to expected exposure to HAV.
VAQTA may be administered along with immune globulin (IG) at a
separate site with a separate syringe
for post-exposure prophylaxis_ [see Clinical Studies (14.5)]_.
1.2
LIMITATIONS OF USE
VAQTA will not prevent hepatitis caused by infectious agents other
than hepatitis A virus. Because of
the long incubation period (approximately 20 to 50 days) for hepatitis
A, it is possible for unrecognized
hepatitis A infection to be present at the time the vaccine is given.
The vaccine may not prevent hepatitis A
in such individuals.
Vaccination with VAQTA may not result in a protective response in all
susceptible vaccinees.
2
DOSAGE AND ADMINISTRATION
2.1
DOSAGE AND SCHEDULE
_Children/Adolescents (12 months through 18 years of age):
_Vaccination consists of a primary 0.5-mL dose
administered intramuscularly, and a 0.5-mL booster dose administered
intramuscularly 6 to 18 months later.
_ _
_Adults_ (≥_19 years of age_): Vaccination consists of a primary
1.0-mL dose administered intramuscularly, and
a 1.0-mL booster dose administered intramuscularly_ _6 to 18 months
later.
_Interchangeability of the Booster Dose_: A booster dose of VAQTA may
be given at 6 to 12 months following
the primary dose of another inactivated hepatitis_ _A vaccine_
_(_i.e_._, _HAVRIX
2
)_ [see Clinical Studies (14.6)]._
2.2
METHOD OF ADMINISTRATION
For intramuscular use only.
•
Shake well to obtain a slightly opaque, white suspension before
withdrawal and use.
•
Thoroughly agitate to maintain suspension of the vaccine.
•
Discard if the suspension does not appear homogenous or if extraneous
particulate matter remains or
discoloration