Singapore - English - 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.

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

abbott rapid diagnostics pty ltd - ct184 - clinical chemistry toxicology/drug detection ivds - in vitro diagnostics intended to evaluate drugs or drug metabolites in biological matrices.

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

siemens healthcare pty ltd -

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

siemens healthcare pty ltd -

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)

rare disease therapeutics, inc - pit viper (crotalinae) immune globulin antivenin (equine) (unii: 92vv7g83ed) (pit viper (crotalinae) immune globulin antivenin (equine) - unii:92vv7g83ed) - pit viper (crotalinae) immune globulin antivenin (equine) 24 mg in 1 ml - anavip [crotalidae immune f(ab')2 (equine)] is an equine-derived antivenin indicated for the management of adult and pediatric patients with north american pit viper envenomation.

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

aptevo biotherapeutics llc - 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 - hepagam b [hepatitis b immune globulin intravenous (human)] is an intravenous immune globulin indicated for the following: including - acute exposure to hbsag-positive blood, plasma, or serum (parenteral exposure, direct mucus membrane contact, oral ingestion, etc), - perinatal exposure of infants born to hbsag-positive mothers, - sexual exposure to hbsag-positive persons, and - household exposure to persons with acute hbv infection. - individuals known to have anaphylactic or severe systemic reactions to the parenteral administration of human globulin preparations should not receive hepagam b. - individuals who are deficient in iga may have the potential to develop anti-iga antibodies and have an anaphylactoid reaction. hepagam b contains less than 40 micrograms per milliliter of iga. - hepagam b contains less than 40 micrograms per milliliter of iga. - for postexposure prophylaxis indications, hepagam b must be administered intramuscularly only. in patients who have severe thrombocytopenia or any coagulat

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.

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