HEPAGAM B- human hepatitis b virus immune globulin injection, solution

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Kamada Ltd.

מסלול נתינה (של תרופות):

INTRAVENOUS

סממני תרפויטית:

HepaGam B [Hepatitis B immune globulin intravenous (Human)] is an intravenous immune globulin indicated for the following: including - acute exposure to HBsAg-positive blood, plasma, or serum (parenteral exposure, direct mucus membrane contact, oral ingestion, etc.), - perinatal exposure of infants born to HBsAg-positive mothers, - sexual exposure to HBsAg-positive persons, and - household exposure to persons with acute HBV infection. - Individuals known to have anaphylactic or severe systemic reactions to the parenteral administration of human globulin preparations should not receive HepaGam B. - Individuals who are deficient in IgA may have the potential to develop anti-IgA antibodies and have an anaphylactoid reaction. HepaGam B contains less than 40 micrograms per milliliter of IgA. - HepaGam B contains less than 40 micrograms per milliliter of IgA. - For postexposure prophylaxis indications, HepaGam B must be administered intramuscularly only. In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, HepaGam B should be given only if the expected benefits outweigh the potential risks. Pregnancy Category C. Animal reproduction studies have not been conducted with HepaGam B. It is also not known whether HepaGam B can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. HepaGam B should be given to a pregnant woman only if clearly indicated. It is not known whether HepaGam B is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when HepaGam B is administered to a nursing mother. Safety and effectiveness have not been established in pediatric patients. However, for postexposure prophylaxis, the safety and effectiveness of similar hepatitis B immune globulins have been demonstrated in infants and children 8 . Clinical studies of HepaGam B did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

leaflet_short:

NDC 49591-052-51; a carton containing a 1.0 milliliter single dose vial (> 312 IU per milliliter; measured potency of each lot is stamped on the vial label) and a package insert. NDC 49591-051-51; a carton containing a 5.0 milliliter single dose vial (> 312 IU per milliliter; measure potency of each lot is stamped on the vial label) and a package insert. Store at 36 to 46 °F (2 to 8 °C). Do not freeze. Do not use after expiration date. Use within 6 hours after the vial has been entered.

מצב אישור:

Biologic Licensing Application

מאפייני מוצר

HEPAGAM B- HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN INJECTION, SOLUTION
KAMADA LTD.
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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 PER MILLILITER(MEASURED POTENCY STAMPED ON THE VIAL
LABEL)
INITIAL U.S. APPROVAL: 2006
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
For Intravenous or Intramuscular Administration Only
Prevention of Hepatitis B recurrence following Liver Transplantation
in HBsAg-positive liver transplant
patients ( 1.1).
Postexposure Prophylaxis ( 1.2) in the following settings:
Acute Exposure to Blood Containing HBsAg
Perinatal Exposure of Infants Born to HBsAg-positive Mothers
Sexual Exposure to HBsAg-positive Persons
Household Exposure to Persons with Acute HBV Infection
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
POST-OPERATIVE
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 Persons
0.06 milliliter per
kilogram
Administer H