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)

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.

Canada - English - Health Canada

cangene corporation a subsidiary of emergent biosolutions inc. - varicella zoster immunoglobulin (human) - kit - 125unit - varicella zoster immunoglobulin (human) 125unit - serums

Canada - English - Health Canada

ki biopharma llc - varicella zoster immunoglobulin (human) - solution - 125unit - varicella zoster immunoglobulin (human) 125unit - serums

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

glaxosmithkline australia pty ltd - live varicella vaccine, quantity: 4000 pfu/ml; isoleucine, quantity: 0.355 mg; leucine, quantity: 0.432 mg - injection, powder for - excipient ingredients: lactose; sorbitol; mannitol; threonine; serine; proline; glycine; alanine; valine; methionine; tyrosine; phenylalanine; tryptophan; lysine hydrochloride; histidine; arginine - varilrix hsa-free is indicated for active immunisation against varicella of healthy subjects from 9 months of age. groups who would particularly benefit from vaccination include: non-immune adults, especially those in at-risk occupations such as health care workers, teachers and workers in children's day-care centres. non-immune parents of young children. non-immune household contacts, both adults and children, of immunocompromised patients with no history of the disease.

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

glaxosmithkline australia pty ltd - live varicella vaccine, quantity: 4000 pfu/ml; isoleucine, quantity: 0.355 mg - injection, powder for - excipient ingredients: lactose; mannitol; sorbitol; threonine; serine; proline; glycine; alanine; valine; methionine; leucine; tyrosine; phenylalanine; tryptophan; lysine hydrochloride; histidine; arginine - varilrix hsa-free is indicated for active immunisation against varicella of healthy subjects from 9 months of age. groups who would particularly benefit from vaccination include: non-immune adults, especially those in at-risk occupations such as health care workers, teachers and workers in children's day-care centres. non-immune parents of young children. non-immune household contacts, both adults and children, of immunocompromised patients with no history of the disease.

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

glaxosmithkline australia pty ltd - live varicella vaccine, quantity: 4000 pfu/ml - injection, powder for - excipient ingredients: lactose; mannitol; sorbitol; threonine; serine; proline; glycine; alanine; valine; methionine; isoleucine; leucine; tyrosine; phenylalanine; tryptophan; lysine hydrochloride; histidine; arginine - varilrix hsa-free is indicated for active immunisation against varicella of healthy subjects from 9 months of age. groups who would particularly benefit from vaccination include: non-immune adults, especially those in at-risk occupations such as health care workers, teachers and workers in children's day-care centres. non-immune parents of young children. non-immune household contacts, both adults and children, of immuncompromised patients with no history of the disease.

Malta - English - Medicines Authority

glaxosmithkline biologicals s.a. rue de l'institut 89 b-1330 rixensart, belgium - varicella virus, oka strain, live, attenuated, measles virus, schwarz strain, mumps virus, jeryl lynn, level b, rubella virus, wistar ra - powder and solvent for solution for injection in pre-filled syringe - varicella virus oka strain (live, attenuated) measles virus - schwarz strain mumps virus jeryl lynn (level b) strain (live, attenuated) rubella virus wistar ra 27/3 strain (live, attenuated) - vaccines