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Ceprotin Drug Description
CEPROTIN
(Protein C concentrate (human))
DRUG DESCRIPTION
CEPROTIN [Protein C Concentrate (Human)] is manufactured from human plasma
purified by a combination of filtration and chromatographic procedures, including
a column of immobilized mouse monoclonal antibodies on gel beads. See WARNINGS/PRECAUTIONS:
Transmission of Infectious Agents .
The manufacturing process for CEPROTIN includes processing steps designed to reduce the risk of viral transmission. Screening against potentially infectious agents begins with the donor selection process and continues throughout plasma collection and plasma preparation. Each individual plasma donation used in the manufacture of CEPROTIN is collected only at FDA-approved blood establishments and is tested by FDA licensed serological tests for Hepatitis B Surface Antigen (HBsAg), and for antibodies to Human Immunodeficiency Virus (HIV-1/HIV-2) and Hepatitis C Virus (HCV) in accordance with U.S. regulatory requirements. As an additional safety measure, plasma pools for manufacturing are tested for the presence of HIV-1 and HCV by FDA licensed Nucleic Acid Testing (NAT) and found negative.
To further improve the margin of safety, two dedicated, independent and effective virus inactivation steps (Polysorbate 80 [P80] treatment and vapor heating) have been integrated into the manufacturing process in addition to other purification steps such as immunoaffinity chromatography.
Comprehensive virus clearance studies have been performed for the following steps: P80 treatment alone or coupled with an ion exchange chromatography step (IEX I), immunoaffinity chromatography (IAX) and vapor heating. In each study, the validity of the downscaled process has been confirmed by measuring process and biochemical parameters and comparing these with data from the large-scale manufacturing process. Where applicable (i.e. for P80 treatment and for vapor heating), the robustness of virus clearance has also been investigated by adjusting critical process parameters to levels least favorable for virus inactivation (e.g. temperature and incubation time for vapor heating).
Virus clearance studies for CEPROTIN have demonstrated that the process provides for a robust overall virus clearance capacity. A summary of log10 virus reduction factors per virus and manufacturing step is presented in Table 2.



Table 2
Summary of Mean Log10 Virus Reduction Factors for the CEPROTIN Manufacturing
Process


Manufacturing Step
HIV-1
HCV Model Viruses
PRV
HAV
MMV


BVDV
TBEV


P80 Treatment
>5.1
>4.7
n.d.
2.5*
>3.8*
1.4*


IAX
5.7
n.d.
4.8
5.4
3.1
3.6


Vapor Heating
4.6
>5.9
n.d.
5.9
>4.2
1.2


*Coupled with IEX. I
Abbreviations: IEX, Ion Exchange Chromatography; IAX, Immunoaffinity Chromatography;
HIV-1, Human Immunodeficiency Virus Type I; TBEV, Tick-Borne Encephalitis
Virus (model for hepatitis C virus); BVDV, Bovine Viral Diarrhea Virus
(model virus for HCV and other small, enveloped RNA viruses); PRV, Pseudorabies
Virus (model virus for enveloped DNA viruses, e.g. HBV, Hepatitis B Virus);
HAV, Hepatitis A Virus; MMV, Mice Minute Virus (model for Human Parvovirus
B19 and for non enveloped viruses); n.d., not done.



CEPROTIN is supplied as a sterile, white or cream colored, lyophilized powder
for IV injection. It has a pH between 6.7 and 7.3 and an osmolality not lower
than 240 mosmol/kg. One International Unit (IU) of protein C corresponds to
the amidolytically measured activity of protein C in 1 mL of normal plasma.
The potency (IU) is determined using a chromogenic substrate method referenced
against the World Health Organization (WHO) International Standard (86/622).Last reviewed on RxList: 5/18/2007




Ceprotin Drug Description
CEPROTIN
(Protein C concentrate (human))
DRUG DESCRIPTION
CEPROTIN [Protein C Concentrate (Human)] is manufactured from human plasma
purified by a combination of filtration and chromatographic procedures, including
a column of immobilized mouse monoclonal antibodies on gel beads. See WARNINGS/PRECAUTIONS:
Transmission of Infectious Agents .
The manufacturing process for CEPROTIN includes processing steps designed to reduce the risk of viral transmission. Screening against potentially infectious agents begins with the donor selection process and continues throughout plasma collection and plasma preparation. Each individual plasma donation used in the manufacture of CEPROTIN is collected only at FDA-approved blood establishments and is tested by FDA licensed serological tests for Hepatitis B Surface Antigen (HBsAg), and for antibodies to Human Immunodeficiency Virus (HIV-1/HIV-2) and Hepatitis C Virus (HCV) in accordance with U.S. regulatory requirements. As an additional safety measure, plasma pools for manufacturing are tested for the presence of HIV-1 and HCV by FDA licensed Nucleic Acid Testing (NAT) and found negative.
To further improve the margin of safety, two dedicated, independent and effective virus inactivation steps (Polysorbate 80 [P80] treatment and vapor heating) have been integrated into the manufacturing process in addition to other purification steps such as immunoaffinity chromatography.
Comprehensive virus clearance studies have been performed for the following steps: P80 treatment alone or coupled with an ion exchange chromatography step (IEX I), immunoaffinity chromatography (IAX) and vapor heating. In each study, the validity of the downscaled process has been confirmed by measuring process and biochemical parameters and comparing these with data from the large-scale manufacturing process. Where applicable (i.e. for P80 treatment and for vapor heating), the robustness of virus clearance has also been investigated by adjusting critical process parameters to levels least favorable for virus inactivation (e.g. temperature and incubation time for vapor heating).
Virus clearance studies for CEPROTIN have demonstrated that the process provides for a robust overall virus clearance capacity. A summary of log10 virus reduction factors per virus and manufacturing step is presented in Table 2.



Table 2
Summary of Mean Log10 Virus Reduction Factors for the CEPROTIN Manufacturing
Process


Manufacturing Step
HIV-1
HCV Model Viruses
PRV
HAV
MMV


BVDV
TBEV


P80 Treatment
>5.1
>4.7
n.d.
2.5*
>3.8*
1.4*


IAX
5.7
n.d.
4.8
5.4
3.1
3.6


Vapor Heating
4.6
>5.9
n.d.
5.9
>4.2
1.2


*Coupled with IEX. I
Abbreviations: IEX, Ion Exchange Chromatography; IAX, Immunoaffinity Chromatography;
HIV-1, Human Immunodeficiency Virus Type I; TBEV, Tick-Borne Encephalitis
Virus (model for hepatitis C virus); BVDV, Bovine Viral Diarrhea Virus
(model virus for HCV and other small, enveloped RNA viruses); PRV, Pseudorabies
Virus (model virus for enveloped DNA viruses, e.g. HBV, Hepatitis B Virus);
HAV, Hepatitis A Virus; MMV, Mice Minute Virus (model for Human Parvovirus
B19 and for non enveloped viruses); n.d., not done.



CEPROTIN is supplied as a sterile, white or cream colored, lyophilized powder
for IV injection. It has a pH between 6.7 and 7.3 and an osmolality not lower
than 240 mosmol/kg. One International Unit (IU) of protein C corresponds to
the amidolytically measured activity of protein C in 1 mL of normal plasma.
The potency (IU) is determined using a chromogenic substrate method referenced
against the World Health Organization (WHO) International Standard (86/622).Last reviewed on RxList: 5/18/2007




Ceprotin Drug Description
CEPROTIN
(Protein C concentrate (human))
DRUG DESCRIPTION
CEPROTIN [Protein C Concentrate (Human)] is manufactured from human plasma
purified by a combination of filtration and chromatographic procedures, including
a column of immobilized mouse monoclonal antibodies on gel beads. See WARNINGS/PRECAUTIONS:
Transmission of Infectious Agents .
The manufacturing process for CEPROTIN includes processing steps designed to reduce the risk of viral transmission. Screening against potentially infectious agents begins with the donor selection process and continues throughout plasma collection and plasma preparation. Each individual plasma donation used in the manufacture of CEPROTIN is collected only at FDA-approved blood establishments and is tested by FDA licensed serological tests for Hepatitis B Surface Antigen (HBsAg), and for antibodies to Human Immunodeficiency Virus (HIV-1/HIV-2) and Hepatitis C Virus (HCV) in accordance with U.S. regulatory requirements. As an additional safety measure, plasma pools for manufacturing are tested for the presence of HIV-1 and HCV by FDA licensed Nucleic Acid Testing (NAT) and found negative.
To further improve the margin of safety, two dedicated, independent and effective virus inactivation steps (Polysorbate 80 [P80] treatment and vapor heating) have been integrated into the manufacturing process in addition to other purification steps such as immunoaffinity chromatography.
Comprehensive virus clearance studies have been performed for the following steps: P80 treatment alone or coupled with an ion exchange chromatography step (IEX I), immunoaffinity chromatography (IAX) and vapor heating. In each study, the validity of the downscaled process has been confirmed by measuring process and biochemical parameters and comparing these with data from the large-scale manufacturing process. Where applicable (i.e. for P80 treatment and for vapor heating), the robustness of virus clearance has also been investigated by adjusting critical process parameters to levels least favorable for virus inactivation (e.g. temperature and incubation time for vapor heating).
Virus clearance studies for CEPROTIN have demonstrated that the process provides for a robust overall virus clearance capacity. A summary of log10 virus reduction factors per virus and manufacturing step is presented in Table 2.



Table 2
Summary of Mean Log10 Virus Reduction Factors for the CEPROTIN Manufacturing
Process


Manufacturing Step
HIV-1
HCV Model Viruses
PRV
HAV
MMV


BVDV
TBEV


P80 Treatment
>5.1
>4.7
n.d.
2.5*
>3.8*
1.4*


IAX
5.7
n.d.
4.8
5.4
3.1
3.6


Vapor Heating
4.6
>5.9
n.d.
5.9
>4.2
1.2


*Coupled with IEX. I
Abbreviations: IEX, Ion Exchange Chromatography; IAX, Immunoaffinity Chromatography;
HIV-1, Human Immunodeficiency Virus Type I; TBEV, Tick-Borne Encephalitis
Virus (model for hepatitis C virus); BVDV, Bovine Viral Diarrhea Virus
(model virus for HCV and other small, enveloped RNA viruses); PRV, Pseudorabies
Virus (model virus for enveloped DNA viruses, e.g. HBV, Hepatitis B Virus);
HAV, Hepatitis A Virus; MMV, Mice Minute Virus (model for Human Parvovirus
B19 and for non enveloped viruses); n.d., not done.



CEPROTIN is supplied as a sterile, white or cream colored, lyophilized powder
for IV injection. It has a pH between 6.7 and 7.3 and an osmolality not lower
than 240 mosmol/kg. One International Unit (IU) of protein C corresponds to
the amidolytically measured activity of protein C in 1 mL of normal plasma.
The potency (IU) is determined using a chromogenic substrate method referenced
against the World Health Organization (WHO) International Standard (86/622).Last reviewed on RxList: 5/18/2007




Ceprotin Drug Description
CEPROTIN
(Protein C concentrate (human))
DRUG DESCRIPTION
CEPROTIN [Protein C Concentrate (Human)] is manufactured from human plasma
purified by a combination of filtration and chromatographic procedures, including
a column of immobilized mouse monoclonal antibodies on gel beads. See WARNINGS/PRECAUTIONS:
Transmission of Infectious Agents .
The manufacturing process for CEPROTIN includes processing steps designed to reduce the risk of viral transmission. Screening against potentially infectious agents begins with the donor selection process and continues throughout plasma collection and plasma preparation. Each individual plasma donation used in the manufacture of CEPROTIN is collected only at FDA-approved blood establishments and is tested by FDA licensed serological tests for Hepatitis B Surface Antigen (HBsAg), and for antibodies to Human Immunodeficiency Virus (HIV-1/HIV-2) and Hepatitis C Virus (HCV) in accordance with U.S. regulatory requirements. As an additional safety measure, plasma pools for manufacturing are tested for the presence of HIV-1 and HCV by FDA licensed Nucleic Acid Testing (NAT) and found negative.
To further improve the margin of safety, two dedicated, independent and effective virus inactivation steps (Polysorbate 80 [P80] treatment and vapor heating) have been integrated into the manufacturing process in addition to other purification steps such as immunoaffinity chromatography.
Comprehensive virus clearance studies have been performed for the following steps: P80 treatment alone or coupled with an ion exchange chromatography step (IEX I), immunoaffinity chromatography (IAX) and vapor heating. In each study, the validity of the downscaled process has been confirmed by measuring process and biochemical parameters and comparing these with data from the large-scale manufacturing process. Where applicable (i.e. for P80 treatment and for vapor heating), the robustness of virus clearance has also been investigated by adjusting critical process parameters to levels least favorable for virus inactivation (e.g. temperature and incubation time for vapor heating).
Virus clearance studies for CEPROTIN have demonstrated that the process provides for a robust overall virus clearance capacity. A summary of log10 virus reduction factors per virus and manufacturing step is presented in Table 2.



Table 2
Summary of Mean Log10 Virus Reduction Factors for the CEPROTIN Manufacturing
Process


Manufacturing Step
HIV-1
HCV Model Viruses
PRV
HAV
MMV


BVDV
TBEV


P80 Treatment
>5.1
>4.7
n.d.
2.5*
>3.8*
1.4*


IAX
5.7
n.d.
4.8
5.4
3.1
3.6


Vapor Heating
4.6
>5.9
n.d.
5.9
>4.2
1.2


*Coupled with IEX. I
Abbreviations: IEX, Ion Exchange Chromatography; IAX, Immunoaffinity Chromatography;
HIV-1, Human Immunodeficiency Virus Type I; TBEV, Tick-Borne Encephalitis
Virus (model for hepatitis C virus); BVDV, Bovine Viral Diarrhea Virus
(model virus for HCV and other small, enveloped RNA viruses); PRV, Pseudorabies
Virus (model virus for enveloped DNA viruses, e.g. HBV, Hepatitis B Virus);
HAV, Hepatitis A Virus; MMV, Mice Minute Virus (model for Human Parvovirus
B19 and for non enveloped viruses); n.d., not done.



CEPROTIN is supplied as a sterile, white or cream colored, lyophilized powder
for IV injection. It has a pH between 6.7 and 7.3 and an osmolality not lower
than 240 mosmol/kg. One International Unit (IU) of protein C corresponds to
the amidolytically measured activity of protein C in 1 mL of normal plasma.
The potency (IU) is determined using a chromogenic substrate method referenced
against the World Health Organization (WHO) International Standard (86/622).Last reviewed on RxList: 5/18/2007




Ceprotin Drug Description
CEPROTIN
(Protein C concentrate (human))
DRUG DESCRIPTION
CEPROTIN [Protein C Concentrate (Human)] is manufactured from human plasma
purified by a combination of filtration and chromatographic procedures, including
a column of immobilized mouse monoclonal antibodies on gel beads. See WARNINGS/PRECAUTIONS:
Transmission of Infectious Agents .
The manufacturing process for CEPROTIN includes processing steps designed to reduce the risk of viral transmission. Screening against potentially infectious agents begins with the donor selection process and continues throughout plasma collection and plasma preparation. Each individual plasma donation used in the manufacture of CEPROTIN is collected only at FDA-approved blood establishments and is tested by FDA licensed serological tests for Hepatitis B Surface Antigen (HBsAg), and for antibodies to Human Immunodeficiency Virus (HIV-1/HIV-2) and Hepatitis C Virus (HCV) in accordance with U.S. regulatory requirements. As an additional safety measure, plasma pools for manufacturing are tested for the presence of HIV-1 and HCV by FDA licensed Nucleic Acid Testing (NAT) and found negative.
To further improve the margin of safety, two dedicated, independent and effective virus inactivation steps (Polysorbate 80 [P80] treatment and vapor heating) have been integrated into the manufacturing process in addition to other purification steps such as immunoaffinity chromatography.
Comprehensive virus clearance studies have been performed for the following steps: P80 treatment alone or coupled with an ion exchange chromatography step (IEX I), immunoaffinity chromatography (IAX) and vapor heating. In each study, the validity of the downscaled process has been confirmed by measuring process and biochemical parameters and comparing these with data from the large-scale manufacturing process. Where applicable (i.e. for P80 treatment and for vapor heating), the robustness of virus clearance has also been investigated by adjusting critical process parameters to levels least favorable for virus inactivation (e.g. temperature and incubation time for vapor heating).
Virus clearance studies for CEPROTIN have demonstrated that the process provides for a robust overall virus clearance capacity. A summary of log10 virus reduction factors per virus and manufacturing step is presented in Table 2.



Table 2
Summary of Mean Log10 Virus Reduction Factors for the CEPROTIN Manufacturing
Process


Manufacturing Step
HIV-1
HCV Model Viruses
PRV
HAV
MMV


BVDV
TBEV


P80 Treatment
>5.1
>4.7
n.d.
2.5*
>3.8*
1.4*


IAX
5.7
n.d.
4.8
5.4
3.1
3.6


Vapor Heating
4.6
>5.9
n.d.
5.9
>4.2
1.2


*Coupled with IEX. I
Abbreviations: IEX, Ion Exchange Chromatography; IAX, Immunoaffinity Chromatography;
HIV-1, Human Immunodeficiency Virus Type I; TBEV, Tick-Borne Encephalitis
Virus (model for hepatitis C virus); BVDV, Bovine Viral Diarrhea Virus
(model virus for HCV and other small, enveloped RNA viruses); PRV, Pseudorabies
Virus (model virus for enveloped DNA viruses, e.g. HBV, Hepatitis B Virus);
HAV, Hepatitis A Virus; MMV, Mice Minute Virus (model for Human Parvovirus
B19 and for non enveloped viruses); n.d., not done.



CEPROTIN is supplied as a sterile, white or cream colored, lyophilized powder
for IV injection. It has a pH between 6.7 and 7.3 and an osmolality not lower
than 240 mosmol/kg. One International Unit (IU) of protein C corresponds to
the amidolytically measured activity of protein C in 1 mL of normal plasma.
The potency (IU) is determined using a chromogenic substrate method referenced
against the World Health Organization (WHO) International Standard (86/622).Last reviewed on RxList: 5/18/2007





Other reviews about Ceprotin on wordpress

Baxter - Business
  by El Horror
About - 1980's: Contaminated hemophilia blood products infected HIV and Hepatitis C worldwide. - 2001: Malfunctioning dialysis machines resulted in several deaths in Spain. - 2008: Intentional contaminated heparin processed in […]



Other reviews about Ceprotin on web:

Welcome to ceprotin.com. Baxter Healthcare Corporation is a global leader in therapeutics for rare coagulation disorders and this website is a resource for people seeking ... CEPROTIN | Welcome to CEPROTIN.com


Learn about the prescription medication Ceprotin (Protein C Concentrate), drug uses, dosage, side effects, drug interactions, warnings, and patient labeling. Ceprotin (Protein C Concentrate) Drug Information: Uses, Side ...


Ceprotin information from Drugs.com, includes Ceprotin side effects, interactions and indications. Ceprotin Information from Drugs.com


Ceprotin patient information. Detailed drug information for the consumer, includes dosage, Ceprotin side effects and more. Ceprotin consumer information from Drugs.com


1. What is CEPROTIN and what is it used for? The name of your medicine is CEPROTIN, pronounced "see PRO ten." CEPROTIN contains Protein C, a natural protein that is made in the liver ... Patient Package Insert (U.S.)—Information For Patients


Learn about Ceprotin from the publishers of the Physicians Desk Reference. Find prescription drug information resources including interactions, side effects, symptoms, treatment ... Ceprotin | Prescription Drug Information, Side Effects | PDRHealth


Frequently Asked Questions . What does FDA approval of CEPROTIN therapy mean for me? What are Baxter’s long-term plans for CEPROTIN therapy? Is there a patient assistance program? CEPROTIN | Frequently Asked Questions


CEPROTIN (Protein C) drug information for Protein C deficiency from MPR including side effects, drug interactions, dosing, contraindications and warnings/precautions. CEPROTIN (Protein C) drug information from MPR


To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. CEPROTIN [Protein C Concentrate (Human)]


Find patient medical information for Ceprotin (Blue Bar) IV on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Ceprotin (Blue Bar) IV : Uses, Side Effects, Interactions ...





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