Reviews Coagulation Factor VIIa


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Novoseven Drug Description
NovoSeven®
Coagulation Factor VIIa Recombinant
DRUG DESCRIPTION



What are the possible side effects of coagulation factor VIIa (NovoSeven, NovoSeven RT)?

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;
any bleeding that will not stop;
feeling like you might pass out;
urinating less than usual or not at all;
sudden numbness or weakness, especially on one side of the body;
...
Read All Potential Side Effects for Novoseven »




NovoSeven®is recombinant human coagulation Factor VIIa (rFVIIa),
intended for promoting hemostasis by activating the extrinsic pathway of the
coagulation cascade. 1 NovoSeven is a vitamin K-dependent glycoprotein
consisting of 406 amino acid residues (MW 50 K Dalton). NovoSeven is structurally
similar to human plasma-derived Factor VIIa.
The gene for human Factor VII is cloned and expressed in baby hamster kidney
cells (BHK cells). Recombinant FVII is secreted into the culture media (containing
newborn calf serum) in its single-chain form and then proteolytically converted
by autocatalysis to the active two-chain form, rFVIIa, during a chromatographic
purification process. The purification process has been demonstrated to remove
exogenous viruses (MuLV, SV40, Pox virus, Reovirus, BEV, IBR virus). No human
serum or other proteins are used in the production or formulation of NovoSeven.

NovoSeven is supplied as a sterile, white lyophilized powder of rFVIIa in single-use
vials.
Each vial of lyophilized drug contains the following:




Contents
1.2 mg
(60 KIU) Vial
2.4 mg
(120 KIU) Vial
4.8 mg
(240 KIU) Vial


rFVIIa
1200 μg
2400 μg
4800 μg


sodium chloride*
5.84 mg
11.68 mg
23.36 mg


calcium chloride dihydrate*
2.94 mg
5.88 mg
11.76 mg


glycylglycine
2.64 mg
5.28 mg
10.56 mg


polysorbate 80
0.14 mg
0.28 mg
0.56 mg


mannitol
60.0 mg
120.0 mg
240.0 mg


*per mg of rFVIIa:0. 44 mEq sodium, 0. 06
mEq calcium



After reconstitution with the appropriate volume of Sterile Water for Injection,
USP (not supplied), each vial contains approximately 0. 6 mg/mL NovoSeven
(corresponding to 600 μg/mL). The reconstituted vials have a pH of approximately
5. 5 in sodium chloride (3 mg/mL), calcium chloride dihydrate (1. 5 mg/mL),
glycylglycine (1. 3 mg/mL), polysorbate 80 (0. 1 mg/mL), and mannitol (30 mg/mL).

The reconstituted product is a clear colorless solution which contains no preservatives.
NovoSeven contains trace amounts of proteins derived from the manufacturing
and purification processes such as mouse IgG (maximum of 1. 2 ng/mg), bovine
IgG (maximum of 30 ng/mg), and protein from BHK-cells and media (maximum of
19ng/mg).
REFERENCES
1. Roberts, H. R. : Thoughts on the mechanism of action
of FVIIa, 2nd Symposium on New Aspects of Hemophilia Treatment, Copenhagen,
Denmark, 1991, pgs. 153-156.Last reviewed on RxList: 1/12/2009




Novoseven Drug Description
NovoSeven®
Coagulation Factor VIIa Recombinant
DRUG DESCRIPTION



What are the possible side effects of coagulation factor VIIa (NovoSeven, NovoSeven RT)?

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;
any bleeding that will not stop;
feeling like you might pass out;
urinating less than usual or not at all;
sudden numbness or weakness, especially on one side of the body;
...
Read All Potential Side Effects for Novoseven »




NovoSeven®is recombinant human coagulation Factor VIIa (rFVIIa),
intended for promoting hemostasis by activating the extrinsic pathway of the
coagulation cascade. 1 NovoSeven is a vitamin K-dependent glycoprotein
consisting of 406 amino acid residues (MW 50 K Dalton). NovoSeven is structurally
similar to human plasma-derived Factor VIIa.
The gene for human Factor VII is cloned and expressed in baby hamster kidney
cells (BHK cells). Recombinant FVII is secreted into the culture media (containing
newborn calf serum) in its single-chain form and then proteolytically converted
by autocatalysis to the active two-chain form, rFVIIa, during a chromatographic
purification process. The purification process has been demonstrated to remove
exogenous viruses (MuLV, SV40, Pox virus, Reovirus, BEV, IBR virus). No human
serum or other proteins are used in the production or formulation of NovoSeven.

NovoSeven is supplied as a sterile, white lyophilized powder of rFVIIa in single-use
vials.
Each vial of lyophilized drug contains the following:




Contents
1.2 mg
(60 KIU) Vial
2.4 mg
(120 KIU) Vial
4.8 mg
(240 KIU) Vial


rFVIIa
1200 μg
2400 μg
4800 μg


sodium chloride*
5.84 mg
11.68 mg
23.36 mg


calcium chloride dihydrate*
2.94 mg
5.88 mg
11.76 mg


glycylglycine
2.64 mg
5.28 mg
10.56 mg


polysorbate 80
0.14 mg
0.28 mg
0.56 mg


mannitol
60.0 mg
120.0 mg
240.0 mg


*per mg of rFVIIa:0. 44 mEq sodium, 0. 06
mEq calcium



After reconstitution with the appropriate volume of Sterile Water for Injection,
USP (not supplied), each vial contains approximately 0. 6 mg/mL NovoSeven
(corresponding to 600 μg/mL). The reconstituted vials have a pH of approximately
5. 5 in sodium chloride (3 mg/mL), calcium chloride dihydrate (1. 5 mg/mL),
glycylglycine (1. 3 mg/mL), polysorbate 80 (0. 1 mg/mL), and mannitol (30 mg/mL).

The reconstituted product is a clear colorless solution which contains no preservatives.
NovoSeven contains trace amounts of proteins derived from the manufacturing
and purification processes such as mouse IgG (maximum of 1. 2 ng/mg), bovine
IgG (maximum of 30 ng/mg), and protein from BHK-cells and media (maximum of
19ng/mg).
REFERENCES
1. Roberts, H. R. : Thoughts on the mechanism of action
of FVIIa, 2nd Symposium on New Aspects of Hemophilia Treatment, Copenhagen,
Denmark, 1991, pgs. 153-156.Last reviewed on RxList: 1/12/2009




Novoseven Drug Description
NovoSeven®
Coagulation Factor VIIa Recombinant
DRUG DESCRIPTION



What are the possible side effects of coagulation factor VIIa (NovoSeven, NovoSeven RT)?

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;
any bleeding that will not stop;
feeling like you might pass out;
urinating less than usual or not at all;
sudden numbness or weakness, especially on one side of the body;
...
Read All Potential Side Effects for Novoseven »




NovoSeven®is recombinant human coagulation Factor VIIa (rFVIIa),
intended for promoting hemostasis by activating the extrinsic pathway of the
coagulation cascade. 1 NovoSeven is a vitamin K-dependent glycoprotein
consisting of 406 amino acid residues (MW 50 K Dalton). NovoSeven is structurally
similar to human plasma-derived Factor VIIa.
The gene for human Factor VII is cloned and expressed in baby hamster kidney
cells (BHK cells). Recombinant FVII is secreted into the culture media (containing
newborn calf serum) in its single-chain form and then proteolytically converted
by autocatalysis to the active two-chain form, rFVIIa, during a chromatographic
purification process. The purification process has been demonstrated to remove
exogenous viruses (MuLV, SV40, Pox virus, Reovirus, BEV, IBR virus). No human
serum or other proteins are used in the production or formulation of NovoSeven.

NovoSeven is supplied as a sterile, white lyophilized powder of rFVIIa in single-use
vials.
Each vial of lyophilized drug contains the following:




Contents
1.2 mg
(60 KIU) Vial
2.4 mg
(120 KIU) Vial
4.8 mg
(240 KIU) Vial


rFVIIa
1200 μg
2400 μg
4800 μg


sodium chloride*
5.84 mg
11.68 mg
23.36 mg


calcium chloride dihydrate*
2.94 mg
5.88 mg
11.76 mg


glycylglycine
2.64 mg
5.28 mg
10.56 mg


polysorbate 80
0.14 mg
0.28 mg
0.56 mg


mannitol
60.0 mg
120.0 mg
240.0 mg


*per mg of rFVIIa:0. 44 mEq sodium, 0. 06
mEq calcium



After reconstitution with the appropriate volume of Sterile Water for Injection,
USP (not supplied), each vial contains approximately 0. 6 mg/mL NovoSeven
(corresponding to 600 μg/mL). The reconstituted vials have a pH of approximately
5. 5 in sodium chloride (3 mg/mL), calcium chloride dihydrate (1. 5 mg/mL),
glycylglycine (1. 3 mg/mL), polysorbate 80 (0. 1 mg/mL), and mannitol (30 mg/mL).

The reconstituted product is a clear colorless solution which contains no preservatives.
NovoSeven contains trace amounts of proteins derived from the manufacturing
and purification processes such as mouse IgG (maximum of 1. 2 ng/mg), bovine
IgG (maximum of 30 ng/mg), and protein from BHK-cells and media (maximum of
19ng/mg).
REFERENCES
1. Roberts, H. R. : Thoughts on the mechanism of action
of FVIIa, 2nd Symposium on New Aspects of Hemophilia Treatment, Copenhagen,
Denmark, 1991, pgs. 153-156.Last reviewed on RxList: 1/12/2009




Novoseven Drug Description
NovoSeven®
Coagulation Factor VIIa Recombinant
DRUG DESCRIPTION



What are the possible side effects of coagulation factor VIIa (NovoSeven, NovoSeven RT)?

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;
any bleeding that will not stop;
feeling like you might pass out;
urinating less than usual or not at all;
sudden numbness or weakness, especially on one side of the body;
...
Read All Potential Side Effects for Novoseven »




NovoSeven®is recombinant human coagulation Factor VIIa (rFVIIa),
intended for promoting hemostasis by activating the extrinsic pathway of the
coagulation cascade. 1 NovoSeven is a vitamin K-dependent glycoprotein
consisting of 406 amino acid residues (MW 50 K Dalton). NovoSeven is structurally
similar to human plasma-derived Factor VIIa.
The gene for human Factor VII is cloned and expressed in baby hamster kidney
cells (BHK cells). Recombinant FVII is secreted into the culture media (containing
newborn calf serum) in its single-chain form and then proteolytically converted
by autocatalysis to the active two-chain form, rFVIIa, during a chromatographic
purification process. The purification process has been demonstrated to remove
exogenous viruses (MuLV, SV40, Pox virus, Reovirus, BEV, IBR virus). No human
serum or other proteins are used in the production or formulation of NovoSeven.

NovoSeven is supplied as a sterile, white lyophilized powder of rFVIIa in single-use
vials.
Each vial of lyophilized drug contains the following:




Contents
1.2 mg
(60 KIU) Vial
2.4 mg
(120 KIU) Vial
4.8 mg
(240 KIU) Vial


rFVIIa
1200 μg
2400 μg
4800 μg


sodium chloride*
5.84 mg
11.68 mg
23.36 mg


calcium chloride dihydrate*
2.94 mg
5.88 mg
11.76 mg


glycylglycine
2.64 mg
5.28 mg
10.56 mg


polysorbate 80
0.14 mg
0.28 mg
0.56 mg


mannitol
60.0 mg
120.0 mg
240.0 mg


*per mg of rFVIIa:0. 44 mEq sodium, 0. 06
mEq calcium



After reconstitution with the appropriate volume of Sterile Water for Injection,
USP (not supplied), each vial contains approximately 0. 6 mg/mL NovoSeven
(corresponding to 600 μg/mL). The reconstituted vials have a pH of approximately
5. 5 in sodium chloride (3 mg/mL), calcium chloride dihydrate (1. 5 mg/mL),
glycylglycine (1. 3 mg/mL), polysorbate 80 (0. 1 mg/mL), and mannitol (30 mg/mL).

The reconstituted product is a clear colorless solution which contains no preservatives.
NovoSeven contains trace amounts of proteins derived from the manufacturing
and purification processes such as mouse IgG (maximum of 1. 2 ng/mg), bovine
IgG (maximum of 30 ng/mg), and protein from BHK-cells and media (maximum of
19ng/mg).
REFERENCES
1. Roberts, H. R. : Thoughts on the mechanism of action
of FVIIa, 2nd Symposium on New Aspects of Hemophilia Treatment, Copenhagen,
Denmark, 1991, pgs. 153-156.Last reviewed on RxList: 1/12/2009




Novoseven Drug Description
NovoSeven®
Coagulation Factor VIIa Recombinant
DRUG DESCRIPTION



What are the possible side effects of coagulation factor VIIa (NovoSeven, NovoSeven RT)?

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;
any bleeding that will not stop;
feeling like you might pass out;
urinating less than usual or not at all;
sudden numbness or weakness, especially on one side of the body;
...
Read All Potential Side Effects for Novoseven »




NovoSeven®is recombinant human coagulation Factor VIIa (rFVIIa),
intended for promoting hemostasis by activating the extrinsic pathway of the
coagulation cascade. 1 NovoSeven is a vitamin K-dependent glycoprotein
consisting of 406 amino acid residues (MW 50 K Dalton). NovoSeven is structurally
similar to human plasma-derived Factor VIIa.
The gene for human Factor VII is cloned and expressed in baby hamster kidney
cells (BHK cells). Recombinant FVII is secreted into the culture media (containing
newborn calf serum) in its single-chain form and then proteolytically converted
by autocatalysis to the active two-chain form, rFVIIa, during a chromatographic
purification process. The purification process has been demonstrated to remove
exogenous viruses (MuLV, SV40, Pox virus, Reovirus, BEV, IBR virus). No human
serum or other proteins are used in the production or formulation of NovoSeven.

NovoSeven is supplied as a sterile, white lyophilized powder of rFVIIa in single-use
vials.
Each vial of lyophilized drug contains the following:




Contents
1.2 mg
(60 KIU) Vial
2.4 mg
(120 KIU) Vial
4.8 mg
(240 KIU) Vial


rFVIIa
1200 μg
2400 μg
4800 μg


sodium chloride*
5.84 mg
11.68 mg
23.36 mg


calcium chloride dihydrate*
2.94 mg
5.88 mg
11.76 mg


glycylglycine
2.64 mg
5.28 mg
10.56 mg


polysorbate 80
0.14 mg
0.28 mg
0.56 mg


mannitol
60.0 mg
120.0 mg
240.0 mg


*per mg of rFVIIa:0. 44 mEq sodium, 0. 06
mEq calcium



After reconstitution with the appropriate volume of Sterile Water for Injection,
USP (not supplied), each vial contains approximately 0. 6 mg/mL NovoSeven
(corresponding to 600 μg/mL). The reconstituted vials have a pH of approximately
5. 5 in sodium chloride (3 mg/mL), calcium chloride dihydrate (1. 5 mg/mL),
glycylglycine (1. 3 mg/mL), polysorbate 80 (0. 1 mg/mL), and mannitol (30 mg/mL).

The reconstituted product is a clear colorless solution which contains no preservatives.
NovoSeven contains trace amounts of proteins derived from the manufacturing
and purification processes such as mouse IgG (maximum of 1. 2 ng/mg), bovine
IgG (maximum of 30 ng/mg), and protein from BHK-cells and media (maximum of
19ng/mg).
REFERENCES
1. Roberts, H. R. : Thoughts on the mechanism of action
of FVIIa, 2nd Symposium on New Aspects of Hemophilia Treatment, Copenhagen,
Denmark, 1991, pgs. 153-156.Last reviewed on RxList: 1/12/2009





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Other reviews about Coagulation Factor VIIa on web:

^"Thromboembolic adverse events after use of recombinant human coagulation factor VIIa". JAMA 295 (3): 293√ɬĘ√ā¬Ä√ā¬ď8. doi: 10.1001/jama.295.3.293. PMID 16418464. Factor VII - Wikipedia, the free encyclopedia


FactorVIIa.com provides information about topics related to the pathophysiology, pharmacology, and clinical aspects of bleeding, coagulation, and hemostasis, including information ... The Factor VIIa Source


All about Coagulation Factor VIIa (Recombinant). View complete and up to date Coagulation Factor VIIa (Recombinant) information - part of the Drugs.com trusted medication database. Coagulation Factor VIIa (Recombinant) Facts and Comparisons at ...


Physician reviewed coagulation factor VIIa (injection) patient information - includes coagulation factor VIIa description, dosage and directions. coagulation factor VIIa (injection) medical facts from Drugs.com


NovoSeven Package Insert Page 1 NOVOSEVEN √ɬā√ā¬ģ √ɬā√ā¬ģ Coagulation Factor VIIa (Recombinant) For Intravenous Use Only DESCRIPTION NovoSeven is recombinant human coagulation Factor VIIa (rFVIIa ... NOVOSEVEN Coagulation Factor VIIa (Recombinant)


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


^"Thromboembolic adverse events after use of recombinant human coagulation factor VIIa". JAMA 295 (3): 293√ɬĘ√ā¬Ä√ā¬ď8. doi: 10.1001/jama.295.3.293. PMID 16418464. Factor VII: Definition from Answers.com


The invention relates to a pharmaceutical composition comprising Factor VIIa for subcutan, intramuscular or interdermal administration. Factor VIIa administered subcutanously ... Coagulation factor VIIa composition - Patent 6310183


Find patient medical information for Coagulation Factor VIIa Recomb IV on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Coagulation Factor VIIa Recomb IV : Uses, Side Effects ...


NOVOSEVEN SUMMARY NovoSeven√ɬā√ā¬ģ is recombinant human coagulation Factor VIIa (rFVIIa), intended for promoting hemostasis by activating the extrinsic pathway of the coagulation ... Novoseven (Coagulation Factor Viia) - Drug Info, Side Effects ...





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