Ireland - English - 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

Singapore - English - HSA (Health Sciences Authority)

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

Singapore - English - HSA (Health Sciences Authority)

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

United States - English - 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

United States - English - 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

United States - English - 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

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

ethicon inc - human thrombin (unii: 6k15abl77g) (human thrombin - unii:6k15abl77g) - human thrombin 1000 [iu] in 1 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 anaphylactic or severe systemic reaction to human blood products. - do not use for the treatment of severe or brisk arterial bleeding. risk summary there are no clinical 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. in the u.s. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2-4

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

octapharma ab - 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

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

csl behring ag - human rho(d) immune globulin (unii: 48w7181flp) (human rho(d) immune globulin - unii:48w7181flp) - human rho(d) immune globulin 1500 [iu] in 2 ml - rhophylac is a rh(d) immune globulin intravenous (human) (anti-d) product that is indicated for the suppression of rh isoimmunization in non-sensitized rh(d)-negative patients and for the treatment of immune thrombocytopenic purpura (itp) in rh(d)-positive patients. pregnancy and obstetric conditions rhophylac is indicated for suppression of rhesus (rh) isoimmunization in non-sensitized rh(d)-negative women with an rh-incompatible pregnancy, including: - routine antepartum and postpartum rh prophylaxis - rh prophylaxis in cases of: – obstetric complications (e.g., miscarriage, abortion, threatened abortion, ectopic pregnancy or hydatidiform mole, transplacental hemorrhage resulting from antepartum hemorrhage) – invasive procedures during pregnancy (e.g., amniocentesis, chorionic biopsy) or obstetric manipulative procedures (e.g., external version, abdominal trauma) an rh-incompatible pregnancy is assumed if the fetus/baby is either rh(d)-positive or rh(d)-unknown or if the father is either rh(d)-positive or r

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

merck sharp & dohme llc - human papillomavirus type 6 l1 capsid protein antigen (unii: 61746o90dy) (human papillomavirus type 6 l1 capsid protein antigen - unii:61746o90dy), human papillomavirus type 11 l1 capsid protein antigen (unii: z845vhq61p) (human papillomavirus type 11 l1 capsid protein antigen - unii:z845vhq61p), human papillomavirus type 16 l1 capsid protein antigen (unii: 6lte2dnx63) (human papillomavirus type 16 l1 capsid protein antigen - unii:6lte2dnx63), human papillomavirus type 18 l1 capsid protein antigen (unii: - human papillomavirus type 6 l1 capsid protein antigen 20 ug in 0.5 ml - gardasil® is a vaccine indicated in girls and women 9 through 26 years of age for the prevention of the following diseases caused by human papillomavirus (hpv) types included in the vaccine: - cervical, vulvar, vaginal, and anal cancer caused by hpv types 16 and 18 - genital warts (condyloma acuminata) caused by hpv types 6 and 11 and the following precancerous or dysplastic lesions caused by hpv types 6, 11, 16, and 18: - cervical intraepithelial neoplasia (cin) grade 2/3 and cervical adenocarcinoma in situ (ais) - cervical intraepithelial neoplasia (cin) grade 1 - vulvar intraepithelial neoplasia (vin) grade 2 and grade 3 - vaginal intraepithelial neoplasia (vain) grade 2 and grade 3 - anal intraepithelial neoplasia (ain) grades 1, 2, and 3 gardasil is indicated in boys and men 9 through 26 years of age for the prevention of the following diseases caused by hpv types included in the vaccine: - anal cancer caused by hpv types 16 and 18 - genital warts (condyloma acuminata) caused by hpv types 6 and