VAQTA- hepatitis a vaccine, inactivated injection, suspension

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

HEPATITIS A VIRUS STRAIN CR 326F ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: Q04Q922K9Q) (HEPATITIS A VIRUS STRAIN CR 326F ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:Q04Q922K9Q)

متاح من:

Merck Sharp & Dohme LLC

INN (الاسم الدولي):

HEPATITIS A VIRUS STRAIN CR 326F ANTIGEN - UNII:Q04Q922K9Q)

تركيب:

HEPATITIS A VIRUS STRAIN CR 326F ANTIGEN (FORMALDEHYDE INACTIVATED) 25 [iU] in 0.5 mL

طريقة التعاطي:

INTRAMUSCULAR

الخصائص العلاجية:

VAQTA® [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. Do not administer VAQTA to individuals with a history of immediate and/or severe allergic or hypersensitivity reactions (e.g. , anaphylaxis) after a previous dose of any hepatitis A vaccine, or to individuals who have had an anaphylactic reaction to any component of VAQTA, including neomycin [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. There are no adequate and well-controlled studies designed to evaluate VAQTA in pregnant women. Available post-approval data do not suggest an increased risk of miscarriage or major birth def

ملخص المنتج:

VAQTA is available in single-dose vials and prefilled Luer-Lok® syringes. Pediatric/Adolescent Formulations 25U/0.5 mL in single-dose vials and prefilled Luer-Lok® syringes. NDC 0006-4831-41 – box of ten 0.5-mL single dose vials. NDC 0006-4095-02 – carton of ten 0.5-mL prefilled single-dose Luer-Lok® syringes with tip caps. Adult Formulations 50U/1-mL in single-dose vials and prefilled Luer-Lok® syringes. NDC 0006-4841-00 – 1-mL single dose vial. NDC 0006-4841-41 – box of ten 1-mL single dose vials. NDC 0006-4096-02 – carton of ten 1-mL prefilled single-dose Luer-Lok® syringes with tip caps. Store vaccine at 2-8°C (36-46°F). DO NOT FREEZE since freezing destroys potency.

الوضع إذن:

Biologic Licensing Application

خصائص المنتج

VAQTA- HEPATITIS A VACCINE, INACTIVATED INJECTION, SUSPENSION
MERCK SHARP & DOHME LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VAQTA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VAQTA.
VAQTA (HEPATITIS A VACCINE, INACTIVATED)
SUSPENSION FOR INTRAMUSCULAR INJECTION
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
VAQTA is a vaccine 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. (1.1)
DOSAGE AND ADMINISTRATION
For intramuscular administration only. (2)
Children/Adolescents: vaccination consists of a 0.5-mL primary dose
administered intramuscularly, and
a 0.5-mL booster dose administered intramuscularly 6 to 18 months
later. (2.1)
Adults: vaccination consists of a 1-mL primary dose administered
intramuscularly, and a 1-mL booster
dose administered intramuscularly 6 to 18 months later. (2.1)
DOSAGE FORMS AND STRENGTHS
Suspension supplied in four presentations:
0.5-mL pediatric dose in single-dose vials and prefilled syringes. (3,
11, 16)
1-mL adult dose in single-dose vials and prefilled syringes. (3, 11,
16)
CONTRAINDICATIONS
Do not administer VAQTA to individuals with a history of immediate
and/or severe allergic or
hypersensitivity reactions (_e.g._, anaphylaxis) after a previous dose
of any hepatitis A vaccine or with an
anaphylactic reaction to neomycin. (4, 11)
WARNINGS AND PRECAUTIONS
The vial stopper and the syringe plunger stopper and tip cap contain
dry natural latex rubber that may
cause allergic reactions in latex-sensitive individuals. (5.2)
ADVERSE REACTIONS
The most common local adverse reactions and systemic adverse events
(≥15%) reported in different
clinical trials across different age groups when VAQTA was
administered alone or concomitantly were:
Children — 12 through 23 months of age: injection-site
pain/tenderness (37.0%), injection-site
erythema (21.2%)