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

takeda pharmaceuticals australia pty ltd - nonacog gamma, quantity: 250 iu - injection, powder for - excipient ingredients: histidine; sodium chloride; calcium chloride dihydrate; mannitol; sucrose; polysorbate 80 - 1) routine prophylaxis of bleeding episodes in adults with haemophilia b,2) treatment and prevention of bleeding episodes in adults with haemophilia b (congenital factor ix deficiency),3) peri-operative management in adults with haemophilia b 1) routine prophylaxis of bleeding episodes in patients with haemophilia b 2) treatment and prevention of bleeding episodes in patients with haemophilia b (congenital factor ix deficiency) 3) peri-operative management in patients with haemophilia b

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

takeda pharmaceuticals australia pty ltd - nonacog gamma, quantity: 1000 iu - injection, powder for - excipient ingredients: histidine; sodium chloride; calcium chloride dihydrate; mannitol; sucrose; polysorbate 80 - 1) routine prophylaxis of bleeding episodes in adults with haemophilia b,2) treatment and prevention of bleeding episodes in adults with haemophilia b (congenital factor ix deficiency),3) peri-operative management in adults with haemophilia b 1) routine prophylaxis of bleeding episodes in patients with haemophilia b 2) treatment and prevention of bleeding episodes in patients with haemophilia b (congenital factor ix deficiency) 3) peri-operative management in patients with haemophilia b

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

takeda pharmaceuticals australia pty ltd - nonacog gamma, quantity: 3000 iu - injection, powder for - excipient ingredients: histidine; sodium chloride; calcium chloride dihydrate; mannitol; sucrose; polysorbate 80 - 1) routine prophylaxis of bleeding episodes in patients with haemophilia b 2) treatment and prevention of bleeding episodes in patients with haemophilia b (congenital factor ix deficiency) 3) peri-operative management in patients with haemophilia b

Canada - English - Health Canada

quest vitamins a div of purity life health products - gamma-linolenic acid (evening primrose oil); d-alpha tocopherol; vitamin a; vitamin d3; linoleic acid (evening primrose oil) - capsule - 80mg; 25unit; 2500unit; 100unit; 280mg - gamma-linolenic acid (evening primrose oil) 80mg; d-alpha tocopherol 25unit; vitamin a 2500unit; vitamin d3 100unit; linoleic acid (evening primrose oil) 280mg - multivitamin preparations

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 - 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

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

energique, inc. - .gamma.-aminobutyric acid (unii: 2acz6ipc6i) (.gamma.-aminobutyric acid - unii:2acz6ipc6i), levodopa (unii: 46627o600j) (levodopa - unii:46627o600j), norepinephrine (unii: x4w3enh1cv) (norepinephrine - unii:x4w3enh1cv), serotonin (unii: 333do1rdjy) (serotonin - unii:333do1rdjy), corticotropin (unii: k0u68q2txa) (corticotropin - unii:k0u68q2txa), semecarpus anacardium juice (unii: y0f0bu8rdu) (semecarpus anacardium juice - unii:y0f0bu8rdu), arsenic trioxide (unii: s7v92p67ho) (arsenic cation (3+) - un - .gamma.-aminobutyric acid 6 [hp_x] in 1 ml - for temporary relief of symptoms of attention deficit disorder, learning disabilities and hyperactivity.** **these statements are based upon traditional homeopathic practice. they have not been reviewed by the food and drug administration. for temporary relief of symptoms of attention deficit disorder, learning disabilities and hyperactivity.** **these statements are based upon traditional homeopathic practice. they have not been reviewed by the food and drug administration.

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

apotheca company - .gamma.-aminobutyric acid (unii: 2acz6ipc6i) (.gamma.-aminobutyric acid - unii:2acz6ipc6i), norepinephrine (unii: x4w3enh1cv) (norepinephrine - unii:x4w3enh1cv), serotonin (unii: 333do1rdjy) (serotonin - unii:333do1rdjy), semecarpus anacardium juice (unii: y0f0bu8rdu) (semecarpus anacardium juice - unii:y0f0bu8rdu), arsenic trioxide (unii: s7v92p67ho) (arsenic cation (3+) - unii:c96613f5av), barium carbonate (unii: 6p669d8hq8) (barium cation - unii:v645272hln), oyster shell calcium carbonate, crude (u - .gamma.-aminobutyric acid 30 [hp_c] in 1 ml - indications:   for temporary relief of symptoms of attention deficit disorder, learning disabilities and hyperactivity. indications:   for temporary relief of symptoms of attention deficit disorder, learning disabilities and hyperactivity.

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

horizon therapeutics usa, inc. - interferon gamma-1b (unii: 21k6m2i7ag) (interferon gamma-1b - unii:21k6m2i7ag) - interferon gamma-1b 100 ug in 0.5 ml - - actimmune is indicated for reducing the frequency and severity of serious infections associated with chronic granulomatous disease (cgd). - actimmune is indicated for delaying time to disease progression in patients with severe, malignant osteopetrosis (smo). actimmune is contraindicated in patients who develop or have known hypersensitivity to interferon gamma, e. coli derived products, or any component of the product. risk summary there are no adequate and well-controlled studies in pregnant women. actimmune should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. animal data actimmune has shown an increased incidence of abortions in primates when given from gestation day 20 to 80 in doses approximately 100 times the human dose. a study in pregnant primates treated with subcutaneous doses 2 – 100 times the human dose failed to demonstrate teratogenic activity for actimmune. female mice treated subcutaneously with recombinant murine ifn-interferon gamma (rmuifn-gamma) at 280 times the maximum recommended clinical dose of actimmune from shortly after birth through puberty but not during pregnancy had offspring which exhibited decreased body weight during the lactation period. the clinical significance of this finding observed following treatment of mice with rmuifn-gamma is uncertain. for lower doses, there is no evidence of maternal toxicity, embryotoxicity, fetotoxicity or teratogenicity in preclinical studies. risk summary it is not known whether actimmune is excreted in human milk. because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from actimmune, a decision should be made whether to discontinue nursing or to discontinue the drug, dependent upon the importance of the drug to the mother. infertility based on the information available, it cannot be excluded that the presence of higher levels of interferon gamma may impair male fertility and that in certain cases of female infertility increased levels of interferon gamma may have played a role [see nonclinical toxicology (13.1) ]. in younger patients, the long-term effect on fertility is also not known. the safety and effectiveness of actimmune has been established in pediatric patients aged 1 year and older in cgd patients and 1 month and older in smo patients [see clinical studies (14)]. there are no data available for pediatric patients below the age of 1 month. clinical studies of actimmune did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

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

apotheca company - .gamma.-aminobutyric acid (unii: 2acz6ipc6i) (.gamma.-aminobutyric acid - unii:2acz6ipc6i) - .gamma.-aminobutyric acid 30 [hp_c] in 1 ml - indications:   to be used according to standard homeopathic indications. indications: to be used according to standard homeopathic indications.