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

aft pharmaceuticals pty ltd - fosaprepitant dimeglumine, quantity: 245.3 mg (equivalent: fosaprepitant, qty 150 mg) - injection, powder for - excipient ingredients: dilute hydrochloric acid; polysorbate 80; lactose; disodium edetate; sodium hydroxide - fosaprepitant-aft, in combination with other antiemetic agents, is indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of:,? highly emetogenic cancer chemotherapy (see section 4.2 dose and method of administration),? moderately emetogenic cancer chemotherapy (see section 4.2 dose and method of administration).

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

camber pharmaceuticals, inc. - diatrizoate meglumine (unii: 3x9mr4n98u) (diatrizoic acid - unii:5uvc90j1lk), diatrizoate sodium (unii: v5403h8vg7) (diatrizoic acid - unii:5uvc90j1lk) - diatrizoate meglumine and diatrizoate sodium solution is indicated for radiographic examination of segments of the gastrointestinal tract (esophagus, stomach, proximal small intestine, and colon). the preparation is particularly indicated when a more viscous agent such as barium sulfate, which is not water-soluble, is not feasible or is potentially dangerous. diatrizoate meglumine and diatrizoate sodium solution may also be used as an adjunct to contrast enhancement in computed tomography of the torso (body imaging); the preparation is indicated, in conjunction with intravenous administration of a radiopaque contrast agent, when unenhanced imaging may not provide sufficient definition in distinguishing normal loops of bowel from adjacent organs or areas of suspected pathology. do not administer to patients with a known hypersensitivity to diatrizoate meglumine and diatrizoate sodium solution or any of its components.

New Zealand - English - Medsafe (Medicines Safety Authority)

bayer new zealand limited - meglumine amidotrizoate 660 mg/ml (formed from melgumine and amidotrizoic acid); sodium amidotrizoate 100 mg/ml (formed from sodium hydroxide and amidotrizoic acid) - oral solution - active: meglumine amidotrizoate 660 mg/ml (formed from melgumine and amidotrizoic acid) sodium amidotrizoate 100 mg/ml (formed from sodium hydroxide and amidotrizoic acid) excipient: anise oil disodium edetate polysorbate 80 purified water saccharin sodium

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

dent-mat holdings, llc. - sodium fluoride (unii: 8zyq1474w7) (fluoride ion - unii:q80vpu408o), potassium nitrate (unii: ru45x2jn0z) (nitrate ion - unii:t93e9y2844) - fluoride ion 5 mg in 1 g - fluoridex toothpaste is indicated for use as part of a professional program for the prevention and control of dental caries. do not use in children under 12 years of age unless recommended by a dentist or physician. 8.1 pregnancy pregnancy category b it has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissues. animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of skeletal or visceral malformations. there are no adequate or well controlled clinical studies in pregnant women. however, epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in chi

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

dent-mat holdings, llc. - potassium nitrate (unii: ru45x2jn0z) (nitrate ion - unii:t93e9y2844), sodium fluoride (unii: 8zyq1474w7) (fluoride ion - unii:q80vpu408o) - fluoridex toothpaste is indicated for use as part of a professional program for the prevention and control of dental caries. do not use in children under 6 years of age unless recommended by a dentist or physician. 8.1 pregnancy pregnancy category b it has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissues. animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of skeletal or visceral malformations. there are no adequate or well controlled clinical studies in pregnant women. however, epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in chil

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

den-mat holdings, llc. - sodium fluoride (unii: 8zyq1474w7) (fluoride ion - unii:q80vpu408o) - fluoridex toothpaste is indicated for use as part of a professional program for the prevention and control of dental caries. do not use in children under 6 years of age unless recommended by a dentist or physician. 1 pregnancypregnancy category b it has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissues. animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of skeletal or visceral malformations. there are no adequate or well controlled clinical studies in pregnant women. however, epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in childho

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

den-mat holdings, llc. - sodium fluoride (unii: 8zyq1474w7) (fluoride ion - unii:q80vpu408o) - fluoridex toothpaste is indicated for use as part of a professional program for the prevention and control of dental caries. do not use in children under 6 years of age unless recommended by a dentist or physician. 1 pregnancypregnancy category b it has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissues. animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of skeletal or visceral malformations. there are no adequate or well controlled clinical studies in pregnant women. however, epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in childho

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

den-mat holdings, llc. - sodium fluoride (unii: 8zyq1474w7) (fluoride ion - unii:q80vpu408o) - fluoridex toothpaste is indicated for use as part of a professional program for the prevention and control of dental caries. do not use in children under 6 years of age unless recommended by a dentist or physician. 8.1 pregnancypregnancy category b it has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissues. animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of skeletal or visceral malformations. there are no adequate or well controlled clinical studies in pregnant women. however, epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in child

New Zealand - English - Medsafe (Medicines Safety Authority)

bayer new zealand limited - meglumine gadopentetate 469 mg/ml (formed from gadolinium oxide, diethylenetriamine pentetic acid & meglumine) - solution for injection - 469 mg/ml - active: meglumine gadopentetate 469 mg/ml (formed from gadolinium oxide, diethylenetriamine pentetic acid & meglumine) excipient: meglumine pentetic acid water for injection

New Zealand - English - Medsafe (Medicines Safety Authority)

bayer new zealand limited - meglumine gadopentetate 469 mg/ml (formed from gadolinium oxide, diethylenetriamine pentetic acid & meglumine) - solution for injection - 469 mg/ml - active: meglumine gadopentetate 469 mg/ml (formed from gadolinium oxide, diethylenetriamine pentetic acid & meglumine) excipient: meglumine pentetic acid water for injection - for diagnostic use by intravenous administration only. cranial and spinal magnetic resonance imaging (mri) in particular for the demonstration of tumours and for further differential-diagnostic clarification in suspected meningioma, (acoustic) neurinoma, invasive tumours (e.g. glioma) and metastases; for the demonstration of small and/or isointense tumours; in suspected recurrence after surgery or radiotherapy; for the differentiated demonstration of rare neoplasms such as haemangioblastomas, ependymomas and small pituitary adenomas; for improved determination of the spread of tumours not of cerebral origin. additionally in spinal mri: differentiation of intra- and extramedullary tumours; demonstration of solid tumour areas in known syrinx; determination of intramedullary tumour spread. whole body mri including the facial skull, the neck region, the thoracic and abdominal space, the female breast, the pelvis and the active and passive locomotive apparatus and imaging of vessels throughout the body. in particular, magnevist permits diagnostic information: · for the demonstration or exclusion of tumours, inflammation and vascular lesions; · for determination of the spread and demarcation of these lesions; · for the differentiation of the internal structure of lesions; · for assessment of the circulatory situation of normal and pathologically changed tissues; · for the differentiation of tumour and scar tissue after therapy; · for the recognition of recurrent prolapse of a disk after surgery. · for the semi-quantitative evaluation of the renal function combined with anatomical organ diagnosis.