Reviews Immune Globulin Subcutaneous


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Vivaglobin Drug Description
Vivaglobin®
Immune Globulin Subcutaneous
(Human)
DRUG DESCRIPTION



What are the possible side effects of immune globulin (Vivaglobin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:

fever, chills, shaking, nausea, vomiting;
fast heartbeat; or
nervousness.

Less serious side effects may include:

redness, itching, and swelling of skin where the shots are given;
...
Read All Potential Side Effects for Vivaglobin »




Vivaglobin® Immune Globulin Subcutaneous (Human), is a pasteurized, polyvalent
human normal immunoglobulin for subcutaneous infusion. Vivaglobin® is manufactured
from large pools of human plasma by cold alcohol fractionation and is not chemically
altered or enzymatically degraded.
Vivaglobin® is supplied as a sterile liquid to be administered by the subcutaneous
route. Vivaglobin® is a 16% (160 mg/mL) protein solution, with a content
of at least 96% immunoglobulin G (IgG). The distribution of IgG subclasses is
similar to that present in normal human plasma. Vivaglobin® contains 2.25%
glycine, 0.3% sodium chloride, and water for injection, U.S.P. The pH of Vivaglobin®
is 6.4 to 7.2. Vivaglobin® contains no preservative.
All plasma used in the manufacture of Vivaglobin® is tested using FDA-licensed
serological assays for hepatitis B surface antigen and antibodies to hepatitis
C virus (HCV) and human immunodeficiency virus types 1 and 2 (HIV-1/2) as well
as FDA-licensed Nucleic Acid Testing (NAT) for HCV and HIV-1 and found to be
nonreactive (negative). For hepatitis B virus (HBV), an investigational NAT
procedure is used and the plasma found to be negative. However, the significance
of a negative result has not been established. In addition, the plasma has been
tested by NAT for hepatitis A virus (HAV) and parvovirus B19 (B19). Only plasma
that passed virus-screening is used for production and the limit for B19 in
the fractionation pool is set not to exceed 104 IU of B19 DNA per mL.
The manufacturing procedure for Vivaglobin® includes multiple processing
steps that reduce the risk of virus transmission. The virus reduction capacity
of two steps was evaluated in a series of in vitro spiking experiments;
the steps were ethanol - fatty alcohol / pH precipitation and pasteurization
in aqueous solution at 60°C for 10 hours. Total mean cumulative virus reductions
ranged from 9.0 to ≥ 14.1 log10 as shown in Table 1.
Table 1: Mean Virus Reduction Factors CSL Behring



Virus Studied:
Ethanol - Fatty
Alcohol / pH
Precipitation [log10]
Pasteurization
[log10]
Total Cumulative
[log10]


Enveloped Viruses


HIV-1
≥ 6.2
≥ 6.5
≥ 12.7


BVDV
≥ 5.3
≥ 8.7
≥ 14.0


WNV
≥ 4.4
≥ 9.3
≥ 13.7


PRV
≥ 6.2
≥ 7.9
≥ 14.1


Non-enveloped Viruses


PEV
≥ 6.7
3.7
≥ 10.4


CPV
6.7
2.3*
9.0


HIV-1: Human immunodeficiency virus type
1, model for HIV types 1 and 2
BVDV: Bovine viral diarrhea virus, model for HCV and WNV
WNV: West Nile virus
PRV: Pseudorabies virus, model for large enveloped DNA viruses (e.g.,
herpes virus)
PEV: Porcine enterovirus, model for HAV (in an immunoglobulin product)
CPV: Canine parvovirus, model for parvovirus B19
* Reduction of parvovirus B19 (evaluated using porcine IgG) by pasteurization
was ≥ 3.5 log10.


Last reviewed on RxList: 3/3/2009




Vivaglobin Drug Description
Vivaglobin®
Immune Globulin Subcutaneous
(Human)
DRUG DESCRIPTION



What are the possible side effects of immune globulin (Vivaglobin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:

fever, chills, shaking, nausea, vomiting;
fast heartbeat; or
nervousness.

Less serious side effects may include:

redness, itching, and swelling of skin where the shots are given;
...
Read All Potential Side Effects for Vivaglobin »




Vivaglobin® Immune Globulin Subcutaneous (Human), is a pasteurized, polyvalent
human normal immunoglobulin for subcutaneous infusion. Vivaglobin® is manufactured
from large pools of human plasma by cold alcohol fractionation and is not chemically
altered or enzymatically degraded.
Vivaglobin® is supplied as a sterile liquid to be administered by the subcutaneous
route. Vivaglobin® is a 16% (160 mg/mL) protein solution, with a content
of at least 96% immunoglobulin G (IgG). The distribution of IgG subclasses is
similar to that present in normal human plasma. Vivaglobin® contains 2.25%
glycine, 0.3% sodium chloride, and water for injection, U.S.P. The pH of Vivaglobin®
is 6.4 to 7.2. Vivaglobin® contains no preservative.
All plasma used in the manufacture of Vivaglobin® is tested using FDA-licensed
serological assays for hepatitis B surface antigen and antibodies to hepatitis
C virus (HCV) and human immunodeficiency virus types 1 and 2 (HIV-1/2) as well
as FDA-licensed Nucleic Acid Testing (NAT) for HCV and HIV-1 and found to be
nonreactive (negative). For hepatitis B virus (HBV), an investigational NAT
procedure is used and the plasma found to be negative. However, the significance
of a negative result has not been established. In addition, the plasma has been
tested by NAT for hepatitis A virus (HAV) and parvovirus B19 (B19). Only plasma
that passed virus-screening is used for production and the limit for B19 in
the fractionation pool is set not to exceed 104 IU of B19 DNA per mL.
The manufacturing procedure for Vivaglobin® includes multiple processing
steps that reduce the risk of virus transmission. The virus reduction capacity
of two steps was evaluated in a series of in vitro spiking experiments;
the steps were ethanol - fatty alcohol / pH precipitation and pasteurization
in aqueous solution at 60°C for 10 hours. Total mean cumulative virus reductions
ranged from 9.0 to ≥ 14.1 log10 as shown in Table 1.
Table 1: Mean Virus Reduction Factors CSL Behring



Virus Studied:
Ethanol - Fatty
Alcohol / pH
Precipitation [log10]
Pasteurization
[log10]
Total Cumulative
[log10]


Enveloped Viruses


HIV-1
≥ 6.2
≥ 6.5
≥ 12.7


BVDV
≥ 5.3
≥ 8.7
≥ 14.0


WNV
≥ 4.4
≥ 9.3
≥ 13.7


PRV
≥ 6.2
≥ 7.9
≥ 14.1


Non-enveloped Viruses


PEV
≥ 6.7
3.7
≥ 10.4


CPV
6.7
2.3*
9.0


HIV-1: Human immunodeficiency virus type
1, model for HIV types 1 and 2
BVDV: Bovine viral diarrhea virus, model for HCV and WNV
WNV: West Nile virus
PRV: Pseudorabies virus, model for large enveloped DNA viruses (e.g.,
herpes virus)
PEV: Porcine enterovirus, model for HAV (in an immunoglobulin product)
CPV: Canine parvovirus, model for parvovirus B19
* Reduction of parvovirus B19 (evaluated using porcine IgG) by pasteurization
was ≥ 3.5 log10.


Last reviewed on RxList: 3/3/2009




Vivaglobin Drug Description
Vivaglobin®
Immune Globulin Subcutaneous
(Human)
DRUG DESCRIPTION



What are the possible side effects of immune globulin (Vivaglobin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:

fever, chills, shaking, nausea, vomiting;
fast heartbeat; or
nervousness.

Less serious side effects may include:

redness, itching, and swelling of skin where the shots are given;
...
Read All Potential Side Effects for Vivaglobin »




Vivaglobin® Immune Globulin Subcutaneous (Human), is a pasteurized, polyvalent
human normal immunoglobulin for subcutaneous infusion. Vivaglobin® is manufactured
from large pools of human plasma by cold alcohol fractionation and is not chemically
altered or enzymatically degraded.
Vivaglobin® is supplied as a sterile liquid to be administered by the subcutaneous
route. Vivaglobin® is a 16% (160 mg/mL) protein solution, with a content
of at least 96% immunoglobulin G (IgG). The distribution of IgG subclasses is
similar to that present in normal human plasma. Vivaglobin® contains 2.25%
glycine, 0.3% sodium chloride, and water for injection, U.S.P. The pH of Vivaglobin®
is 6.4 to 7.2. Vivaglobin® contains no preservative.
All plasma used in the manufacture of Vivaglobin® is tested using FDA-licensed
serological assays for hepatitis B surface antigen and antibodies to hepatitis
C virus (HCV) and human immunodeficiency virus types 1 and 2 (HIV-1/2) as well
as FDA-licensed Nucleic Acid Testing (NAT) for HCV and HIV-1 and found to be
nonreactive (negative). For hepatitis B virus (HBV), an investigational NAT
procedure is used and the plasma found to be negative. However, the significance
of a negative result has not been established. In addition, the plasma has been
tested by NAT for hepatitis A virus (HAV) and parvovirus B19 (B19). Only plasma
that passed virus-screening is used for production and the limit for B19 in
the fractionation pool is set not to exceed 104 IU of B19 DNA per mL.
The manufacturing procedure for Vivaglobin® includes multiple processing
steps that reduce the risk of virus transmission. The virus reduction capacity
of two steps was evaluated in a series of in vitro spiking experiments;
the steps were ethanol - fatty alcohol / pH precipitation and pasteurization
in aqueous solution at 60°C for 10 hours. Total mean cumulative virus reductions
ranged from 9.0 to ≥ 14.1 log10 as shown in Table 1.
Table 1: Mean Virus Reduction Factors CSL Behring



Virus Studied:
Ethanol - Fatty
Alcohol / pH
Precipitation [log10]
Pasteurization
[log10]
Total Cumulative
[log10]


Enveloped Viruses


HIV-1
≥ 6.2
≥ 6.5
≥ 12.7


BVDV
≥ 5.3
≥ 8.7
≥ 14.0


WNV
≥ 4.4
≥ 9.3
≥ 13.7


PRV
≥ 6.2
≥ 7.9
≥ 14.1


Non-enveloped Viruses


PEV
≥ 6.7
3.7
≥ 10.4


CPV
6.7
2.3*
9.0


HIV-1: Human immunodeficiency virus type
1, model for HIV types 1 and 2
BVDV: Bovine viral diarrhea virus, model for HCV and WNV
WNV: West Nile virus
PRV: Pseudorabies virus, model for large enveloped DNA viruses (e.g.,
herpes virus)
PEV: Porcine enterovirus, model for HAV (in an immunoglobulin product)
CPV: Canine parvovirus, model for parvovirus B19
* Reduction of parvovirus B19 (evaluated using porcine IgG) by pasteurization
was ≥ 3.5 log10.


Last reviewed on RxList: 3/3/2009




Vivaglobin Drug Description
Vivaglobin®
Immune Globulin Subcutaneous
(Human)
DRUG DESCRIPTION



What are the possible side effects of immune globulin (Vivaglobin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:

fever, chills, shaking, nausea, vomiting;
fast heartbeat; or
nervousness.

Less serious side effects may include:

redness, itching, and swelling of skin where the shots are given;
...
Read All Potential Side Effects for Vivaglobin »




Vivaglobin® Immune Globulin Subcutaneous (Human), is a pasteurized, polyvalent
human normal immunoglobulin for subcutaneous infusion. Vivaglobin® is manufactured
from large pools of human plasma by cold alcohol fractionation and is not chemically
altered or enzymatically degraded.
Vivaglobin® is supplied as a sterile liquid to be administered by the subcutaneous
route. Vivaglobin® is a 16% (160 mg/mL) protein solution, with a content
of at least 96% immunoglobulin G (IgG). The distribution of IgG subclasses is
similar to that present in normal human plasma. Vivaglobin® contains 2.25%
glycine, 0.3% sodium chloride, and water for injection, U.S.P. The pH of Vivaglobin®
is 6.4 to 7.2. Vivaglobin® contains no preservative.
All plasma used in the manufacture of Vivaglobin® is tested using FDA-licensed
serological assays for hepatitis B surface antigen and antibodies to hepatitis
C virus (HCV) and human immunodeficiency virus types 1 and 2 (HIV-1/2) as well
as FDA-licensed Nucleic Acid Testing (NAT) for HCV and HIV-1 and found to be
nonreactive (negative). For hepatitis B virus (HBV), an investigational NAT
procedure is used and the plasma found to be negative. However, the significance
of a negative result has not been established. In addition, the plasma has been
tested by NAT for hepatitis A virus (HAV) and parvovirus B19 (B19). Only plasma
that passed virus-screening is used for production and the limit for B19 in
the fractionation pool is set not to exceed 104 IU of B19 DNA per mL.
The manufacturing procedure for Vivaglobin® includes multiple processing
steps that reduce the risk of virus transmission. The virus reduction capacity
of two steps was evaluated in a series of in vitro spiking experiments;
the steps were ethanol - fatty alcohol / pH precipitation and pasteurization
in aqueous solution at 60°C for 10 hours. Total mean cumulative virus reductions
ranged from 9.0 to ≥ 14.1 log10 as shown in Table 1.
Table 1: Mean Virus Reduction Factors CSL Behring



Virus Studied:
Ethanol - Fatty
Alcohol / pH
Precipitation [log10]
Pasteurization
[log10]
Total Cumulative
[log10]


Enveloped Viruses


HIV-1
≥ 6.2
≥ 6.5
≥ 12.7


BVDV
≥ 5.3
≥ 8.7
≥ 14.0


WNV
≥ 4.4
≥ 9.3
≥ 13.7


PRV
≥ 6.2
≥ 7.9
≥ 14.1


Non-enveloped Viruses


PEV
≥ 6.7
3.7
≥ 10.4


CPV
6.7
2.3*
9.0


HIV-1: Human immunodeficiency virus type
1, model for HIV types 1 and 2
BVDV: Bovine viral diarrhea virus, model for HCV and WNV
WNV: West Nile virus
PRV: Pseudorabies virus, model for large enveloped DNA viruses (e.g.,
herpes virus)
PEV: Porcine enterovirus, model for HAV (in an immunoglobulin product)
CPV: Canine parvovirus, model for parvovirus B19
* Reduction of parvovirus B19 (evaluated using porcine IgG) by pasteurization
was ≥ 3.5 log10.


Last reviewed on RxList: 3/3/2009




Vivaglobin Drug Description
Vivaglobin®
Immune Globulin Subcutaneous
(Human)
DRUG DESCRIPTION



What are the possible side effects of immune globulin (Vivaglobin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:

fever, chills, shaking, nausea, vomiting;
fast heartbeat; or
nervousness.

Less serious side effects may include:

redness, itching, and swelling of skin where the shots are given;
...
Read All Potential Side Effects for Vivaglobin »




Vivaglobin® Immune Globulin Subcutaneous (Human), is a pasteurized, polyvalent
human normal immunoglobulin for subcutaneous infusion. Vivaglobin® is manufactured
from large pools of human plasma by cold alcohol fractionation and is not chemically
altered or enzymatically degraded.
Vivaglobin® is supplied as a sterile liquid to be administered by the subcutaneous
route. Vivaglobin® is a 16% (160 mg/mL) protein solution, with a content
of at least 96% immunoglobulin G (IgG). The distribution of IgG subclasses is
similar to that present in normal human plasma. Vivaglobin® contains 2.25%
glycine, 0.3% sodium chloride, and water for injection, U.S.P. The pH of Vivaglobin®
is 6.4 to 7.2. Vivaglobin® contains no preservative.
All plasma used in the manufacture of Vivaglobin® is tested using FDA-licensed
serological assays for hepatitis B surface antigen and antibodies to hepatitis
C virus (HCV) and human immunodeficiency virus types 1 and 2 (HIV-1/2) as well
as FDA-licensed Nucleic Acid Testing (NAT) for HCV and HIV-1 and found to be
nonreactive (negative). For hepatitis B virus (HBV), an investigational NAT
procedure is used and the plasma found to be negative. However, the significance
of a negative result has not been established. In addition, the plasma has been
tested by NAT for hepatitis A virus (HAV) and parvovirus B19 (B19). Only plasma
that passed virus-screening is used for production and the limit for B19 in
the fractionation pool is set not to exceed 104 IU of B19 DNA per mL.
The manufacturing procedure for Vivaglobin® includes multiple processing
steps that reduce the risk of virus transmission. The virus reduction capacity
of two steps was evaluated in a series of in vitro spiking experiments;
the steps were ethanol - fatty alcohol / pH precipitation and pasteurization
in aqueous solution at 60°C for 10 hours. Total mean cumulative virus reductions
ranged from 9.0 to ≥ 14.1 log10 as shown in Table 1.
Table 1: Mean Virus Reduction Factors CSL Behring



Virus Studied:
Ethanol - Fatty
Alcohol / pH
Precipitation [log10]
Pasteurization
[log10]
Total Cumulative
[log10]


Enveloped Viruses


HIV-1
≥ 6.2
≥ 6.5
≥ 12.7


BVDV
≥ 5.3
≥ 8.7
≥ 14.0


WNV
≥ 4.4
≥ 9.3
≥ 13.7


PRV
≥ 6.2
≥ 7.9
≥ 14.1


Non-enveloped Viruses


PEV
≥ 6.7
3.7
≥ 10.4


CPV
6.7
2.3*
9.0


HIV-1: Human immunodeficiency virus type
1, model for HIV types 1 and 2
BVDV: Bovine viral diarrhea virus, model for HCV and WNV
WNV: West Nile virus
PRV: Pseudorabies virus, model for large enveloped DNA viruses (e.g.,
herpes virus)
PEV: Porcine enterovirus, model for HAV (in an immunoglobulin product)
CPV: Canine parvovirus, model for parvovirus B19
* Reduction of parvovirus B19 (evaluated using porcine IgG) by pasteurization
was ≥ 3.5 log10.


Last reviewed on RxList: 3/3/2009





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Other reviews about Immune Globulin Subcutaneous on web:

This Product Profiler introduces health care professionals to immune globulin subcutaneous (human), Vivaglobin®, a treatment for patients with primary immunodeficiency (PI ... Immune Globulin Subcutaneous (Human) Vivaglobin®


B lueCross BlueShield of Tennessee Medical Policy Manual. Subcutaneous Immune Globulin. DESCRIPTION. Subcutaneous immune globulin is manufactured from human plasma by cold alcohol ... Subcutaneous Immune Globulin


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


Immune Globulin (im-MYOON GLOB-yoo-lin) Treats problems with your immune system. Helps prevent infections or make the infection less severe. Increases the amount of immune globulin ... Allina Hospitals & Clinics - Immune globulin subcutaneous (Injection)


Immune Globulin Subcutaneous professional patient advice. Specific and up to date information about Immune Globulin Subcutaneous. Complete Immune Globulin Subcutaneous information from Drugs.com


What is the most important information I should know about immune globulin? Use this medication exactly as it was prescribed for you. Do not use it in larger doses or for longer ... Providence Health & Services - immune globulin (subcutaneous)


Immune globulin subcutaneous is a sterilized solution made from human plasma. It contains the antibodies to help your body protect itself against infection from various diseases. immune globulin subcutaneous Information - Drugs and Treatments ...


CSL Behring FULL PRESCRIBING INFORMATION Vivaglobin ® Immune Globulin Subcutaneous (Human) 16% Liquid 1 INDICATIONS AND USAGE Vivaglobin is an Immune Globulin Subcutaneous (Human) (IGSC ... HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not ...


Physician reviewed immune globulin (subcutaneous) patient information - includes immune globulin description, dosage and directions. immune globulin (subcutaneous) medical facts from Drugs.com


C IGNA P HARMACY C OVERAGE P OLICY The following Coverage Policy applies to all plans administered by CIGNA Companies including plans administered by Great-West Healthcare, which is now ... immune globulin subcutaneous (human) (Vivaglobin)





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