CEVENFACTA Powder and solvent for solution for injection Ref.[50508] Active ingredients: Coagulation factor VIIa

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: Laboratoire français du Fractionnement et des Biotechnologies, Tour W, 102 Terrasse Boieldieu, 19ème Étage, 92800 Puteaux, France

Product name and form

CEVENFACTA 1 mg (45 KIU) powder and solvent for solution for injection.

CEVENFACTA 2 mg (90 KIU) powder and solvent for solution for injection.

CEVENFACTA 5 mg (225 KIU) powder and solvent for solution for injection.

Pharmaceutical Form

Powder and solvent for solution for injection.

White to off-white lyophilised powder.

Solvent: clear and colourless solution.

The solution has a pH of approximately 6. The osmolality is approximately 290 mOsm/kg.

Qualitative and quantitative composition

CEVENFACTA 1 mg (45 KIU) powder and solvent for solution for injection: Each vial contains nominally 1 mg eptacog beta (activated) (45 KIU/vial) corresponding to a concentration of approximately 1 mg/mL (45 KIU/mL) when reconstituted with 1.1 mL of water for injections.

CEVENFACTA 2 mg (90 KIU) powder and solvent for solution for injection: Each vial contains nominally 2 mg eptacog beta (activated) (90 KIU/vial) corresponding to a concentration of approximately 1 mg/mL (45 KIU/mL) when reconstituted with 2.2 mL of water for injections.

CEVENFACTA 5 mg (225 KIU) powder and solvent for solution for injection: Each vial contains nominally 5 mg eptacog beta (activated)(225 KIU/vial) corresponding to a concentration of approximately 1 mg/mL (45 KIU/mL) when reconstituted with 5.2 mL of water for injections.

The potency (IU) is determined using a clotting assay. 1 KIU equals 1 000 IU (International Units).

Eptacog beta (activated) is a recombinant coagulation Factor VIIa (rFVIIa) with a molecular mass of approximately 50 000 Daltons produced from rabbit milk by recombinant DNA technology.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Coagulation factor VIIa

Pharmacological doses of rFVIIa activate factor X directly on the surface of activated platelets, localized to the site of injury, independently of tissue factor. This results in the conversion of prothrombin into large amounts of thrombin independently of tissue factor.
List of Excipients

Powder:

Arginine hydrochloride
Isoleucine
Trisodium citrate dihydrate
Glycine
Lysine hydrochloride
Polysorbate 80
Hydrochloric acid (for pH adjustment)

Solvent:

Water for injections

Pack sizes and marketing

Each pack contains:

CEVENFACTA 1 mg (45 KIU) powder and solvent for solution for injection:

  • 1 glass vial with powder (1 mg) for solution for injection,
  • 1 sterile vial adapter for reconstitution equipped with a 5 µm filter,
  • 1 prefilled syringe of water for injections (1.1 mL),
  • 1 plunger rod and backstop.

CEVENFACTA 2 mg (90 KIU) powder and solvent for solution for injection:

  • 1 glass vial with powder (2 mg) for solution for injection,
  • 1 sterile vial adapter for reconstitution equipped with a 5 µm filter,
  • 1 prefilled syringe of water for injections (2.2 mL),
  • 1 plunger rod and backstop.

CEVENFACTA 5 mg (225 KIU) powder and solvent for solution for injection:

  • 1 glass vial with powder (5 mg) for solution for injection,
  • 1 sterile vial adapter for reconstitution equipped with a 5 µm filter,
  • 1 prefilled syringe of water for injections (5.2 mL),
  • 1 plunger rod and backstop.

Marketing authorization holder

Laboratoire français du Fractionnement et des Biotechnologies, Tour W, 102 Terrasse Boieldieu, 19ème Étage, 92800 Puteaux, France

Marketing authorization dates and numbers

EU/1/22/1664/001
EU/1/22/1664/002
EU/1/22/1664/003

Drugs

Drug Countries
CEVENFACTA Austria, France, Croatia, Italy, Lithuania, United Kingdom
 
Next: Usage >

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.

⇈