Australia - English - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - human immunoglobulin g, quantity: 160 mg/ml; zoster immunoglobulin, quantity: 200 iu - injection, solution - excipient ingredients: water for injections; glycine; human immunoglobulin a - indications as at 8 august 2002 : zoster immunoglobulin is indicated for prophylaxis against varicella in patients who meet all four of the criteria listed below: 1. one of the following underlying illnesses or conditions: a. neoplastic disease (leukaemia or lymphoma); b. congenital or acquired immunodeficiency; c. immunosuppressive therapy with steroids or antimetabolites. 2. one of the following types of exposure to chickenpox or shingles patients: a. household contact; b. playmate contact (>1 hour play indoors); c. hospital contact (in same 2 to 4 bedroom or adjacent beds in a large ward); d. newborn contact (newborn of mother who had onset of chickenpox <5 days before delivery or within 48 hours after delivery); e. premature infant (>= 28 weeks gestation) whose mother lacks a prior history of chickenpox; f. premature infant (< 28 weeks gestation or <= 1000g) regardless of maternal history. 3. negative or unknown history of chickenpox. 4. if zoster immunoglobulin can be administered within 96 hours after exposure. zoster immunoglobulin, normal immunoglobulin (immunoglobulin for intramuscular use) or plasma are of no value in the treatment of established varicella or zoster infection. high levels of circulating antibody do not prevent dissemination of infection. zoster immunoglobulin is not indicated for prophylactic use in immunodeficient children or adults when there is a history of varicella, unless the patient's immunosuppressed status is that which is associated with bone marrow transplantation.

Ireland - English - 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

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)

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

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