아일랜드 - 영어 - HPRA (Health Products Regulatory Authority)

instituto grifols s.a. - human plasma protein - solution for infusion - 50 gram(s)/litre - blood substitutes and plasma protein fractions; albumin

아일랜드 - 영어 - HPRA (Health Products Regulatory Authority)

instituto grifols s.a. - human albumin - solution for infusion - 200 gram(s)/litre - blood substitutes and plasma protein fractions; albumin

싱가포르 - 영어 - HSA (Health Sciences Authority)

takeda pharmaceuticals (asia pacific) pte. ltd. - human albumin - solution, sterile - 200 mg/ml - human albumin 200 mg/ml

싱가포르 - 영어 - HSA (Health Sciences Authority)

csl behring pte. ltd. - human albumin - infusion, solution - 200g/l - human albumin 200g/l

유럽 연합 - 영어 - EMA (European Medicines Agency)

biotest pharma gmbh - human hepatitis b immunoglobulin - immunization, passive; hepatitis b; liver transplantation - immune sera and immunoglobulins, - prevention of hepatitis b virus (hbv) re-infection in hbsag and hbv-dna negative adult patients at least one week after liver transplantation for hepatitis b induced liver failure. hbv-dna negative status should be confirmed within the last 3 months prior to olt. patients should be hbsag negative before treatment start. the concomitant use of adequate virostatic agents should be considered as standard of hepatitis b re-infection prophylaxis.,

미국 - 영어 - NLM (National Library of Medicine)

grifols usa, llc - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - human immunoglobulin g 0.165 g in 1 ml - gamastan is a human immune globulin indicated for: gamastan is indicated for prophylaxis following exposure to hepatitis a.(1,2) the prophylactic value of gamastan is greatest when given before or soon after exposure to hepatitis a. gamastan is not indicated in persons with clinical manifestations of hepatitis a or in those exposed more than 2 weeks previously. gamastan is indicated to prevent or modify measles in a susceptible person exposed fewer than 6 days previously.(3) a susceptible person is one who has not been vaccinated and has not had measles previously. - gamastan may be especially indicated for susceptible household contacts of measles patients, particularly contacts under 1 year of age, for whom the risk of complications is highest.(3) - gamastan is also indicated for pregnant women without evidence of immunity. - do not give gamastan and measles vaccine at the same time. if a child is older than 12 months and has received gamastan, give measles vaccine about five months later when the measles a

미국 - 영어 - NLM (National Library of Medicine)

sanofi pasteur inc. - poliovirus type 1 antigen (formaldehyde inactivated) (unii: 0lvy784c09) (poliovirus type 1 antigen (formaldehyde inactivated) - unii:0lvy784c09), poliovirus type 2 antigen (formaldehyde inactivated) (unii: 23je9kdf4r) (poliovirus type 2 antigen (formaldehyde inactivated) - unii:23je9kdf4r), poliovirus type 3 antigen (formaldehyde inactivated) (unii: 459rom8m9m) (poliovirus type 3 antigen (formaldehyde inactivated) - unii:459rom8m9m) - poliovirus type 1 antigen (formaldehyde inactivated) 40 [d'ag'u] in 0.5 ml - ipol vaccine is indicated for active immunization of infants (as young as 6 weeks of age), children, and adults for the prevention of poliomyelitis caused by poliovirus types 1, 2, and 3. (28) it is recommended that all infants (as young as 6 weeks of age), unimmunized children, and adolescents not previously immunized be vaccinated routinely against paralytic poliomyelitis. (29) following the eradication of poliomyelitis caused by wild poliovirus from the western hemisphere (including north and south america) (30), an ipv-only schedule was recommended to eliminate vapp. (7) all children should receive four doses of ipv at ages 2, 4, 6 to 18 months, and 4 to 6 years. opv is no longer available in the us and is not recommended for routine immunization. (7) previous clinical poliomyelitis (usually due to only a single poliovirus type) or incomplete immunization with opv are not contraindications to completing the primary series of immunization with ipol vaccine. children of all ages should have their immuni

미국 - 영어 - NLM (National Library of Medicine)

octapharma pharmazeutika produktionsgesellschaft m.b.h. - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - human immunoglobulin g 50 mg in 1 ml - octagam is an immune globulin intravenous (human) 5% liquid indicated for treatment of primary humoral immunodeficiency (pi), such as congenital agammaglobulinemia, common variable immunodeficiency, x-linked agammaglobulinemia, wiskott-aldrich syndrome and severe combined immunodeficiencies. octagam 5% liquid is contraindicated in patients who have acute severe hypersensitivity reactions to human immunoglobulin. octagam 5% liquid contains trace amounts of iga (not more than 0.2 mg/ml in a 5% solution). it is contraindicated in iga deficient patients with antibodies against iga and history of hypersensitivity (see description [11]). octagam 5% liquid is contraindicated in patients with acute hypersensitivity reaction to corn. octagam 5% liquid contains maltose, a disaccharide sugar which is derived from corn. patients known to have corn allergies should avoid using octagam 5% liquid. pregnancy category c. animal reproduction studies have not been conducted with octagam 5% liquid. it is also not known whether o

미국 - 영어 - NLM (National Library of Medicine)

csl behring gmbh - human c1-esterase inhibitor (unii: 6kic4bb60g) (human c1-esterase inhibitor - unii:6kic4bb60g) - human c1-esterase inhibitor 2000 [iu] in 4 ml - haegarda is a plasma-derived concentrate of c1 esterase inhibitor (human) (c1-inh) indicated for routine prophylaxis to prevent hereditary angioedema (hae) attacks in patients 6 years of age and older. haegarda is contraindicated in individuals who have experienced life-threatening hypersensitivity reactions, including anaphylaxis, to c1-inh preparations or its excipients [see description (11)]. risk summary there are no prospective clinical data from haegarda use in pregnant women. c1-inh is a normal component of human plasma. animal developmental or reproduction toxicity studies have not been conducted with haegarda. in the u.s. general population, the estimated background risk of major birth defects occurs in 2-4% of the general population and miscarriage occurs in 15-20% of clinically recognized pregnancies. data in a retrospective case collection study, 22 pregnant women with type i hae and ranging in age from 20 to 38 years received c1-inh doses of 500 or 1000 iu per i.v. administration for the treatmen

미국 - 영어 - NLM (National Library of Medicine)

octapharma usa inc - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - human immunoglobulin g 50 mg in 1 ml - octagam is an immune globulin intravenous (human) 5% liquid indicated for treatment of primary humoral immunodeficiency (pi), such as congenital agammaglobulinemia, common variable immunodeficiency, x-linked agammaglobulinemia, wiskott-aldrich syndrome and severe combined immunodeficiencies. octagam 5% liquid is contraindicated - in patients who have acute severe hypersensitivity reactions to human immunoglobulin. - in iga deficient patients with antibodies against iga and history of hypersensitivity. octagam 5% liquid contains trace amounts of iga (not more than 0.2 mg/ml in a 5% solution). (see description [ 11 ]) - in patients with acute hypersensitivity reaction to corn. octagam 5% liquid contains maltose, a disaccharide sugar that is derived from corn. patients known to have corn allergies should avoid using octagam 5% liquid. risk summary no human data are available to indicate the presence or absence of drug-associated risk. animal reproduction studies have not been conducted with octagam 5% liquid