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

legacy pharmaceutical packaging, llc - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride 500 mg - metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. metformin hydrochloride tablets are contraindicated in patients with: - severe renal impairment (egfr below 30 ml/min/1.73 m2) [see warnings and precautions (5.1)]. - hypersensitivity to metformin. - acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. risk summary limited data with metformin hydrochloride tablets in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk [see data]. there are risks to the mother and fetus associated with poorly controlled diabetes mellitus in pregnancy [see clinical considerations ]. no adverse developmental effects were observed when met

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

direct_rx - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. metformin hydrochloride tablets are contraindicated in patients with: severe renal impairment (egfr below 30 ml/min/1.73 m2) [see warnings and precautions (5.1)]. hypersensitivity to metformin. acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. 8.1 pregnancy risk summary limited data with metformin hydrochloride tablets in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk [see data]. there are risks to the mother and fetus associated with poorly controlled diabetes mellitus in pregnancy [see clinical considerations]. no adverse developmental effects were obs

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

direct_rx - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. 8.1 pregnancy risk summary limited data with metformin hydrochloride tablets in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk [see data]. there are risks to the mother and fetus associated with poorly controlled diabetes mellitus in pregnancy [see clinical considerations]. no adverse developmental effects were observed when metformin was administered to pregnant sprague dawley rats and rabbits during the period of organogenesis at doses up to 2- and 5-times, respectively, a 2550 mg clinical dose, based on body surface area [see data]. the estimated background risk of major birth defects is 6 to 10% in wo

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

direct_rx - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. metformin hydrochloride tablets are contraindicated in patients with: severe renal impairment (egfr below 30 ml/min/1.73 m2) [see warnings and precautions (5.1)]. hypersensitivity to metformin. acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. 8.1 pregnancy risk summary limited data with metformin hydrochloride tablets in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk [see data]. there are risks to the mother and fetus associated with poorly controlled diabetes mellitus in pregnancy [see clinical considerations]. no adverse developmental effects were obs

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)

legacy pharmaceutical packaging, llc - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride 500 mg - metformin hydrochloride tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. metformin hydrochloride extended-release tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. metformin hydrochloride tablets and metformin hydrochloride extended-release tablets are contraindicated in patients with: 1.  severe renal impairment (egfr below 30 ml/min/1.73m 2  (see warnings and precautions ). 2.  known hypersensitivity to metformin hydrochloride. 3.  acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. diabetic ketoacidosis should be treated with insulin.

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

guna spa - melatonin (unii: jl5dk93rcl) (melatonin - unii:jl5dk93rcl), acetylcysteine (unii: wyq7n0bpyc) (acetylcysteine - unii:wyq7n0bpyc), strychnos nux-vomica seed (unii: 269xh13919) (strychnos nux-vomica seed - unii:269xh13919), penicillium glabrum (unii: 2in23yue0i) (penicillium glabrum - unii:2in23yue0i), rhodotorula rubra (unii: 15w81v867r) (rhodotorula rubra - unii:15w81v867r), sus scrofa stomach (unii: t0920p9z9a) (sus scrofa stomach - unii:t0920p9z9a), sus scrofa superior gastric plexus (unii: f4679cee - epinephrine 9 [hp_c] in 4 g - temporarily relieves symptoms of stress, such as: - restlessness

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

guna spa - turmeric (unii: 856yo1z64f) (turmeric - unii:856yo1z64f), angelica sinensis root (unii: b66f4574ug) (angelica sinensis root - unii:b66f4574ug), arnica montana (unii: o80ty208zw) (arnica montana - unii:o80ty208zw), silybum marianum seed (unii: u946sh95ee) (silybum marianum seed - unii:u946sh95ee), echinacea angustifolia (unii: vb06av5us8) (echinacea angustifolia - unii:vb06av5us8), asian ginseng (unii: cuq3a77yxi) (asian ginseng - unii:cuq3a77yxi), pork liver (unii: 6ec706hi7f) (pork liver - unii:6ec7 - angelica sinensis root 3 [hp_x] in 4 g - angelica sinensis, radix    3x    detoxification arnica montana            4x, 6x, 8x    anti-inflammation carduus marianus        3x    detoxification echinacea angustifolia        3x    immune support ginseng                1x    improve stamina hepar                4c    detoxification interferon gamma        4c 7c    immune support ling chi mushroom        8x    antioxidant lymphatic gland            4c    immune support paeonia officinalis        3x    immune support turkey tail            8x    antioxidant turmeric            3x    pain relief for the temporary relief of symptoms due to sore throat, such as: •mild discomfort with swallowing •run-down feeling directions : turn tube upside down and rotate cap to release pellets into cap. unscrew cap and without touching pellets tip them into the mouth under the tongue. allow to dissolve t

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

guna spa - onion (unii: 492225q21h) (onion - unii:492225q21h), apis mellifera (unii: 7s82p3r43z) (apis mellifera - unii:7s82p3r43z), aralia racemosa root (unii: t90w4582du) (aralia racemosa root - unii:t90w4582du), silver nitrate (unii: 95it3w8jze) (silver cation - unii:57n7b0k90a), ascorbic acid (unii: pq6ck8pd0r) (ascorbic acid - unii:pq6ck8pd0r), black currant (unii: 9755t40d11) (black currant - unii:9755t40d11), helianthemum canadense (unii: 46g3w789q3) (helianthemum canadense - unii:46g3w789q3), copper (un - onion 8 [hp_x] in 30 ml - alium cepa            6x, 8x, 12x    expectorant apis mellifica            12x, 30x, 200x    decongestant aralia racemosa            1x    antitussive argentum nitricum        10x    analgesic ascorbic acid            2x    antioxidant black currant, bark         1x    detoxification cistus canadensis        4x    helps bronchial secretion cuprum metallicum        4x    antioxidant euphorbium officinarum        4x    mucolytic histaminum hydrochloricum    30x, 200x    anti-inflammatory interferon gamma        4c    antiviral interleukin 10            4c    anti-inflammatory interleukin 12            4c    supports immune activity manganese gluconate        4x    decongestant melilotus officinalis         3x    decongestant plantago major            2x    detoxification rosa canina, bark   

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

guna spa - ambrosia artemisiifolia (unii: 9w34l2cq9a) (ambrosia artemisiifolia - unii:9w34l2cq9a), arundo pliniana root (unii: zxe7lb03wc) (arundo pliniana root - unii:zxe7lb03wc), asclepias curassavica (unii: jsz93e47ep) (asclepias curassavica - unii:jsz93e47ep), black currant (unii: 9755t40d11) (black currant - unii:9755t40d11), citric acid monohydrate (unii: 2968phw8qp) (anhydrous citric acid - unii:xf417d3psl), histamine dihydrochloride (unii: 3poa0q644u) (histamine - unii:820484n8i3), interferon gamma-1b (u - ambrosia artemisiifolia 18 [hp_x] in 30 ml - ambrosia artemisiifolia 18x ragweed sensitivity arundo mauritanica 18x detoxification activity asclepias vincetoxicum 6x, 10x, 30x immune support black currant 1x detoxification activity citricum acidum 6x antioxidant histaminum hydrochloricum 12x, 30x, 200x antihistamine interferon gamma 4c immune support interleukin 12 4c immune support manganese gluconate 4x immune support natrum pyruvicum 6x anti-allergy natrum sulf 12x, 30x, 200x metabolic support parietaria officinalis 18x pellitory of the wall sensitivity phleum pratense 18x timothy sensitivity serum anguillae 12x, 30x, 200x anti-allergy succinicum acidum 6x metabolic support sulfur 12x, 30x, 200x skin detoxification urtica urens 18