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

Singapore - English - HSA (Health Sciences Authority)

grifols asia pacific pte. ltd. - hepatitis b immune globulin (human) - injection - 15-18% - hepatitis b immune globulin (human) 15-18%

Singapore - English - HSA (Health Sciences Authority)

grifols asia pacific pte. ltd. - hepatitis b immune globulin (human) - injection - 15-18% - hepatitis b immune globulin (human) 15-18%

Singapore - English - HSA (Health Sciences Authority)

grifols asia pacific pte. ltd. - hepatitis b immune globulin (human) - injection - 15 - 18% - hepatitis b immune globulin (human) 15 - 18%

Singapore - English - HSA (Health Sciences Authority)

grifols asia pacific pte. ltd. - tetanus immune globulin (human) - injection - 250 units - tetanus immune globulin (human) 250 units

Singapore - English - HSA (Health Sciences Authority)

grifols asia pacific pte. ltd. - albumin (human) - injection - 5 g/20 ml - albumin (human) 5 g/20 ml

Singapore - English - HSA (Health Sciences Authority)

grifols asia pacific pte. ltd. - plasma proteins (human) - injection - 5 g/100 ml - plasma proteins (human) 5 g/100 ml

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

grifols malaysia sdn. bhd. - factor viii/antihaemophilic factor/ahf -

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

grifols usa, llc - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - human immunoglobulin g 0.05 g in 1 ml - flebogamma 5% dif is an immune globulin intravenous (human) solution indicated in adults and pediatric patients 2 years of age and older for the treatment of primary immunodeficiency (pi), including the humoral immune defects in common variable immunodeficiency, x-linked agammaglobulinemia, severe combined immunodeficiency, and wiskott-aldrich syndrome. - flebogamma 5% dif is contraindicated in patients who have had a history of anaphylactic or severe systemic hypersensitivity reactions to the administration of human immune globulin. - flebogamma 5% dif is contraindicated in iga-deficient patients with antibodies to iga and a history of hypersensitivity. (see warnings and precautions [5.1] ) risk summary there are no studies of flebogamma 5% dif use in pregnant women. animal reproduction studies have not been performed with flebogamma 5% dif. it is also not known whether flebogamma 5% dif can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. immunoglobulins cross the placenta from maternal circulation increasingly after 30 weeks of gestation. flebogamma 5% dif should be given to a pregnant woman only if clearly needed. risk summary there is no information regarding the presence of flebogamma 5% dif in human milk, its effects on the breastfed infant, or its effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for flebogamma 5% dif and any potential adverse effects on the breastfed infant from flebogamma 5% dif or from the underlying maternal condition. flebogamma 5% dif was studied in a multicenter clinical trial for the treatment of pi in 24 subjects aged 2-16 years (seven were 2-5 years of age, seven were 6-11 years, and ten were 12-16 years), and found to be efficacious for the prevention of acute serious bacterial infections. no pediatric-specific dose requirements were necessary to achieve the desired serum igg levels. twenty subjects (83.3%) had at least one adverse reaction at some time during the study that was considered product-related. there were no deaths or serious adverse reactions. treatment-related adverse reactions that occurred with an incidence of at least 5% on a per-subject basis included headache (42%), pyrexia (29%), hypotension (25%), tachycardia (25%), diastolic hypotension (21%), nausea (8%), abdominal pain (8%), diarrhea (8%), pain (8%), and vomiting (8%). safety and efficacy of flebogamma 5% dif in pediatric patients below the age of 2 years have not been established. limited information is available for the geriatric use of flebogamma 5% dif. clinical studies of flebogamma 5% dif did not include sufficient numbers of subjects over the age of 65 to determine whether they respond differently from younger subjects. use caution when administering flebogamma 5% dif to patients age 65 and over who are judged to be at increased risk for developing thrombosis or renal insufficiency. do not exceed recommended dose, and administer flebogamma 5% dif at the minimum dose and infusion rate practicable, and at less than 0.06 ml per kg per minute (3 mg per kg per min). (see boxed warning, warning and precautions [5.2, 5.4], and dosage and administration [2.3] )

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

grifols usa, llc - factor ix complex (unii: fw411qxd5m) (factor ix complex - unii:fw411qxd5m) - factor ix complex 500 [iu] in 5 ml - profilnine, factor ix complex, is indicated for the prevention and control of bleeding in patients with factor ix deficiency (hemophilia b). profilnine contains non-therapeutic levels of factor vii and is not indicated for use in the treatment of factor vii deficiency. none known.