Reviews Rho


No reviews yet.

Rhogam Drug Description
RhoGAM®
Ultra-Filtered - 300 μg (1500 IU*)
MICRhoGAM®
Ultra-Filtered - 50 μg (250 IU*)
(Rho(D) Immune Globulin (Human))
For Intramuscular Injection Only.
Preservative-free, latex-free delivery system
DRUG DESCRIPTION



What are the possible side effects of Rho(D) IG?

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, or shaking;
urinating less than normal;
a change in color of your urine;
sudden weight gain, swelling in your hands, feet, or ankles;
back pain; or
shortness of breath.

Less serious side...
Read All Potential Side Effects for Rhogam »




RhoGAM® and MICRhoGAM® Rho(D) Immune Globulin (Human) are
sterile solutions containing IgG anti-D (anti-Rh) for use in preventing Rh immunization.
They are manufactured from human plasma containing anti-D. A single dose of RhoGAM contains sufficient anti-D (approximately 300 μg or 1500 IU)* to suppress
the immune response to 15 mL (or less) of Rh-positive red blood cells.2,3
A single dose of MICRhoGAM contains sufficient anti-D (approximately 50
μg or 250 IU)* to suppress the immune response to 2.5 mL (or less) of Rh-positive
red blood cells. The anti-D dose is measured by comparison to the RhoGAM in-house
reference standard, the potency of which is established relative to the US/WHO/EP
Standard Anti-D Immunoglobulin Rho(D) Immune Globulin (Human) CBER
Lot 4: NIBSC Lot 01/572 (285 IU/ampoule).
All donors are carefully screened by history and laboratory testing to reduce
the risk of transmitting blood-borne pathogens from infected donors. Fractionation
of the plasma is performed by a modification of the cold alcohol procedure that
has been shown to significantly lower viral titers.4 Following fractionation,
an additional viral-clearance filtration step is incorporated into the manufacturing
process. This filtration step removes viruses via a size-exclusion mechanism
utilizing a patented Viresolve† 180 ultrafiltration membrane with
defined pore-size distribution of 12-18 nanometers. The ultrafiltration step
utilizes tangential flow filtration to permit filtration of IgG while effectively
retarding enveloped and non-enveloped viruses above the pore-size distribution
cutoff. The filter is inert to the product. Non-enveloped viruses are known
to be resistant to chemical and physical inactivation.5,6 Laboratory
spiking studies have shown that the cumulative viral removal capability of the
RhoGAM/MICRhoGAM manufacturing process exceeds 13 logs for human immunodeficiency virus (HIV). Clearance of model viruses for hepatitis C virus (HCV), hepatitis
B virus (HBV) and parvovirus B19 (a non-enveloped virus) exceeds 11 logs.4
The donor selection process, the fractionation process and the Viresolve
ultrafiltration step are designed to increase product safety by reducing the
risk of transmission of enveloped and non-enveloped viruses. Rho(D)
Immune Globulin (Human) intended for intramuscular use and prepared by cold
alcohol fractionation has not been reported to transmit hepatitis or other infectious
diseases.7
The safety of Rho(D) Immune Globulin (Human) has been further shown
in an empirical study of viral marker rates in female blood donors in the United
States.8 This study revealed that Rh-negative donors, of whom an
estimated 55-60% had received Rho(D) Immune Globulin (Human) for
pregnancy-related indications, had prevalence and incidence viral marker rates
similar to those of Rh-positive female donors who had not received Rho(D)
Immune Globulin (Human). However, even after the fractionation and virus-filtration
steps, there remains a risk of contracting blood-borne pathogens from a plasma-derived
product.
The final product contains approximately 5 ±1% gamma globulin, 2.9 mg/mL sodium
chloride, 0.01% polysorbate 80 and 15 mg/mL glycine. Small amounts of IgA, typically
less than 15 μg per dose, are present.9 The pH range is 6.20-6.55.
The product contains no preservative and utilizes a latex-free delivery system.

REFERENCES
*The anti-D content of RhoGAM/MICRhoGAM is expressed as μg per dose or as
International Units (IU) per dose. The conversion factor is 1 μg = 5 IU.1

†Viresolve is a trademark of Millipore Corporation.
1. Gunson HH, Bowell PJ, Kirkwood TBL. Collaborative study to
recalibrate the International Reference Preparation of anti-D immunoglobulin.
J Clin Pathol 1980;33:249-53.
2. Pollack W, Ascari WQ, Kochesky RJ, O'Connor RR, Ho TY, Tripodi
D. Studies on Rh prophylaxis. I. Relationship between doses of anti-Rh and size
of antigenic stimulus. Transfusion 1971;11:333-39.
3. Pollack W, Ascari WQ, Crispen JF, O'Connor RR, Ho TY. Studies
on Rh prophylaxis. II. Rh immune prophylaxis after transfusion with Rh-positive
blood. Transfusion 1971;11:340-44.
4. Data on file at Ortho-Clinical Diagnostics, Inc.
5. Prowse C, Ludlam CA, Yap PL. Human parvovirus B19 and blood
products. Vox Sang 1997;72:1-10.
6. Mannucci PM, Gdovin S, Gringeri A, Colombo M, Mele A, Schinaia
N, Ciavarella N, Emerson SU, Purcell RH. Transmission of hepatitis A to patients
with hemophilia by Factor VIII concentrates treated with organic solvent and
detergent to inactivate viruses. Ann Intern Med 1994;120:1-7.
7. Tabor E. The epidemiology of virus transmission by plasma
derivatives: clinical studies verifying the lack of transmission of hepatitis
B and C viruses and HIV type 1. Transfusion 1999;39:1160-68.
8. Watanabe KK, Busch MP, Schreiber GB, Zuck TF. Evaluation
of the safety of Rh Immunoglobulin by monitoring viral markers among Rh-negative
female blood donors. Vox Sang 2000;8:1-6.
9. Data on file at Ortho-Clinical Diagnostics, Inc.Last reviewed on RxList: 5/8/2008




Rhogam Drug Description
RhoGAM®
Ultra-Filtered - 300 μg (1500 IU*)
MICRhoGAM®
Ultra-Filtered - 50 μg (250 IU*)
(Rho(D) Immune Globulin (Human))
For Intramuscular Injection Only.
Preservative-free, latex-free delivery system
DRUG DESCRIPTION



What are the possible side effects of Rho(D) IG?

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, or shaking;
urinating less than normal;
a change in color of your urine;
sudden weight gain, swelling in your hands, feet, or ankles;
back pain; or
shortness of breath.

Less serious side...
Read All Potential Side Effects for Rhogam »




RhoGAM® and MICRhoGAM® Rho(D) Immune Globulin (Human) are
sterile solutions containing IgG anti-D (anti-Rh) for use in preventing Rh immunization.
They are manufactured from human plasma containing anti-D. A single dose of RhoGAM contains sufficient anti-D (approximately 300 μg or 1500 IU)* to suppress
the immune response to 15 mL (or less) of Rh-positive red blood cells.2,3
A single dose of MICRhoGAM contains sufficient anti-D (approximately 50
μg or 250 IU)* to suppress the immune response to 2.5 mL (or less) of Rh-positive
red blood cells. The anti-D dose is measured by comparison to the RhoGAM in-house
reference standard, the potency of which is established relative to the US/WHO/EP
Standard Anti-D Immunoglobulin Rho(D) Immune Globulin (Human) CBER
Lot 4: NIBSC Lot 01/572 (285 IU/ampoule).
All donors are carefully screened by history and laboratory testing to reduce
the risk of transmitting blood-borne pathogens from infected donors. Fractionation
of the plasma is performed by a modification of the cold alcohol procedure that
has been shown to significantly lower viral titers.4 Following fractionation,
an additional viral-clearance filtration step is incorporated into the manufacturing
process. This filtration step removes viruses via a size-exclusion mechanism
utilizing a patented Viresolve† 180 ultrafiltration membrane with
defined pore-size distribution of 12-18 nanometers. The ultrafiltration step
utilizes tangential flow filtration to permit filtration of IgG while effectively
retarding enveloped and non-enveloped viruses above the pore-size distribution
cutoff. The filter is inert to the product. Non-enveloped viruses are known
to be resistant to chemical and physical inactivation.5,6 Laboratory
spiking studies have shown that the cumulative viral removal capability of the
RhoGAM/MICRhoGAM manufacturing process exceeds 13 logs for human immunodeficiency virus (HIV). Clearance of model viruses for hepatitis C virus (HCV), hepatitis
B virus (HBV) and parvovirus B19 (a non-enveloped virus) exceeds 11 logs.4
The donor selection process, the fractionation process and the Viresolve
ultrafiltration step are designed to increase product safety by reducing the
risk of transmission of enveloped and non-enveloped viruses. Rho(D)
Immune Globulin (Human) intended for intramuscular use and prepared by cold
alcohol fractionation has not been reported to transmit hepatitis or other infectious
diseases.7
The safety of Rho(D) Immune Globulin (Human) has been further shown
in an empirical study of viral marker rates in female blood donors in the United
States.8 This study revealed that Rh-negative donors, of whom an
estimated 55-60% had received Rho(D) Immune Globulin (Human) for
pregnancy-related indications, had prevalence and incidence viral marker rates
similar to those of Rh-positive female donors who had not received Rho(D)
Immune Globulin (Human). However, even after the fractionation and virus-filtration
steps, there remains a risk of contracting blood-borne pathogens from a plasma-derived
product.
The final product contains approximately 5 ±1% gamma globulin, 2.9 mg/mL sodium
chloride, 0.01% polysorbate 80 and 15 mg/mL glycine. Small amounts of IgA, typically
less than 15 μg per dose, are present.9 The pH range is 6.20-6.55.
The product contains no preservative and utilizes a latex-free delivery system.

REFERENCES
*The anti-D content of RhoGAM/MICRhoGAM is expressed as μg per dose or as
International Units (IU) per dose. The conversion factor is 1 μg = 5 IU.1

†Viresolve is a trademark of Millipore Corporation.
1. Gunson HH, Bowell PJ, Kirkwood TBL. Collaborative study to
recalibrate the International Reference Preparation of anti-D immunoglobulin.
J Clin Pathol 1980;33:249-53.
2. Pollack W, Ascari WQ, Kochesky RJ, O'Connor RR, Ho TY, Tripodi
D. Studies on Rh prophylaxis. I. Relationship between doses of anti-Rh and size
of antigenic stimulus. Transfusion 1971;11:333-39.
3. Pollack W, Ascari WQ, Crispen JF, O'Connor RR, Ho TY. Studies
on Rh prophylaxis. II. Rh immune prophylaxis after transfusion with Rh-positive
blood. Transfusion 1971;11:340-44.
4. Data on file at Ortho-Clinical Diagnostics, Inc.
5. Prowse C, Ludlam CA, Yap PL. Human parvovirus B19 and blood
products. Vox Sang 1997;72:1-10.
6. Mannucci PM, Gdovin S, Gringeri A, Colombo M, Mele A, Schinaia
N, Ciavarella N, Emerson SU, Purcell RH. Transmission of hepatitis A to patients
with hemophilia by Factor VIII concentrates treated with organic solvent and
detergent to inactivate viruses. Ann Intern Med 1994;120:1-7.
7. Tabor E. The epidemiology of virus transmission by plasma
derivatives: clinical studies verifying the lack of transmission of hepatitis
B and C viruses and HIV type 1. Transfusion 1999;39:1160-68.
8. Watanabe KK, Busch MP, Schreiber GB, Zuck TF. Evaluation
of the safety of Rh Immunoglobulin by monitoring viral markers among Rh-negative
female blood donors. Vox Sang 2000;8:1-6.
9. Data on file at Ortho-Clinical Diagnostics, Inc.Last reviewed on RxList: 5/8/2008




Rhogam Drug Description
RhoGAM®
Ultra-Filtered - 300 μg (1500 IU*)
MICRhoGAM®
Ultra-Filtered - 50 μg (250 IU*)
(Rho(D) Immune Globulin (Human))
For Intramuscular Injection Only.
Preservative-free, latex-free delivery system
DRUG DESCRIPTION



What are the possible side effects of Rho(D) IG?

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, or shaking;
urinating less than normal;
a change in color of your urine;
sudden weight gain, swelling in your hands, feet, or ankles;
back pain; or
shortness of breath.

Less serious side...
Read All Potential Side Effects for Rhogam »




RhoGAM® and MICRhoGAM® Rho(D) Immune Globulin (Human) are
sterile solutions containing IgG anti-D (anti-Rh) for use in preventing Rh immunization.
They are manufactured from human plasma containing anti-D. A single dose of RhoGAM contains sufficient anti-D (approximately 300 μg or 1500 IU)* to suppress
the immune response to 15 mL (or less) of Rh-positive red blood cells.2,3
A single dose of MICRhoGAM contains sufficient anti-D (approximately 50
μg or 250 IU)* to suppress the immune response to 2.5 mL (or less) of Rh-positive
red blood cells. The anti-D dose is measured by comparison to the RhoGAM in-house
reference standard, the potency of which is established relative to the US/WHO/EP
Standard Anti-D Immunoglobulin Rho(D) Immune Globulin (Human) CBER
Lot 4: NIBSC Lot 01/572 (285 IU/ampoule).
All donors are carefully screened by history and laboratory testing to reduce
the risk of transmitting blood-borne pathogens from infected donors. Fractionation
of the plasma is performed by a modification of the cold alcohol procedure that
has been shown to significantly lower viral titers.4 Following fractionation,
an additional viral-clearance filtration step is incorporated into the manufacturing
process. This filtration step removes viruses via a size-exclusion mechanism
utilizing a patented Viresolve† 180 ultrafiltration membrane with
defined pore-size distribution of 12-18 nanometers. The ultrafiltration step
utilizes tangential flow filtration to permit filtration of IgG while effectively
retarding enveloped and non-enveloped viruses above the pore-size distribution
cutoff. The filter is inert to the product. Non-enveloped viruses are known
to be resistant to chemical and physical inactivation.5,6 Laboratory
spiking studies have shown that the cumulative viral removal capability of the
RhoGAM/MICRhoGAM manufacturing process exceeds 13 logs for human immunodeficiency virus (HIV). Clearance of model viruses for hepatitis C virus (HCV), hepatitis
B virus (HBV) and parvovirus B19 (a non-enveloped virus) exceeds 11 logs.4
The donor selection process, the fractionation process and the Viresolve
ultrafiltration step are designed to increase product safety by reducing the
risk of transmission of enveloped and non-enveloped viruses. Rho(D)
Immune Globulin (Human) intended for intramuscular use and prepared by cold
alcohol fractionation has not been reported to transmit hepatitis or other infectious
diseases.7
The safety of Rho(D) Immune Globulin (Human) has been further shown
in an empirical study of viral marker rates in female blood donors in the United
States.8 This study revealed that Rh-negative donors, of whom an
estimated 55-60% had received Rho(D) Immune Globulin (Human) for
pregnancy-related indications, had prevalence and incidence viral marker rates
similar to those of Rh-positive female donors who had not received Rho(D)
Immune Globulin (Human). However, even after the fractionation and virus-filtration
steps, there remains a risk of contracting blood-borne pathogens from a plasma-derived
product.
The final product contains approximately 5 ±1% gamma globulin, 2.9 mg/mL sodium
chloride, 0.01% polysorbate 80 and 15 mg/mL glycine. Small amounts of IgA, typically
less than 15 μg per dose, are present.9 The pH range is 6.20-6.55.
The product contains no preservative and utilizes a latex-free delivery system.

REFERENCES
*The anti-D content of RhoGAM/MICRhoGAM is expressed as μg per dose or as
International Units (IU) per dose. The conversion factor is 1 μg = 5 IU.1

†Viresolve is a trademark of Millipore Corporation.
1. Gunson HH, Bowell PJ, Kirkwood TBL. Collaborative study to
recalibrate the International Reference Preparation of anti-D immunoglobulin.
J Clin Pathol 1980;33:249-53.
2. Pollack W, Ascari WQ, Kochesky RJ, O'Connor RR, Ho TY, Tripodi
D. Studies on Rh prophylaxis. I. Relationship between doses of anti-Rh and size
of antigenic stimulus. Transfusion 1971;11:333-39.
3. Pollack W, Ascari WQ, Crispen JF, O'Connor RR, Ho TY. Studies
on Rh prophylaxis. II. Rh immune prophylaxis after transfusion with Rh-positive
blood. Transfusion 1971;11:340-44.
4. Data on file at Ortho-Clinical Diagnostics, Inc.
5. Prowse C, Ludlam CA, Yap PL. Human parvovirus B19 and blood
products. Vox Sang 1997;72:1-10.
6. Mannucci PM, Gdovin S, Gringeri A, Colombo M, Mele A, Schinaia
N, Ciavarella N, Emerson SU, Purcell RH. Transmission of hepatitis A to patients
with hemophilia by Factor VIII concentrates treated with organic solvent and
detergent to inactivate viruses. Ann Intern Med 1994;120:1-7.
7. Tabor E. The epidemiology of virus transmission by plasma
derivatives: clinical studies verifying the lack of transmission of hepatitis
B and C viruses and HIV type 1. Transfusion 1999;39:1160-68.
8. Watanabe KK, Busch MP, Schreiber GB, Zuck TF. Evaluation
of the safety of Rh Immunoglobulin by monitoring viral markers among Rh-negative
female blood donors. Vox Sang 2000;8:1-6.
9. Data on file at Ortho-Clinical Diagnostics, Inc.Last reviewed on RxList: 5/8/2008




Rhogam Drug Description
RhoGAM®
Ultra-Filtered - 300 μg (1500 IU*)
MICRhoGAM®
Ultra-Filtered - 50 μg (250 IU*)
(Rho(D) Immune Globulin (Human))
For Intramuscular Injection Only.
Preservative-free, latex-free delivery system
DRUG DESCRIPTION



What are the possible side effects of Rho(D) IG?

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, or shaking;
urinating less than normal;
a change in color of your urine;
sudden weight gain, swelling in your hands, feet, or ankles;
back pain; or
shortness of breath.

Less serious side...
Read All Potential Side Effects for Rhogam »




RhoGAM® and MICRhoGAM® Rho(D) Immune Globulin (Human) are
sterile solutions containing IgG anti-D (anti-Rh) for use in preventing Rh immunization.
They are manufactured from human plasma containing anti-D. A single dose of RhoGAM contains sufficient anti-D (approximately 300 μg or 1500 IU)* to suppress
the immune response to 15 mL (or less) of Rh-positive red blood cells.2,3
A single dose of MICRhoGAM contains sufficient anti-D (approximately 50
μg or 250 IU)* to suppress the immune response to 2.5 mL (or less) of Rh-positive
red blood cells. The anti-D dose is measured by comparison to the RhoGAM in-house
reference standard, the potency of which is established relative to the US/WHO/EP
Standard Anti-D Immunoglobulin Rho(D) Immune Globulin (Human) CBER
Lot 4: NIBSC Lot 01/572 (285 IU/ampoule).
All donors are carefully screened by history and laboratory testing to reduce
the risk of transmitting blood-borne pathogens from infected donors. Fractionation
of the plasma is performed by a modification of the cold alcohol procedure that
has been shown to significantly lower viral titers.4 Following fractionation,
an additional viral-clearance filtration step is incorporated into the manufacturing
process. This filtration step removes viruses via a size-exclusion mechanism
utilizing a patented Viresolve† 180 ultrafiltration membrane with
defined pore-size distribution of 12-18 nanometers. The ultrafiltration step
utilizes tangential flow filtration to permit filtration of IgG while effectively
retarding enveloped and non-enveloped viruses above the pore-size distribution
cutoff. The filter is inert to the product. Non-enveloped viruses are known
to be resistant to chemical and physical inactivation.5,6 Laboratory
spiking studies have shown that the cumulative viral removal capability of the
RhoGAM/MICRhoGAM manufacturing process exceeds 13 logs for human immunodeficiency virus (HIV). Clearance of model viruses for hepatitis C virus (HCV), hepatitis
B virus (HBV) and parvovirus B19 (a non-enveloped virus) exceeds 11 logs.4
The donor selection process, the fractionation process and the Viresolve
ultrafiltration step are designed to increase product safety by reducing the
risk of transmission of enveloped and non-enveloped viruses. Rho(D)
Immune Globulin (Human) intended for intramuscular use and prepared by cold
alcohol fractionation has not been reported to transmit hepatitis or other infectious
diseases.7
The safety of Rho(D) Immune Globulin (Human) has been further shown
in an empirical study of viral marker rates in female blood donors in the United
States.8 This study revealed that Rh-negative donors, of whom an
estimated 55-60% had received Rho(D) Immune Globulin (Human) for
pregnancy-related indications, had prevalence and incidence viral marker rates
similar to those of Rh-positive female donors who had not received Rho(D)
Immune Globulin (Human). However, even after the fractionation and virus-filtration
steps, there remains a risk of contracting blood-borne pathogens from a plasma-derived
product.
The final product contains approximately 5 ±1% gamma globulin, 2.9 mg/mL sodium
chloride, 0.01% polysorbate 80 and 15 mg/mL glycine. Small amounts of IgA, typically
less than 15 μg per dose, are present.9 The pH range is 6.20-6.55.
The product contains no preservative and utilizes a latex-free delivery system.

REFERENCES
*The anti-D content of RhoGAM/MICRhoGAM is expressed as μg per dose or as
International Units (IU) per dose. The conversion factor is 1 μg = 5 IU.1

†Viresolve is a trademark of Millipore Corporation.
1. Gunson HH, Bowell PJ, Kirkwood TBL. Collaborative study to
recalibrate the International Reference Preparation of anti-D immunoglobulin.
J Clin Pathol 1980;33:249-53.
2. Pollack W, Ascari WQ, Kochesky RJ, O'Connor RR, Ho TY, Tripodi
D. Studies on Rh prophylaxis. I. Relationship between doses of anti-Rh and size
of antigenic stimulus. Transfusion 1971;11:333-39.
3. Pollack W, Ascari WQ, Crispen JF, O'Connor RR, Ho TY. Studies
on Rh prophylaxis. II. Rh immune prophylaxis after transfusion with Rh-positive
blood. Transfusion 1971;11:340-44.
4. Data on file at Ortho-Clinical Diagnostics, Inc.
5. Prowse C, Ludlam CA, Yap PL. Human parvovirus B19 and blood
products. Vox Sang 1997;72:1-10.
6. Mannucci PM, Gdovin S, Gringeri A, Colombo M, Mele A, Schinaia
N, Ciavarella N, Emerson SU, Purcell RH. Transmission of hepatitis A to patients
with hemophilia by Factor VIII concentrates treated with organic solvent and
detergent to inactivate viruses. Ann Intern Med 1994;120:1-7.
7. Tabor E. The epidemiology of virus transmission by plasma
derivatives: clinical studies verifying the lack of transmission of hepatitis
B and C viruses and HIV type 1. Transfusion 1999;39:1160-68.
8. Watanabe KK, Busch MP, Schreiber GB, Zuck TF. Evaluation
of the safety of Rh Immunoglobulin by monitoring viral markers among Rh-negative
female blood donors. Vox Sang 2000;8:1-6.
9. Data on file at Ortho-Clinical Diagnostics, Inc.Last reviewed on RxList: 5/8/2008




Rhogam Drug Description
RhoGAM®
Ultra-Filtered - 300 μg (1500 IU*)
MICRhoGAM®
Ultra-Filtered - 50 μg (250 IU*)
(Rho(D) Immune Globulin (Human))
For Intramuscular Injection Only.
Preservative-free, latex-free delivery system
DRUG DESCRIPTION



What are the possible side effects of Rho(D) IG?

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, or shaking;
urinating less than normal;
a change in color of your urine;
sudden weight gain, swelling in your hands, feet, or ankles;
back pain; or
shortness of breath.

Less serious side...
Read All Potential Side Effects for Rhogam »




RhoGAM® and MICRhoGAM® Rho(D) Immune Globulin (Human) are
sterile solutions containing IgG anti-D (anti-Rh) for use in preventing Rh immunization.
They are manufactured from human plasma containing anti-D. A single dose of RhoGAM contains sufficient anti-D (approximately 300 μg or 1500 IU)* to suppress
the immune response to 15 mL (or less) of Rh-positive red blood cells.2,3
A single dose of MICRhoGAM contains sufficient anti-D (approximately 50
μg or 250 IU)* to suppress the immune response to 2.5 mL (or less) of Rh-positive
red blood cells. The anti-D dose is measured by comparison to the RhoGAM in-house
reference standard, the potency of which is established relative to the US/WHO/EP
Standard Anti-D Immunoglobulin Rho(D) Immune Globulin (Human) CBER
Lot 4: NIBSC Lot 01/572 (285 IU/ampoule).
All donors are carefully screened by history and laboratory testing to reduce
the risk of transmitting blood-borne pathogens from infected donors. Fractionation
of the plasma is performed by a modification of the cold alcohol procedure that
has been shown to significantly lower viral titers.4 Following fractionation,
an additional viral-clearance filtration step is incorporated into the manufacturing
process. This filtration step removes viruses via a size-exclusion mechanism
utilizing a patented Viresolve† 180 ultrafiltration membrane with
defined pore-size distribution of 12-18 nanometers. The ultrafiltration step
utilizes tangential flow filtration to permit filtration of IgG while effectively
retarding enveloped and non-enveloped viruses above the pore-size distribution
cutoff. The filter is inert to the product. Non-enveloped viruses are known
to be resistant to chemical and physical inactivation.5,6 Laboratory
spiking studies have shown that the cumulative viral removal capability of the
RhoGAM/MICRhoGAM manufacturing process exceeds 13 logs for human immunodeficiency virus (HIV). Clearance of model viruses for hepatitis C virus (HCV), hepatitis
B virus (HBV) and parvovirus B19 (a non-enveloped virus) exceeds 11 logs.4
The donor selection process, the fractionation process and the Viresolve
ultrafiltration step are designed to increase product safety by reducing the
risk of transmission of enveloped and non-enveloped viruses. Rho(D)
Immune Globulin (Human) intended for intramuscular use and prepared by cold
alcohol fractionation has not been reported to transmit hepatitis or other infectious
diseases.7
The safety of Rho(D) Immune Globulin (Human) has been further shown
in an empirical study of viral marker rates in female blood donors in the United
States.8 This study revealed that Rh-negative donors, of whom an
estimated 55-60% had received Rho(D) Immune Globulin (Human) for
pregnancy-related indications, had prevalence and incidence viral marker rates
similar to those of Rh-positive female donors who had not received Rho(D)
Immune Globulin (Human). However, even after the fractionation and virus-filtration
steps, there remains a risk of contracting blood-borne pathogens from a plasma-derived
product.
The final product contains approximately 5 ±1% gamma globulin, 2.9 mg/mL sodium
chloride, 0.01% polysorbate 80 and 15 mg/mL glycine. Small amounts of IgA, typically
less than 15 μg per dose, are present.9 The pH range is 6.20-6.55.
The product contains no preservative and utilizes a latex-free delivery system.

REFERENCES
*The anti-D content of RhoGAM/MICRhoGAM is expressed as μg per dose or as
International Units (IU) per dose. The conversion factor is 1 μg = 5 IU.1

†Viresolve is a trademark of Millipore Corporation.
1. Gunson HH, Bowell PJ, Kirkwood TBL. Collaborative study to
recalibrate the International Reference Preparation of anti-D immunoglobulin.
J Clin Pathol 1980;33:249-53.
2. Pollack W, Ascari WQ, Kochesky RJ, O'Connor RR, Ho TY, Tripodi
D. Studies on Rh prophylaxis. I. Relationship between doses of anti-Rh and size
of antigenic stimulus. Transfusion 1971;11:333-39.
3. Pollack W, Ascari WQ, Crispen JF, O'Connor RR, Ho TY. Studies
on Rh prophylaxis. II. Rh immune prophylaxis after transfusion with Rh-positive
blood. Transfusion 1971;11:340-44.
4. Data on file at Ortho-Clinical Diagnostics, Inc.
5. Prowse C, Ludlam CA, Yap PL. Human parvovirus B19 and blood
products. Vox Sang 1997;72:1-10.
6. Mannucci PM, Gdovin S, Gringeri A, Colombo M, Mele A, Schinaia
N, Ciavarella N, Emerson SU, Purcell RH. Transmission of hepatitis A to patients
with hemophilia by Factor VIII concentrates treated with organic solvent and
detergent to inactivate viruses. Ann Intern Med 1994;120:1-7.
7. Tabor E. The epidemiology of virus transmission by plasma
derivatives: clinical studies verifying the lack of transmission of hepatitis
B and C viruses and HIV type 1. Transfusion 1999;39:1160-68.
8. Watanabe KK, Busch MP, Schreiber GB, Zuck TF. Evaluation
of the safety of Rh Immunoglobulin by monitoring viral markers among Rh-negative
female blood donors. Vox Sang 2000;8:1-6.
9. Data on file at Ortho-Clinical Diagnostics, Inc.Last reviewed on RxList: 5/8/2008





Other reviews about Rho on wordpress

Swing Rho,
  by kinasepro
Sweet Chariot... Ehhem, umm, uhh, pardon me, pardon me, though its not unlike Kinasepro to break into song in the presence of greatness, so perhaps you'll grant […]


Hello Brothers! Welcome to the Rho Rho Blog!
  by Shawn Kimball
After creating a wiki (an open, editable webspace) for the purpose of compiling a collaborative Rho Rho history, I thought we would attempt to have a blog presence […]


Chi Rho
  by Jason K.
Some questions have been asked as to what the symbol was next to my former blog on the top, and at the footer of the blog.   Here's the story... Chi-Rho […]


Mobile Suit Chi Rho Gundam
  by Charz
Mobile Suit Crossbone Gundam Chi Rho Chi Rho (☧) are the first two letters in the Greek spelling of the word Christ ( Greek : "Χριστός" ), and so have […]


Chi Rho ATC
  by goodfruit
This is personally, one of my favorite symbols,  and one of the favorite cards I did. Chi Rho is Greek for the first two letters of Christ. Chi = […]


CrimsonCanary announce the availability of COT and Rho kinase competitor pipelines
  by crimsoncanary
CrimsonCanary and KinaseCentral are pleased to announce the availability of two new pipelines for sale: COT Kinase inhibitors, September 2008, Table of Contents, Buy Pipeline, $150 Rho Kinase inhibitors, September […]


Pollard's rho algorithm for integer factorization
  by L'tty
In the publications section you will find now a Mathematica notebook implementing Pollard's rho algorithm is a special-purpose integer factorization algorithm. It was invented by John Pollard in […]


Rho
  by beckatz
[vimeo 6806811] Rho grew up in Toronto and now lives in Los Angeles with her partner, Jen, and their beautiful daughter, Sophie. Rho first fell in love with a […]


Rho Coronae Borealis
  by T. A.
Rho Coronae Borealis is a yellow dwarf star considered to be a solar twin: a star with roughly equal mass, luminosity and radius to the Sun. In 1997, […]


Sonic Hedgehog Induces Angiogenesis via Rho Kinase-dependent Signaling in Endothelial Cells
  by Oldcola
Sonic Hedgehog Induces Angiogenesis via Rho Kinase-dependent Signaling in Endothelial Cells Marie-Ange Renault, Jérôme Roncalli, Jörn Tongers, Tina Thorne, Ekaterina Klyachko, Sol Misener, Olga V. Volpert, Shanu Mehta, Aaron […]



Other reviews about Rho on web:

Rho (uppercase Ρ, lowercase ρ or ϱ), pronounced /ˈroʊ/ in English, is the 17th letter of the Greek alphabet. In the system of Greek numerals it has a value of 100. Rho (letter) - Wikipedia, the free encyclopedia


Rho Capital Partners: Rho Capital Partners is the parent company to Rho’s three operating divisions, Rho Ventures, Rho Canada and Rho Fund Investors. Rho Capital Partners


Rho is a full-service contract research organization (CRO) that delivers an unsurpassed degree of expertise, integrity, and passion for medical research. Full-Service Contract Research Organization (CRO) | Rho


Rho may refer to: Rho (letter), a letter of the Greek alphabet, upper case Ρ, lower case ρ; Symbols in mathematics. Spectral radius in a spherical coordinate system Rho - Wikipedia, the free encyclopedia


RHO is an online information resource for health program managers and decision-makers working in developing countries and low-resource settings. RHO offers some of the best ... RHO Cervical Cancer: a resource on human papillomavirus (HPV) from ...


rho n. The 17th letter of the Greek alphabet. [Greek rhō , of Phoenician origin.] rho: Definition from Answers.com


Welcome to rho.net, a provider of information services on the Internet. Feel free to explore our site and contact us for more information. rho.net - Home


Rho Canada Portfolio News 08/03/10 Accedian Networks Raises $19.5M in Growth Equity Funding Led by Summit Partners. 05/27/10 Darwin Dimensions Announces Evolver™ Custom ... RHO Canada


Kappa Delta Rho was founded on May 17, 1905 at Middlebury College in Middlebury, VT. Since then we have grown to 25,000+ initiated members and have 35 active chapters across the ... Home Page || National Fraternity of KAPPA DELTA RHO


Rho offers more than typical clinical research job openings—we offer exciting career opportunities in a family-friendly, collaborative corporate culture. Clinical Research Career Opportunities and Job Openings | Rho





Featured Reviews

Reviews DesOwen

DesOwen Drug Description DesOwen® (desonide cream, ointment and lotion) Cream 0.05%, Ointment 0.05% and Lotion 0.05% For Dermatologic Use Only - Not for Ophthalmic Use - DRUG DESCRIPTION What are the possible side effects...
Read More  |  Review This
Reviews Docetaxel for Injection

Taxotere Drug Description TAXOTERE (docetaxel) Injection Concentrate, Intravenous Infusion WARNING The incidence of treatment-related mortality associated with TAXOTERE therapy is increased in patients with abnormal liver function,...
Read More  |  Review This
Reviews Heparin Sodium Injection Preservative Free

Heparin Preservative Free Drug Description Heparin Sodium Injection, USP DERIVED FROM PORCINE INTESTINAL MUCOSA. PRESERVATIVE FREE DRUG DESCRIPTION Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called...
Read More  |  Review This
Reviews Hepatitis B Vaccine Recombinant

Nabi-HB Drug Description Nabi-HB® Hepatitis B Immune Globulin (Human) Solvent/Detergent Treated and Filtered DRUG DESCRIPTION What are the possible side effects of hepatitis B immune globulin (HepaGam B, HepaGam B NovaPlus,...
Read More  |  Review This
Reviews Inderide

Inderide Drug Description INDERIDE® (propranolol hydrochloride [Inderal®] and hydrochlorothiazide) DRUG DESCRIPTION What are the possible side effects of hydrochlorothiazide and propranolol (Inderide)? Get emergency medical...
Read More  |  Review This
Recent News
59sec - the BEST lead management system around!
We tested 59sec - THE lead management system and we love it. 59sec helps small and medium companies to answer leads in maximum 59 seconds. Why...
MOVEorPAY - our favorite facebook app
We do love MOVEorPAY motivational facebook app, because it is very cool and useful. It makes you finish stuff that you know are good for you, but from various reasons, you never do...
ReviewsAZ is almost ready to be officially launched
yes, we have just a few loose ends to tie and we are ready to go :) meanwhile, I am putting some reviews on the site, so people will not get an empty site at the launch....