Declan schreef op 9 februari 2015 15:08:
Van onze vriend van de overkant Jurpsy die van wel iedereen het beste op de hoogte is wat betreft Pharming/Ruconest.
Bedankt voor het lenen van je materiaal.
Hoop dat je het niet erg vind even stiekum met je vr.... gedanst ;-)
jurpsy @ 08-02-2015 11:34:54 (http://www.ErikErik.com / Pharming)
Serious arterial and venous thromboembolic (TE) events have been reported at the recommended dose of C1 Esterase Inhibitor (Human) products, including Berinert.....................
Serious arterial and venous thromboembolic (TE) events have been reported at the recommended dose of C1 Esterase Inhibitor (Human)
products, including CINRYZE,.........................................
jurpsy @ 08-02-2015 11:30:51 (http://www.ErikErik.com / Pharming)
WARNINGS AND PRECAUTIONS-----------------------
• Hypersensitivity reactions may occur. Epinephrine should be immediately available to treat any acute severe hypersensitivity reactions following discontinuation of administration (5.1).
• Serious arterial and venous thromboembolic (TE) events have been reported at the recommended dose of C1 Esterase Inhibitor (Human) products, including Berinert, following administration in patients with HAE. Risk factors may include the presence of an indwelling venous catheter/access device, prior history of thrombosis, underlying atherosclerosis, use of oral contraceptives or certain androgens, morbid obesity, and immobility. Benefits of treatment of HAE attacks should be weighed against the risks of TE in patients with underlying risk factors. Monitor patients with known risk factors for TE events during and after Berinert administration.
TE events have been reported following administration of a C1 Esterase Inhibitor (Human) product when used off-label at higher than labeled doses.1 (5.2).
• Berinert is made from human plasma and may contain infectious agents, eg, viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent (5.3).
• Laryngeal attacks: Following self-administration of Berinert for laryngeal attacks, advise patients to immediately seek medical attention.
jurpsy @ 08-02-2015 11:28:54 (http://www.ErikErik.com / Pharming)
-----------------------WARNINGS AND PRECAUTIONS------------------------
! Hypersensitivity reactions, including anaphylaxis may occur. Should
symptoms occur, discontinue RUCONEST and administer appropriate
treatment. (5.1)
! Serious arterial and venous thromboembolic (TE) events have been
reported at the recommended dose of plasma derived C1 esterase
inhibitor products in patients with risk factors. Monitor patients with
known risk factors for TE events during and after RUCONEST
administration.
jurpsy @ 08-02-2015 11:34:54 (http://www.ErikErik.com / Pharming)
Serious arterial and venous thromboembolic (TE) events have been reported at the recommended dose of C1 Esterase Inhibitor (Human) products, including Berinert.....................
Serious arterial and venous thromboembolic (TE) events have been reported at the recommended dose of C1 Esterase Inhibitor (Human)
products, including CINRYZE,.........................................
jurpsy @ 08-02-2015 18:29:30 (http://www.ErikErik.com / Pharming)
Bottom line is Ruconest will sell. Talk to any physician in the space. I've sold in HAE and have spoken to many. Cinryze failures/breakthrough attacks, etc. will get Ruconest 10-15% of the market which is just fine. Not to mention the usage from physicians who just plain old like their Ruconest Rep.. This is sales.............
Recombinant dominates over plasma in every area it exists...........
said the man...
Ruud..