687:
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.
552:
38:
740:(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.
2117:
1154:
1103:
992:
674:. 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.
651:
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
682:
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
656:
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
690:
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
686:
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
718:
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
635:
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).
704:
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.
1088:
1540:
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".
643:
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
1588:
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".
632:
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.
269:
224:
1211:
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".
752:, 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.
1300:, 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".
1076:
816:
562:
733:
722:
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
136:
977:
698:
of coagulation factor VIIa (recombinant)-jncw are headache, dizziness, infusion site discomfort, infusion related reaction, infusion site hematoma and fever.
1691:
1139:
1518:
1473:
2004:
173:
648:, failed to show benefit following further study and is no longer recommended. A possible role in severe postpartum hemorrhage has been suggested.
639:
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
1497:
Text was copied from this source which is copyright
European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
944:
Text was copied from this source which is copyright
European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
701:
Coagulation factor VIIa (recombinant)-jncw is contraindicated in those with known allergy or hypersensitivity to rabbits or rabbit proteins.
1627:"Recombinant activated clotting factor VII (rFVIIa) in the treatment of surgical and spontaneous bleeding episodes in hemophilic patients"
609:
for the treatment of bleeding episodes and for the prevention of bleeding in surgical interventions or invasive procedures in people with
535:(a collection of blood under the skin) as well as injection-related reactions, an increase in body temperature, dizziness and headache.
48:
1186:
592:
76:
841:
808:
777:
1922:
1877:
254:
154:
683:
genetically engineered rabbits used for the production of
Sevenfact was approved by the FDA's Center for Veterinary Medicine.
2014:
1684:
616:
Novoseven RT is indicated for the treatment of bleeding episodes and peri-operative management in adults and children with
531:
and reduced effectiveness of treatment. The most common side effects with
Cevenfacta include injection site discomfort and
629:
2107:
1180:
1133:
1082:
1023:
971:
574:
378:
538:
Novoseven was approved for medical use in the
European Union in February 1996, and in the United States in March 1999.
1029:
1809:
965:
770:"NovoSeven 1 mg (50KIU) powder and solvent for solution for injection - Summary of Product Characteristics (SmPC)"
2137:
1970:
1677:
1478:
929:
881:
737:
729:
In April 2020, coagulation factor VIIa (recombinant)-jncw (Sevenfact) was approved for use in the United States.
1819:
645:
475:
1127:
719:
prevention of bleeding in surgical interventions or invasive procedures in patients with acquired hemophilia.
1508:
2053:
1484:
210:
2142:
1445:
726:
on serious thrombotic adverse events associated with the use of
Novoseven RT outside labeled indications.
427:
1785:
625:
217:
1347:"Rationale for the Potential Use of Recombinant Activated Factor VII in Severe Post-Partum Hemorrhage"
610:
435:
1077:"FDA Approves Additional Treatment for Adults and Adolescents with Hemophilia A or B and Inhibitors"
2072:
640:
322:
1999:
1789:
1613:
1566:
184:
924:
2043:
1793:
1658:
1605:
1558:
1513:
1427:
1378:
1327:
1279:
1256:
Mayer SA, Brun NC, Begtrup K, Broderick J, Davis S, Diringer MN, et al. (February 2005).
1238:
876:
516:
295:
282:
108:
2028:
1975:
1648:
1638:
1597:
1550:
1417:
1409:
1368:
1358:
1317:
1309:
1297:
1269:
1228:
1220:
331:
387:
2121:
2048:
1805:
1801:
1797:
1713:
1700:
748:
Recombinant factor VIIa was used routinely in severely wounded
American troops during the
1174:
121:
rFVIIa, Coagulation factor VIIa (recombinant), Coagulation factor VIIa (recombinant)-jncw
1373:
1346:
1653:
1626:
1422:
1398:"International recommendations on the diagnosis and treatment of acquired hemophilia A"
1397:
2131:
1948:
1943:
1901:
1743:
1601:
1396:
Tiede A, Collins P, Knoebl P, Teitel J, Kessler C, Shima M, et al. (July 2020).
1158:
1107:
996:
769:
723:
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617:
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1570:
1322:
146:
2077:
1933:
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1823:
1704:
1224:
237:
232:
1413:
2092:
1994:
1985:
1938:
1928:
1863:
1781:
1766:
1718:
695:
671:
657:
inherited deficiency of factor VII, and people with
Glanzmann's thrombasthenia.
653:
431:
2037:
1989:
1911:
1906:
1896:
1858:
1834:
1643:
652:
the drug. These inhibitors often increase over time and inhibit the action of
506:
439:
423:
362:
126:
2067:
1815:
1752:
1735:
1554:
606:
140:
1662:
1609:
1562:
1431:
1382:
1331:
1283:
1242:
1014:
1313:
1015:"NovoSeven Coagulation Factor VIIa (Recombinant) For Intravenous Use Only"
2082:
2009:
1980:
1853:
1848:
1669:
1274:
1257:
749:
532:
342:
168:
17:
1363:
351:
1233:
670:
This treatment results in activation of the extrinsic pathway of blood
2061:
1258:"Recombinant activated factor VII for acute intracerebral hemorrhage"
407:
1468:
1466:
528:
524:
438:, among other indications. There are several disimilar forms, and
47:
may be in need of reorganization to comply with Knowledge (XXG)'s
1345:Ács N, Korte WC, von Heymann CC, Windyga J, Blatný J (May 2024).
1157:
This article incorporates text from this source, which is in the
1106:
This article incorporates text from this source, which is in the
995:
This article incorporates text from this source, which is in the
520:
398:
301:
276:
54:
Information scattered in Medical use and jncw (rabbit) sections.
1673:
289:
163:
545:
31:
509:, produced through rabbit milk. Approved in the EU in 2022.
434:. It is used to treat bleeding episodes in people who have
263:
195:
842:"Sevenfact- coagulation factor viia recombinant human kit"
561:
deal primarily with United States and do not represent a
93:
809:"NovoSeven RT (coagulation factor viia- recombinant kit"
803:
801:
799:
797:
795:
570:
58:
1175:"Sevenfact coagulation factor VIIa (recombinant)-jncw"
2105:
1009:
1007:
1005:
836:
834:
519:(problems caused by blood clots in the veins), rash,
515:
The most common side effects with Novoseven include
2027:
1963:
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330:
734:Committee for Medicinal Products for Human Use
61:to make improvements to the overall structure.
1685:
559:The examples and perspective in this section
446:List of recombinant factor VIIa formulations
8:
172:
89:
1213:The Cochrane Database of Systematic Reviews
500:coagulation factor VIIa (recombinant)-jncw
309:In general: ℞ (Prescription only)
1731:
1724:
1692:
1678:
1670:
678:Coagulation factor VIIa (recombinant)-jncw
577:, or create a new section, as appropriate.
2005:Tetragalacturonic acid hydroxymethylester
1652:
1642:
1421:
1372:
1362:
1321:
1273:
1232:
593:Learn how and when to remove this message
386:
77:Learn how and when to remove this message
691:evaluated in the study described above.
444:
2112:
1543:Journal of the Royal Army Medical Corps
761:
492:Approved in the US in 2008. BHK cells.
350:
486:coagulation factor VIIa (recombinant)
468:coagulation factor VIIa (recombinant)
88:
1032:from the original on 14 December 2019
980:from the original on 17 December 2019
174:Coagulation factor VIIa (recombinant)
145:
7:
1450:Union Register of medicinal products
1142:from the original on 20 October 2020
780:from the original on 15 January 2021
236:
1631:Vascular Health and Risk Management
1302:The New England Journal of Medicine
1262:The New England Journal of Medicine
442:for each. All forms are activated.
406:
819:from the original on 25 March 2021
25:
1880:(II, VII, IX, X, protein C and S)
1521:from the original on 2 April 2020
1474:"Cevenfacta: Pending EC decision"
1189:from the original on 1 April 2020
1091:from the original on 2 April 2020
2115:
1602:10.2165/00063030-200822020-00005
1446:"Cevenfacta Product information"
1152:
1101:
990:
550:
503:Sevenfact (US), Cevenfacta (EU)
36:
1923:thrombopoietin receptor agonist
1878:Prothrombin complex concentrate
1087:(Press release). 1 April 2020.
426:that has been manufactured via
2015:Hemostatic Powder Spray TC-325
1225:10.1002/14651858.CD005011.pub4
1:
1507:Little R (19 November 2006).
1483:. 19 May 2022. Archived from
1414:10.3324/haematol.2019.230771
1181:Food and Drug Administration
1134:Food and Drug Administration
1083:Food and Drug Administration
1024:Food and Drug Administration
972:Food and Drug Administration
624:with inhibitors, congenital
517:venous thromboembolic events
430:. It is administered via an
422:(rfVIIa) is a form of blood
113:Novoseven, Sevenfact, others
573:, discuss the issue on the
2159:
1810:Valoctocogene roxaparvovec
630:Glanzmann's thrombasthenia
1971:Absorbable gelatin sponge
1644:10.2147/vhrm.2006.2.4.433
1479:European Medicines Agency
930:European Medicines Agency
882:European Medicines Agency
738:European Medicines Agency
497:Eptacog beta (activated)
483:Eptacog alfa (activated)
476:Baby hamster kidney cells
465:Eptacog alfa (activated)
1820:Fidanacogene elaparvovec
1323:10067/688040151162165141
646:intracerebral hemorrhage
2054:Aminomethylbenzoic acid
1555:10.1136/jramc-153-04-18
420:Recombinant factor VIIa
90:Recombinant factor VIIa
52:. The reason given is:
1625:Ng HJ, Lee LH (2006).
428:recombinant technology
1786:Damoctocog alfa pegol
1314:10.1056/NEJMoa0707534
626:factor VII deficiency
432:injection into a vein
218:Intravenous injection
1275:10.1056/NEJMoa042991
776:. 21 November 2019.
571:improve this section
474:Oldest formulation,
436:acquired haemophilia
1364:10.3390/jcm13102928
886:. 17 September 2018
709:Society and culture
666:Mechanism of action
641:arterial thrombosis
611:acquired hemophilia
447:
285:(Prescription only)
272:(Prescription only)
99:
59:editing the article
2000:Oxidized cellulose
1790:Efanesoctocog alfa
1509:"Dangerous Remedy"
1138:. 1 October 2017.
445:
2103:
2102:
2073:Alfa1 antitrypsin
2044:Aminocaproic acid
2029:Antifibrinolytics
2023:
2022:
1959:
1958:
1794:Efmoroctocog alfa
1744:Phytomenadione (K
1514:The Baltimore Sun
1308:(20): 2127–2137.
925:"Cevenfacta EPAR"
732:In May 2022, the
603:
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512:
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416:
305:
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49:layout guidelines
16:(Redirected from
2150:
2138:Antihemorrhagics
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2111:
1976:Calcium alginate
1732:
1725:
1714:Antihemorrhagics
1701:Antihemorrhagics
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1456:
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1436:
1435:
1425:
1408:(7): 1791–1801.
1393:
1387:
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1376:
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1342:
1336:
1335:
1325:
1294:
1288:
1287:
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1185:. 1 April 2020.
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1028:. Novo Nordisk.
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976:. 22 July 2017.
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943:
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921:
896:
895:
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891:
877:"NovoSeven EPAR"
873:
858:
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838:
829:
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826:
824:
815:. Novo Nordisk.
805:
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694:The most common
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2099:
2049:Tranexamic acid
2019:
1955:
1889:
1883:
1806:Turoctocog alfa
1802:Susoctocog alfa
1798:Moroctocog alfa
1768:
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1708:
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1582:Further reading
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1219:(3): CD005011.
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848:. 12 April 2020
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1637:(4): 433–440.
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1549:(4): 307–309.
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1499:
1487:on 20 May 2022
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1268:(8): 777–785.
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966:"NovoSeven RT"
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736:(CHMP) of the
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563:worldwide view
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2143:Glycoproteins
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2094:
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2088:
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2079:
2076:
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2016:
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1991:
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1984:
1982:
1979:
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1969:
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1950:
1949:Rafutrombopag
1947:
1945:
1944:Lusutrombopag
1942:
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1937:
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1932:
1930:
1927:
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1918:
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1913:
1910:
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1902:Carbazochrome
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1875:combinations:
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1486:
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1469:
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1463:
1451:
1447:
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1402:Haematologica
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1303:
1299:
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1263:
1259:
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997:public domain
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934:. 17 May 2022
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771:
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727:
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724:boxed warning
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583:December 2023
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489:Novoseven RT
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306: Rx-only
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103:Clinical data
101:
81:
78:
70:
67:December 2023
60:
55:
51:
50:
45:This article
43:
34:
33:
30:
19:
2078:C1-inhibitor
2060:
2036:
1934:Avatrombopag
1921:
1917:Fostamatinib
1874:
1868:Catridecacog
1859:I/Fibrinogen
1845:
1839:Eptacog alfa
1838:
1831:
1824:Nonacog alfa
1776:
1753:Menadione (K
1634:
1630:
1593:
1589:
1546:
1542:
1535:
1523:. Retrieved
1512:
1502:
1489:. Retrieved
1485:the original
1477:
1453:. Retrieved
1449:
1440:
1405:
1401:
1391:
1354:
1350:
1340:
1305:
1301:
1292:
1265:
1261:
1251:
1216:
1212:
1191:. Retrieved
1178:
1144:. Retrieved
1131:
1093:. Retrieved
1080:
1034:. Retrieved
1021:
982:. Retrieved
969:
936:. Retrieved
928:
888:. Retrieved
880:
850:. Retrieved
845:
821:. Retrieved
812:
782:. Retrieved
773:
764:
747:
744:Military use
731:
728:
721:
717:
714:Legal status
703:
700:
696:side effects
693:
689:
685:
681:
669:
661:Pharmacology
650:
638:
634:
618:hemophilia A
615:
604:
589:
580:
560:
542:Medical uses
537:
514:
419:
418:
255:Legal status
249:Legal status
155:License data
98:Eptacog alfa
73:
64:
53:
46:
29:
2093:Ulinastatin
2038:amino acids
1995:Fibrin glue
1986:Epinephrine
1939:Eltrombopag
1929:Romiplostim
1854:II/Thrombin
1767:Coagulation
1719:coagulation
1234:10871/13808
1128:"NovoSeven"
890:27 February
672:coagulation
654:coagulation
523:(itching),
457:Brand name
440:biosimilars
332:102786-61-8
317:Identifiers
127:Biosimilars
118:Other names
109:Trade names
2132:Categories
1990:adrenalone
1912:Etamsylate
1907:Concizumab
1897:Batroxobin
1832:extrinsic:
1777:intrinsic:
1351:J Clin Med
756:References
507:Biosimilar
471:Novoseven
424:factor VII
388:AC71R787OV
363:ChemSpider
323:CAS Number
27:Medication
2089:unsorted
2068:Aprotinin
1736:Vitamin K
607:indicated
575:talk page
527:(hives),
525:urticaria
211:Routes of
185:Pregnancy
147:Monograph
141:Drugs.com
131:Aryoseven
18:Sevenfact
2122:Medicine
2083:Camostat
2010:Thrombin
1981:Collagen
1890:systemic
1728:Systemic
1663:17323597
1618:25678733
1610:18345709
1590:BioDrugs
1571:10776054
1563:18619169
1519:Archived
1432:32381574
1383:38792469
1374:11122570
1332:18480205
1298:Mayer SA
1284:15728810
1243:22419303
1187:Archived
1140:Archived
1089:Archived
1030:Archived
978:Archived
846:DailyMed
817:Archived
813:DailyMed
778:Archived
750:Iraq War
569:You may
533:hematoma
521:pruritus
343:DrugBank
225:ATC code
200: B1
187:category
169:DailyMed
2062:serpins
1846:common:
1769:factors
1654:1994012
1525:1 April
1455:3 March
1423:7327664
1193:2 April
1146:1 April
1095:1 April
1036:2 April
984:1 April
938:3 March
852:3 March
823:1 April
784:1 April
478:(BHK).
352:DB00036
241:)
235: (
233:B02BD08
171::
2108:Portal
1661:
1651:
1616:
1608:
1569:
1561:
1491:20 May
1430:
1420:
1381:
1371:
1357:(10).
1330:
1282:
1241:
628:, and
460:Notes
408:D00172
296:℞-only
294:
281:
268:
167:
1964:Local
1888:Other
1614:S2CID
1567:S2CID
1481:(EMA)
1183:(FDA)
1179:U.S.
1136:(FDA)
1132:U.S.
1085:(FDA)
1081:U.S.
1026:(FDA)
1022:U.S.
1018:(PDF)
974:(FDA)
970:U.S.
932:(EMA)
884:(EMA)
774:(emc)
529:fever
454:USAN
1864:XIII
1782:VIII
1659:PMID
1606:PMID
1559:PMID
1527:2020
1493:2022
1457:2023
1428:PMID
1379:PMID
1328:PMID
1280:PMID
1239:PMID
1195:2020
1148:2020
1097:2020
1038:2020
986:2020
940:2023
892:2023
854:2023
825:2020
786:2020
451:INN
399:KEGG
379:UNII
370:none
137:AHFS
1835:VII
1705:B02
1649:PMC
1639:doi
1598:doi
1551:doi
1547:153
1418:PMC
1410:doi
1406:105
1369:PMC
1359:doi
1318:hdl
1310:doi
1306:358
1270:doi
1266:352
1229:hdl
1221:doi
620:or
283:POM
238:WHO
94:INN
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