IXIARO- japanese encephalitis vaccine, inactivated, adsorbed injection, suspension

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

JAPANESE ENCEPHALITIS VIRUS STRAIN SA 14-14-2 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: DZ854I04ZE) (JAPANESE ENCEPHALITIS VIRUS STRAIN SA 14-14-2 ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:DZ854I04ZE)

Հասանելի է:

Valneva Scotland Ltd.

INN (Միջազգային անվանումը):

JAPANESE ENCEPHALITIS VIRUS STRAIN SA 14-14-2 ANTIGEN - UNII:DZ854I04ZE)

Կազմը:

JAPANESE ENCEPHALITIS VIRUS STRAIN SA 14-14-2 ANTIGEN (FORMALDEHYDE INACTIVATED) 6 ug in 0.5 mL

Կառավարման երթուղին:

INTRAMUSCULAR

Թերապեւտիկ ցուցումներ:

IXIARO is a vaccine indicated for the prevention of disease caused by Japanese encephalitis virus (JEV). IXIARO is approved for use in individuals 2 months of age and older. Severe allergic reaction (e.g., anaphylaxis) after a previous dose of IXIARO, any other Japanese Encephalitis Virus vaccine, or any component of IXIARO, including protamine sulfate, is a contraindication to administration of IXIARO [See Description (11)]. Alternatively, because of uncertainty as to which component of the vaccine may be responsible, individuals with a history of severe allergic reaction to another Japanese Encephalitis vaccine may be referred to an allergist for evaluation if immunization with IXIARO is considered. Pregnancy category B. Reproduction studies have been performed in female rats at doses approximately 300-fold excess relative to the projected human dose (on a mg/kg basis) and have revealed no evidence of impaired fertility or harm to the fetus due to IXIARO. There are, however, no adequate and well‑controlled

Ապրանքի ամփոփագիր:

IXIARO is supplied as a sterile 0.5 mL suspension in a pre filled syringe (Type I glass) with a plunger stopper (chlorobutyl elastomer) in a pack size of 1 single-dose syringe with or without a separate needle. See Section 2.3 for information on preparing a 0.25 mL dose for children 2 months to <3 years of age and a 0.5 mL dose for individuals 3 years of age and older. NDC 42515-001-01. Neither the syringe nor the packaging materials are made with natural rubber latex. Store in a refrigerator at 2° to 8° C (35° to 46° F).  Do not freeze . Do not use the vaccine after the expiration date shown on the label. Store in the original package in order to protect from light. During storage, a clear liquid with a white precipitate can be observed.

Լիազորման կարգավիճակը:

Biologic Licensing Application

Ապրանքի հատկությունները

IXIARO- JAPANESE ENCEPHALITIS VACCINE, INACTIVATED, ADSORBED
INJECTION, SUSPENSION
VALNEVA SCOTLAND LTD.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
IXIARO SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR IXIARO.
IXIARO (JAPANESE ENCEPHALITIS VACCINE, INACTIVATED, ADSORBED)
SUSPENSION FOR INTRAMUSCULAR INJECTION
INITIAL U.S. APPROVAL: 2009
INDICATIONS AND USAGE
IXIARO is a vaccine indicated for active immunization for the
prevention of disease caused by Japanese encephalitis
virus (JEV). IXIARO is approved for use in individuals 2 months of age
and older. (1)
DOSAGE AND ADMINISTRATION
For intramuscular administration only. (2)
Age (2)
Dose* (2)
Primary Series (2)
Children 2 months to <3 years of age (2) 0.25 mL (2) 2 doses,
28 days apart (2)
Individuals 3 years of age and older (2)
0.5 mL (2)
2 doses,
28 days apart (2)
*To administer a 0.25 mL dose, expel and discard half of the volume
from the 0.5 mL pre-filled syringe by pushing the
plunger stopper up to the edge of the red line on the syringe barrel
prior to injection. (2.3) (2)
Complete the primary immunization series at least 1 week prior to
potential exposure to JEV. (2.1, 14) (2)
Individuals 17 years of age and older who have received a primary
immunization series more than 1 year previously may
be given a booster dose if ongoing exposure or re-exposure to JEV is
expected. (2.1) (2)
(2)
DOSAGE FORMS AND STRENGTHS
Suspension for injection supplied in 0.5 mL single dose syringes.
CONTRAINDICATIONS
Severe allergic reaction, (e.g., anaphylaxis,) after a previous dose
of IXIARO, any other Japanese Encephalitis Virus
vaccine, or any component of IXIARO, including protamine sulfate, is a
contraindication to administration of IXIARO. (4)
(4)
WARNINGS AND PRECAUTIONS
IXIARO contains protamine sulfate, a compound known to cause
hypersensitivity reactions in some individuals. (5.1) (5)
ADVERSE REACTIONS
In infants 2 months to <1 year of age, the most common injection site
reaction was