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

lupin pharmaceuticals, inc. - nitazoxanide (unii: soa12p041n) (nitazoxanide - unii:soa12p041n) - nitazoxanide 100 mg in 5 ml - diarrhea caused by giardia lamblia or cryptosporidium parvum: alinia for oral suspension (patients 1 year of age and older) and alinia tablets (patients 12 years and older) are indicated for the treatment of diarrhea caused by giardia lamblia or cryptosporidium parvum . limitations of use alinia for oral suspension and alinia 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)] alinia tablets and alinia for oral suspension are contraindicated in patients with a prior hypersensitivity to nitazoxanide or any other ingredient in the formulations. risk summary there are no data with alinia 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 alinia and any potential adverse effects on the breastfed infant from alinia or from the underlying maternal condition. the safety and efficacy of alinia for oral suspension for the treatment of diarrhea caused by g. lamblia or c. parvum in pediatric patients 1 to 11 years of age has been established based on three (3) randomized, controlled studies with 104 pediatric subjects treated with alinia for oral suspension 100 mg/5 ml. furthermore, the safety and efficacy of alinia for oral suspension 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 two (2) randomized controlled studies with 44 pediatric subjects treated with alinia for oral suspension 100 mg/5 ml. [ see clinical studies (14.1)] the safety and efficacy of alinia 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 alinia tablets 500 mg. a single alinia tablet contains a greater amount of nitazoxanide than is recommended for use in pediatric patients 11 years or younger. [ see dosage and administration (2.1)]. safety and efficacy of alinia for oral suspension in pediatric patients less than one year of age has not been studied. clinical studies of alinia tablets and alinia for oral suspension 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 alinia tablets and alinia for oral suspension. the pharmacokinetics of nitzoxanide in patients with compromised renal or hepatic function has not been studied. alinia tablets and alinia for oral suspension have not been studied for the treatment of diarrhea caused by g. lamblia in hiv-infected or immunodeficient patients. alinia tablets and alinia for oral suspension 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)]

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

thermo fisher scientific australia pty ltd - ct945 - general laboratoryware ivds - laboratoryware such as general reagents, laboratory products, and consumables to be used with thermo fisher scientific genetic analyzers.

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

thermo fisher scientific australia pty ltd - ct945 - general laboratoryware ivds - general laboratoryware ivds such as general reagents, laboratory products, buffers, balanced salts, cell culture media, consumables and biological stains that are intended to be used specifically as an ivd in the testing of clinical specimens within any discipline of a pathology laboratory.

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

telecore australia pty ltd -

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

pz cussons australia pty ltd - 9950 - disinfectant, hospital grade - other therapeutic

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

hydrix services pty ltd - 35777 - electroencephalographic spectrum analyser - the cortiq pro is intended to statistically evaluate brain activity reflected in a broad band of high-gamma frequencies in the human electroencephalogram (eeg). these measures should always be interpreted in conjunction with review of the original eeg waveform. the device must be used either by a medical expert, such as a medical doctor with expertise in neurology or neurosurgery, or by a medical technical expert such as neuroscience specialists. a user is only eligible to operate the device after completing device training.

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

collective mode pty ltd - 16730 - denture base resin, cured - this medical device is designed to be used in the dental laboratory to manufacture dental prosthesis or appliance (eg. denture base, occlusal splint/night guard) with heat, light, and/or time and shaped by cad/cam technology. it can be non-patient-worn devices (drilling templates using 3d printing).

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

collective mode pty ltd - 31783 - crown/bridge, temporary, polymer based - this device is a polymer material used in dentistry that is intended to be used for temporary or permanent restorations such as crowns, inlays, onlays, veneers and artificial teeth during dental restorative procedures.

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

advanced skin technology - zinc oxide, quantity: 227.5 mg/g - cream - excipient ingredients: coco-octanoate/decanoate; polyglyceryl-3 polyricinoleate; isostearic acid; purified water; xanthan gum; gluconolactone; sodium benzoate; glycerol; octyldodecanol; medium chain triglycerides; sodium chloride; peg-30 dipolyhydroxystearate; disodium edetate; iron oxide black; iron oxide yellow; iron oxide red; centella asiatica; argania spinosa kernel oil; cetearyl glucoside; cetostearyl alcohol - spf 50 plus broad spectrum very high protection sunscreen

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

hydrix services pty ltd - 46573 - physical therapy electrical stimulation system, battery-powered - recoverix pro is intended for: ? muscle re-education by powered muscle stimulation, and ? neurofeedback. the indication for use of recoverix pro for muscle re-education is given when the extensor digitorum communis muscles of the upper limb, or the tibialis anterior muscles of the lower limb which are partly or fully paralysed due to stroke, should be contracted to generate movement.