How is NovoSeven administered?
First, invert the NovoSeven® RT vial and slowly draw the solution into the syringe. Next, detach the syringe from the vial adapter by turning the syringe counterclockwise. Attach the syringe to the luer end of an infusion needle set. Then, inject the reconstituted NovoSeven® RT intravenously slowly over 2 to 5 minutes.
What is NovoSeven made of?
NovoSeven is a novel product and contains activated recombinant DNA human coagulation factor VII (rFVIIa). The recombinant molecule is produced in baby hamster kidney (BHK) cells. Recombinant FVIIa is almost identical to human plasma FVIIa except for a difference in glycosylation.
How long does NovoSeven last?
NovoSeven must not be mixed with infusion solutions or be given in a drip. The shelf life for the product packed for sale is 3 years when the product is stored below 25°C. In vial After reconstitution, chemical and physical stability has been demonstrated for 6 hours at 25°C and 24 hours at 5°C.
Is NovoSeven human derived?
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.
What is the difference between NovoSeven and NovoSeven RT?
The new NovoSeven RT provides the same safety and efficacy as the original NovoSeven(R)-but it can be transported and administered quickly.” NovoSeven RT has been manufactured to be room temperature stable (from 36 degrees F to 77 degrees F outside a refrigerator).
When should I take NovoSeven?
Keep NovoSeven® RT on hand to treat as soon as possible after a bleeding episode starts. Get an overview of doses for bleeds and perioperative management for each indication. For detailed dosing information, please see the Prescribing Information. The approximate duration of post-hemostatic dosing has not been studied.
What does RT stand for in NovoSeven RT?
NovoSeven® RT (coagulation Factor VIIa, recombinant) for HCPs. Rare Bleeding Disorders.
What is NovoSeven used for?
This medication is used to treat and prevent bleeding in people with certain conditions (such as hemophilia type A or B, low levels of factor VII, Glanzmann’s thrombasthenia).
Is NovoSeven a bypassing agent?
FEIBA (factor VIII inhibitor-bypassing activity), an activated prothrombin complex concentrate (aPCC), and NovoSeven, recombinant factor VIIa (rFVIIa), are used as hemostatic bypassing agents in treating patients with inhibitors.
What does rFVIIa stand for?
DESCRIPTION NovoSeven®is recombinant human coagulation Factor VIIa (rFVIIa), intended for promoting hemostasis by activating the extrinsic pathway of the coagulation cascade.1NovoSeven is a vitamin K-dependent glycoprotein consisting of 406 amino acid residues (MW 50 K Dalton).
What is recombinant FVIIa?
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
What are the clinical trials of rFVIIa?
Surgery Studies Two clinical trials (Studies C and D) were conducted to evaluate the safety and efficacy of rFVIIa administration during and after surgery in hemophilia A or B patients with inhibitors. Study Cwas a randomized, double-blind, parallel group clinical trial (29 patients with
How many mg of rFVIIa is in a vial?
The amount of rFVIIa in milligrams and in micrograms is stated on the label as follows: 1.2 mg per vial (1200 μg/vial) NDC 0169-7060-01 2.4 mg per vial (2400 μg/vial) NDC 0169-7061-01 4.8 mg per vial (4800 μg/vial) NDC 0169-7062-01 Storage Prior to reconstitution, keep refrigerated (2 – 8° C / 36 – 46° F).