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

grifols usa, llc - human clostridium tetani toxoid immune globulin (unii: v4swi4rf4j) (human clostridium tetani toxoid immune globulin - unii:v4swi4rf4j) - human clostridium tetani toxoid immune globulin 250 [iu] in 1 ml - hypertet is indicated for prophylaxis against tetanus following injury in patients whose immunization is incomplete or uncertain (see below). it is also indicated, although evidence of effectiveness is limited, in the regimen of treatment of active cases of tetanus.(8,9,16) a thorough attempt must be made to determine whether a patient has completed primary vaccination. patients with unknown or uncertain previous vaccination histories should be considered to have had no previous tetanus toxoid doses. persons who had military service since 1941 can be considered to have received at least one dose, and although most of them may have completed a primary series of tetanus toxoid, this cannot be assumed for each individual. patients who have not completed a primary series may require tetanus toxoid and passive immunization at the time of wound cleaning and debridement.(3) the following table is a summary guide to tetanus prophylaxis in wound management: none known.

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

wyeth pharmaceuticals llc, a subsidiary of pfizer inc. - coral snake (micrurus fulvius) immune globulin antivenin (equine) (unii: y605xbm2gl) (coral snake (micrurus fulvius) immune globulin antivenin (equine) - unii:y605xbm2gl) - coral snake (micrurus fulvius) immune globulin antivenin (equine) 250 [arb'u] in 10 ml - north american coral snake antivenin (equine) is indicated only for the treatment of envenomation caused by bites of north american coral snakes - micrurus (including the eastern and texas varieties). risk summary there are no available human data that establish developmental toxicity related to the use of north american coral snake antivenin (equine). there are no available animal data informing the north american coral snake antivenin (equine)-associated risk. north american coral snake antivenin (equine) should be given to a pregnant woman only if clearly required. in the us general population, the background risk of major birth defects is 2–4% and of miscarriage is 15–20% in clinically recognized pregnancies. risk summary lactation studies have not been conducted with north american coral snake antivenin (equine). it is not known whether north american coral snake antivenin (equine) is excreted in human milk. north american coral snake antivenin (equine) should be administered to lactating women only if

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) - 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 infec- tion 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 hbeag 12 . - sexual exposure to hbsag-positive persons: sexual partners of hbsag-positive persons. - household exposure to persons with acute hbv infection: household exposure to persons with acute hbv infection: infants less than 12 months old whose mother or primary caregiver is positive for hbsag. o

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

savage laboratories, a division of nycomed us inc. - ovine digoxin immune fab (unii: yb12nqz1yn) (ovine digoxin immune fab - unii:yb12nqz1yn) - ovine digoxin immune fab 38 mg

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

takeda malaysia sdn bhd - von willebrand factor; human blood coagulation factor viii -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

takeda malaysia sdn bhd - von willebrand factor; human blood coagulation factor viii -

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

saol therapeutics - human varicella-zoster immune globulin (unii: 33t61iwl27) (human varicella-zoster immune globulin - unii:33t61iwl27) - 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

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

kamada ltd. - human varicella-zoster immune globulin (unii: 33t61iwl27) (human varicella-zoster immune globulin - unii:33t61iwl27) - 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 marrow transplantation. - individuals known to have anaphylactic or severe systemic (hypersensitivity) reactions to human immune globulin preparations should not receive varizig. - iga-deficient patients with antibodies against iga and a history of hypersensitivity may have an anaphylactoid reaction. - varizig contains less than 40 micrograms per milliliter of iga. 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 6adverse reactions and 14clinical 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 mother. the dosing recommendations in the treatment of pediatric patients are by body weight [see 2dosage and administration ]. the safety and effectiveness of varizig have been evaluated for post-exposure prophylaxis in the varizig expanded access clinical trial in 374 pediatric patients, including immunocompromised pediatric patients: - 94 preterm newborns and infants, - 53 term newborns, - 45 infants and toddlers, - 176 children and, - 43 adolescents. in the eap, follow up data were available for 110 varizig treatments in infants (including newborns, pre-term infants, and infants less than 1 year old). three severe infections were reported, all three with pox count greater than 100, one of which also had pneumonia and another one also developed probable varicella encephalitis. clinical studies of varizig administered intramuscularly for post-exposure prophylaxis did not include sufficient numbers of geriatric subjects (aged 65 and over) to determine whether they respond differently from younger subjects. use caution when administering varizig to patients aged 65 and over who are judged to be at increased risk of thrombotic events [see 5warnings and precautions ]. do not exceed recommended doses and administer varizig intramuscularly only. in the eap, both adult (n=37) and pediatric immunocompromised subjects (n=235) were treated. twelve immunocompromised subjects developed clinical varicella and none developed varicella pneumonitis; however at least five are reported to have received concomitant acyclovir and due to incomplete reporting, it is not known if others also received acyclovir.

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

cangene biopharma 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

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

cangene biopharma, llc - human hepatitis b virus immune globulin (unii: xii270yc6m) (human hepatitis b virus immune globulin - unii:xii270yc6m) - human hepatitis b virus immune globulin 50 mg in 1 ml