মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

adma biologics, 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 - indications and usage 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 infection 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 hbeag12. sexual exposure to hbsag-positive persons sexual partners of hbsag-positive persons. household exposure to persons with acute hbv infection infants less than 12 months old whose mother or primary caregiver is positive for hbsag. other household contacts with an identifiable blood exposure to the i

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

grifols usa, llc - human rabies virus immune globulin (unii: 95f619atq2) (human rabies virus immune globulin - unii:95f619atq2) - human rabies virus immune globulin 300 [iu] in 1 ml - hyperrab is a human rabies immune globulin indicated for postexposure prophylaxis, along with rabies vaccine, for all persons suspected of exposure to rabies. limitations of use persons who have been previously immunized with rabies vaccine and have a confirmed adequate rabies antibody titer should receive only vaccine.(1-3) for unvaccinated persons, the combination of hyperrab and vaccine is recommended for both bite and nonbite exposures regardless of the time interval between exposure and initiation of postexposure prophylaxis.(1-3) beyond 7 days (after the first vaccine dose), hyperrab is not indicated since an antibody response to vaccine is presumed to have occurred. none. risk summary there are no data with hyperrab use in pregnant women to inform a drug-associated risk.  animal reproduction studies have not been conducted with hyperrab.  it is not known whether hyperrab can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.  hyperrab should be given to a pregna

সিঙ্গাপুর - ইংরেজি - HSA (Health Sciences Authority)

siemens healthcare pte. ltd. - clinical toxicology - the immunalysis ketamine urine assay is intended for the qualitative and semi-quantitative assay of ketamine in human urine. the immunalysis ketamine urine eia kit provides only a preliminary analytical test result. a more specific alternate chemical method must be used in order to obtain a confirmed analytical result. liquid or gas chromatography/mass spectrometry (lc-ms or gc-ms) is the preferred confirmatory method. clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

grifols usa, llc - human rabies virus immune globulin (unii: 95f619atq2) (human rabies virus immune globulin - unii:95f619atq2) - human rabies virus immune globulin 150 [iu] in 1 ml - rabies vaccine and hyperrab s/d should be given to all persons suspected of exposure to rabies with one exception: persons who have been previously immunized with rabies vaccine and have a confirmed adequate rabies antibody titer should receive only vaccine. hyperrab s/d should be administered as promptly as possible after exposure, but can be administered up to the eighth day after the first dose of vaccine is given. recommendations for use of passive and active immunization after exposure to an animal suspected of having rabies have been detailed by the u.s. public health service advisory committee on immunization practices (acip). [19] every exposure to possible rabies infection must be individually evaluated. the following factors should be considered before specific antirabies treatment is initiated: carnivorous wild animals (especially skunks, foxes, coyotes, raccoons, and bobcats) and bats are the animals most commonly infected with rabies and have caused most of the indigenous cases of human rabies

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

grifols usa, llc - human rho(d) immune globulin (unii: 48w7181flp) (human rho(d) immune globulin - unii:48w7181flp) - human rho(d) immune globulin 1500 [iu] - hyperrho s/d full dose is recommended for the prevention of rh hemolytic disease of the newborn by its administration to the rho (d) negative mother within 72 hours after birth of an rho (d) positive infant,(12) providing the following criteria are met: - the mother must be rho (d) negative and must not already be sensitized to the rho (d) factor. the mother must be rho (d) negative and must not already be sensitized to the rho (d) factor. - her child must be rho (d) positive, and should have a negative direct antiglobulin test (see precautions). her child must be rho (d) positive, and should have a negative direct antiglobulin test (see precautions). if hyperrho s/d full dose is administered antepartum, it is essential that the mother receive another dose of hyperrho s/d full dose after delivery of an rho (d) positive infant. if the father can be determined to be rho (d) negative, hyperrho s/d full dose need not be given. hyperrho s/d full dose should be administered within 72 hours to all nonimmuni

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

sanofi pasteur inc. - human rabies virus immune globulin (unii: 95f619atq2) (human rabies virus immune globulin - unii:95f619atq2) - human rabies virus immune globulin 150 [iu] in 1 ml - rabies immune globulin (human) heat treated, imogam rabies – ht, in conjunction with the standard series of rabies vaccine vaccinations, is indicated for individuals suspected of exposure to rabies, particularly severe exposure, with one exception: persons who have been previously immunized with rabies vaccine. previously immunized persons are those who have had a documented rabies virus neutralizing antibody titer and who have completed one of the recommended regimens (pre-exposure or post-exposure) with a cell culture vaccine or another vaccine. administer only vaccine to these persons (i.e., post-exposure for a person previously vaccinated). (1) inject imogam rabies – ht, as promptly as possible after exposure, along with the first dose of vaccine. if initiation of treatment is delayed for any reason, still administer imogam rabies – ht and the first dose of vaccine, regardless of the interval between exposure and treatment. if rabies immune globulin (human) was not administered when vaccination was begun

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

pharmacia & upjohn company llc - equine thymocyte immune globulin (unii: 475247qf1z) (equine thymocyte immune globulin - unii:475247qf1z) - equine thymocyte immune globulin 50 mg in 1 ml - atgam is indicated for the management of allograft rejection in renal transplant patients; when administered with conventional therapy at the time of rejection atgam increases the frequency of resolution of the acute rejection episode [see clinical studies (14.1)] . atgam is indicated for the treatment of moderate to severe aplastic anemia in patients unsuitable for bone marrow transplantation [see clinical studies (14.2)] . the usefulness of atgam has not been demonstrated in patients with aplastic anemia who are suitable candidates for bone marrow transplantation or in patients with aplastic anemia secondary to neoplastic disease, storage disease, myelofibrosis, fanconi's syndrome, or in patients known to have been exposed to myelotoxic agents or radiation. do not administer atgam to a patient who has had an anaphylactic reaction during prior administration of atgam or any other equine gamma globulin preparation [see warnings and precautions (5.1)]. risk summary there are no adequate and well-controlled studies in pregnant women. there is a limited amount of data from the use of atgam in pregnant women. it is also not known whether atgam can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. the outcome of pregnancies cannot be determined. use atgam during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. 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 outcome. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data in embryo-fetal toxicity studies, atgam was administered to rats and cynomolgus monkeys for 11 and 16 days, respectively during organogenesis. in rats, hypoplastic cervical vertebrae, a finding consistent with delayed skeletal development, were observed in fetuses whose dams received atgam at doses of 100 mg/kg/day during organogenesis. in monkey reproduction studies, maternal toxicity (vaginal bleeding, decreased body weight and loss of appetite) was observed with atgam doses ≥20 mg/kg/day after 16 days of dosing. fetal deaths occurred in dams treated with 20 mg/kg/day atgam earlier in organogenesis (days 20‑35), but not when treatment was given at a later part of organogenesis (days 35-50). the maternal and fetal deaths were attributed to maternal anemia due to red blood cell antigen that humans do not share. therefore, this toxicity is not considered relevant to human fetal development. risk summary it is not known if atgam is excreted in human milk. because many drugs are excreted in human milk and because of the potential for serious adverse reactions in breast-feeding neonates and infants from atgam, a decision should be made whether to discontinue breast-feeding or to discontinue the drug taking into account the importance of the drug to the mother. data in animal studies, a single dose of atgam up to 40 mg/kg was not detected at the limit of quantification in the milk of lactating cynomolgus monkeys. contraception females it is not known if atgam can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . advise females of reproductive potential to use effective contraception during treatment with atgam and for at least 10 weeks after cessation of therapy. males advise males with a female partner of reproductive potential to use effective contraception during treatment with atgam and for at least 10 weeks after cessation of therapy. infertility in fertility studies, atgam at doses 10, 20 and 40 mg/kg/day was administered to cynomolgus monkeys (macaca fascicularis) for 14 days either before (male monkeys) or before and after (female monkeys) cohabitation with untreated mates. atgam treatment was not associated with male or female hormonal or copulation behavior changes. a decrease in fertility index in female monkeys receiving atgam was seen. female toxicity, including death, was observed with atgam doses of ≥20 mg/kg/day. while the etiology of this toxicity is uncertain, it may be attributed to hemolytic anemia due to cross-reactivity of atgam to a monkey red blood antigen. experience with children has been limited. atgam has been administered safely to a small number of pediatric renal allograft recipients and pediatric aplastic anemia patients at dosage levels comparable to those in adults. clinical experience in a limited number of elderly patients (≥65 years of age) has not identified differences in responses between the elderly and younger patients. select the dose for an elderly patient with caution, starting at the low end of the dosage range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of comorbidities or other drug therapy in this age group.

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

csl behring ag - human cytomegalovirus immune globulin (unii: 129l90a25n) (human cytomegalovirus immune globulin - unii:129l90a25n) - human cytomegalovirus immune globulin 50 mg in 1 ml - cytomegalovirus immune globulin intravenous (human) is indicated for the prophylaxis of cytomegalovirus disease associated with transplantation of kidney, lung, liver, pancreas and heart. in transplants of these organs other than kidney from cmv seropositive donors into seronegative recipients, prophylactic cmv-igiv should be considered in combination with ganciclovir. cytogam should not be used in individuals with a history of a prior severe reaction associated with the administration of this or other human immunoglobulin preparations. persons with selective immunoglobulin a deficiency have the potential for developing antibodies to immunoglobulin a and could have anaphylactic reactions to subsequent administration of blood products that contain immunoglobulin a, including cytogam.

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

california department of public health - human botulinum neurotoxin a/b immune globulin (unii: x641y30oa7) (human botulinum neurotoxin a/b immune globulin - unii:x641y30oa7) - human botulinum neurotoxin a/b immune globulin 50 mg in 1 ml - babybig® , botulism immune globulin intravenous (human), is indicated for the treatment of infant botulism caused by toxin type a or b in patients below one year of age. - as with other immunoglobulin preparations, babybig should not be used in individuals with a prior history of severe reaction to other human immunoglobulin preparations.[1-4] - individuals with selective immunoglobulin a deficiency have the potential for developing antibodies to immunoglobulin a and could have anaphylactic reactions to the subsequent administration of blood products that contain immunoglobulin a. babybig has been studied for safety and efficacy only in patients below one year of age [see adverse reactions (6) and clinical studies (14) ]. it has not been tested in other populations. ndc 68403-1100-7 rx only 100 mg igg, 100 mg sucrose 20 mg albumin (human) lyophilized solvent detergent treated botulism immune globulin intravenous (human) (big-iv) babybig® store between 2°c and 8°c (35.6°f and 46.4°f).

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - 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