Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 5BFC8LZ6LQ) (HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:5BFC8LZ6LQ)
Dispensing Solutions, Inc.
HEPATITIS A VIRUS STRAIN HM175 ANTIGEN - UNII:5BFC8LZ6LQ)
HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED) 1440 [iU] in 1 mL
INTRAMUSCULAR
HAVRIX® is indicated for active immunization against disease caused by hepatitis A virus (HAV). HAVRIX is approved for use in persons 12 months of age and older. Primary immunization should be administered at least 2 weeks prior to expected exposure to HAV. Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis A-containing vaccine, or to any component of HAVRIX, including neomycin, is a contraindication to administration of HAVRIX [see Description (11)] . Pregnancy Category C Animal reproduction studies have not been conducted with HAVRIX. It is also not known whether HAVRIX can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. HAVRIX should be given to a pregnant woman only if clearly needed. It is not known whether HAVRIX is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when HAVRIX is administered to a nursing woman. The safety and effectiveness of HAVRIX, doses of 360 EL.U. or 720 E
HAVRIX is available in single-dose vials (contain no latex) and prefilled TIP-LOK syringes (may contain latex) (packaged without needles) (Preservative Free Formulation): 720 EL.U./0.5 mL NDC 58160-825-01 Vial (contains no latex) in Package of 10: NDC 58160-825-11 NDC 58160-825-43 Syringe (tip cap may contain latex) in Package of 10: NDC 58160-825-52 NDC 58160-825-41 Syringe (tip cap and plunger contain latex) in Package of 5: NDC 58160-825-46 NDC 58160-825-41 Syringe (tip cap and plunger contain latex) in Package of 10: NDC 58160-825-51 1440 EL.U./mL NDC 58160-826-01 Vial (contains no latex) in Package of 10: NDC 58160-826-11 NDC 58160-826-43 Syringe (tip cap may contain latex) in Package of 5: NDC 58160-826-48 NDC 58160-826-43 Syringe (tip cap may contain latex) in Package of 10: NDC 58160-826-52 NDC 58160-826-32 Syringe (tip cap and plunger contain latex) in Package of 1: NDC 58160-826-32 NDC 58160-826-41 Syringe (tip cap and plunger contain latex) in Package of 5: NDC 58160-826-46 Store refrigerated between 2° and 8°C (36° and 46°F). Do not freeze. Discard if the vaccine has been frozen. Do not dilute to administer.
Biologic Licensing Application
HAVRIX - HEPATITIS A VACCINE INJECTION, SUSPENSION DISPENSING SOLUTIONS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE HAVRIX SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR HAVRIX. HAVRIX (HEPATITIS A VACCINE) SUSPENSION FOR INTRAMUSCULAR INJECTION INITIAL U.S. APPROVAL: 1995 INDICATIONS AND USAGE DOSAGE AND ADMINISTRATION Children and adolescents: A single 0.5-mL dose and a 0.5-mL booster dose administered between 6 to 12 months later. (2.2) Adults: A single 1-mL dose and a 1-mL booster dose administered between 6 to 12 months later. (2.2) For intramuscular use only. (2.2) DOSAGE FORMS AND STRENGTHS Suspension for injection available in the following presentations: 0.5-mL single-dose vials and prefilled syringes. (3) 1-mL single-dose vials and prefilled syringes. (3) CONTRAINDICATIONS WARNINGS AND PRECAUTIONS ADVERSE REACTIONS In studies of adults and children 2 years of age and older, the most common solicited adverse events were injection-site soreness (56% of adults and 21% of children) and headache (14% of adults and less than 9% of children). (6.1) In studies of children 11 to 25 months of age, the most frequently reported solicited local reactions were pain (32%) and redness (29%). Common solicited general adverse events were irritability (42%), drowsiness (28%), and loss of appetite (28%). (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GLAXOSMITHKLINE AT 1-888-825-5249 OR VAERS AT 1- 800-822-7967 OR WWW.VAERS.HHS.GOV. (6) DRUG INTERACTIONS USE IN SPECIFIC POPULATIONS SEE 17 FOR PATIENT COUNSELING INFORMATION. REVISED: 1/2011 HAVRIX is a vaccine indicated for active immunization against disease caused by hepatitis A virus (HAV). HAVRIX is approved for use in persons 12 months of age or older. Primary immunization should be administered at least 2 weeks prior to expected exposure to HAV. (1) Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis A-containing vaccine, or to any component Đọc toàn bộ tài liệu