United States - English - 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 250 [iu] - hyperrho s/d mini-dose is recommended to prevent the isoimmunization of rho (d) negative women at the time of spontaneous or induced abortion of up to 12 weeks’ gestation provided the following criteria are met: - the mother must be rho (d) negative and must not already be sensitized to the rho (d) antigen.  the mother must be rho (d) negative and must not already be sensitized to the rho (d) antigen.  - the father is not known to be rho (d) negative. the father is not known to be rho (d) negative. - gestation is not more than 12 weeks at termination. gestation is not more than 12 weeks at termination. note: rho (d) immune globulin (human) prophylaxis is not indicated if the fetus or father can be determined to be rh negative. if the rh status of the fetus is unknown, the fetus must be assumed to be rho (d) positive, and hyperrho s/d mini-dose should be administered to the mother. for abortions or miscarriages occurring after 12 weeks’ gestation, a standard dose of rho (d) immune globulin (human) is i

United States - English - 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

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)

kedrion biopharma inc - human rho(d) immune globulin (unii: 48w7181flp) (human rho(d) immune globulin - unii:48w7181flp) - human rho(d) immune globulin 300 ug - rhogam and micrhogam are indicated for administration to rh-negative women not previously sensitized to the rho(d) factor, unless the father or baby are conclusively rh-negative, in case of: - delivery of an rh-positive baby irrespective of the abo groups of the mother and baby - antepartum prophylaxis at 26 to 28 weeks gestation - antepartum fetal-maternal hemorrhage (suspected or proven) as a result of placenta previa, amniocentesis, chorionic villus sampling, percutaneous umbilical blood sampling, other obstetrical manipulative procedure (e.g., version) or abdominal trauma - actual or threatened pregnancy loss at any stage of gestation - ectopic pregnancy rhogam and micrhogam are indicated for prevention of rh immunization in any rh-negative person after incompatible transfusion of rh-positive blood or blood products (e.g., red blood cells, platelet concentrates, granulocyte concentrates). pregnancy and other obstetrical conditions in the case of postpartum use, rhogam and micrhogam are intended for matern

United States - English - 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

United States - English - 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

United States - English - 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

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

emergent biosolutions canada inc. - human vaccinia virus immune globulin (unii: 7ub4j759td) (human vaccinia virus immune globulin - unii:7ub4j759td) - human vaccinia virus immune globulin 1 [iu] in 1 ml - vigiv (vaccinia immune globulin intravenous, human) is indicated for the treatment and/or modification of the following conditions: vigiv is not considered to be effective in the treatment of postvaccinial encephalitis. vigiv is contraindicated in: risk summary there are no data on the use of vigiv in pregnant women to inform on drug-associated risk. animal reproduction studies have not been conducted with vigiv. risk summary there are no data to assess the presence or absence of vigiv in human milk, the effects on the breastfed child or the effects on milk production/excretion. safety and effectiveness in the pediatric population (<16 yrs of age) has not been established for vigiv. safety and effectiveness in the geriatric population (>65 yrs of age) has not been established for vigiv.

Singapore - English - HSA (Health Sciences Authority)

grifols asia pacific pte. ltd. - rho(d) immune globulin (human) - injection - at least 1500 iu/dose - rho(d) immune globulin (human) at least 1500 iu/dose

United States - English - 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