Reviews C1 Esterase Inhibitor [Human] Freeze Dried Powder


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Cinryze Drug Description
CINRYZE™
(c1 esterase inhibitor [human]) Freeze Dried Powder
DRUG DESCRIPTION



What are the possible side effects of complement C1 esterase inhibitor (Cinryze)?

Stop your IV infusion and get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing or difficult breathing; feeling like you might pass out; or swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any other serious side effect, such as:

sudden numbness or weakness, especially on one side of the body;
sudden headache, confusion, problems with vision, speech, or balance;
...
Read All Potential Side Effects for Cinryze »




CINRYZE (C1 esterase inhibitor [Human]) is a sterile, stable, lyophilized preparation of C1 esterase inhibitor derived from human plasma. CINRYZE is manufactured from human plasma purified by a combination of filtration and chromatographic procedures. The specific activity of CINRYZE is 4.0 – 9.0 units/mg protein. The purity is ≥ 90% human C1 esterase inhibitor. Following reconstitution with 5 mL of Sterile Water for Injection, USP, each vial contains approximately 500 units of functionally active C1 esterase inhibitor, pH 6.6 - 7.4, and an osmolality between 200 – 400 mosmol/kg. One unit (U) of CINRYZE corresponds to the mean quantity of C1 esterase inhibitor present in 1 ml of normal fresh plasma.
CINRYZE, when reconstituted with 5 mL of Sterile Water for Injection contains the following excipients: 4.1 mg/mL sodium chloride, 21 mg/mL sucrose, 2.6 mg/mL trisodium citrate, 2.0 mg/mL L-Valine, 1.2 mg/mL L-Alanine, and 4.5 mg/mL L-Threonine.
The following manufacturing steps are designed to reduce the risk of viral transmission:

Screening donors at U.S. licensed blood collection centers to rule out
infection with Human Immunodeficiency Virus (HIV-1/HIV-2), Hepatitis B Virus,
or Hepatitis C Virus.
Testing plasma pools by in-process NAT for parvovirus B19 via minipool
testing and the limit of B19 in the manufacturing pool is set not to exceed
104 IU of B19 DNA per mL.
Use of two independent viral reduction steps in the manufacture of CINRYZE:
pasteurization (heat treatment at 60°C for 10 hours in solution with stabilizers)
and nanofiltration through two sequential 15 nm Planova filters.

These viral reduction steps, along with a step in the manufacturing process,
PEG precipitation, have been validated in a series of in vitro experiments
for their capacity to inactivate/remove a wide range of viruses of diverse physicochemical
characteristics including: Human Immunodeficiency Virus (HIV), Hepatitis A Virus
(HAV), and the following model viruses: Bovine Viral Diarrhea Virus (BVDV) as
a model virus for HCV, Canine Parvovirus (CPV) as a model virus for Parvovirus
B19, Pseudorabies Virus (PRV) as a model virus for large enveloped DNA viruses
(e.g. herpes virus). Total mean log10 reductions are shown in Table 3.
Table 3: Log10 Virus Reduction Factor for Selected Viruses



Process step
Log10 Virus Reduction


Enveloped viruses
Non-enveloped viruses


HIV
BVDV
PRV
HAV
CPV


PEG precipitation
5.1 ± 0.2
4.5 ± 0.3
6.0 ± 0.3
2.8 ± 0.2
4.2 ± 0.2


Pasteurization
> 6.1 ± 0.2
> 6.7 ± 0.3
> 6.7 ± 0.2
2.8 ± 0.3
0.1 ± 0.3


Nanofiltration
> 5.6 ± 0.2
> 5.5 ± 0.2
> 6.4 ± 0.3
> 4.9 ± 0.2
> 4.5 ± 0.3


Total reduction
> 16.8
> 16.7
> 19.1
> 10.5
> 8.7



Last reviewed on RxList: 10/2/2009




Cinryze Drug Description
CINRYZE™
(c1 esterase inhibitor [human]) Freeze Dried Powder
DRUG DESCRIPTION



What are the possible side effects of complement C1 esterase inhibitor (Cinryze)?

Stop your IV infusion and get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing or difficult breathing; feeling like you might pass out; or swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any other serious side effect, such as:

sudden numbness or weakness, especially on one side of the body;
sudden headache, confusion, problems with vision, speech, or balance;
...
Read All Potential Side Effects for Cinryze »




CINRYZE (C1 esterase inhibitor [Human]) is a sterile, stable, lyophilized preparation of C1 esterase inhibitor derived from human plasma. CINRYZE is manufactured from human plasma purified by a combination of filtration and chromatographic procedures. The specific activity of CINRYZE is 4.0 – 9.0 units/mg protein. The purity is ≥ 90% human C1 esterase inhibitor. Following reconstitution with 5 mL of Sterile Water for Injection, USP, each vial contains approximately 500 units of functionally active C1 esterase inhibitor, pH 6.6 - 7.4, and an osmolality between 200 – 400 mosmol/kg. One unit (U) of CINRYZE corresponds to the mean quantity of C1 esterase inhibitor present in 1 ml of normal fresh plasma.
CINRYZE, when reconstituted with 5 mL of Sterile Water for Injection contains the following excipients: 4.1 mg/mL sodium chloride, 21 mg/mL sucrose, 2.6 mg/mL trisodium citrate, 2.0 mg/mL L-Valine, 1.2 mg/mL L-Alanine, and 4.5 mg/mL L-Threonine.
The following manufacturing steps are designed to reduce the risk of viral transmission:

Screening donors at U.S. licensed blood collection centers to rule out
infection with Human Immunodeficiency Virus (HIV-1/HIV-2), Hepatitis B Virus,
or Hepatitis C Virus.
Testing plasma pools by in-process NAT for parvovirus B19 via minipool
testing and the limit of B19 in the manufacturing pool is set not to exceed
104 IU of B19 DNA per mL.
Use of two independent viral reduction steps in the manufacture of CINRYZE:
pasteurization (heat treatment at 60°C for 10 hours in solution with stabilizers)
and nanofiltration through two sequential 15 nm Planova filters.

These viral reduction steps, along with a step in the manufacturing process,
PEG precipitation, have been validated in a series of in vitro experiments
for their capacity to inactivate/remove a wide range of viruses of diverse physicochemical
characteristics including: Human Immunodeficiency Virus (HIV), Hepatitis A Virus
(HAV), and the following model viruses: Bovine Viral Diarrhea Virus (BVDV) as
a model virus for HCV, Canine Parvovirus (CPV) as a model virus for Parvovirus
B19, Pseudorabies Virus (PRV) as a model virus for large enveloped DNA viruses
(e.g. herpes virus). Total mean log10 reductions are shown in Table 3.
Table 3: Log10 Virus Reduction Factor for Selected Viruses



Process step
Log10 Virus Reduction


Enveloped viruses
Non-enveloped viruses


HIV
BVDV
PRV
HAV
CPV


PEG precipitation
5.1 ± 0.2
4.5 ± 0.3
6.0 ± 0.3
2.8 ± 0.2
4.2 ± 0.2


Pasteurization
> 6.1 ± 0.2
> 6.7 ± 0.3
> 6.7 ± 0.2
2.8 ± 0.3
0.1 ± 0.3


Nanofiltration
> 5.6 ± 0.2
> 5.5 ± 0.2
> 6.4 ± 0.3
> 4.9 ± 0.2
> 4.5 ± 0.3


Total reduction
> 16.8
> 16.7
> 19.1
> 10.5
> 8.7



Last reviewed on RxList: 10/2/2009




Cinryze Drug Description
CINRYZE™
(c1 esterase inhibitor [human]) Freeze Dried Powder
DRUG DESCRIPTION



What are the possible side effects of complement C1 esterase inhibitor (Cinryze)?

Stop your IV infusion and get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing or difficult breathing; feeling like you might pass out; or swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any other serious side effect, such as:

sudden numbness or weakness, especially on one side of the body;
sudden headache, confusion, problems with vision, speech, or balance;
...
Read All Potential Side Effects for Cinryze »




CINRYZE (C1 esterase inhibitor [Human]) is a sterile, stable, lyophilized preparation of C1 esterase inhibitor derived from human plasma. CINRYZE is manufactured from human plasma purified by a combination of filtration and chromatographic procedures. The specific activity of CINRYZE is 4.0 – 9.0 units/mg protein. The purity is ≥ 90% human C1 esterase inhibitor. Following reconstitution with 5 mL of Sterile Water for Injection, USP, each vial contains approximately 500 units of functionally active C1 esterase inhibitor, pH 6.6 - 7.4, and an osmolality between 200 – 400 mosmol/kg. One unit (U) of CINRYZE corresponds to the mean quantity of C1 esterase inhibitor present in 1 ml of normal fresh plasma.
CINRYZE, when reconstituted with 5 mL of Sterile Water for Injection contains the following excipients: 4.1 mg/mL sodium chloride, 21 mg/mL sucrose, 2.6 mg/mL trisodium citrate, 2.0 mg/mL L-Valine, 1.2 mg/mL L-Alanine, and 4.5 mg/mL L-Threonine.
The following manufacturing steps are designed to reduce the risk of viral transmission:

Screening donors at U.S. licensed blood collection centers to rule out
infection with Human Immunodeficiency Virus (HIV-1/HIV-2), Hepatitis B Virus,
or Hepatitis C Virus.
Testing plasma pools by in-process NAT for parvovirus B19 via minipool
testing and the limit of B19 in the manufacturing pool is set not to exceed
104 IU of B19 DNA per mL.
Use of two independent viral reduction steps in the manufacture of CINRYZE:
pasteurization (heat treatment at 60°C for 10 hours in solution with stabilizers)
and nanofiltration through two sequential 15 nm Planova filters.

These viral reduction steps, along with a step in the manufacturing process,
PEG precipitation, have been validated in a series of in vitro experiments
for their capacity to inactivate/remove a wide range of viruses of diverse physicochemical
characteristics including: Human Immunodeficiency Virus (HIV), Hepatitis A Virus
(HAV), and the following model viruses: Bovine Viral Diarrhea Virus (BVDV) as
a model virus for HCV, Canine Parvovirus (CPV) as a model virus for Parvovirus
B19, Pseudorabies Virus (PRV) as a model virus for large enveloped DNA viruses
(e.g. herpes virus). Total mean log10 reductions are shown in Table 3.
Table 3: Log10 Virus Reduction Factor for Selected Viruses



Process step
Log10 Virus Reduction


Enveloped viruses
Non-enveloped viruses


HIV
BVDV
PRV
HAV
CPV


PEG precipitation
5.1 ± 0.2
4.5 ± 0.3
6.0 ± 0.3
2.8 ± 0.2
4.2 ± 0.2


Pasteurization
> 6.1 ± 0.2
> 6.7 ± 0.3
> 6.7 ± 0.2
2.8 ± 0.3
0.1 ± 0.3


Nanofiltration
> 5.6 ± 0.2
> 5.5 ± 0.2
> 6.4 ± 0.3
> 4.9 ± 0.2
> 4.5 ± 0.3


Total reduction
> 16.8
> 16.7
> 19.1
> 10.5
> 8.7



Last reviewed on RxList: 10/2/2009




Cinryze Drug Description
CINRYZE™
(c1 esterase inhibitor [human]) Freeze Dried Powder
DRUG DESCRIPTION



What are the possible side effects of complement C1 esterase inhibitor (Cinryze)?

Stop your IV infusion and get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing or difficult breathing; feeling like you might pass out; or swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any other serious side effect, such as:

sudden numbness or weakness, especially on one side of the body;
sudden headache, confusion, problems with vision, speech, or balance;
...
Read All Potential Side Effects for Cinryze »




CINRYZE (C1 esterase inhibitor [Human]) is a sterile, stable, lyophilized preparation of C1 esterase inhibitor derived from human plasma. CINRYZE is manufactured from human plasma purified by a combination of filtration and chromatographic procedures. The specific activity of CINRYZE is 4.0 – 9.0 units/mg protein. The purity is ≥ 90% human C1 esterase inhibitor. Following reconstitution with 5 mL of Sterile Water for Injection, USP, each vial contains approximately 500 units of functionally active C1 esterase inhibitor, pH 6.6 - 7.4, and an osmolality between 200 – 400 mosmol/kg. One unit (U) of CINRYZE corresponds to the mean quantity of C1 esterase inhibitor present in 1 ml of normal fresh plasma.
CINRYZE, when reconstituted with 5 mL of Sterile Water for Injection contains the following excipients: 4.1 mg/mL sodium chloride, 21 mg/mL sucrose, 2.6 mg/mL trisodium citrate, 2.0 mg/mL L-Valine, 1.2 mg/mL L-Alanine, and 4.5 mg/mL L-Threonine.
The following manufacturing steps are designed to reduce the risk of viral transmission:

Screening donors at U.S. licensed blood collection centers to rule out
infection with Human Immunodeficiency Virus (HIV-1/HIV-2), Hepatitis B Virus,
or Hepatitis C Virus.
Testing plasma pools by in-process NAT for parvovirus B19 via minipool
testing and the limit of B19 in the manufacturing pool is set not to exceed
104 IU of B19 DNA per mL.
Use of two independent viral reduction steps in the manufacture of CINRYZE:
pasteurization (heat treatment at 60°C for 10 hours in solution with stabilizers)
and nanofiltration through two sequential 15 nm Planova filters.

These viral reduction steps, along with a step in the manufacturing process,
PEG precipitation, have been validated in a series of in vitro experiments
for their capacity to inactivate/remove a wide range of viruses of diverse physicochemical
characteristics including: Human Immunodeficiency Virus (HIV), Hepatitis A Virus
(HAV), and the following model viruses: Bovine Viral Diarrhea Virus (BVDV) as
a model virus for HCV, Canine Parvovirus (CPV) as a model virus for Parvovirus
B19, Pseudorabies Virus (PRV) as a model virus for large enveloped DNA viruses
(e.g. herpes virus). Total mean log10 reductions are shown in Table 3.
Table 3: Log10 Virus Reduction Factor for Selected Viruses



Process step
Log10 Virus Reduction


Enveloped viruses
Non-enveloped viruses


HIV
BVDV
PRV
HAV
CPV


PEG precipitation
5.1 ± 0.2
4.5 ± 0.3
6.0 ± 0.3
2.8 ± 0.2
4.2 ± 0.2


Pasteurization
> 6.1 ± 0.2
> 6.7 ± 0.3
> 6.7 ± 0.2
2.8 ± 0.3
0.1 ± 0.3


Nanofiltration
> 5.6 ± 0.2
> 5.5 ± 0.2
> 6.4 ± 0.3
> 4.9 ± 0.2
> 4.5 ± 0.3


Total reduction
> 16.8
> 16.7
> 19.1
> 10.5
> 8.7



Last reviewed on RxList: 10/2/2009




Cinryze Drug Description
CINRYZE™
(c1 esterase inhibitor [human]) Freeze Dried Powder
DRUG DESCRIPTION



What are the possible side effects of complement C1 esterase inhibitor (Cinryze)?

Stop your IV infusion and get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing or difficult breathing; feeling like you might pass out; or swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any other serious side effect, such as:

sudden numbness or weakness, especially on one side of the body;
sudden headache, confusion, problems with vision, speech, or balance;
...
Read All Potential Side Effects for Cinryze »




CINRYZE (C1 esterase inhibitor [Human]) is a sterile, stable, lyophilized preparation of C1 esterase inhibitor derived from human plasma. CINRYZE is manufactured from human plasma purified by a combination of filtration and chromatographic procedures. The specific activity of CINRYZE is 4.0 – 9.0 units/mg protein. The purity is ≥ 90% human C1 esterase inhibitor. Following reconstitution with 5 mL of Sterile Water for Injection, USP, each vial contains approximately 500 units of functionally active C1 esterase inhibitor, pH 6.6 - 7.4, and an osmolality between 200 – 400 mosmol/kg. One unit (U) of CINRYZE corresponds to the mean quantity of C1 esterase inhibitor present in 1 ml of normal fresh plasma.
CINRYZE, when reconstituted with 5 mL of Sterile Water for Injection contains the following excipients: 4.1 mg/mL sodium chloride, 21 mg/mL sucrose, 2.6 mg/mL trisodium citrate, 2.0 mg/mL L-Valine, 1.2 mg/mL L-Alanine, and 4.5 mg/mL L-Threonine.
The following manufacturing steps are designed to reduce the risk of viral transmission:

Screening donors at U.S. licensed blood collection centers to rule out
infection with Human Immunodeficiency Virus (HIV-1/HIV-2), Hepatitis B Virus,
or Hepatitis C Virus.
Testing plasma pools by in-process NAT for parvovirus B19 via minipool
testing and the limit of B19 in the manufacturing pool is set not to exceed
104 IU of B19 DNA per mL.
Use of two independent viral reduction steps in the manufacture of CINRYZE:
pasteurization (heat treatment at 60°C for 10 hours in solution with stabilizers)
and nanofiltration through two sequential 15 nm Planova filters.

These viral reduction steps, along with a step in the manufacturing process,
PEG precipitation, have been validated in a series of in vitro experiments
for their capacity to inactivate/remove a wide range of viruses of diverse physicochemical
characteristics including: Human Immunodeficiency Virus (HIV), Hepatitis A Virus
(HAV), and the following model viruses: Bovine Viral Diarrhea Virus (BVDV) as
a model virus for HCV, Canine Parvovirus (CPV) as a model virus for Parvovirus
B19, Pseudorabies Virus (PRV) as a model virus for large enveloped DNA viruses
(e.g. herpes virus). Total mean log10 reductions are shown in Table 3.
Table 3: Log10 Virus Reduction Factor for Selected Viruses



Process step
Log10 Virus Reduction


Enveloped viruses
Non-enveloped viruses


HIV
BVDV
PRV
HAV
CPV


PEG precipitation
5.1 ± 0.2
4.5 ± 0.3
6.0 ± 0.3
2.8 ± 0.2
4.2 ± 0.2


Pasteurization
> 6.1 ± 0.2
> 6.7 ± 0.3
> 6.7 ± 0.2
2.8 ± 0.3
0.1 ± 0.3


Nanofiltration
> 5.6 ± 0.2
> 5.5 ± 0.2
> 6.4 ± 0.3
> 4.9 ± 0.2
> 4.5 ± 0.3


Total reduction
> 16.8
> 16.7
> 19.1
> 10.5
> 8.7



Last reviewed on RxList: 10/2/2009





Other reviews about C1 Esterase Inhibitor [Human] Freeze Dried Powder on web:

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FULL PRESCRIBING INFORMATION CINRYZE ™ (C1 Esterase Inhibitor [Human]) Freeze dried powder 1 INDICATIONS AND USAGE CINRYZE is a C1 esterase inhibitor indicated for routine ... CINRYZE (C1Esterase Inhibitor [Human])


FULL PRESCRIBING INFORMATION CINRYZE™ (C1 Esterase Inhibitor [Human]) Freeze dried powder 1 INDICATIONS AND USAGE CINRYZE is a C1 esterase inhibitor indicated for routine ... HIGHLIGHTS OF PRESCRIBING INFORMATION


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Berinert [C1 Esterase Inhibitor (Human)] For intravenous use. Freeze-Dried Powder for Reconstitution. Initial U.S. Approval: 2009-----INDICATIONS AND ... HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not ...





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