United States - English - NLM (National Library of Medicine)

csl behring gmbh - factor xiii concentrate (human) (unii: f7r0fbc1xd) (factor xiii concentrate (human) - unii:f7r0fbc1xd) - factor xiii concentrate (human) 1600 [iu] in 20 ml - corifact is a factor xiii concentrate indicated for routine prophylactic treatment and peri-operative management of surgical bleeding in adult and pediatric patients with congenital fxiii deficiency. corifact is contraindicated in patients with known anaphylactic or severe systemic reactions to human plasma-derived products [see description (11)] . risk summary animal reproduction studies have not been conducted with corifact. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations: disease-associated maternal and/or embryo/fetal risk miscarriage is a known complication of congenital fxiii deficiency with a rate of 91% observed in 136 pregnancies without routine fxiii supplementation prophylaxis and 11% in 45 pregnancies with routine fxiii prophylaxis1 . risk summary there is no information available on the presence of corifact in human milk, the effects on the breastfed

United States - English - NLM (National Library of Medicine)

novo nordisk - catridecacog (unii: nu23q531g1) (catridecacog - unii:nu23q531g1) - factor xiii concentrate (human) 2500 [iu] in 3 ml - tretten, coagulation factor xiii a-subunit (recombinant), is indicated for routine prophylaxis for bleeding in patients with congenital factor xiii a-subunit deficiency. tretten is not for use in patients with congenital factor xiii b‑subunit deficiency tretten is contraindicated in patients who have known hypersensitivity to the active substance or to any of the excipients [see description (11)]. risk summary there are no adequate and well-controlled studies using tretten in pregnant women to determine whether there is a drug-associated risk. animal reproduction studies have not been conducted with tretten. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. miscarriage is a known complication of congenital fxiii deficiency. pooling data from 39 publications, the miscarriage rate was 66% in 63 patients with 192 pregnancies (70% in 179 pregnancies in fxiii a-subunit deficiency women). miscar

Israel - English - Ministry of Health

medici medical ltd, israel - factor viii (human) - powder for solution for injection - factor viii (human) 1500 iu/dose - factor viii inhibitor bypassing activity - factor viii inhibitor bypassing activity - is indicated for the prevention and control of bleeding in patients with moderate or severe factor viii deficiency due to classical hemophilia a . fanhdi is not effective in controlling the bleeding of patients with von willebrond's disease.

Israel - English - Ministry of Health

medici medical ltd, israel - factor viii (human) - powder for solution for injection - factor viii (human) 250 iu - coagulation factor viii - coagulation factor viii - is indicated for the prevention and control of bleeding in patients with moderate or severe factor viii deficiency due to classical hemophilia a .fanhdi is not effective in controlling the bleeding of patients with von willebrond's disease.

Israel - English - Ministry of Health

medici medical ltd, israel - factor viii (human) - powder for solution for injection - factor viii (human) 500 iu - coagulation factor viii - coagulation factor viii - is indicated for the prevention and control of bleeding in patients with moderate or severe factor viii deficiency due to classical hemophilia a . fanhdi is not effective in controlling the bleeding of patients with von willebrond's disease.

Israel - English - Ministry of Health

medici medical ltd, israel - factor viii (human) - powder for solution for injection - factor viii (human) 1000 iu - coagulation factor viii - coagulation factor viii - is indicated for the prevention and control of bleeding in patients with moderate or severe factor viii deficiency due to classical hemophilia a . fanhdi is not effective in controlling the bleeding of patients with von willebrond's disease.

United States - English - NLM (National Library of Medicine)

grifols usa, llc - albumin human (unii: zif514rvzr) (albumin human - unii:zif514rvzr) - albumin human 12.5 g in 50 ml - for restoration and maintenance of circulating blood volume where hypovolemia is demonstrated and colloid use is appropriate. when hypovolemia is long standing and hypoalbuminemia exists accompanied by adequate hydration or edema, 20-25% albumin solutions should be used.1,2,3 acute liver failure is a special situation in which both hypovolemia and hypoalbuminemia can be present. human albumin grifols® 25% can be used in such cases.1 human albumin grifols 25% may be of value in the treatment of shock or hypotension in renal dialysis patients.1 preoperative dilution of blood using albumin and crystalloid can be used in cardiopulmonary bypass procedures. albumin also may be used in the priming fluid.4,5,6 human albumin grifols 25% may be used to treat peripheral edema in patients with acute nephrosis who are refractory to cyclophosphamide, corticosteroid therapy or diuretics.1,2,7 human albumin grifols 25% may be indicated for subjects with hypoalbuminemia who are critically ill and/or actively bleeding. when

United States - English - NLM (National Library of Medicine)

ethicon, inc - human thrombin (unii: 6k15abl77g) (human thrombin - unii:6k15abl77g) - human thrombin 2000 [iu] in 2 ml - evithrom® thrombin, topical (human), is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. evithrom® thrombin, topical (human), may be used in conjunction with an absorbable gelatin sponge, usp. - do not use in individuals known to have an anaphylactic or severe systemic reaction to evithrom® or to human blood products. - do not use for the treatment of severe or brisk arterial bleeding. risk summary there are no data with evithrom® use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with evithrom® . it is not known whether evithrom® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. evithrom® should be given to a pregnant woman only if clearly needed. in the u.s. general population, the estimated background

Israel - English - Ministry of Health

csl behring ltd., israel - factor xiii - powder and solvent for solution for injection/solution for infusion - factor xiii 200 - 320 iu - coagulation factor xiii - coagulation factor xiii - fibrogammin is indicated for adult and paediatric patients • for prophylactic treatment of congenital fxiii deficiency and • for peri-operative management of surgical bleeding with congentital fxiii deficiency. fibrogammin is furthermore indicated • for haemorrhagic diatheses caused completely or in part by acquired fxiii deficiency • for supportive therapy in case of disturbance in wound healing, especially in ulcus cruris, after large surgery or injuries.

Israel - English - Ministry of Health

csl behring ltd., israel - factor xiii - powder and solvent for solution for injection/solution for infusion - factor xiii 1250 iu - coagulation factor xiii - coagulation factor xiii - fibrogammin is indicated for adult and paediatric patients • for prophylactic treatment of congenital fxiii deficiency and • for peri-operative management of surgical bleeding with congentital fxiii deficiency. fibrogammin is furthermore indicated • for haemorrhagic diatheses caused completely or in part by acquired fxiii deficiency • for supportive therapy in case of disturbance in wound healing, especially in ulcus cruris, after large surgery or injuries.