HAVRIX- hepatitis a vaccine injection, suspension

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 5BFC8LZ6LQ) (HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:5BFC8LZ6LQ)

Mevcut itibaren:

GlaxoSmithKline Biologicals SA

INN (International Adı):

HEPATITIS A VIRUS STRAIN HM175 ANTIGEN - UNII:5BFC8LZ6LQ)

Kompozisyon:

HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED) 720 [iU] in 0.5 mL

Uygulama yolu:

INTRAMUSCULAR

Terapötik endikasyonlar:

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)] . 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 of HAVRIX in pregnant women in the U.S. Available data do not suggest an increased risk of major birth defects and miscarriage in women who received HAVRIX during pregnancy (see Data) . There are no animal studies with HAVRIX to inform use during pregnancy. Data Human Data: In pre- and post-licensure clinical studies of HAVRIX, 175 pregnant women (177 outcomes, including two sets of twins) were inadvertently administered HAVRIX following their last menstrual period. After excluding ectopic pregnancies (n = 2), molar pregnancies (n = 1), elective terminations (n = 22, including one of a fetus with a birth defect), those that were lost to follow-up (n = 9), and those with an unknown exposure timing (n = 5), there were 138 known pregnancy outcomes with exposure during the first or second trimester. Of these, miscarriage was reported in 11% of pregnancies exposed prior to 20 weeks gestation (15/136) and major birth defects were reported in 3.3% (4/123) of live births. The rates of miscarriage and major birth defects were consistent with estimated background rates. Risk Summary There is no information regarding the presence of HAVRIX in human milk, the effects on the breastfed child, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for HAVRIX and any potential adverse effects on the breastfed child from HAVRIX or from the underlying maternal condition. For preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine. The safety and effectiveness of HAVRIX, doses of 360 EL.U. or 720 EL.U., have been evaluated in more than 22,000 subjects aged 1 to 18 years. The safety and effectiveness of HAVRIX have not been established in subjects younger than 12 months. Clinical studies of HAVRIX did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in overall safety between these subjects and younger adult subjects. Subjects with chronic liver disease had a lower antibody response to HAVRIX than healthy subjects [see Clinical Studies (14.3)] .

Ürün özeti:

HAVRIX is available in single-dose prefilled disposable TIP-LOK syringes (Luer Lock syringes) packaged without needles (Preservative-Free Formulation). TIP-LOK syringes are to be used with Luer Lock compatible needles. The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex. 720 EL.U./0.5 mL NDC 58160-825-43 Prefilled Syringe in Package of 10: NDC 58160-825-52 1440 EL.U./mL NDC 58160-826-43 Prefilled Syringe in Package of 10: NDC 58160-826-52 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.

Yetkilendirme durumu:

Biologic Licensing Application

Ürün özellikleri

HAVRIX- HEPATITIS A VACCINE INJECTION, SUSPENSION
GLAXOSMITHKLINE BIOLOGICALS SA
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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) INJECTABLE SUSPENSION, FOR INTRAMUSCULAR
USE
INITIAL U.S. APPROVAL: 1995
RECENT MAJOR CHANGES
Warnings and Precautions, Latex (5.1) - Removed
10/2023
INDICATIONS AND USAGE
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 and older.
Primary immunization should be
administered at least 2 weeks prior to expected exposure to HAV. (1)
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
•
•
•
CONTRAINDICATIONS
Severe allergic reaction (e.g., anaphylaxis) after a previous dose of
any hepatitis A-containing vaccine, or
to any component of HAVRIX, including neomycin. (4)
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
•
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GLAXOSMITHKLINE AT
1-888-825-5249 OR
VAERS AT 1-800-822-7967 OR WWW.VAERS.HHS.GOV.
DRUG INTERACTIONS
Do not mix HAVRIX with any other vaccine or product in the same
syringe. (7.1)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 10/2023
HAVRIX is administered by intramuscular injection. (2.2)
Children and adolescents: A single 0.5-mL dose and a 0.5-mL booster
dose administered between 6
to 12 months later. (2.3)
Adults: A single 1-mL dose and a 1-mL booster dose administered
between 6 to 12 months later.
(2.3)
Suspension for injection available in the following presentations:
0.5-mL single-dose prefilled syringes. (3)
1-mL single-dose prefilled syringes. (3)
Syncope (fainting) can occur in association with administration of
injectable vaccines, including
HAVRIX. Procedures should be in place to avoid falling injury and to
restore cerebral perfusion
following syncope. (5.1)
In studies of adults and children 2 years of age and older, t