Nova Zelanda - anglès - Medsafe (Medicines Safety Authority)

csl behring (nz) ltd - hepatitis b immunoglobulin, human 160 mg/ml (( >= 98%) as human plasma proteins (ex nz)) - solution for injection - 400 iu - active: hepatitis b immunoglobulin, human 160 mg/ml (( >= 98%) as human plasma proteins (ex nz)) excipient: glycine water for injection - hepatitis b immunoglobulin-vf is indicated for post-exposure prophylaxis in persons who did not receive prior vaccination, or whose prior vaccination regimen is incomplete, or when the hepatitis b antibody level is inadequate (< 10 iu/l). post-exposure prophylaxis should be considered following percutaneous or permucosal exposure to hbsag-positive or suspected hbsag-positive material, for example, by needle stick, oral ingestion or sexual exposure. hepatitis b immunoglobulin-vf is also indicated for prophylaxis in infants born to hbsag-positive mothers.

Malta - anglès - 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

Malta - anglès - Medicines Authority

bio products laboratory limited dagger lane, elstree hertfordshire, wd6 3bx, united kingdom - immunoglobulin g, human - solution for injection - immunoglobulin g, human 5 % (w/v) - immune sera and immunoglobulins

Estats Units - anglès - 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

Austràlia - anglès - 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.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - human immunoglobulin g, quantity: 50 mg/ml; cytomegalovirus immunoglobulin, quantity: 1500000 u - injection, intravenous infusion - excipient ingredients: water for injections; human immunoglobulin a; maltose - cmv immunoglobulin-vf is indicated for the prevention of cmv infection following bone marrow and renal transplants. specifically, the product is indicated when the recipient is seronegative for cmv and receives a graft from a cmv positive donor. cmv immunoglobulin-vf may also be a helpful adjunct to therapy in patients with established cmv infection, e.g. cmv pneumonitis.

Estats Units - anglès - 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

Estats Units - anglès - NLM (National Library of Medicine)

takeda pharmaceuticals america, inc. - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - human immunoglobulin g 100 mg in 1 ml - hyqvia is an immune globulin infusion 10% (human) with a recombinant human hyaluronidase (rhuph20) indicated for the treatment of primary immunodeficiency (pi) in adults and pediatric patients two years of age and older. this includes, but is not limited to, common variable immunodeficiency (cvid), x-linked agammaglobulinemia, congenital agammaglobulinemia, wiskott-aldrich syndrome, and severe combined immunodeficiencies.1,2 hyqvia is indicated for the treatment of chronic inflammatory demyelinating polyneuropathy (cidp) as maintenance therapy to prevent relapse of neuromuscular disability and impairment in adults. hyqvia is contraindicated in: - patients who have had a history of anaphylactic or severe systemic reactions to the administration of igg. - iga deficient patients with antibodies to iga and a history of hypersensitivity. - patients with known systemic hypersensitivity to hyaluronidase including rhuph20 of hyqvia. - patients with known systemic hypersensitivity to human albumin (in the hyaluronidase solution)]. risk summary limited human data are available to assess the presence or absence of drug-associated risk in pregnancy. in a postmarketing pregnancy study, two out of 5 infants born to mothers taking hyqvia during pregnancy had congenital abnormalities (1 cleft lip and 1 talipes calcaneovalgus). animal reproduction studies have not been conducted with the immune globulin infusion 10% (human) component of hyqvia. immune globulins increasingly cross the placenta from maternal circulation after 30 weeks of gestation. there was no evidence of teratogenicity in animal studies for rhuph20, (a component of hyqvia). the effects of antibodies to the rhuph20 on the human embryo or fetal development are unknown. it is not known whether hyqvia can cause fetal harm when administered to a pregnant woman or if it can affect reproductive capacity. hyqvia should be given to a pregnant woman only if clearly needed. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data human data: nine women treated with hyqvia were enrolled in a prospective, uncontrolled, open-label, multicenter post-authorization pregnancy registry. seven mothers continued hyqvia, and two mothers were treated with immune globulin other than hyqvia during the pregnancy. one mother discontinued from the registry before the expected delivery. of the eight pregnancies with known outcomes, there were eight live births. there were no specified labor or delivery complications. two out of 5 infants whose mothers took hyqvia during pregnancy had congenital abnormalities (cleft lip without cleft palate and talipes calcaneovalgus). data from the hyqvia pregnancy registry are insufficient to establish causality. the interpretation of the registry findings is limited by the small sample size, by the potential that selection bias may have increased enrollment of mothers of infants with congenital abnormalities, the absence of fetal outcomes in some exposed maternal-fetal pairs, and incomplete data on other potential etiologies. the following adverse events were identified in post-approval reports: spontaneous abortions and fetal deaths. the following congenital anomalies were identified in post-approval reports in infants whose mothers took hyqvia during pregnancy: cleft palate, atrial septal defect, ventricular septal defect, cleft lip, hypoplastic left heart syndrome (aortic atresia, mitral valve atresia), endocardial fibroelastosis, and tricuspid valve incompetence. because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. animal data: animal reproduction studies have not been conducted with immune globulin infusion 10% (human) component of hyqvia. development and reproductive toxicology studies have been conducted with rhuph20 in mice and rabbits [see nonclinical toxicology (13.2)] . no adverse effects on pregnancy were associated with anti-rhuph20 antibodies at a dose of 3 mg/kg rhuph20 in mice, which is 4800 times higher than the typical monthly human dose. no teratogenicity or signs of maternal toxicity were observed at doses up to 18 mg/kg, which is 28,800 times higher than the typical monthly human dose. doses of 9 and 18 mg/kg (14,400 and 28,800 times higher than the typical monthly human dose) in mice were associated with reduced fetal weight and an increased number of fetal resorptions. in these studies, maternal antibodies to rhuph20 were transferred to offspring in utero. the effects of antibodies to the rhuph20 component of hyqvia on the human embryo or on human fetal development are unknown. risk summary it is not known whether hyqvia can cause harm to the breastfed infant when administered to a lactating woman. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for hyqvia and any potential adverse effects on the breastfed infant from hyqvia or from the underlying maternal condition. data from the hyqvia pregnancy registry are insufficient to predict effects on the breastfed child from exposure to hyqvia through human milk. data animal data: in animal studies, maternal antibodies binding to rhuph20 were transferred to offspring during lactation. no adverse effects on pregnancy or offspring development were associated with anti-rhuph20 antibodies. the effects of antibodies that bind to rhuph20 of hyqvia transferred during human lactation are unknown. risk summary animal studies do not indicate direct or indirect harmful effects of (rhuph20) with respect to reproductive potential at the doses used for facilitating administration of ig 10% [see nonclinical toxicology (13.1)]. primary immunodeficiency (pi) the safety and effectiveness of hyqvia for the treatment of primary immunodeficiency have been established in pediatric patients 2 years and older. use of hyqvia for this indication is supported by evidence from the pivotal efficacy and safety study in 44 pediatric subjects (aged 2 to 16 years of age). results from pre-specified interim data analysis, where all subjects completed 12 months of participation (one year of observation period) in the study, indicated similar safety profiles to adults. no pediatric-specific dose requirements were necessary to achieve the desired serum igg levels. [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14.1)]. safety and effectiveness of hyqvia has not been evaluated in patients <2 years of age. chronic inflammatory demyelinating polyneuropathy (cidp) the safety and effectiveness of hyqvia for the treatment of cidp have not been established in pediatric patients under the age of 18 years. primary immunodeficiency (pi) hyqvia was evaluated in 7 subjects over age 65 in the pi clinical trial. the available data are too limited to draw safety conclusions. chronic inflammatory demyelinating polyneuropathy hyqvia was evaluated in 13 subjects over age 65 in the pivotal clinical trial. no clinically significant differences in safety were observed between those 13 elderly subjects and the subjects 18 to 65 years of age. use caution when administering hyqvia to patients age 65 and over who are judged to be at increased risk of developing thrombosis and acute renal insufficiency [see boxed warning, warnings and precautions (5.2, 5.6)] . do not exceed recommended doses and administer hyqvia at the minimum dose and infusion rate practicable.

Estats Units - anglès - NLM (National Library of Medicine)

aptevo biotherapeutics llc - human varicella-zoster immune globulin (unii: 33t61iwl27) (human varicella-zoster immune globulin - unii:33t61iwl27) - human varicella-zoster immune globulin 125 [iu] - varizig® [varicella zoster immune globulin (human)] is indicated for post-exposure prophylaxis of varicella in high risk individuals. high risk groups include: - immunocompromised children and adults, - newborns of mothers with varicella shortly before or after delivery, - premature infants, - neonates and infants less than one year of age, - adults without evidence of immunity, - pregnant women. varizig administration is intended to reduce the severity of varicella. administer varizig as soon as possible following varicella zoster virus (vzv) exposure, ideally within 96 hours for greatest effectiveness. - there is no convincing evidence that varizig reduces the incidence of chickenpox infection after exposure to vzv. - there is no convincing evidence that established infections with vzv can be modified by varizig administration. - there is no indication for the prophylactic use of varizig in immunodeficient children or adults when there is a past history of varicella, unless the patient is undergoing bone m

Estats Units - anglès - NLM (National Library of Medicine)

cangene biopharma - human varicella-zoster immune globulin (unii: 33t61iwl27) (human varicella-zoster immune globulin - unii:33t61iwl27) - human varicella-zoster immune globulin 1.25 [iu] in 1 ml - varizig® [varicella zoster immune globulin (human)] is indicated for post-exposure prophylaxis of varicella in high risk individuals. high risk groups include: varizig administration is intended to reduce the severity of varicella. administer varizig as soon as possible following varicella zoster virus (vzv) exposure, ideally within 96 hours for greatest effectiveness. pregnancy category c. animal reproduction studies have not been conducted with varizig. it also is not known whether varizig can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. varizig should be given to a pregnant woman only if clearly needed. the safety and effectiveness of varizig have been evaluated for post-exposure prophylaxis in clinical trials in 166 pregnant women [see 6 adverse reactions and 14 clinical studies]. it is not known whether varizig is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when varizig is administered to a nursing moth