Kenya - English - Pharmacy and Poisons Board

human bioplazma llc h-2100 godollo transics milhaly ut 80hungary - human albumin - solution for infusion - 20%human albumin - blood substitutes and plasma protein fractions

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

adma biologics, inc - human hepatitis b virus immune globulin (unii: xii270yc6m) (human hepatitis b virus immune globulin - unii:xii270yc6m) - human hepatitis b virus immune globulin 1560 [iu] in 5 ml - indications and usage nabi-hb, hepatitis b immune globulin (human), is indicated for treatment of acute exposure to blood containing hbsag, perinatal exposure of infants born to hbsag-positive mothers, sexual exposure to hbsag-positive persons and household exposure to persons with acute hbv infection in the following settings: acute exposure to blood containing hbsag following either parenteral exposure (needlestick, bite, sharps), direct mucous membrane contact (accidental splash), or oral ingestion (pipetting accident), involving hbsag-positive materials such as blood, plasma, or serum. perinatal exposure of infants born to hbsag-positive mothers infants born to mothers positive for hbsag with or without hbeag12. sexual exposure to hbsag-positive persons sexual partners of hbsag-positive persons. household exposure to persons with acute hbv infection infants less than 12 months old whose mother or primary caregiver is positive for hbsag. other household contacts with an identifiable blood exposure to the i

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

adma biologics, inc - human hepatitis b virus immune globulin (unii: xii270yc6m) (human hepatitis b virus immune globulin - unii:xii270yc6m) - human hepatitis b virus immune globulin 312 [iu] in 1 ml - indications and usage nabi-hb, hepatitis b immune globulin (human), is indicated for treatment of acute exposure to blood containing hbsag, perinatal exposure of infants born to hbsag-positive mothers, sexual exposure to hbsag-positive persons and household exposure to persons with acute hbv infection in the following settings: acute exposure to blood containing hbsag following either parenteral exposure (needlestick, bite, sharps), direct mucous membrane contact (accidental splash), or oral ingestion (pipetting accident), involving hbsag-positive materials such as blood, plasma, or serum. perinatal exposure of infants born to hbsag-positive mothers infants born to mothers positive for hbsag with or without hbeag12. sexual exposure to hbsag-positive persons sexual partners of hbsag-positive persons. household exposure to persons with acute hbv infection infants less than 12 months old whose mother or primary caregiver is positive for hbsag. other household contacts with an identifiable blood exposure to the i

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

grifols usa, llc - antithrombin iii human (unii: t0lto7l82x) (antithrombin iii human - unii:t0lto7l82x) - antithrombin iii human 50 [iu] in 1 ml - thrombate iii is a human antithrombin (at) indicated in patients with hereditary antithrombin deficiency for: - treatment and prevention of thromboembolism - prevention of peri-operative and peri-partum thromboembolism none. risk summary there are no data with thrombate iii use in pregnant women to inform a drug-associated risk. however, there are clinical considerations [see clinical considerations] . it is not known whether thrombate iii can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. thrombate iii should be given to a pregnant woman only if clearly needed. 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. reproduction studies have been performed in rats and rabbits at doses up to four times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to thrombate iii. clinical considerations labor or delivery suspend heparin (or low molecular weight heparin) administration and continue thrombate iii administration during labor and delivery. risk summary there is no information regarding the presence of thrombate iii in human milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for thrombate iii and any potential adverse effects on the breastfed infant from thrombate iii or from the underlying maternal condition. safety and effectiveness in the pediatric population have not been established. the safety and effectiveness in the geriatric population have not been established.

Malta - English - Medicines Authority

biotest pharma gmbh landsteinerstrasse 5, 63303 dreieich, germany - human plasma, protein - solution for infusion - human plasma protein 200 g/l - blood substitutes and perfusion solutions

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)

mallinckrodt hospital products inc. - thrombin alfa (unii: sck81amr7r) (thrombin alfa - unii:sck81amr7r) - thrombin alfa 1000 [iu] in 1 ml - recothrom® thrombin topical (recombinant), is a topical thrombin indicated to aid 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 in adults and pediatric populations greater than or equal to one month of age. recothrom may be used in conjunction with an absorbable gelatin sponge, usp. - do not inject directly into the circulatory system. - do not use for the treatment of massive or brisk arterial bleeding. - do not administer to patients with a history of hypersensitivity to recothrom or any components of recothrom. - do not use in patients with known hypersensitivity to hamster proteins. pregnancy category c animal reproduction studies have not been conducted with recothrom. it is also not known whether recothrom can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. recothrom should be given

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

the medicines company - thrombin alfa (unii: sck81amr7r) (thrombin alfa - unii:sck81amr7r) - thrombin alfa 1000 [iu] in 1 ml - recothrom ®, thrombin topical (recombinant), is a topical thrombin indicated to aid 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 in adults and pediatric populations greater than or equal to one month of age. recothrom may be used in conjunction with an absorbable gelatin sponge, usp. - do not inject directly into the circulatory system. - do not use for the treatment of massive or brisk arterial bleeding. - do not administer to patients with a history of hypersensitivity to recothrom or any components of recothrom. - do not use in patients with known hypersensitivity to hamster proteins. pregnancy category c animal reproduction studies have not been conducted with recothrom. it is also not known whether recothrom can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. recothrom should be give

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

csl behring gmbh - prothrombin (unii: 8fb1k07f16) (prothrombin - unii:8fb1k07f16), coagulation factor vii human (unii: 4156xvb4qd) (coagulation factor vii human - unii:4156xvb4qd), coagulation factor ix human (unii: 6u90y1795t) (coagulation factor ix human - unii:6u90y1795t), coagulation factor x human (unii: 0p94uqe6sy) (coagulation factor x human - unii:0p94uqe6sy), protein c (unii: 3z6s89txpw) (protein c - unii:3z6s89txpw), protein s human (unii: 90j3f6n5fn) (protein s human - unii:90j3f6n5fn) - prothrombin 590 u in 20 ml - kcentra, (prothrombin complex concentrate (human)), is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by vitamin k antagonist (vka, e.g., warfarin) therapy in adult patients with: - acute major bleeding or - need for an urgent surgery/invasive procedure. kcentra is contraindicated in: - patients with known anaphylactic or severe systemic reactions to kcentra or any components in kcentra including heparin, factors ii, vii, ix, x, proteins c and s, antithrombin iii and human albumin. - patients with disseminated intravascular coagulation (dic). - patients with known heparin-induced thrombocytopenia (hit). kcentra contains heparin [see description (11)] . risk summary there are no data with kcentra use in pregnancy to inform on drug-associated risk. animal reproduction studies have not been conducted with kcentra. it is not known whether kcentra can cause fetal harm when administered to a pregnant woman or can affect reproduction

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

lundbeck inc. - antithrombin alfa (unii: awv6i5l6h2) (antithrombin alfa - unii:awv6i5l6h2) - antithrombin alfa 1750 [iu] in 10 ml - atryn® is a recombinant antithrombin indicated for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients1 . it is not indicated for treatment of thromboembolic events in hereditary antithrombin deficient patients. atryn is contraindicated in patients with known hypersensitivity to goat and goat milk proteins. pregnancy category c: in rats, a dose of 210 mg/kg/day atryn (5-6 times the human dose for pregnant women) administered during most of the pregnancy and entire lactation showed a slight but statistically significant increase in pup mortality in day one through day four when compared to concurrent control (90% compared to 94% viability index for 210 mg/kg/day versus control). this slight statistical difference does not reflect a true treatment-related effect. this same dose was shown to be safe in a second rat study when administered around parturition and during lactation where the no adverse effect level for dam and pups was 210 mg/kg/day