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

medi-physics, inc. dba ge healthcare - technetium tc-99m exametazime (unii: 3b744ag22n) (technetium tc-99m exametazime - unii:3b744ag22n) - ceretec, when reconstituted with technetium tc 99m exametazime (without cobalt stabilizer solution), is indicated in adults and pediatric patients age 2 to 17 for leukocyte labeled scintigraphy as an adjunct in the localization of intraabdominal infection and inflammatory bowel disease. ceretec, when reconstituted with technetium tc 99m exametazime (with or without cobalt stabilizer solution), is indicated in adults and pediatric patients age 2 to 17 for cerebral scintigraphy as an adjunct in the detection of altered regional cerebral perfusion in stroke. none risk summary limited available data with technetium tc 99m exametazime use in pregnant women are insufficient to inform any drug associated risks for major birth defects and miscarriage. technetium tc 99m exametazime is transferred across the placenta [see data]. animal reproduction studies with technetium tc 99m exametazime have not been conducted. however, all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. if considering technetium tc 99m exametazime administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from technetium tc 99m exametazime and the gestational timing of exposure. 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 estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data human data limited published literature describes tc 99m exametazime crossing the placental barrier and visualization of radioactivity in the fetal liver. no adverse fetal effects or radiation-related risks have been identified for diagnostic procedures involving less than 50 mgy, which represents less than 10 mgy fetal doses. risk summary there are limited data available in the scientific literature on the presence of technetium tc 99m exametazime in human milk. there are no data available regarding the effects of technetium tc 99m exametazime on the breastfed infant or on milk production. exposure of technetium tc 99m exametazime to a breast fed infant can be minimized by temporary discontinuation of breastfeeding [see clinical considerations ]. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ceretec and any potential adverse effects on the breastfed child from ceretec or from the underlying maternal condition. clinical considerations to decrease radiation exposure to the breastfed infant, advise a lactating woman to pump and discard breast milk after the administration of technetium tc 99m exametazime injection or technetium tc 99m exametazime-labeled leukocytes for 12 to 24 hours, where the duration corresponds to the typical range of administered activity, 259 mbq to 925 mbq (7 mci to 25 mci). ceretec is indicated for use in pediatric patients from 2 to 17 years of age for leukocyte labelled scintigraphy and brain scintigraphy. the use of ceretec for leukocyte labelled scintigraphy and brain scintigraphy is supported by extrapolation from clinical effectiveness in adults. the safety and dosing recommendations are based on clinical experience. safety and effectiveness in pediatric patients less than 2 years of age have not been established. clinical studies of ceretec did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. 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. this drug is known to be substantially excreted by the kidney, and radiation exposure may be greater in patients with impaired renal function. a reduction in administered tc 99m can be considered provided an adequate number of leukocytes are administered.

Ireland - English - HPRA (Health Products Regulatory Authority)

grampian pharmaceuticals ltd. - cobaltous sulphate heptahydrate - bovine - miscellaneous

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

international animal health products pty ltd - cobaltous sulfate heptahydrate | nicotinic acid | ferrous sulfate - monohydrate | copper sulfate - pentahydrate | manganese oxide | vitamin a = retinyl | choline bitartrate | vitamin b12 = cyanocobalamin | vitamin b5 calcium salt = calcium pantothenate | vitamin b2 = riboflavin | vitamin b1 = thiamine | vitamin b6 = pyridoxine | vitamin c = ascorbic acid | vitamin d3 = cholecalciferol | vitamin e-dl = alpha tocopherol-dl | vitamin m = folic acid = pga - nutrition & metabolism - dog | small animals | bitch | castrate | puppy - not applicable (vet)

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

deseret biologicals, inc. - american ginseng (unii: 8w75vcv53q) (american ginseng - unii:8w75vcv53q), ginkgo (unii: 19fuj2c58t) (ginkgo - unii:19fuj2c58t), centella asiatica (unii: 7m867g6t1u) (centella asiatica - unii:7m867g6t1u), lomatium dissectum root (unii: 5329928g5n) (lomatium dissectum root - unii:5329928g5n), cobalt (unii: 3g0h8c9362) (cobalt - unii:3g0h8c9362), copper (unii: 789u1901c5) (copper - unii:789u1901c5), gelsemium sempervirens root (unii: 639kr60q1q) (gelsemium sempervirens root - unii:639kr60q1q), iodine (u - american ginseng 3 [hp_x] in 1 ml - for temporary relief of symptoms related to general stress factors including mood swings, sleep difficulties, nausea and vomiting, poor digestion and headache.** **these statements are based upon traditional homeopathic principles. they have not been reviewed by the food and drug administration. for temporary relief of symptoms related to general stress factors including mood swings, sleep difficulties, nausea and vomiting, poor digestion and headache.** **these statements are based upon traditional homeopathic principles. they have not been reviewed by the food and drug administration.

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

energique, inc. - american ginseng (unii: 8w75vcv53q) (american ginseng - unii:8w75vcv53q), ginkgo (unii: 19fuj2c58t) (ginkgo - unii:19fuj2c58t), sus scrofa pancreas (unii: 9y3j3362ry) (sus scrofa pancreas - unii:9y3j3362ry), sus scrofa spleen (unii: 92amn5j79y) (sus scrofa spleen - unii:92amn5j79y), sus scrofa stomach (unii: t0920p9z9a) (sus scrofa stomach - unii:t0920p9z9a), germanium sesquioxide (unii: 96we91n25t) (germanium sesquioxide - unii:96we91n25t), cobalt (unii: 3g0h8c9362) (cobalt - unii:3g0h8c9362), nicke - american ginseng 3 [hp_x] in 1 ml - may temporarily relieve heaviness and fullness after eating little, stomach pain, and weak digestion.** **claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated. may temporarily relieve heaviness and fullness after eating little, stomach pain, weak digestion.** **claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated.

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

energique, inc. - american ginseng (unii: 8w75vcv53q) (american ginseng - unii:8w75vcv53q), ginkgo (unii: 19fuj2c58t) (ginkgo - unii:19fuj2c58t), sus scrofa pancreas (unii: 9y3j3362ry) (sus scrofa pancreas - unii:9y3j3362ry), sus scrofa spleen (unii: 92amn5j79y) (sus scrofa spleen - unii:92amn5j79y), sus scrofa stomach (unii: t0920p9z9a) (sus scrofa stomach - unii:t0920p9z9a), germanium sesquioxide (unii: 96we91n25t) (germanium sesquioxide - unii:96we91n25t), cobalt (unii: 3g0h8c9362) (cobalt - unii:3g0h8c9362), nicke - american ginseng 3 [hp_x] in 1 ml - spleen, pancreas, stomach support.** **these statements are based upon traditional homeopathic practice. they have not been reviewed by the food and drug administration. spleen, pancreas, stomach support.** **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)

deseret biologicals, inc. - solidago virgaurea 1x, asparagus officinalis 2x, juniperus communis 2x, sabal serrulata 2x, uva-ursi 2x, berberis vulgaris 3x, equisetum arvense 3x, rhus aromatica 3x, urtica dioica 3x, cantharis 6x, rubia tinctorum 6x, staphysagria 6x, beech 8x, cobaltum metallicum 8x, glandula suprarenalis suis 8x, gorse 8x, hepar sulphuris calcareum 8x, kidney (suis) 8x, larch 8x, manganum metallicum 8x, mimulus 8x, nitricum acidum 8x, silicea 8x, benzoicum acidum 12x -

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

deseret biologicals, inc. - beta vulgaris (unii: 4g174v5051) (beta vulgaris - unii:4g174v5051), peumus boldus leaf (unii: q4ewm09m3o) (peumus boldus leaf - unii:q4ewm09m3o), chelidonium majus (unii: 7e889u5rnn) (chelidonium majus - unii:7e889u5rnn), petroselinum crispum (unii: 1wza4y92ex) (petroselinum crispum - unii:1wza4y92ex), taraxacum officinale (unii: 39981fm375) (taraxacum officinale - unii:39981fm375), arsenic trioxide (unii: s7v92p67ho) (arsenic cation (3+) - unii:c96613f5av), cobalt (unii: 3g0h8c9362) (cobalt - unii:3 - beta vulgaris 3 [hp_x] in 1 ml - for temporary relief of symptoms related to food additives, herbicides and insecticides including muscle weakness, skin irritation, poor muscle coordination, headache, cough, diarrhea, dizziness, fatigue, fever, stomach pain and vomiting.** **these statements are based upon homeopathic principles. they have not been reviewed by the food and drug administration. for temporary relief of symptoms related to food additives, herbicides and insecticides including muscle weakness, skin irritation, poor muscle coordination, headache, cough, diarrhea, dizziness, fatigue, fever, stomach pain and vomiting.** **these statements are based upon homeopathic principles. they have not been reviewed by the food and drug administration.

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

bioactive nutritional, inc. - pork heart (unii: x876kjm95l) (pork heart - unii:x876kjm95l), pork intestine (unii: 40gmi0r60l) (pork intestine - unii:40gmi0r60l), germanium sesquioxide (unii: 96we91n25t) (germanium sesquioxide - unii:96we91n25t), cobalt (unii: 3g0h8c9362) (cobalt - unii:3g0h8c9362), cysteine (unii: k848jz4886) (cysteine - unii:k848jz4886), manganese (unii: 42z2k6zl8p) (manganese - unii:42z2k6zl8p), manganese gluconate (unii: 9yy2f980sv) (manganese cation (2+) - unii:h6ep7w5457), .alpha.-ketoglutaric acid (unii: 8i - for temporary relief of inflammation of bones, bone & joint pain, worse in morning, fatigue and agitation, pain in back & soreness, worse while sitting, growing pains & weak ankles.  for temporary relief of inflammation of bones, bone & joint pain, worse in morning, fatigue and agitation, pain in back & soreness, worse while sitting, growing pains & weak ankles.

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

warsan homoeopathic laboratories - bryonia alba root (unii: t7j046yi2b) (bryonia alba root - unii:t7j046yi2b), calcium fluoride (unii: o3b55k4yki) (fluoride ion - unii:q80vpu408o), amanita muscaria fruiting body (unii: dif093i037) (amanita muscaria fruiting body - unii:dif093i037), pseudognaphalium obtusifolium (unii: 36xq854nww) (pseudognaphalium obtusifolium - unii:36xq854nww), hypericum perforatum (unii: xk4iux8mnb) (hypericum perforatum - unii:xk4iux8mnb), arnica montana (unii: o80ty208zw) (arnica montana - unii:o80ty208zw), cobalt - temporary relief from lower back pain, pain that starts in lower back and goes down in leg(s).. temporary relief from lower back pain, pain that starts in lower back and goes down in leg(s).