মাল্টা - ইংরেজি - Medicines Authority

octapharma (ip) limited - immunoglobulin g, human - solution for infusion - immunoglobulin g, human 100 mg i/ml - immune sera and immunoglobulins

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

grifols usa, llc - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - human immunoglobulin g 0.165 g in 1 ml - gamastan is a human immune globulin indicated for: gamastan is indicated for prophylaxis following exposure to hepatitis a.(1,2) the prophylactic value of gamastan is greatest when given before or soon after exposure to hepatitis a. gamastan is not indicated in persons with clinical manifestations of hepatitis a or in those exposed more than 2 weeks previously. gamastan is indicated to prevent or modify measles in a susceptible person exposed fewer than 6 days previously.(3) a susceptible person is one who has not been vaccinated and has not had measles previously. - gamastan may be especially indicated for susceptible household contacts of measles patients, particularly contacts under 1 year of age, for whom the risk of complications is highest.(3) - gamastan is also indicated for pregnant women without evidence of immunity. - do not give gamastan and measles vaccine at the same time. if a child is older than 12 months and has received gamastan, give measles vaccine about five months later when the measles a

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - 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] )

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

grifols usa, llc - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - human immunoglobulin g 5 g in 50 ml - flebogamma 10% dif is an immune globulin intravenous (human) solution indicated for the treatment of: flebogamma 10% dif is indicated as replacement therapy in primary immunodeficiency (pi) including the humoral immune defects in common variable immunodeficiency, x-linked agammaglobulinemia, severe combined immunodeficiency, and wiskott-aldrich syndrome. flebogamma 10% dif is indicated for the treatment of patients 2 years of age and older with chronic primary immune thrombocytopenia to raise platelet count. - flebogamma 10% 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 10% 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 10% dif use in pregnant women. animal reproduction studies have not been performed with flebogamma 10% dif. it is

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

takeda pharmaceuticals america, inc. - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - human immunoglobulin g 100 mg in 1 ml - hyqvia is an immune globulin infusion 10% (human) with a recombinant human hyaluronidase (rhuph20) indicated for the treatment of primary immunodeficiency (pi) in adults and pediatric patients two years of age and older. this includes, but is not limited to, common variable immunodeficiency (cvid), x-linked agammaglobulinemia, congenital agammaglobulinemia, wiskott-aldrich syndrome, and severe combined immunodeficiencies.1,2 hyqvia is indicated for the treatment of chronic inflammatory demyelinating polyneuropathy (cidp) as maintenance therapy to prevent relapse of neuromuscular disability and impairment in adults. hyqvia is contraindicated in: - patients who have had a history of anaphylactic or severe systemic reactions to the administration of igg. - iga deficient patients with antibodies to iga and a history of hypersensitivity. - patients with known systemic hypersensitivity to hyaluronidase including rhuph20 of hyqvia. - patients with known systemic hypersensitivity to human albumin (in the hyaluronidase solution)]. risk summary limited human data are available to assess the presence or absence of drug-associated risk in pregnancy. in a postmarketing pregnancy study, two out of 5 infants born to mothers taking hyqvia during pregnancy had congenital abnormalities (1 cleft lip and 1 talipes calcaneovalgus). animal reproduction studies have not been conducted with the immune globulin infusion 10% (human) component of hyqvia. immune globulins increasingly cross the placenta from maternal circulation after 30 weeks of gestation. there was no evidence of teratogenicity in animal studies for rhuph20, (a component of hyqvia). the effects of antibodies to the rhuph20 on the human embryo or fetal development are unknown. it is not known whether hyqvia can cause fetal harm when administered to a pregnant woman or if it can affect reproductive capacity. hyqvia should be given to a pregnant woman only if clearly needed. 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 outcomes. in the u.s. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data human data: nine women treated with hyqvia were enrolled in a prospective, uncontrolled, open-label, multicenter post-authorization pregnancy registry. seven mothers continued hyqvia, and two mothers were treated with immune globulin other than hyqvia during the pregnancy. one mother discontinued from the registry before the expected delivery. of the eight pregnancies with known outcomes, there were eight live births. there were no specified labor or delivery complications. two out of 5 infants whose mothers took hyqvia during pregnancy had congenital abnormalities (cleft lip without cleft palate and talipes calcaneovalgus). data from the hyqvia pregnancy registry are insufficient to establish causality. the interpretation of the registry findings is limited by the small sample size, by the potential that selection bias may have increased enrollment of mothers of infants with congenital abnormalities, the absence of fetal outcomes in some exposed maternal-fetal pairs, and incomplete data on other potential etiologies. the following adverse events were identified in post-approval reports: spontaneous abortions and fetal deaths. the following congenital anomalies were identified in post-approval reports in infants whose mothers took hyqvia during pregnancy: cleft palate, atrial septal defect, ventricular septal defect, cleft lip, hypoplastic left heart syndrome (aortic atresia, mitral valve atresia), endocardial fibroelastosis, and tricuspid valve incompetence. because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. animal data: animal reproduction studies have not been conducted with immune globulin infusion 10% (human) component of hyqvia. development and reproductive toxicology studies have been conducted with rhuph20 in mice and rabbits [see nonclinical toxicology (13.2)] . no adverse effects on pregnancy were associated with anti-rhuph20 antibodies at a dose of 3 mg/kg rhuph20 in mice, which is 4800 times higher than the typical monthly human dose. no teratogenicity or signs of maternal toxicity were observed at doses up to 18 mg/kg, which is 28,800 times higher than the typical monthly human dose. doses of 9 and 18 mg/kg (14,400 and 28,800 times higher than the typical monthly human dose) in mice were associated with reduced fetal weight and an increased number of fetal resorptions. in these studies, maternal antibodies to rhuph20 were transferred to offspring in utero. the effects of antibodies to the rhuph20 component of hyqvia on the human embryo or on human fetal development are unknown. risk summary it is not known whether hyqvia can cause harm to the breastfed infant when administered to a lactating woman. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for hyqvia and any potential adverse effects on the breastfed infant from hyqvia or from the underlying maternal condition. data from the hyqvia pregnancy registry are insufficient to predict effects on the breastfed child from exposure to hyqvia through human milk. data animal data: in animal studies, maternal antibodies binding to rhuph20 were transferred to offspring during lactation. no adverse effects on pregnancy or offspring development were associated with anti-rhuph20 antibodies. the effects of antibodies that bind to rhuph20 of hyqvia transferred during human lactation are unknown. risk summary animal studies do not indicate direct or indirect harmful effects of (rhuph20) with respect to reproductive potential at the doses used for facilitating administration of ig 10% [see nonclinical toxicology (13.1)]. primary immunodeficiency (pi) the safety and effectiveness of hyqvia for the treatment of primary immunodeficiency have been established in pediatric patients 2 years and older. use of hyqvia for this indication is supported by evidence from the pivotal efficacy and safety study in 44 pediatric subjects (aged 2 to 16 years of age). results from pre-specified interim data analysis, where all subjects completed 12 months of participation (one year of observation period) in the study, indicated similar safety profiles to adults. no pediatric-specific dose requirements were necessary to achieve the desired serum igg levels. [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14.1)]. safety and effectiveness of hyqvia has not been evaluated in patients <2 years of age. chronic inflammatory demyelinating polyneuropathy (cidp) the safety and effectiveness of hyqvia for the treatment of cidp have not been established in pediatric patients under the age of 18 years. primary immunodeficiency (pi) hyqvia was evaluated in 7 subjects over age 65 in the pi clinical trial. the available data are too limited to draw safety conclusions. chronic inflammatory demyelinating polyneuropathy hyqvia was evaluated in 13 subjects over age 65 in the pivotal clinical trial. no clinically significant differences in safety were observed between those 13 elderly subjects and the subjects 18 to 65 years of age. use caution when administering hyqvia to patients age 65 and over who are judged to be at increased risk of developing thrombosis and acute renal insufficiency [see boxed warning, warnings and precautions (5.2, 5.6)] . do not exceed recommended doses and administer hyqvia at the minimum dose and infusion rate practicable.

মাল্টা - ইংরেজি - Medicines Authority

octapharma (ip) sprl alle de la recherche 65, 1070 (anderlecht), belgium - immunoglobulin g, human - solution for infusion - immunoglobulin g, human 100 mg i/ml - immune sera and immunoglobulins

মাল্টা - ইংরেজি - Medicines Authority

csl behring gmbh emil-von-behring-strasse 76, 35041 marburg, germany - immunoglobulin tetanus, human - solution for injection - immunoglobulin tetanus, human 250 iu - immune sera and immunoglobulins

মাল্টা - ইংরেজি - Medicines Authority

csl behring gmbh emil-von-behring-strasse 76, 35041 marburg, germany - immunoglobulin tetanus, human - solution for injection - immunoglobulin tetanus, human 250 iu - immune sera and immunoglobulins

নিউ জিলণ্ড - ইংরেজি - Medsafe (Medicines Safety Authority)

abbvie limited - risankizumab 150 mg/ml;   - solution for injection - 150 mg/ml - active: risankizumab 150 mg/ml   excipient: glacial acetic acid polysorbate 20 sodium acetate trihydrate trehalose dihydrate water for injection - psoriatic arthritis: skyrizi is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to or are intolerant to one or more disease modifying antirheumatic drugs (dmards). skyrizi may be used as monotherapy or in combination with a conventional synthetic disease modifying antirheumatic drug (csdmard).

নিউ জিলণ্ড - ইংরেজি - Medsafe (Medicines Safety Authority)

abbvie limited - risankizumab 150 mg/ml;   - solution for injection - 150 mg/ml - active: risankizumab 150 mg/ml   excipient: glacial acetic acid polysorbate 20 sodium acetate trihydrate trehalose dihydrate water for injection - psoriatic arthritis: skyrizi is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to or are intolerant to one or more disease modifying antirheumatic drugs (dmards). skyrizi may be used as monotherapy or in combination with a conventional synthetic disease modifying antirheumatic drug (csdmard).