HEPAGAM B hepatitis immune globulin (human) injection solution

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN (UNII: XII270YC6M) (HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN - UNII:XII270YC6M)

Boleh didapati daripada:

Cangene bioPharma Inc.

INN (Nama Antarabangsa):

HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN

Komposisi:

HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN 312 [iU] in 1 mL

Status kebenaran:

Biologic Licensing Application

Ciri produk

HEPAGAM B- HEPATITIS B IMMUNE GLOBULIN (HUMAN) INJECTION, SOLUTION
CANGENE BIOPHARMA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HEPAGAM B SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR HEPAGAM B .
HEPAGAM B
[HEPATITIS B IMMUNE GLOBULIN INTRAVENOUS (HUMAN)],
STERILE SOLUTION FOR INTRAVENOUS OR INTRAMUSCULAR INJECTION
SOLVENT/DETERGENT TREATED AND FILTERED. >312
IU/ML (MEASURED POTENCY STAMPED ON THE VIAL LABEL)
INITIAL U.S. APPROVAL: 2006
RECENT MAJOR CHANGES
Dosage and Administration, Preparation (2.3) 1/2012
Warning and Precautions, Thrombotic events (5.7) 1/2012
Clinical Trials in Liver Transplant Patients (14.1) 1/2012
INDICATIONS AND USAGE
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DOSAGE AND ADMINISTRATION
PREVENTION OF HEPATITIS B RECURRENCE FOLLOWING LIVER TRANSPLANTATION
(2.1)
HepaGam B is administered intravenously at doses of 20,000 IU
(calculated from the measured potency stamped on the
vial label) according to the following regimen to attain serum
anti-HBs > 500 IU per liter:
ANHEPATIC PHASE
WEEK 1 POST-OPERATIVE
WEEKS 2-12
PO ST-OPE RATIVE
MONTH 4 ONWARDS
First dose
Daily from Day 1-7
Every two weeks from Day 14 Monthly
_REGULARLY MONITOR SERUM ANTI-HBS TO ALLOW FOR TREATMENT ADJUSTMENTS._
POSTEXPOSURE PROPHYLAXIS (2.2)
HepaGam B must be administered intramuscularly only as directed below:
Acute Exposure to Blood Containing
HBsAg
0.06 milliliter per kilogram
Administer as soon as possible after
exposure and within 24 hours if
possible .
Perinatal Exposure of Infants Born to
HBsAg-positive Mothers
0.5 milliliter
Administer after physiologic stabilization
of the infant and preferably within 12
hours of birth.
Sexual Exposure to HBsAg-positive
Pe rsons
0.06 milliliter per kilogram
Administer HepaGam B within 14 days
of the last sexual contact or if sexual
contact with the infected person will
continue .
Household Exposure to Persons with
Acute HBV Infection
0.5 milliliter
Infants < 12 months: Administer
HepaGam B + Hepatitis B v