AryoSevenTM is produced using recombinant BHK cells, which is stored in liquid nitrogen (-185) under cell bank regulations.

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AryoSeven

AryoSevenTM

One of the most important products of AryoGen Pharmed is Recombinant Activated Human Blood Coagulation Factor VIIa, with the trade name of AryoSevenTM.

AryoSevenTM, (rFVIIa), is a glycoprotein produced in Baby Hamster Kidney cell line (BHK) via recombinant technology and is highly purified to be acceptable as an injectable human medicine. AryoSevenTM is indicated for control, treatment and prevention of bleeding episodes in patients with:

  • Congenital hemophilia A or B with inhibitors
  • Acquired hemophilia
  • Congenital factor VII deficiency
  • Glanzmann’s thrombasthenia

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AryoSevenTM is marketed in 3 different doses of 1.2 mg (60 KIU), 2.4 mg (120 KIU) and 4.8 mg (240 KIU) as white lyophilised powder for solution for injection which is supplied in a glass vial with a rubber stopper. The solvent vial contains a clear and colorless solution. The reconstituted solution is a colorless solution. After reconstitution with sWFI the final solution contains approximately 0.6 mg/ml of rFVIIa. The AryoSevenTM package contains:

  • One labeled vial with white powder (AryoSeven) for solution for injection,
  • One labeled vial with solvent (sterile Water for Injections) for reconstitution,
  • One alcohol swab,
  • One syringe.

AryoSevenTM has proven to be as safe and effective as the reference medicinal product. It is to be injected intravenously immediately after the start of a bleeding episode. The recommended doses are:

  • In bleeding episodes in patient with congenital hemophilia A and B with inhibitors- 90 μg/kg intravenous bolus injection (over 2-5 minutes) every 2 – 3 hours until hemostasis is achieved.,
  • In bleeding episodes in patient with acquired hemophilia- 90 μg/kg every 2 to 3 hours until hemostasis is achieved.
  • In bleeding episodes and surgical interventions in patient with congenital factor VII deficiency- 15-30 μg/kg every 4-6 hours until hemostasis is achieved. Dose and frequency of injections should be adapted to each individual.
  • In bleeding episodes in patients with Glanzmann’s thromboasthenia- 90 μg/kg (range 80-120 μg /kg) every 2 hours. At least three doses should be administered to secure achievement of effective haemostasis.

patient information leaflet