Amerika Serikat - Inggris - NLM (National Library of Medicine)

csl behring ag - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - human immunoglobulin g 6 g - carimune® nf is indicated for the maintenance treatment of patients with primary immunodeficiencies (pid), e.g., common variable immunodeficiency, x-linked agammaglobulinemia, severe combined immunodeficiency.30,32-34 carimune® nf is preferable to intramuscular immune globulin (human) preparations in treating patients who require an immediate and large increase in the intravascular immunoglobulin level28 , in patients with limited muscle mass, and in patients with bleeding tendencies for whom intramuscular injections are contraindicated. the infusions must be repeated at regular intervals. please see dosage and administration section. a controlled study was performed in children in which carimune® was compared with steroids for the treatment of acute (defined as less than 6 months duration) itp. in this study sequential platelet levels of 30,000, 100,000, and 150,000/µl were all achieved faster with carimune® than with steroids and without any of the side effects associated with steroids.29,35 howeve

Amerika Serikat - Inggris - 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] )

Amerika Serikat - Inggris - 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

Amerika Serikat - Inggris - NLM (National Library of Medicine)

california department of public health - human botulinum neurotoxin a/b immune globulin (unii: x641y30oa7) (human botulinum neurotoxin a/b immune globulin - unii:x641y30oa7) - human botulinum neurotoxin a/b immune globulin 50 mg in 1 ml - babybig® , botulism immune globulin intravenous (human), is indicated for the treatment of infant botulism caused by toxin type a or b in patients below one year of age. - as with other immunoglobulin preparations, babybig should not be used in individuals with a prior history of severe reaction to other human immunoglobulin preparations.[1-4] - individuals with selective immunoglobulin a deficiency have the potential for developing antibodies to immunoglobulin a and could have anaphylactic reactions to the subsequent administration of blood products that contain immunoglobulin a. babybig has been studied for safety and efficacy only in patients below one year of age [see adverse reactions (6) and clinical studies (14) ]. it has not been tested in other populations. ndc 68403-1100-7 rx only 100 mg igg, 100 mg sucrose 20 mg albumin (human) lyophilized solvent detergent treated botulism immune globulin intravenous (human) (big-iv) babybig® store between 2°c and 8°c (35.6°f and 46.4°f).

Amerika Serikat - Inggris - NLM (National Library of Medicine)

sanofi-aventis u.s. llc - insulin human (unii: 1y17cti5sr) (insulin human - unii:1y17cti5sr) - insulin human 4

Amerika Serikat - Inggris - NLM (National Library of Medicine)

dispensing solutions, inc. - insulin lispro (unii: gfx7qis1ii) (insulin lispro - unii:gfx7qis1ii) - insulin lispro 100 [iu] in 1 ml - humalog is an insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus. humalog is contraindicated: - during episodes of hypoglycemia - in patients who are hypersensitive to humalog or to any of its excipients. pregnancy category b. all pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. this background risk is increased in pregnancies complicated by hyperglycemia and may be decreased with good metabolic control. it is essential for patients with diabetes or history of gestational diabetes to maintain good metabolic control before conception and throughout pregnancy. in patients with diabetes or gestational diabetes insulin requirements may decrease during the first trimester, generally increase during the second and third trimesters, and rapidly decline after delivery. careful monitoring of glucose control is essential in these patients. therefore, female patients should be advised to tell their physicians

Inggris - Inggris - MHRA (Medicines & Healthcare Products Regulatory Agency)

eli lilly and company ltd - insulin lispro; insulin lispro protamine - suspension for injection - 25unit/1ml ; 75unit/1ml

Inggris - Inggris - MHRA (Medicines & Healthcare Products Regulatory Agency)

eli lilly and company ltd - insulin lispro; insulin lispro protamine - suspension for injection - 50unit/1ml ; 50unit/1ml

Inggris - Inggris - MHRA (Medicines & Healthcare Products Regulatory Agency)

eli lilly and company ltd - insulin lispro; insulin lispro protamine - suspension for injection - 25unit/1ml ; 75unit/1ml

Inggris - Inggris - MHRA (Medicines & Healthcare Products Regulatory Agency)

eli lilly and company ltd - insulin lispro; insulin lispro protamine - suspension for injection - 50unit/1ml ; 50unit/1ml