Egyesült Államok - angol - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - nitazoxanide (unii: soa12p041n) (nitazoxanide - unii:soa12p041n) - nitazoxanide tablets are indicated for the treatment of diarrhea caused by giardia lamblia or cryptosporidium parvum in patients 12 years and older. limitations of use nitazoxanide tablets have not been shown to be effective for the treatment of diarrhea caused by cryptosporidium parvum in hiv-infected or immunodeficient patients [ see clinical studies (14.2)]. nitazoxanide tablets are contraindicated in patients with a prior hypersensitivity to nitazoxanide or any other ingredient in the formulations. risk summary there are no data with nitazoxanide in pregnant women to inform a drug-associated risk. no teratogenicity or fetotoxicity was observed in animal reproduction studies with administration of nitazoxanide to pregnant rats and rabbits during organogenesis at exposure 30 and 2 times, respectively, the exposure at the maximum recommended human dose of 500 mg twice daily based on body surface area (bsa). in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data nitazoxanide was administered orally to pregnant rats at doses of 0, 200, 800 or 3200 mg/kg/day on gestation days 6 to 15. nitazoxanide produced no evidence of systemic maternal toxicity when administer once daily via oral gavage to pregnant female rats at levels up to 3200 mg/kg/day during the period of organogenesis . in rabbits, nitazoxanide was administered at doses of 0, 25, 50, or 100 mg/kg/day on gestation days 7 to 20. oral treatment of pregnant rabbits with nitazoxanide during organogenesis resulted in minimal maternal toxicity and no external fetal anomalies. risk summary no information regarding the presence of nitazoxanide in human milk, the effects on the breastfed infant, or the effects on milk production is available. the development and health benefits of breastfeeding should be considered along with the mother’s clinical need for nitazoxanide and any potential adverse effects on the breastfed infant from nitazoxanide or from the underlying maternal condition. the safety and efficacy of nitazoxanide tablets for the treatment of diarrhea caused by g. lamblia or c. parvum in pediatric patients 12 to 17 years of age has been established based on three (3) randomized, controlled studies with 47 pediatric subjects treated with nitazoxanide tablets [ see clinical studies (14)]. a single nitazoxanide tablet contains a greater amount of nitazoxanide than is recommended for use in pediatric patients 11 years or younger. therefore, nitazoxanide tablets should not be administered to peridatric patients 11 years of age or younger [ see dosage and administration (2)]. clinical studies of nitazoxanide tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. in general, the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in elderly patients should be considered when prescribing nitazoxanide tablets. the pharmacokinetics of nitazoxanide in patients with compromised renal or hepatic function has not been studied. nitazoxanide tablets have not been studied for the treatment of diarrhea caused by g. lamblia in hiv-infected or immunodeficient patients. nitazoxanide tablets have not been shown to be superior to placebo for the treatment of diarrhea caused by c. parvum in hiv-infected or immunodeficient patients [ see clinical studies (14)].

Szingapúr - angol - HSA (Health Sciences Authority)

its science & medical pte ltd - general & plastic surgery - the biopsy site marker is indicated to mark an open or percutaneous biopsy site to radiographically mark the location of the biopsy site.

Kanada - angol - Health Canada

emd serono, a division of emd inc., canada - cetrorelix (cetrorelix acetate) - powder for solution - 0.25mg - cetrorelix (cetrorelix acetate) 0.25mg - gonadotropin-releasing hormone antagonists

Kanada - angol - Health Canada

emd serono, a division of emd inc., canada - cetrorelix (cetrorelix acetate) - powder for solution - 3mg - cetrorelix (cetrorelix acetate) 3mg - gonadotropin-releasing hormone antagonists

Írország - angol - HPRA (Health Products Regulatory Authority)

gp-pharm, s.a. - leuprorelin acetate - powder and solvent for prolonged-release suspension for injection - 22.5 milligram(s) - gonadotropin releasing hormone analogues; leuprorelin

Szingapúr - angol - HSA (Health Sciences Authority)

medquest marketing pte ltd - general & plastic surgery - indicated to provide tissue samples for diagnostic sampling of breast abnormalities.

Szingapúr - angol - HSA (Health Sciences Authority)

medquest marketing pte ltd - general & plastic surgery - indicated to provide tissue samples for diagnostic sampling of breast abnormalities. the mammotome biopsy system is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. the mammotome biopsy system is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.

Egyesült Királyság - angol - VMD (Veterinary Medicines Directorate)

virbac s.a. - dimpylate -

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

thermo fisher scientific australia pty ltd - ct943 - instrument/analyser ivds - instruments designed to measure fluorescent signals of labelled dna and rna targets hybridized to affymetrix arrays that aid in the diagnosis of various physiological states or congenital abnormalities.