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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 500IU /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.

This is a pre-certified EPD, meaning that no PCR is yet available for the product category. This EPD thus only have a one-year validity, which cannot be renewed. More information about pre-certification is available here.

Detailed information

Registration No: S-EP-00888
This is a precertified EPD.
Read more about pre-certifications here.
Registration date: 2016-05-09
Valid until: 2016-12-07
Verified by: SGS Italia S.p.A.
Geographical scope: Global

Company information

Kedrion SpA
Company name: Kedrion SpA
Country: Italy
Contact: Marta Bonaldi
Website: www.kedrion.com

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