Emoclot 500 IU/10ml

S-P-00888 Image 1

Product information

Emoclot is a concentrated solution of the anti-haemorrhagic factor VIII containing the essential protein for blood coagulation. It is a human plasma derived product for intravenous injection, lyophilized after a double viral inactivation.

Emoclot is used in:

  • haemorrhages treatment and prophylaxis of patients with congenital deficit of factor VIII (haemophilia A); treatment of acquired deficit of factor VIII;
  • treatment of haemophilic patients with developed antibody against factor VIII (inhibitors).

The therapy can be both “on demand” for treating haemorrhages and for prophylaxis by continuous administration to prevent haemorrhages.

Emoclot is provided in 500IU1/10ml bottles containing 80IU/mg specific activity proteins.

Components in Emoclot are: human plasma derived factor VIII (active substance), sodium chloride, glycine, calcium chloride and trisodium citrate (excipient). For intravenous injection, this is combined with a bottle of solvent containing water for injection.

A single dose kit includes: 20ml vial containing 500IU/10ml Factor VIII; syringe; butterfly valve; pipe; needle; 10ml vial solvent; leaflet; cardboard box.

Detailed information

Registration number:
S-P-00888
Status:
Registered
Registration date:
January 23, 2018
Version date:
June 5, 2019
Valid until:
April 8, 2024
Geographical scopes:
Global

Company information

Company Name:
Kedrion SpA
Country:
Italy
Contact:
Website:

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