676:
efficacy of treatment twelve hours after the initial dose was given. The proportion of mild or moderate bleeding episodes treated successfully both with the lower dose of 75mcg/kg and higher dose of 225 mcg/kg (requiring no further treatment for the bleeding episode, no administration of blood products and no increase in pain beyond 12 hours from initial dose) was approximately 86%. The study also included three severe bleeding episodes that were treated successfully with the higher dose.
541:
27:
729:(EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Cevenfacta, intended for the treatment of bleeding episodes. The applicant for this medicinal product is Laboratoire français du Fractionnement et des Biotechnologies (LFB). Eptacog beta (activated) was approved for medical use in the EU in July 2022.
2106:
1143:
1092:
981:
663:. Recombinant factor VIIa activates factor X, which starts the clotting process and thereby provides control of the bleeding. Because factor VII acts directly on factor X, independently from factors VIII and IX, recombinant factor VIIa can be used to restore haemostasis in their absence or in the presence of inhibitors.
640:
In people with hemophilia type A and B who have a deficiency of factors VIII and IX, these two factors are administered for controlling bleeding or as prophylaxis medication before starting surgeries. However, in some cases they subsequently develop neutralizing antibodies, called inhibitors, against
671:
Coagulation factor VIIa (recombinant)-jncw (Sevenfact) is expressed in the mammary gland of genetically engineered rabbits and secreted into the rabbits' milk. During purification and processing of the milk, FVII is converted into activated FVII (FVIIa). The recombinant DNA (rDNA) construct in the
645:
in the body. Recombinant factor VIIa, which is an activated form of factor VII, bypasses factors VIII and IX and causes coagulation without the need for factors VIII and IX. It may be used in acquired hemophilia patients with higher inhibitor titers. Other indications include use for patients with
679:
Another study evaluated the safety and pharmacokinetics of three escalating doses of coagulation factor VIIa (recombinant)-jncw in 15 subjects with severe hemophilia A or B with or without inhibitors. Results from this study were used to select the two doses, 75mcg/kg and 225 mcg/kg, that were
675:
The safety and efficacy of coagulation factor VIIa (recombinant)-jncw were determined using data from a clinical study that evaluated 27 patients with hemophilia A or B with inhibitors, which included treatment of 465 mild or moderate, and three severe bleeding episodes. The study assessed the
707:
Novoseven was approved for use in the United States in March 1999, and indicated for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX. It was approved in
October 2006, and indicated for the treatment of bleeding episodes and for the
624:
Sevenfact is approved for use in the United States and is indicated for the treatment and control of bleeding episodes occurring in adults and adolescents twelve years of age and older with hemophilia A or B with inhibitors (neutralizing antibodies).
693:
In 2022, the EU approved eptacog beta (Cevenfacta), which is very similar to jncw. Both are made by the same manufacturer (LFB) and through rabiit milk. Eptacog beta is almost identical to, and functions like, coagulation factor VII.
1077:
1529:
Hodgetts TJ, Kirkman E, Mahoney PF, Russell R, Thomas R, Midwinter M (December 2007). "UK defence medical services guidance for the use of recombinant factor VIIa (rFVIIa) in the deployed military setting".
632:
with its use and thus, other than in those with factor VII deficiency or acquired hemophilia, it should only be given in clinical trials. Recombinant human factor VII, while initially looking promising in
1577:
Croom KF, McCormack PL (2008). "Recombinant factor VIIa (eptacog alfa): a review of its use in congenital hemophilia with inhibitors, acquired hemophilia, and other congenital bleeding disorders".
621:
with refractoriness to platelet transfusions, with or without antibodies to platelets and for the treatment of bleeding episodes and peri-operative management in adults with acquired hemophilia.
258:
213:
1200:
Simpson E, Lin Y, Stanworth S, Birchall J, Doree C, Hyde C (March 2012). "Recombinant factor VIIa for the prevention and treatment of bleeding in patients without haemophilia".
741:, credited with saving many lives but also resulting in a high number of deep venous thromboses and pulmonary emboli, as well as unexpected strokes, heart attacks, and deaths.
1289:, Brun NC, Begtrup K, Broderick J, Davis S, Diringer MN, et al. (May 2008). "Efficacy and safety of recombinant activated factor VII for acute intracerebral hemorrhage".
1065:
805:
551:
722:
711:
Novoseven RT was approved for use in the United States in May 2008 as a room-temperature stable formulation. In
January 2010, the label was updated to include a
125:
966:
687:
of coagulation factor VIIa (recombinant)-jncw are headache, dizziness, infusion site discomfort, infusion related reaction, infusion site hematoma and fever.
1680:
1128:
1507:
1462:
1993:
162:
637:, failed to show benefit following further study and is no longer recommended. A possible role in severe postpartum hemorrhage has been suggested.
628:
As of 2012, recombinant factor VIIa is not supported by the evidence for treating most cases of major bleeding. There is a significant risk of
1486:
Text was copied from this source which is copyright
European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
933:
Text was copied from this source which is copyright
European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
690:
Coagulation factor VIIa (recombinant)-jncw is contraindicated in those with known allergy or hypersensitivity to rabbits or rabbit proteins.
1616:"Recombinant activated clotting factor VII (rFVIIa) in the treatment of surgical and spontaneous bleeding episodes in hemophilic patients"
598:
for the treatment of bleeding episodes and for the prevention of bleeding in surgical interventions or invasive procedures in people with
524:(a collection of blood under the skin) as well as injection-related reactions, an increase in body temperature, dizziness and headache.
37:
1175:
581:
65:
830:
797:
766:
1911:
1866:
243:
143:
672:
genetically engineered rabbits used for the production of
Sevenfact was approved by the FDA's Center for Veterinary Medicine.
2003:
1673:
605:
Novoseven RT is indicated for the treatment of bleeding episodes and peri-operative management in adults and children with
520:
and reduced effectiveness of treatment. The most common side effects with
Cevenfacta include injection site discomfort and
618:
2096:
1169:
1122:
1071:
1012:
960:
563:
367:
527:
Novoseven was approved for medical use in the
European Union in February 1996, and in the United States in March 1999.
1018:
1798:
954:
759:"NovoSeven 1 mg (50KIU) powder and solvent for solution for injection - Summary of Product Characteristics (SmPC)"
2126:
1959:
1666:
1467:
918:
870:
726:
718:
In April 2020, coagulation factor VIIa (recombinant)-jncw (Sevenfact) was approved for use in the United States.
1808:
634:
464:
1116:
708:
prevention of bleeding in surgical interventions or invasive procedures in patients with acquired hemophilia.
1497:
2042:
1473:
199:
2131:
1434:
715:
on serious thrombotic adverse events associated with the use of
Novoseven RT outside labeled indications.
416:
1774:
614:
206:
1336:"Rationale for the Potential Use of Recombinant Activated Factor VII in Severe Post-Partum Hemorrhage"
599:
424:
1066:"FDA Approves Additional Treatment for Adults and Adolescents with Hemophilia A or B and Inhibitors"
2061:
629:
311:
1988:
1778:
1602:
1555:
173:
913:
2032:
1782:
1647:
1594:
1547:
1502:
1416:
1367:
1316:
1268:
1245:
Mayer SA, Brun NC, Begtrup K, Broderick J, Davis S, Diringer MN, et al. (February 2005).
1227:
865:
505:
284:
271:
97:
2017:
1964:
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1627:
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1539:
1406:
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1258:
1217:
1209:
320:
376:
2110:
2037:
1794:
1790:
1786:
1702:
1689:
737:
Recombinant factor VIIa was used routinely in severely wounded
American troops during the
1163:
110:
rFVIIa, Coagulation factor VIIa (recombinant), Coagulation factor VIIa (recombinant)-jncw
1362:
1335:
1642:
1615:
1411:
1387:"International recommendations on the diagnosis and treatment of acquired hemophilia A"
1386:
2120:
1937:
1932:
1890:
1732:
1590:
1385:
Tiede A, Collins P, Knoebl P, Teitel J, Kessler C, Shima M, et al. (July 2020).
1147:
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985:
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712:
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606:
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1311:
135:
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1922:
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226:
221:
1402:
2081:
1983:
1974:
1927:
1917:
1852:
1770:
1755:
1707:
684:
660:
646:
inherited deficiency of factor VII, and people with
Glanzmann's thrombasthenia.
642:
420:
2026:
1978:
1900:
1895:
1885:
1847:
1823:
1632:
641:
the drug. These inhibitors often increase over time and inhibit the action of
495:
428:
412:
351:
115:
2056:
1804:
1741:
1724:
1543:
595:
129:
1651:
1598:
1551:
1420:
1371:
1320:
1272:
1231:
1003:
1302:
1004:"NovoSeven Coagulation Factor VIIa (Recombinant) For Intravenous Use Only"
2071:
1998:
1969:
1842:
1837:
1658:
1263:
1246:
738:
521:
331:
157:
1352:
340:
1222:
659:
This treatment results in activation of the extrinsic pathway of blood
2050:
1247:"Recombinant activated factor VII for acute intracerebral hemorrhage"
396:
1457:
1455:
517:
513:
427:, among other indications. There are several disimilar forms, and
36:
may be in need of reorganization to comply with Knowledge (XXG)'s
1334:Ács N, Korte WC, von Heymann CC, Windyga J, Blatný J (May 2024).
1146:
This article incorporates text from this source, which is in the
1095:
This article incorporates text from this source, which is in the
984:
This article incorporates text from this source, which is in the
509:
387:
290:
265:
43:
Information scattered in Medical use and jncw (rabbit) sections.
1662:
278:
152:
534:
20:
498:, produced through rabbit milk. Approved in the EU in 2022.
423:. It is used to treat bleeding episodes in people who have
252:
184:
831:"Sevenfact- coagulation factor viia recombinant human kit"
550:
deal primarily with United States and do not represent a
82:
798:"NovoSeven RT (coagulation factor viia- recombinant kit"
792:
790:
788:
786:
784:
559:
47:
1164:"Sevenfact coagulation factor VIIa (recombinant)-jncw"
2094:
998:
996:
994:
825:
823:
508:(problems caused by blood clots in the veins), rash,
504:
The most common side effects with Novoseven include
2016:
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723:Committee for Medicinal Products for Human Use
50:to make improvements to the overall structure.
1674:
548:The examples and perspective in this section
435:List of recombinant factor VIIa formulations
8:
161:
78:
1202:The Cochrane Database of Systematic Reviews
489:coagulation factor VIIa (recombinant)-jncw
298:In general: ℞ (Prescription only)
1720:
1713:
1681:
1667:
1659:
667:Coagulation factor VIIa (recombinant)-jncw
566:, or create a new section, as appropriate.
1994:Tetragalacturonic acid hydroxymethylester
1641:
1631:
1410:
1361:
1351:
1310:
1262:
1221:
582:Learn how and when to remove this message
375:
66:Learn how and when to remove this message
680:evaluated in the study described above.
433:
2101:
1532:Journal of the Royal Army Medical Corps
750:
481:Approved in the US in 2008. BHK cells.
339:
475:coagulation factor VIIa (recombinant)
457:coagulation factor VIIa (recombinant)
77:
1021:from the original on 14 December 2019
969:from the original on 17 December 2019
163:Coagulation factor VIIa (recombinant)
134:
7:
1439:Union Register of medicinal products
1131:from the original on 20 October 2020
769:from the original on 15 January 2021
225:
1620:Vascular Health and Risk Management
1291:The New England Journal of Medicine
1251:The New England Journal of Medicine
431:for each. All forms are activated.
395:
808:from the original on 25 March 2021
14:
1869:(II, VII, IX, X, protein C and S)
1510:from the original on 2 April 2020
1463:"Cevenfacta: Pending EC decision"
1178:from the original on 1 April 2020
1080:from the original on 2 April 2020
2104:
1591:10.2165/00063030-200822020-00005
1435:"Cevenfacta Product information"
1141:
1090:
979:
539:
492:Sevenfact (US), Cevenfacta (EU)
25:
1912:thrombopoietin receptor agonist
1867:Prothrombin complex concentrate
1076:(Press release). 1 April 2020.
415:that has been manufactured via
2004:Hemostatic Powder Spray TC-325
1214:10.1002/14651858.CD005011.pub4
1:
1496:Little R (19 November 2006).
1472:. 19 May 2022. Archived from
1403:10.3324/haematol.2019.230771
1170:Food and Drug Administration
1123:Food and Drug Administration
1072:Food and Drug Administration
1013:Food and Drug Administration
961:Food and Drug Administration
613:with inhibitors, congenital
506:venous thromboembolic events
419:. It is administered via an
411:(rfVIIa) is a form of blood
102:Novoseven, Sevenfact, others
562:, discuss the issue on the
2148:
1799:Valoctocogene roxaparvovec
619:Glanzmann's thrombasthenia
1960:Absorbable gelatin sponge
1633:10.2147/vhrm.2006.2.4.433
1468:European Medicines Agency
919:European Medicines Agency
871:European Medicines Agency
727:European Medicines Agency
486:Eptacog beta (activated)
472:Eptacog alfa (activated)
465:Baby hamster kidney cells
454:Eptacog alfa (activated)
1809:Fidanacogene elaparvovec
1312:10067/688040151162165141
635:intracerebral hemorrhage
2043:Aminomethylbenzoic acid
1544:10.1136/jramc-153-04-18
409:Recombinant factor VIIa
79:Recombinant factor VIIa
41:. The reason given is:
1614:Ng HJ, Lee LH (2006).
417:recombinant technology
1775:Damoctocog alfa pegol
1303:10.1056/NEJMoa0707534
615:factor VII deficiency
421:injection into a vein
207:Intravenous injection
1264:10.1056/NEJMoa042991
765:. 21 November 2019.
560:improve this section
463:Oldest formulation,
425:acquired haemophilia
1353:10.3390/jcm13102928
875:. 17 September 2018
698:Society and culture
655:Mechanism of action
630:arterial thrombosis
600:acquired hemophilia
436:
274:(Prescription only)
261:(Prescription only)
88:
48:editing the article
1989:Oxidized cellulose
1779:Efanesoctocog alfa
1498:"Dangerous Remedy"
1127:. 1 October 2017.
434:
2092:
2091:
2062:Alfa1 antitrypsin
2033:Aminocaproic acid
2018:Antifibrinolytics
2012:
2011:
1948:
1947:
1783:Efmoroctocog alfa
1733:Phytomenadione (K
1503:The Baltimore Sun
1297:(20): 2127–2137.
914:"Cevenfacta EPAR"
721:In May 2022, the
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405:
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38:layout guidelines
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2127:Antihemorrhagics
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1965:Calcium alginate
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1714:
1703:Antihemorrhagics
1690:Antihemorrhagics
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1414:
1397:(7): 1791–1801.
1382:
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1365:
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1331:
1325:
1324:
1314:
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1174:. 1 April 2020.
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1017:. Novo Nordisk.
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965:. 22 July 2017.
951:
934:
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928:
910:
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866:"NovoSeven EPAR"
862:
847:
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842:
827:
818:
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804:. Novo Nordisk.
794:
779:
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683:The most common
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2095:
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2038:Tranexamic acid
2008:
1944:
1878:
1872:
1795:Turoctocog alfa
1791:Susoctocog alfa
1787:Moroctocog alfa
1757:
1750:
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1687:
1613:
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1571:Further reading
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1208:(3): CD005011.
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837:. 12 April 2020
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1626:(4): 433–440.
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1538:(4): 307–309.
1521:
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1476:on 20 May 2022
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1257:(8): 777–785.
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955:"NovoSeven RT"
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725:(CHMP) of the
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2058:
2055:
2054:
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2052:
2048:
2044:
2041:
2039:
2036:
2034:
2031:
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2024:
2023:
2021:
2019:
2015:
2005:
2002:
2000:
1997:
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1987:
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1982:
1980:
1976:
1973:
1971:
1968:
1966:
1963:
1961:
1958:
1957:
1955:
1951:
1939:
1938:Rafutrombopag
1936:
1934:
1933:Lusutrombopag
1931:
1929:
1926:
1924:
1921:
1919:
1916:
1915:
1914:
1913:
1909:
1907:
1904:
1902:
1899:
1897:
1894:
1892:
1891:Carbazochrome
1889:
1887:
1884:
1883:
1881:
1875:
1868:
1865:
1864:combinations:
1862:
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1596:
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1570:
1561:
1557:
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1549:
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1537:
1533:
1525:
1522:
1509:
1505:
1504:
1499:
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1475:
1471:
1469:
1464:
1458:
1456:
1452:
1440:
1436:
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1422:
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1413:
1408:
1404:
1400:
1396:
1392:
1391:Haematologica
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1359:
1354:
1349:
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1327:
1322:
1318:
1313:
1308:
1304:
1300:
1296:
1292:
1288:
1282:
1279:
1274:
1270:
1265:
1260:
1256:
1252:
1248:
1241:
1238:
1233:
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1224:
1219:
1215:
1211:
1207:
1203:
1196:
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1177:
1173:
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1165:
1159:
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1153:
1149:
1148:public domain
1130:
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1098:
1097:public domain
1079:
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1005:
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987:
986:public domain
968:
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946:
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940:
936:
923:. 17 May 2022
922:
920:
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849:
836:
832:
826:
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820:
807:
803:
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793:
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787:
785:
781:
768:
764:
760:
754:
751:
744:
742:
740:
732:
730:
728:
724:
719:
716:
714:
713:boxed warning
709:
702:
697:
695:
691:
688:
686:
681:
677:
673:
666:
664:
662:
654:
649:
647:
644:
638:
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631:
626:
622:
620:
616:
612:
608:
603:
601:
597:
594:Novoseven is
586:
583:
575:
572:December 2023
565:
561:
555:
553:
546:
537:
536:
530:
528:
525:
523:
519:
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511:
507:
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494:
491:
488:
485:
484:
480:
478:Novoseven RT
477:
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459:
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448:
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349:
342:
338:
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329:
322:
318:
317:
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313:
309:
304:
297:
295: Rx-only
288:
286:
276:
273:
263:
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241:
236:
228:
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182:
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141:
137:
133:
131:
127:
123:
119:
117:
113:
109:
105:
101:
99:
95:
92:Clinical data
90:
70:
67:
59:
56:December 2023
49:
44:
40:
39:
34:This article
32:
23:
22:
19:
2067:C1-inhibitor
2049:
2025:
1923:Avatrombopag
1910:
1906:Fostamatinib
1863:
1857:Catridecacog
1848:I/Fibrinogen
1834:
1828:Eptacog alfa
1827:
1820:
1813:Nonacog alfa
1765:
1742:Menadione (K
1623:
1619:
1582:
1578:
1535:
1531:
1524:
1512:. Retrieved
1501:
1491:
1478:. Retrieved
1474:the original
1466:
1442:. Retrieved
1438:
1429:
1394:
1390:
1380:
1343:
1339:
1329:
1294:
1290:
1281:
1254:
1250:
1240:
1205:
1201:
1180:. Retrieved
1167:
1133:. Retrieved
1120:
1082:. Retrieved
1069:
1023:. Retrieved
1010:
971:. Retrieved
958:
925:. Retrieved
917:
877:. Retrieved
869:
839:. Retrieved
834:
810:. Retrieved
801:
771:. Retrieved
762:
753:
736:
733:Military use
720:
717:
710:
706:
703:Legal status
692:
689:
685:side effects
682:
678:
674:
670:
658:
650:Pharmacology
639:
627:
623:
607:hemophilia A
604:
593:
578:
569:
549:
531:Medical uses
526:
503:
408:
407:
244:Legal status
238:Legal status
144:License data
87:Eptacog alfa
62:
53:
42:
35:
18:
2082:Ulinastatin
2027:amino acids
1984:Fibrin glue
1975:Epinephrine
1928:Eltrombopag
1918:Romiplostim
1843:II/Thrombin
1756:Coagulation
1708:coagulation
1223:10871/13808
1117:"NovoSeven"
879:27 February
661:coagulation
643:coagulation
512:(itching),
446:Brand name
429:biosimilars
321:102786-61-8
306:Identifiers
116:Biosimilars
107:Other names
98:Trade names
2121:Categories
1979:adrenalone
1901:Etamsylate
1896:Concizumab
1886:Batroxobin
1821:extrinsic:
1766:intrinsic:
1340:J Clin Med
745:References
496:Biosimilar
460:Novoseven
413:factor VII
377:AC71R787OV
352:ChemSpider
312:CAS Number
16:Medication
2078:unsorted
2057:Aprotinin
1725:Vitamin K
596:indicated
564:talk page
516:(hives),
514:urticaria
200:Routes of
174:Pregnancy
136:Monograph
130:Drugs.com
120:Aryoseven
2111:Medicine
2072:Camostat
1999:Thrombin
1970:Collagen
1879:systemic
1717:Systemic
1652:17323597
1607:25678733
1599:18345709
1579:BioDrugs
1560:10776054
1552:18619169
1508:Archived
1421:32381574
1372:38792469
1363:11122570
1321:18480205
1287:Mayer SA
1273:15728810
1232:22419303
1176:Archived
1129:Archived
1078:Archived
1019:Archived
967:Archived
835:DailyMed
806:Archived
802:DailyMed
767:Archived
739:Iraq War
558:You may
522:hematoma
510:pruritus
332:DrugBank
214:ATC code
189: B1
176:category
158:DailyMed
2051:serpins
1835:common:
1758:factors
1643:1994012
1514:1 April
1444:3 March
1412:7327664
1182:2 April
1135:1 April
1084:1 April
1025:2 April
973:1 April
927:3 March
841:3 March
812:1 April
773:1 April
467:(BHK).
341:DB00036
230:)
224: (
222:B02BD08
160::
2097:Portal
1650:
1640:
1605:
1597:
1558:
1550:
1480:20 May
1419:
1409:
1370:
1360:
1346:(10).
1319:
1271:
1230:
617:, and
449:Notes
397:D00172
285:℞-only
283:
270:
257:
156:
1953:Local
1877:Other
1603:S2CID
1556:S2CID
1470:(EMA)
1172:(FDA)
1168:U.S.
1125:(FDA)
1121:U.S.
1074:(FDA)
1070:U.S.
1015:(FDA)
1011:U.S.
1007:(PDF)
963:(FDA)
959:U.S.
921:(EMA)
873:(EMA)
763:(emc)
518:fever
443:USAN
1853:XIII
1771:VIII
1648:PMID
1595:PMID
1548:PMID
1516:2020
1482:2022
1446:2023
1417:PMID
1368:PMID
1317:PMID
1269:PMID
1228:PMID
1184:2020
1137:2020
1086:2020
1027:2020
975:2020
929:2023
881:2023
843:2023
814:2020
775:2020
440:INN
388:KEGG
368:UNII
359:none
126:AHFS
1824:VII
1694:B02
1638:PMC
1628:doi
1587:doi
1540:doi
1536:153
1407:PMC
1399:doi
1395:105
1358:PMC
1348:doi
1307:hdl
1299:doi
1295:358
1259:doi
1255:352
1218:hdl
1210:doi
609:or
272:POM
227:WHO
83:INN
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