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NovoSeven RT

NovoSeven RT Description

eptacog alfa (activated)

Manufacturer:

Novo Nordisk A/S

Distributor:

Novo Nordisk

Marketer:

Novo Nordisk
Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage Patient Counseling Information MIMS Class ATC Classification Regulatory Classification Presentation/Packing
Full Prescribing Info
Description
Powder and solvent for solution for injection.
White lyophilised powder. Solvent: clear colourless solution.
The reconstituted solution has a pH of approximately 6.0.
Eptacog alfa (activated) 1 mg/vial (corresponds to 50 KIU/vial),1 mg/ml after reconstitution.
1 KIU equals 1,000 IU (International Units).
Eptacog alfa (activated) is recombinant coagulation factor VIIa (rFVIIa) with a molecular mass of approximately 50,000 Daltons produced in baby hamster kidney cells (BHK cells) by recombinant DNA technology.
After reconstitution, the product contains 1 mg/ml eptacog alfa (activated) when reconstituted with solvent.
Excipients/Inactive Ingredients: Powder: Sodium chloride, calcium chloride dihydrate, glycylglycine, polysorbate 80, mannitol, sucrose, methionine, hydrochloric acid (for pH-adjustment) and sodium hydroxide (for pH-adjustment).
Solvent: Histidine, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH-adjustment) and water for injections.