Reviews Hepatitis B Immune Globulin


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BayHep B Drug Description
BayHep B®(Hepatitis B Immune Globulin (Human))
Solvent/Detergent Treated
DRUG DESCRIPTION
Hepatitis B Immune Globulin (Human)
BayHep B® treated with solvent/detergent is a sterile
solution of hepatitis B hyperimmune immune globulin for intramuscular
administration; it contains no preservative. BayHep B is prepared by cold
ethanol fractionation from the plasma of donors with high titers of antibody to
the hepatitis B surface antigen (anti-HBs). The immune globulin is isolated
from solubilized Cohn Fraction II. The Fraction II solution is adjusted to a
final concentration of 0.3% tri-n-butyl phosphate (TNBP) and 0.2% sodium
cholate. After the addition of solvent (TNBP) and detergent (sodium cholate), the
solution is heated to 30°C and maintained at that temperature for not less than
6 hours. After the viral inactivation step, the reactants are removed by
precipitation, filtration and finally ultrafiltration and diafiltration. BayHep
B is formulated as a 15–18% protein solution at a pH of 6.4–7.2 in 0.21–0.32 M glycine.
BayHep B is then incubated in the final container for 21–28 days at 20–27°C.
Each vial contains anti-HBs antibody equivalent to or exceeding the potency of
anti-HBs in a U.S. reference hepatitis B immune globulin (Center for Biologics
Evaluation and Research, FDA). The U.S. reference has been tested against the
World Health Organization standard Hepatitis B Immune Globulin and found to be equal
to 217 international units (IU) per mL.
The removal and inactivation of spiked model enveloped and
non-enveloped viruses during the manufacturing process for BayHep B has been
validated in laboratory studies. Human Immunodeficiency Virus, Type 1 (HIV-1),
was chosen as the relevant virus for blood products; Bovine Viral Diarrhea
Virus (BVDV) was chosen to model Hepatitis C virus; Pseudorabies virus (PRV)
was chosen to model Hepatitis B virus and the Herpes viruses; and Reo virus
type 3 (Reo) was chosen to model non-enveloped viruses and for its resistance
to physical and chemical inactivation. Significant removal of model enveloped
and non-enveloped viruses is achieved at two steps in the Cohn fractionation
process leading to the collection of Cohn Fraction II: the precipitation and
removal of Fraction III in the processing of Fraction II + IIIW suspension to
Effluent III and the filtration step in the processing of Effluent III to
Filtrate III. Significant inactivation of enveloped viruses is achieved at the
time of treatment of solubilized Cohn Fraction II with TNBP/sodium cholate.Last reviewed on RxList: 10/29/2009




BayHep B Drug Description
BayHep B®(Hepatitis B Immune Globulin (Human))
Solvent/Detergent Treated
DRUG DESCRIPTION
Hepatitis B Immune Globulin (Human)
BayHep B® treated with solvent/detergent is a sterile
solution of hepatitis B hyperimmune immune globulin for intramuscular
administration; it contains no preservative. BayHep B is prepared by cold
ethanol fractionation from the plasma of donors with high titers of antibody to
the hepatitis B surface antigen (anti-HBs). The immune globulin is isolated
from solubilized Cohn Fraction II. The Fraction II solution is adjusted to a
final concentration of 0.3% tri-n-butyl phosphate (TNBP) and 0.2% sodium
cholate. After the addition of solvent (TNBP) and detergent (sodium cholate), the
solution is heated to 30°C and maintained at that temperature for not less than
6 hours. After the viral inactivation step, the reactants are removed by
precipitation, filtration and finally ultrafiltration and diafiltration. BayHep
B is formulated as a 15–18% protein solution at a pH of 6.4–7.2 in 0.21–0.32 M glycine.
BayHep B is then incubated in the final container for 21–28 days at 20–27°C.
Each vial contains anti-HBs antibody equivalent to or exceeding the potency of
anti-HBs in a U.S. reference hepatitis B immune globulin (Center for Biologics
Evaluation and Research, FDA). The U.S. reference has been tested against the
World Health Organization standard Hepatitis B Immune Globulin and found to be equal
to 217 international units (IU) per mL.
The removal and inactivation of spiked model enveloped and
non-enveloped viruses during the manufacturing process for BayHep B has been
validated in laboratory studies. Human Immunodeficiency Virus, Type 1 (HIV-1),
was chosen as the relevant virus for blood products; Bovine Viral Diarrhea
Virus (BVDV) was chosen to model Hepatitis C virus; Pseudorabies virus (PRV)
was chosen to model Hepatitis B virus and the Herpes viruses; and Reo virus
type 3 (Reo) was chosen to model non-enveloped viruses and for its resistance
to physical and chemical inactivation. Significant removal of model enveloped
and non-enveloped viruses is achieved at two steps in the Cohn fractionation
process leading to the collection of Cohn Fraction II: the precipitation and
removal of Fraction III in the processing of Fraction II + IIIW suspension to
Effluent III and the filtration step in the processing of Effluent III to
Filtrate III. Significant inactivation of enveloped viruses is achieved at the
time of treatment of solubilized Cohn Fraction II with TNBP/sodium cholate.Last reviewed on RxList: 10/29/2009




BayHep B Drug Description
BayHep B®(Hepatitis B Immune Globulin (Human))
Solvent/Detergent Treated
DRUG DESCRIPTION
Hepatitis B Immune Globulin (Human)
BayHep B® treated with solvent/detergent is a sterile
solution of hepatitis B hyperimmune immune globulin for intramuscular
administration; it contains no preservative. BayHep B is prepared by cold
ethanol fractionation from the plasma of donors with high titers of antibody to
the hepatitis B surface antigen (anti-HBs). The immune globulin is isolated
from solubilized Cohn Fraction II. The Fraction II solution is adjusted to a
final concentration of 0.3% tri-n-butyl phosphate (TNBP) and 0.2% sodium
cholate. After the addition of solvent (TNBP) and detergent (sodium cholate), the
solution is heated to 30°C and maintained at that temperature for not less than
6 hours. After the viral inactivation step, the reactants are removed by
precipitation, filtration and finally ultrafiltration and diafiltration. BayHep
B is formulated as a 15–18% protein solution at a pH of 6.4–7.2 in 0.21–0.32 M glycine.
BayHep B is then incubated in the final container for 21–28 days at 20–27°C.
Each vial contains anti-HBs antibody equivalent to or exceeding the potency of
anti-HBs in a U.S. reference hepatitis B immune globulin (Center for Biologics
Evaluation and Research, FDA). The U.S. reference has been tested against the
World Health Organization standard Hepatitis B Immune Globulin and found to be equal
to 217 international units (IU) per mL.
The removal and inactivation of spiked model enveloped and
non-enveloped viruses during the manufacturing process for BayHep B has been
validated in laboratory studies. Human Immunodeficiency Virus, Type 1 (HIV-1),
was chosen as the relevant virus for blood products; Bovine Viral Diarrhea
Virus (BVDV) was chosen to model Hepatitis C virus; Pseudorabies virus (PRV)
was chosen to model Hepatitis B virus and the Herpes viruses; and Reo virus
type 3 (Reo) was chosen to model non-enveloped viruses and for its resistance
to physical and chemical inactivation. Significant removal of model enveloped
and non-enveloped viruses is achieved at two steps in the Cohn fractionation
process leading to the collection of Cohn Fraction II: the precipitation and
removal of Fraction III in the processing of Fraction II + IIIW suspension to
Effluent III and the filtration step in the processing of Effluent III to
Filtrate III. Significant inactivation of enveloped viruses is achieved at the
time of treatment of solubilized Cohn Fraction II with TNBP/sodium cholate.Last reviewed on RxList: 10/29/2009




BayHep B Drug Description
BayHep B®(Hepatitis B Immune Globulin (Human))
Solvent/Detergent Treated
DRUG DESCRIPTION
Hepatitis B Immune Globulin (Human)
BayHep B® treated with solvent/detergent is a sterile
solution of hepatitis B hyperimmune immune globulin for intramuscular
administration; it contains no preservative. BayHep B is prepared by cold
ethanol fractionation from the plasma of donors with high titers of antibody to
the hepatitis B surface antigen (anti-HBs). The immune globulin is isolated
from solubilized Cohn Fraction II. The Fraction II solution is adjusted to a
final concentration of 0.3% tri-n-butyl phosphate (TNBP) and 0.2% sodium
cholate. After the addition of solvent (TNBP) and detergent (sodium cholate), the
solution is heated to 30°C and maintained at that temperature for not less than
6 hours. After the viral inactivation step, the reactants are removed by
precipitation, filtration and finally ultrafiltration and diafiltration. BayHep
B is formulated as a 15–18% protein solution at a pH of 6.4–7.2 in 0.21–0.32 M glycine.
BayHep B is then incubated in the final container for 21–28 days at 20–27°C.
Each vial contains anti-HBs antibody equivalent to or exceeding the potency of
anti-HBs in a U.S. reference hepatitis B immune globulin (Center for Biologics
Evaluation and Research, FDA). The U.S. reference has been tested against the
World Health Organization standard Hepatitis B Immune Globulin and found to be equal
to 217 international units (IU) per mL.
The removal and inactivation of spiked model enveloped and
non-enveloped viruses during the manufacturing process for BayHep B has been
validated in laboratory studies. Human Immunodeficiency Virus, Type 1 (HIV-1),
was chosen as the relevant virus for blood products; Bovine Viral Diarrhea
Virus (BVDV) was chosen to model Hepatitis C virus; Pseudorabies virus (PRV)
was chosen to model Hepatitis B virus and the Herpes viruses; and Reo virus
type 3 (Reo) was chosen to model non-enveloped viruses and for its resistance
to physical and chemical inactivation. Significant removal of model enveloped
and non-enveloped viruses is achieved at two steps in the Cohn fractionation
process leading to the collection of Cohn Fraction II: the precipitation and
removal of Fraction III in the processing of Fraction II + IIIW suspension to
Effluent III and the filtration step in the processing of Effluent III to
Filtrate III. Significant inactivation of enveloped viruses is achieved at the
time of treatment of solubilized Cohn Fraction II with TNBP/sodium cholate.Last reviewed on RxList: 10/29/2009




BayHep B Drug Description
BayHep B®(Hepatitis B Immune Globulin (Human))
Solvent/Detergent Treated
DRUG DESCRIPTION
Hepatitis B Immune Globulin (Human)
BayHep B® treated with solvent/detergent is a sterile
solution of hepatitis B hyperimmune immune globulin for intramuscular
administration; it contains no preservative. BayHep B is prepared by cold
ethanol fractionation from the plasma of donors with high titers of antibody to
the hepatitis B surface antigen (anti-HBs). The immune globulin is isolated
from solubilized Cohn Fraction II. The Fraction II solution is adjusted to a
final concentration of 0.3% tri-n-butyl phosphate (TNBP) and 0.2% sodium
cholate. After the addition of solvent (TNBP) and detergent (sodium cholate), the
solution is heated to 30°C and maintained at that temperature for not less than
6 hours. After the viral inactivation step, the reactants are removed by
precipitation, filtration and finally ultrafiltration and diafiltration. BayHep
B is formulated as a 15–18% protein solution at a pH of 6.4–7.2 in 0.21–0.32 M glycine.
BayHep B is then incubated in the final container for 21–28 days at 20–27°C.
Each vial contains anti-HBs antibody equivalent to or exceeding the potency of
anti-HBs in a U.S. reference hepatitis B immune globulin (Center for Biologics
Evaluation and Research, FDA). The U.S. reference has been tested against the
World Health Organization standard Hepatitis B Immune Globulin and found to be equal
to 217 international units (IU) per mL.
The removal and inactivation of spiked model enveloped and
non-enveloped viruses during the manufacturing process for BayHep B has been
validated in laboratory studies. Human Immunodeficiency Virus, Type 1 (HIV-1),
was chosen as the relevant virus for blood products; Bovine Viral Diarrhea
Virus (BVDV) was chosen to model Hepatitis C virus; Pseudorabies virus (PRV)
was chosen to model Hepatitis B virus and the Herpes viruses; and Reo virus
type 3 (Reo) was chosen to model non-enveloped viruses and for its resistance
to physical and chemical inactivation. Significant removal of model enveloped
and non-enveloped viruses is achieved at two steps in the Cohn fractionation
process leading to the collection of Cohn Fraction II: the precipitation and
removal of Fraction III in the processing of Fraction II + IIIW suspension to
Effluent III and the filtration step in the processing of Effluent III to
Filtrate III. Significant inactivation of enveloped viruses is achieved at the
time of treatment of solubilized Cohn Fraction II with TNBP/sodium cholate.Last reviewed on RxList: 10/29/2009





Other reviews about Hepatitis B Immune Globulin on wordpress

Dilemma? Not really.
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"But Doctor, I'm sure it's just a mistake. See, here's my inoculation booklet. I've been vaccinated, for crying out loud!" Anna* was a 19-year-old newlywed when she decided to […]


An Ounce of Prevention
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The Northeast Regional Health Office reports seven cases of Hepatitis A have been confirmed in the Mooresburg community of Hawkins County and vaccinations will be offered to all […]


Hepatitis..
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hepatitis.. waaaaw... ugm lagi dilanda KLB.. hepatitis.. banyak banget mahasiswa ugm yang kena hepatitis.. sekarang.. moga2 gak nular ni ke gw.. takut juga.. blum di vaksin lgi..hehe.. okey.. moga2 info ini bermanfaat.. maaf bhasa […]


HEPATITIS VIRAL
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What is hepatitis?Hepatitis means liver inflammation. Viral hepatitis means that a person has liver inflammation due to a virus. Viral infection of the liver makes the liver swell […]


Hepatitis B Vaccine Administered to Students of Gorkha High School Aizawl
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Photo Feature Of Vaccination Camp At Gorkha High School Aizawl,Mizoram:- [caption id="attachment_2688" align="aligncenter" width="518" caption="Students of Gorkha High School being vaccinated under the watchful eyes of school teachers and […]


I need a shot - not that kind
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I checked out the CDC website today to find out what vaccines I need before going to Belize (nothing like waiting until the last minute!). I need a […]


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GHM team members are responsible for getting all necessary immunizations for travel to Ghana. All participants should see a health care provider or travel clinic at least 3 […]


Hepatitis Tests
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Hepatitis During Childhood An event that will push the panic button in most schools is for a child to show up with hepatitis. This activates a massive cleaning program […]


HEPATITIS A
  by jz4u
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  by gingerplumbo
Treatment to reduce recurrence of hepatitis B appears to improve liver transplant outcomes for some patients, according to a Mayo Clinic study. "We found that in patients with hepatitis […]



Other reviews about Hepatitis B Immune Globulin on web:

Hepatitis B immune globulin (HBIG) is a human immune globulin that is used to prevent the development of hepatitis B. Hepatitis B immune globulin - Wikipedia, the free encyclopedia


Learn about the prescription medication HyperHep B (Hepatitis B Immune Globulin (Human)), drug uses, dosage, side effects, drug interactions, warnings, reviews and patient labeling HyperHep B (Hepatitis B Immune Globulin (Human)) Drug Information ...


Mayo Clinic offers award-winning medical and health information and tools for healthy living. Hepatitis B Immune Globulin (Intramuscular Route) - MayoClinic.com


Hepatitis B Immune Globulin (HBIG) professional patient advice. Specific and up to date information about Hepatitis B Immune Globulin (HBIG). Complete Hepatitis B Immune Globulin (HBIG) information from Drugs.com


Hepatitis B Immune Globulin, HBIG Brand names: BayHep B™Hep-B-Gammagee™HepaGam B™HyperHEP B™ SDNabi-HB® Drug Forms: Hepatitis Hepatitis B immune globulin: Information from Answers.com


All about Hepatitis B Immune Globulin. View complete and up to date Hepatitis B Immune Globulin information - part of the Drugs.com trusted medication database. Hepatitis B Immune Globulin Facts and Comparisons at Drugs.com


Learn more about Hepatitis B Immune Globulin. Find the Web's best health guides, medical reports, news, videos and tools for Hepatitis B Immune Globulin. Share Hepatitis B ... Hepatitis B Immune Globulin Overview - References, Advice, News ...


Hepatitis B Immune Globulin, HBIG injection To return to the main entry click here . What is hepatitis B immune globulin injection? HEPATITIS B IMMUNE Hepatitis B Immune Globulin, HBIG injection: Information from ...


Immune globulin (IG) contains antibodies that destroy the hepatitis A virus (HAV ... no cases of transmission of the human immunodeficiency virus (HIV) or hepatitis B ... Immune globulin (IG) for hepatitis A


08938829 (Rev. May 2008) Hepatitis B Immune Globulin (Human) Hyper HEP B m S/D Solvent/Detergent Treated DESCRIPTION Hepatitis B Immune Globulin (Human) — Hyper HEP B mS/D ... Hepatitis B Immune Globulin





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