Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
HEPATITIS A VIRUS STRAIN CR 326F ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: Q04Q922K9Q) (HEPATITIS A VIRUS STRAIN CR 326F ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:Q04Q922K9Q)
Merck Sharp & Dohme LLC
HEPATITIS A VIRUS STRAIN CR 326F ANTIGEN - UNII:Q04Q922K9Q)
HEPATITIS A VIRUS STRAIN CR 326F ANTIGEN (FORMALDEHYDE INACTIVATED) 25 [iU] in 0.5 mL
INTRAMUSCULAR
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
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.
Biologic Licensing Application
VAQTA- HEPATITIS A VACCINE, INACTIVATED INJECTION, SUSPENSION MERCK SHARP & DOHME LLC ---------- 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%) Läs hela dokumentet