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Kogenate FS Drug Description

Antihemophilic Factor (Recombinant) Kogenate® FS Formulated with Sucrose

DRUG DESCRIPTION



What are the possible side effects of recombinant antihemophilic factor?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.
Stop using this medication and call your doctor at once if you have any of these serious side effects:

chest pain;
easy bruising, increased bleeding episodes; or
bleeding from a wound or where the medicine was injected.

Less serious side effects may...
Read All Potential Side Effects for Kogenate FS »




Kogenate® FS Antihemophilic Factor (Recombinant) is a sterile, stable, purified, nonpyrogenic, dried concentrate that has been manufactured using recombinant DNA technology. Kogenate FS is intended for use in the treatment of classical hemophilia (hemophilia A), and is produced by Baby Hamster Kidney (BHK) cells into which the human factor VIII (FVIII) gene has been introduced.1 The cell culture medium contains Human Plasma Protein Solution (HPPS) and recombinant insulin, but does not contain any proteins derived from animal sources. Kogenate FS is a highly purified glycoprotein consisting of multiple peptides including an 80 kD and various extensions of the 90 kD subunit. It has the same biological activity as FVIII derived from human plasma. Compared to its predecessor product KOGENATE® Antihemophilic Factor (Recombinant), Kogenate FS incorporates a revised purification and formulation process that eliminates the addition of Albumin (Human). The purification process includes an effective solvent/detergent virus inactivation step in addition to the use of the classical purification methods of ion exchange chromatography, monoclonal antibody immunoaffinity chromatography, along with other chromatographic steps designed to purify recombinant FVIII and remove contaminating substances.
Kogenate FS is formulated with sucrose (0.9-1.3%), glycine (21-25 mg/mL), and histidine (18-23 mM) as stabilizers in the final container in place of Albumin (Human) as used in KOGENATE, and is then lyophilized. The final product also contains calcium chloride (2-3 mM), sodium (27-36 mEq/L), chloride (32-40 mEq/L), polysorbate 80 (not more than [NMT] 96 µg/mL), imidazole (NMT 20 µg/1000 IU), tri-n-butyl phosphate (NMT 5 µg/1000 IU), and copper (NMT 0.6 µg/1000 IU). The product contains no preservatives. The amount of sucrose in each vial is 28 mg. Intravenous administration of sucrose contained in Kogenate FS will not affect blood glucose levels.
Each vial of Kogenate FS contains the labeled amount of recombinant FVIII in international units (IU). One IU, as defined by the World Health Organization standard for blood coagulation FVIII, human, is approximately equal to the level of FVIII activity found in 1 mL of fresh pooled human plasma. Kogenate FS must be administered by the intravenous route.
REFERENCES
1.  Lawn RM, Vehar GA: The molecular genetics of hemophilia. Sci Am 254(3):48-54, 1986.Last reviewed on RxList: 10/26/2005




Kogenate FS Drug Description

Antihemophilic Factor (Recombinant) Kogenate® FS Formulated with Sucrose

DRUG DESCRIPTION



What are the possible side effects of recombinant antihemophilic factor?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.
Stop using this medication and call your doctor at once if you have any of these serious side effects:

chest pain;
easy bruising, increased bleeding episodes; or
bleeding from a wound or where the medicine was injected.

Less serious side effects may...
Read All Potential Side Effects for Kogenate FS »




Kogenate® FS Antihemophilic Factor (Recombinant) is a sterile, stable, purified, nonpyrogenic, dried concentrate that has been manufactured using recombinant DNA technology. Kogenate FS is intended for use in the treatment of classical hemophilia (hemophilia A), and is produced by Baby Hamster Kidney (BHK) cells into which the human factor VIII (FVIII) gene has been introduced.1 The cell culture medium contains Human Plasma Protein Solution (HPPS) and recombinant insulin, but does not contain any proteins derived from animal sources. Kogenate FS is a highly purified glycoprotein consisting of multiple peptides including an 80 kD and various extensions of the 90 kD subunit. It has the same biological activity as FVIII derived from human plasma. Compared to its predecessor product KOGENATE® Antihemophilic Factor (Recombinant), Kogenate FS incorporates a revised purification and formulation process that eliminates the addition of Albumin (Human). The purification process includes an effective solvent/detergent virus inactivation step in addition to the use of the classical purification methods of ion exchange chromatography, monoclonal antibody immunoaffinity chromatography, along with other chromatographic steps designed to purify recombinant FVIII and remove contaminating substances.
Kogenate FS is formulated with sucrose (0.9-1.3%), glycine (21-25 mg/mL), and histidine (18-23 mM) as stabilizers in the final container in place of Albumin (Human) as used in KOGENATE, and is then lyophilized. The final product also contains calcium chloride (2-3 mM), sodium (27-36 mEq/L), chloride (32-40 mEq/L), polysorbate 80 (not more than [NMT] 96 µg/mL), imidazole (NMT 20 µg/1000 IU), tri-n-butyl phosphate (NMT 5 µg/1000 IU), and copper (NMT 0.6 µg/1000 IU). The product contains no preservatives. The amount of sucrose in each vial is 28 mg. Intravenous administration of sucrose contained in Kogenate FS will not affect blood glucose levels.
Each vial of Kogenate FS contains the labeled amount of recombinant FVIII in international units (IU). One IU, as defined by the World Health Organization standard for blood coagulation FVIII, human, is approximately equal to the level of FVIII activity found in 1 mL of fresh pooled human plasma. Kogenate FS must be administered by the intravenous route.
REFERENCES
1.  Lawn RM, Vehar GA: The molecular genetics of hemophilia. Sci Am 254(3):48-54, 1986.Last reviewed on RxList: 10/26/2005




Kogenate FS Drug Description

Antihemophilic Factor (Recombinant) Kogenate® FS Formulated with Sucrose

DRUG DESCRIPTION



What are the possible side effects of recombinant antihemophilic factor?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.
Stop using this medication and call your doctor at once if you have any of these serious side effects:

chest pain;
easy bruising, increased bleeding episodes; or
bleeding from a wound or where the medicine was injected.

Less serious side effects may...
Read All Potential Side Effects for Kogenate FS »




Kogenate® FS Antihemophilic Factor (Recombinant) is a sterile, stable, purified, nonpyrogenic, dried concentrate that has been manufactured using recombinant DNA technology. Kogenate FS is intended for use in the treatment of classical hemophilia (hemophilia A), and is produced by Baby Hamster Kidney (BHK) cells into which the human factor VIII (FVIII) gene has been introduced.1 The cell culture medium contains Human Plasma Protein Solution (HPPS) and recombinant insulin, but does not contain any proteins derived from animal sources. Kogenate FS is a highly purified glycoprotein consisting of multiple peptides including an 80 kD and various extensions of the 90 kD subunit. It has the same biological activity as FVIII derived from human plasma. Compared to its predecessor product KOGENATE® Antihemophilic Factor (Recombinant), Kogenate FS incorporates a revised purification and formulation process that eliminates the addition of Albumin (Human). The purification process includes an effective solvent/detergent virus inactivation step in addition to the use of the classical purification methods of ion exchange chromatography, monoclonal antibody immunoaffinity chromatography, along with other chromatographic steps designed to purify recombinant FVIII and remove contaminating substances.
Kogenate FS is formulated with sucrose (0.9-1.3%), glycine (21-25 mg/mL), and histidine (18-23 mM) as stabilizers in the final container in place of Albumin (Human) as used in KOGENATE, and is then lyophilized. The final product also contains calcium chloride (2-3 mM), sodium (27-36 mEq/L), chloride (32-40 mEq/L), polysorbate 80 (not more than [NMT] 96 µg/mL), imidazole (NMT 20 µg/1000 IU), tri-n-butyl phosphate (NMT 5 µg/1000 IU), and copper (NMT 0.6 µg/1000 IU). The product contains no preservatives. The amount of sucrose in each vial is 28 mg. Intravenous administration of sucrose contained in Kogenate FS will not affect blood glucose levels.
Each vial of Kogenate FS contains the labeled amount of recombinant FVIII in international units (IU). One IU, as defined by the World Health Organization standard for blood coagulation FVIII, human, is approximately equal to the level of FVIII activity found in 1 mL of fresh pooled human plasma. Kogenate FS must be administered by the intravenous route.
REFERENCES
1.  Lawn RM, Vehar GA: The molecular genetics of hemophilia. Sci Am 254(3):48-54, 1986.Last reviewed on RxList: 10/26/2005




Kogenate FS Drug Description

Antihemophilic Factor (Recombinant) Kogenate® FS Formulated with Sucrose

DRUG DESCRIPTION



What are the possible side effects of recombinant antihemophilic factor?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.
Stop using this medication and call your doctor at once if you have any of these serious side effects:

chest pain;
easy bruising, increased bleeding episodes; or
bleeding from a wound or where the medicine was injected.

Less serious side effects may...
Read All Potential Side Effects for Kogenate FS »




Kogenate® FS Antihemophilic Factor (Recombinant) is a sterile, stable, purified, nonpyrogenic, dried concentrate that has been manufactured using recombinant DNA technology. Kogenate FS is intended for use in the treatment of classical hemophilia (hemophilia A), and is produced by Baby Hamster Kidney (BHK) cells into which the human factor VIII (FVIII) gene has been introduced.1 The cell culture medium contains Human Plasma Protein Solution (HPPS) and recombinant insulin, but does not contain any proteins derived from animal sources. Kogenate FS is a highly purified glycoprotein consisting of multiple peptides including an 80 kD and various extensions of the 90 kD subunit. It has the same biological activity as FVIII derived from human plasma. Compared to its predecessor product KOGENATE® Antihemophilic Factor (Recombinant), Kogenate FS incorporates a revised purification and formulation process that eliminates the addition of Albumin (Human). The purification process includes an effective solvent/detergent virus inactivation step in addition to the use of the classical purification methods of ion exchange chromatography, monoclonal antibody immunoaffinity chromatography, along with other chromatographic steps designed to purify recombinant FVIII and remove contaminating substances.
Kogenate FS is formulated with sucrose (0.9-1.3%), glycine (21-25 mg/mL), and histidine (18-23 mM) as stabilizers in the final container in place of Albumin (Human) as used in KOGENATE, and is then lyophilized. The final product also contains calcium chloride (2-3 mM), sodium (27-36 mEq/L), chloride (32-40 mEq/L), polysorbate 80 (not more than [NMT] 96 µg/mL), imidazole (NMT 20 µg/1000 IU), tri-n-butyl phosphate (NMT 5 µg/1000 IU), and copper (NMT 0.6 µg/1000 IU). The product contains no preservatives. The amount of sucrose in each vial is 28 mg. Intravenous administration of sucrose contained in Kogenate FS will not affect blood glucose levels.
Each vial of Kogenate FS contains the labeled amount of recombinant FVIII in international units (IU). One IU, as defined by the World Health Organization standard for blood coagulation FVIII, human, is approximately equal to the level of FVIII activity found in 1 mL of fresh pooled human plasma. Kogenate FS must be administered by the intravenous route.
REFERENCES
1.  Lawn RM, Vehar GA: The molecular genetics of hemophilia. Sci Am 254(3):48-54, 1986.Last reviewed on RxList: 10/26/2005




Kogenate FS Drug Description

Antihemophilic Factor (Recombinant) Kogenate® FS Formulated with Sucrose

DRUG DESCRIPTION



What are the possible side effects of recombinant antihemophilic factor?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.
Stop using this medication and call your doctor at once if you have any of these serious side effects:

chest pain;
easy bruising, increased bleeding episodes; or
bleeding from a wound or where the medicine was injected.

Less serious side effects may...
Read All Potential Side Effects for Kogenate FS »




Kogenate® FS Antihemophilic Factor (Recombinant) is a sterile, stable, purified, nonpyrogenic, dried concentrate that has been manufactured using recombinant DNA technology. Kogenate FS is intended for use in the treatment of classical hemophilia (hemophilia A), and is produced by Baby Hamster Kidney (BHK) cells into which the human factor VIII (FVIII) gene has been introduced.1 The cell culture medium contains Human Plasma Protein Solution (HPPS) and recombinant insulin, but does not contain any proteins derived from animal sources. Kogenate FS is a highly purified glycoprotein consisting of multiple peptides including an 80 kD and various extensions of the 90 kD subunit. It has the same biological activity as FVIII derived from human plasma. Compared to its predecessor product KOGENATE® Antihemophilic Factor (Recombinant), Kogenate FS incorporates a revised purification and formulation process that eliminates the addition of Albumin (Human). The purification process includes an effective solvent/detergent virus inactivation step in addition to the use of the classical purification methods of ion exchange chromatography, monoclonal antibody immunoaffinity chromatography, along with other chromatographic steps designed to purify recombinant FVIII and remove contaminating substances.
Kogenate FS is formulated with sucrose (0.9-1.3%), glycine (21-25 mg/mL), and histidine (18-23 mM) as stabilizers in the final container in place of Albumin (Human) as used in KOGENATE, and is then lyophilized. The final product also contains calcium chloride (2-3 mM), sodium (27-36 mEq/L), chloride (32-40 mEq/L), polysorbate 80 (not more than [NMT] 96 µg/mL), imidazole (NMT 20 µg/1000 IU), tri-n-butyl phosphate (NMT 5 µg/1000 IU), and copper (NMT 0.6 µg/1000 IU). The product contains no preservatives. The amount of sucrose in each vial is 28 mg. Intravenous administration of sucrose contained in Kogenate FS will not affect blood glucose levels.
Each vial of Kogenate FS contains the labeled amount of recombinant FVIII in international units (IU). One IU, as defined by the World Health Organization standard for blood coagulation FVIII, human, is approximately equal to the level of FVIII activity found in 1 mL of fresh pooled human plasma. Kogenate FS must be administered by the intravenous route.
REFERENCES
1.  Lawn RM, Vehar GA: The molecular genetics of hemophilia. Sci Am 254(3):48-54, 1986.Last reviewed on RxList: 10/26/2005





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Other reviews about Kogenate FS on web:

KogenateFS.com is a resource from Bayer HealthCare for patients, parents, caregivers, and healthcare providers in regards to the treatment of hemophilia A. Kogenateテδづつョ FS ... Kogenateテδづつョ FS - Antihemophilic Factor (Recombinant) for the ...


KogenateFS.com is a resource from Bayer HealthCare for patients, parents, caregivers, and healthcare providers in regards to the treatment of hemophilia A. Kogenateテδづつョ FS ... Kogenateテδづつョ FS - Prescribing Information


Learn about the prescription medication Kogenate FS (Antihemophilic Factor (Recombinant)), drug uses, dosage, side effects, drug interactions, warnings, and patient labeling. Kogenate FS (Antihemophilic Factor (Recombinant)) Drug Information ...


Kogenate (antihemophilic factor) is used to prevent bleeding in adults and children with hemophilia A. Includes Kogenate side effects, interactions and indications. Kogenate FS Information from Drugs.com


Accurate, FDA approved Kogenate FS information for healthcare professionals and patients - brought to you by Drugs.com. Kogenate FS Official FDA information, side effects and uses.


KogenateテδづつョFS : Manufacturer: Bayer Corporation Generic Name: Antihemophilic Factor VIII (Recombinant) Indications: Kogenateテδづつョ FS is an antihemophilic factor that is indicated for the ... Prodigy Healthcare Supplier


Kogenate FS. Proper Name: Antihemophilic Factor (Recombinant) Tradename: Kogenate FS Manufacturer: Bayer Corp, License #0008. Indications: To include routine prophylaxis to reduce the ... Kogenate FS


Bayer has developed the Kogenate FS Patient Assistance Program (PAP) for patients who 1) need short-term assistance with obtaining Kogenate FS treatment but have no insurance ... Kogenate Factor Solutions


What is Kogenate FS (Antihemophilic Factor)? Antihemophilic factor is a naturally occurring protein in the blood that helps blood to clot. A lack of antihemophilic factor VIII is ... Kogenate FS - Drugs & Treatments - Revolution Health


The U.S. Food and Drug Administration approved a new use for the blood product Kogenate FS to reduce the frequency of bleeding episodes and prevent joint damage in children with ... Rapaflo (silodosin)- uses and side effects





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