Reviews Coagulation Factor IX


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Mononine Drug Description
Mononine®
Coagulation Factor IX (Human)
Monoclonal Antibody Purified
DRUG DESCRIPTION



What are the possible side effects of coagulation factor IX (Alphanine SD, Benefix, Mononine)?

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 or chills;
continued bleeding after treatment;
feeling like you might pass out;
sudden numbness or weakness, especially on one side of the body;
sudden headache, confusion,...
Read All Potential Side Effects for Mononine »




Coagulation Factor IX (Human), Mononine®, is a sterile, stable, lyophilized
concentrate of Factor IX prepared from pooled human plasma and is intended for
use in therapy of Factor IX deficiency, known as Hemophilia B or Christmas disease.
Mononine® is purified of extraneous plasma-derived proteins, including Factors
II, VII and X, by use of immunoaffinity chromatography. A murine monoclonal
antibody to Factor IX is used as an affinity ligand to isolate Factor IX from
the source material. Factor IX is then dissociated from the mon-oclonal antibody,
recovered, purified further, formulated and provided as a sterile, lyophilized
powder. The immunoaffinity protocol utilized results in a highly pure Factor
IX preparation. It shows predominantly a single component by SDS polyacrylamide
electrophoretic evaluation and has a specific activity of not less than 190
Factor IX units per mg total protein.
All Source Plasma used in the manufacture of this product was tested by FDA-licensed
Nucleic Acid Tests (NAT) for HCV and HIV-1 and found to be nonreactive (negative).

An investigational NAT for HBV was also performed on all Source Plasma used
in the manufacture of this product and found to be nonreactive (negative). The
aim of the HBV test is to detect low levels of viral mate-rial, however, the
significance of a nonreactive (negative) result has not been established.
This concentrate has been processed by monoclonal antibody immunoaffinity chromatography
during its manufacture, which has been shown to be capable of reducing the risk
of viral transmission. Additionally, a chemical treatment protocol and two sequential
ultrafiltration steps used in its manufacture have also been shown to be capable
of significant virus reductions. However, no procedure has been shown to be
totally effective in removing the risk of viral infectivity from coagulation
factor concentrates (see CLINICAL PHARMACOLOGY
and WARNINGS).
Mononine® is a highly purified preparation of Factor IX. When stored as
directed, it will maintain its labeled potency for the period indicated on the
container label.
Each vial contains the labeled amount of Factor IX activity expressed in International
Units (IU). One IU represents the activity of Factor IX present in 1 mL of normal,
pooled plasma. When reconstituted as recommended, the resulting solution is
a clear, colorless, isotonic preparation of neutral pH, containing approximately
100 times the Factor IX potency found in an equal volume of plasma. Each mL
of the reconstituted concentrate contains approximately 100 IU of Factor IX
and non-detectable levels of Factors II, VII and X ( < 0.0025 IU per Factor
IX unit using standard coagulation assays). Each vial also contains histidine
(approx. 10mM), sodium chloride (approx. 0.066M), mannitol (approx. 3%) and
polysorbate 80 (approx. 0.0075%). Hydrochloric acid and/or sodium hydroxide
may have been used to adjust pH. Mononine® also contains trace amounts ( ≤ 50
ng mouse protein/100 Factor IX activity units) of the murine monoclonal antibody
used in its purification (see CLINICAL PHARMACOLOGY).
Mononine® is to be administered only intravenously.Last reviewed on RxList: 3/6/2009




Mononine Drug Description
Mononine®
Coagulation Factor IX (Human)
Monoclonal Antibody Purified
DRUG DESCRIPTION



What are the possible side effects of coagulation factor IX (Alphanine SD, Benefix, Mononine)?

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 or chills;
continued bleeding after treatment;
feeling like you might pass out;
sudden numbness or weakness, especially on one side of the body;
sudden headache, confusion,...
Read All Potential Side Effects for Mononine »




Coagulation Factor IX (Human), Mononine®, is a sterile, stable, lyophilized
concentrate of Factor IX prepared from pooled human plasma and is intended for
use in therapy of Factor IX deficiency, known as Hemophilia B or Christmas disease.
Mononine® is purified of extraneous plasma-derived proteins, including Factors
II, VII and X, by use of immunoaffinity chromatography. A murine monoclonal
antibody to Factor IX is used as an affinity ligand to isolate Factor IX from
the source material. Factor IX is then dissociated from the mon-oclonal antibody,
recovered, purified further, formulated and provided as a sterile, lyophilized
powder. The immunoaffinity protocol utilized results in a highly pure Factor
IX preparation. It shows predominantly a single component by SDS polyacrylamide
electrophoretic evaluation and has a specific activity of not less than 190
Factor IX units per mg total protein.
All Source Plasma used in the manufacture of this product was tested by FDA-licensed
Nucleic Acid Tests (NAT) for HCV and HIV-1 and found to be nonreactive (negative).

An investigational NAT for HBV was also performed on all Source Plasma used
in the manufacture of this product and found to be nonreactive (negative). The
aim of the HBV test is to detect low levels of viral mate-rial, however, the
significance of a nonreactive (negative) result has not been established.
This concentrate has been processed by monoclonal antibody immunoaffinity chromatography
during its manufacture, which has been shown to be capable of reducing the risk
of viral transmission. Additionally, a chemical treatment protocol and two sequential
ultrafiltration steps used in its manufacture have also been shown to be capable
of significant virus reductions. However, no procedure has been shown to be
totally effective in removing the risk of viral infectivity from coagulation
factor concentrates (see CLINICAL PHARMACOLOGY
and WARNINGS).
Mononine® is a highly purified preparation of Factor IX. When stored as
directed, it will maintain its labeled potency for the period indicated on the
container label.
Each vial contains the labeled amount of Factor IX activity expressed in International
Units (IU). One IU represents the activity of Factor IX present in 1 mL of normal,
pooled plasma. When reconstituted as recommended, the resulting solution is
a clear, colorless, isotonic preparation of neutral pH, containing approximately
100 times the Factor IX potency found in an equal volume of plasma. Each mL
of the reconstituted concentrate contains approximately 100 IU of Factor IX
and non-detectable levels of Factors II, VII and X ( < 0.0025 IU per Factor
IX unit using standard coagulation assays). Each vial also contains histidine
(approx. 10mM), sodium chloride (approx. 0.066M), mannitol (approx. 3%) and
polysorbate 80 (approx. 0.0075%). Hydrochloric acid and/or sodium hydroxide
may have been used to adjust pH. Mononine® also contains trace amounts ( ≤ 50
ng mouse protein/100 Factor IX activity units) of the murine monoclonal antibody
used in its purification (see CLINICAL PHARMACOLOGY).
Mononine® is to be administered only intravenously.Last reviewed on RxList: 3/6/2009




Mononine Drug Description
Mononine®
Coagulation Factor IX (Human)
Monoclonal Antibody Purified
DRUG DESCRIPTION



What are the possible side effects of coagulation factor IX (Alphanine SD, Benefix, Mononine)?

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 or chills;
continued bleeding after treatment;
feeling like you might pass out;
sudden numbness or weakness, especially on one side of the body;
sudden headache, confusion,...
Read All Potential Side Effects for Mononine »




Coagulation Factor IX (Human), Mononine®, is a sterile, stable, lyophilized
concentrate of Factor IX prepared from pooled human plasma and is intended for
use in therapy of Factor IX deficiency, known as Hemophilia B or Christmas disease.
Mononine® is purified of extraneous plasma-derived proteins, including Factors
II, VII and X, by use of immunoaffinity chromatography. A murine monoclonal
antibody to Factor IX is used as an affinity ligand to isolate Factor IX from
the source material. Factor IX is then dissociated from the mon-oclonal antibody,
recovered, purified further, formulated and provided as a sterile, lyophilized
powder. The immunoaffinity protocol utilized results in a highly pure Factor
IX preparation. It shows predominantly a single component by SDS polyacrylamide
electrophoretic evaluation and has a specific activity of not less than 190
Factor IX units per mg total protein.
All Source Plasma used in the manufacture of this product was tested by FDA-licensed
Nucleic Acid Tests (NAT) for HCV and HIV-1 and found to be nonreactive (negative).

An investigational NAT for HBV was also performed on all Source Plasma used
in the manufacture of this product and found to be nonreactive (negative). The
aim of the HBV test is to detect low levels of viral mate-rial, however, the
significance of a nonreactive (negative) result has not been established.
This concentrate has been processed by monoclonal antibody immunoaffinity chromatography
during its manufacture, which has been shown to be capable of reducing the risk
of viral transmission. Additionally, a chemical treatment protocol and two sequential
ultrafiltration steps used in its manufacture have also been shown to be capable
of significant virus reductions. However, no procedure has been shown to be
totally effective in removing the risk of viral infectivity from coagulation
factor concentrates (see CLINICAL PHARMACOLOGY
and WARNINGS).
Mononine® is a highly purified preparation of Factor IX. When stored as
directed, it will maintain its labeled potency for the period indicated on the
container label.
Each vial contains the labeled amount of Factor IX activity expressed in International
Units (IU). One IU represents the activity of Factor IX present in 1 mL of normal,
pooled plasma. When reconstituted as recommended, the resulting solution is
a clear, colorless, isotonic preparation of neutral pH, containing approximately
100 times the Factor IX potency found in an equal volume of plasma. Each mL
of the reconstituted concentrate contains approximately 100 IU of Factor IX
and non-detectable levels of Factors II, VII and X ( < 0.0025 IU per Factor
IX unit using standard coagulation assays). Each vial also contains histidine
(approx. 10mM), sodium chloride (approx. 0.066M), mannitol (approx. 3%) and
polysorbate 80 (approx. 0.0075%). Hydrochloric acid and/or sodium hydroxide
may have been used to adjust pH. Mononine® also contains trace amounts ( ≤ 50
ng mouse protein/100 Factor IX activity units) of the murine monoclonal antibody
used in its purification (see CLINICAL PHARMACOLOGY).
Mononine® is to be administered only intravenously.Last reviewed on RxList: 3/6/2009




Mononine Drug Description
Mononine®
Coagulation Factor IX (Human)
Monoclonal Antibody Purified
DRUG DESCRIPTION



What are the possible side effects of coagulation factor IX (Alphanine SD, Benefix, Mononine)?

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 or chills;
continued bleeding after treatment;
feeling like you might pass out;
sudden numbness or weakness, especially on one side of the body;
sudden headache, confusion,...
Read All Potential Side Effects for Mononine »




Coagulation Factor IX (Human), Mononine®, is a sterile, stable, lyophilized
concentrate of Factor IX prepared from pooled human plasma and is intended for
use in therapy of Factor IX deficiency, known as Hemophilia B or Christmas disease.
Mononine® is purified of extraneous plasma-derived proteins, including Factors
II, VII and X, by use of immunoaffinity chromatography. A murine monoclonal
antibody to Factor IX is used as an affinity ligand to isolate Factor IX from
the source material. Factor IX is then dissociated from the mon-oclonal antibody,
recovered, purified further, formulated and provided as a sterile, lyophilized
powder. The immunoaffinity protocol utilized results in a highly pure Factor
IX preparation. It shows predominantly a single component by SDS polyacrylamide
electrophoretic evaluation and has a specific activity of not less than 190
Factor IX units per mg total protein.
All Source Plasma used in the manufacture of this product was tested by FDA-licensed
Nucleic Acid Tests (NAT) for HCV and HIV-1 and found to be nonreactive (negative).

An investigational NAT for HBV was also performed on all Source Plasma used
in the manufacture of this product and found to be nonreactive (negative). The
aim of the HBV test is to detect low levels of viral mate-rial, however, the
significance of a nonreactive (negative) result has not been established.
This concentrate has been processed by monoclonal antibody immunoaffinity chromatography
during its manufacture, which has been shown to be capable of reducing the risk
of viral transmission. Additionally, a chemical treatment protocol and two sequential
ultrafiltration steps used in its manufacture have also been shown to be capable
of significant virus reductions. However, no procedure has been shown to be
totally effective in removing the risk of viral infectivity from coagulation
factor concentrates (see CLINICAL PHARMACOLOGY
and WARNINGS).
Mononine® is a highly purified preparation of Factor IX. When stored as
directed, it will maintain its labeled potency for the period indicated on the
container label.
Each vial contains the labeled amount of Factor IX activity expressed in International
Units (IU). One IU represents the activity of Factor IX present in 1 mL of normal,
pooled plasma. When reconstituted as recommended, the resulting solution is
a clear, colorless, isotonic preparation of neutral pH, containing approximately
100 times the Factor IX potency found in an equal volume of plasma. Each mL
of the reconstituted concentrate contains approximately 100 IU of Factor IX
and non-detectable levels of Factors II, VII and X ( < 0.0025 IU per Factor
IX unit using standard coagulation assays). Each vial also contains histidine
(approx. 10mM), sodium chloride (approx. 0.066M), mannitol (approx. 3%) and
polysorbate 80 (approx. 0.0075%). Hydrochloric acid and/or sodium hydroxide
may have been used to adjust pH. Mononine® also contains trace amounts ( ≤ 50
ng mouse protein/100 Factor IX activity units) of the murine monoclonal antibody
used in its purification (see CLINICAL PHARMACOLOGY).
Mononine® is to be administered only intravenously.Last reviewed on RxList: 3/6/2009




Mononine Drug Description
Mononine®
Coagulation Factor IX (Human)
Monoclonal Antibody Purified
DRUG DESCRIPTION



What are the possible side effects of coagulation factor IX (Alphanine SD, Benefix, Mononine)?

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 or chills;
continued bleeding after treatment;
feeling like you might pass out;
sudden numbness or weakness, especially on one side of the body;
sudden headache, confusion,...
Read All Potential Side Effects for Mononine »




Coagulation Factor IX (Human), Mononine®, is a sterile, stable, lyophilized
concentrate of Factor IX prepared from pooled human plasma and is intended for
use in therapy of Factor IX deficiency, known as Hemophilia B or Christmas disease.
Mononine® is purified of extraneous plasma-derived proteins, including Factors
II, VII and X, by use of immunoaffinity chromatography. A murine monoclonal
antibody to Factor IX is used as an affinity ligand to isolate Factor IX from
the source material. Factor IX is then dissociated from the mon-oclonal antibody,
recovered, purified further, formulated and provided as a sterile, lyophilized
powder. The immunoaffinity protocol utilized results in a highly pure Factor
IX preparation. It shows predominantly a single component by SDS polyacrylamide
electrophoretic evaluation and has a specific activity of not less than 190
Factor IX units per mg total protein.
All Source Plasma used in the manufacture of this product was tested by FDA-licensed
Nucleic Acid Tests (NAT) for HCV and HIV-1 and found to be nonreactive (negative).

An investigational NAT for HBV was also performed on all Source Plasma used
in the manufacture of this product and found to be nonreactive (negative). The
aim of the HBV test is to detect low levels of viral mate-rial, however, the
significance of a nonreactive (negative) result has not been established.
This concentrate has been processed by monoclonal antibody immunoaffinity chromatography
during its manufacture, which has been shown to be capable of reducing the risk
of viral transmission. Additionally, a chemical treatment protocol and two sequential
ultrafiltration steps used in its manufacture have also been shown to be capable
of significant virus reductions. However, no procedure has been shown to be
totally effective in removing the risk of viral infectivity from coagulation
factor concentrates (see CLINICAL PHARMACOLOGY
and WARNINGS).
Mononine® is a highly purified preparation of Factor IX. When stored as
directed, it will maintain its labeled potency for the period indicated on the
container label.
Each vial contains the labeled amount of Factor IX activity expressed in International
Units (IU). One IU represents the activity of Factor IX present in 1 mL of normal,
pooled plasma. When reconstituted as recommended, the resulting solution is
a clear, colorless, isotonic preparation of neutral pH, containing approximately
100 times the Factor IX potency found in an equal volume of plasma. Each mL
of the reconstituted concentrate contains approximately 100 IU of Factor IX
and non-detectable levels of Factors II, VII and X ( < 0.0025 IU per Factor
IX unit using standard coagulation assays). Each vial also contains histidine
(approx. 10mM), sodium chloride (approx. 0.066M), mannitol (approx. 3%) and
polysorbate 80 (approx. 0.0075%). Hydrochloric acid and/or sodium hydroxide
may have been used to adjust pH. Mononine® also contains trace amounts ( ≤ 50
ng mouse protein/100 Factor IX activity units) of the murine monoclonal antibody
used in its purification (see CLINICAL PHARMACOLOGY).
Mononine® is to be administered only intravenously.Last reviewed on RxList: 3/6/2009





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Other reviews about Coagulation Factor IX on web:

Factor IX (or Christmas factor) is one of the serine proteases (EC 3.4.21.22) of the coagulation system; it belongs to peptidase family S1. Deficiency of this protein causes hemophilia ... Factor IX - Wikipedia, the free encyclopedia


This webpage was created as an assignment for an undergraduate course at Davidson College. Coagulation Factor IX. a.k.a. Human Clotting Factor IX, Plasma Thromobplastin ... Coagulation Factor IX


Haematologic Technologies, Inc is a primary manufacturer of high-quality coagulation proteins and research reagents including human, mouse and bovine factor IX. Haematologic Technologies - Human Factor IX - Bovine Factor IX ...


Coagulation factor concentrates are used to treat hemophilia, to reverse the effects of ... Co-factor of IX with which it forms the tenase complex: IX (Anti Hemophilic Factor B or ... Coagulation - Wikipedia, the free encyclopedia


The factor IX assay is a blood test that measures the activity of factor IX -- one of the substances involved in blood clotting (coagulation). Factor IX assay: MedlinePlus Medical Encyclopedia


Physician reviewed coagulation factor IX patient information - includes coagulation factor IX description, dosage and directions. coagulation factor IX medical facts from Drugs.com


Learn about the prescription medication Benefix (Coagulation Factor IX Recombinant), drug uses, dosage, side effects, drug interactions, warnings, reviews and patient labeling. Benefix (Coagulation Factor IX Recombinant) Drug Information: Uses ...


What is the most important information I should know about coagulation factor IX? Providence Health & Services - coagulation factor IX


DWG: 5976r1 11.16.04 CI8020-4 BeneF IX Circular - Wyeth Biopharma for United States 4P 13 September 2006 rn Dwg. 5976r1 11.16.04 13.125˝ x 8.5˝ Black of all bleeding episodes were ... Coagulation Factor IX (Recombinant) Benefix


Cleaved into the following 2 chains: Coagulation factor IXa light chain; Coagulation factor IXa heavy chain Coagulation factor IX precursor - Felis catus (Cat)





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