SHINGRIX- zoster vaccine recombinant, adjuvanted kit

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

RECOMBINANT VARICELLA ZOSTER VIRUS GLYCOPROTEIN E ANTIGEN (UNII: COB9FF6I46) (RECOMBINANT VARICELLA ZOSTER VIRUS GLYCOPROTEIN E ANTIGEN - UNII:COB9FF6I46)

Доступна з:

GlaxoSmithKline Biologicals SA

ІПН (Міжнародна Ім'я):

gE: Recombinant Varicella Zoster Virus glycoprotein E glycoprotein E - UNII:COB9FF6I46)

Склад:

gE: Recombinant Varicella Zoster Virus (VZV) glycoprotein E 50 ug in 0.5 mL

Терапевтичні свідчення:

SHINGRIX is a vaccine indicated for prevention of herpes zoster (HZ) (shingles):     •    in adults aged 50 years and older.     •    in adults aged 18 years and older who are or will be at increased risk of HZ due to immunodeficiency or immunosuppression caused by known disease or therapy. Limitations of Use : Do not administer SHINGRIX to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or after a previous dose of SHINGRIX [see Description (11)] . Risk Summary All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The data are insufficient to establish if there is vaccine-associated risk with SHINGRIX in pregnant women. A developmental toxicity study was performed in female rats administered SHINGRIX or the AS01B adjuvant alone prior to mating, during g

Огляд продуктів:

SHINGRIX is supplied as 2 components: A single-dose vial of lyophilized gE antigen component (powder) and a single-dose vial of adjuvant suspension component (liquid) (packaged without syringes or needles). Presentation Carton NDC Number Components Adjuvant Suspension Component (liquid) Lyophilized gE Antigen Component (powder) An outer carton of 1 dose 58160-819-12 Vial 1 of 2 NDC 58160-829-01 Vial 2 of 2 NDC 58160-828-01 An outer carton of 10 doses 58160-823-11 10 vials NDC 58160-829-03 10 vials NDC 58160-828-03 Adjuvant suspension component vials: Store refrigerated between 2° and 8°C (36° and 46°F). Protect vials from light. Do not freeze. Discard if the adjuvant suspension has been frozen. Lyophilized gE antigen component vials: Store refrigerated between 2° and 8°C (36° and 46°F). Protect vials from light. Do not freeze. Discard if the antigen component has been frozen.

Статус Авторизація:

Biologic Licensing Application

Характеристики продукта

SHINGRIX- ZOSTER VACCINE RECOMBINANT, ADJUVANTED
GLAXOSMITHKLINE BIOLOGICALS SA
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SHINGRIX SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SHINGRIX.
SHINGRIX (ZOSTER VACCINE RECOMBINANT, ADJUVANTED), SUSPENSION FOR
INTRAMUSCULAR
INJECTION
INITIAL U.S. APPROVAL: 2017
INDICATIONS AND USAGE
SHINGRIX is a vaccine indicated for prevention of herpes zoster (HZ)
(shingles):
•
•
Limitations of Use (1):
•
DOSAGE AND ADMINISTRATION
FOR INTRAMUSCULAR ADMINISTRATION ONLY.
Two doses (0.5 mL each) administered intramuscularly according to the
following schedules:
•
•
DOSAGE FORMS AND STRENGTHS
Suspension for injection supplied as a single-dose vial of lyophilized
varicella zoster virus glycoprotein E
(gE) antigen component to be reconstituted with the accompanying vial
of AS01 adjuvant suspension
component. After reconstitution, a single dose of SHINGRIX is 0.5 mL.
(3)
CONTRAINDICATIONS
History of severe allergic reaction (e.g., anaphylaxis) to any
component of the vaccine or after a previous
dose of SHINGRIX. (4)
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
•
•
•
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GLAXOSMITHKLINE AT
1-888-825-5249 OR
in adults aged 50 years and older.
in adults aged 18 years and older who are or will be at increased risk
of HZ due to immunodeficiency
or immunosuppression caused by known disease or therapy.
SHINGRIX is not indicated for prevention of primary varicella
infection (chickenpox).
A first dose at Month 0 followed by a second dose administered 2 to 6
months later. (2.3)
For individuals who are or will be immunodeficient or immunosuppressed
and who would benefit from
a shorter vaccination schedule: A first dose at Month 0 followed by a
second dose administered 1 to
2 months later. (2.3)
B
In a postmarketing observational study, an increased risk of
Guillain-Barré syndrome was observed
during the 42 days following vaccination with SHINGRIX.