Australien - engelska - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - rotavirus, quantity: 1000000 ccid50/dose - oral liquid, suspension - excipient ingredients: sucrose; water for injections; adipic acid; sodium hydroxide; glucose monohydrate; sodium chloride; potassium chloride; magnesium sulfate heptahydrate; ferric nitrate nonahydrate; dibasic sodium phosphate dihydrate; sodium pyruvate; folic acid; calcium pantothenate; inositol; choline chloride; nicotinamide; pyridoxine hydrochloride; thiamine hydrochloride; riboflavine; cystine; tyrosine; arginine; glycine; histidine; isoleucine; leucine; lysine; methionine; phenylalanine; threonine; tryptophan; serine; valine; glutamine; calcium chloride dihydrate; sodium bicarbonate - rotarix is indicated for the prevention of rotavirus gastroenteritis (see clinical trials).

Australien - engelska - Department of Health (Therapeutic Goods Administration)

sanofi-aventis healthcare pty ltd t/a sanofi consumer healthcare - fexofenadine hydrochloride, quantity: 6 mg/ml - oral liquid, suspension - excipient ingredients: xanthan gum; butyl hydroxybenzoate; propyl hydroxybenzoate; titanium dioxide; disodium edetate; purified water; monobasic sodium phosphate monohydrate; poloxamer; xylitol; propylene glycol; dibasic sodium phosphate heptahydrate; sucrose; flavour - relief of symptoms associated with seasonal allergic rhinitis and allergic rhinitis in adults and children from 2 years of age. relief of symptoms associated with urticaria in adults and children from 6 months of age.

Storbritannien - engelska - MHRA (Medicines & Healthcare Products Regulatory Agency)

valneva uk ltd - vibrio cholerae - oral suspension

Storbritannien - engelska - MHRA (Medicines & Healthcare Products Regulatory Agency)

novartis pharmaceuticals uk ltd - ciclosporin - oral solution - 100mg/1ml

USA - engelska - NLM (National Library of Medicine)

wyeth pharmaceuticals llc, a subsidiary of pfizer inc. - coral snake (micrurus fulvius) immune globulin antivenin (equine) (unii: y605xbm2gl) (coral snake (micrurus fulvius) immune globulin antivenin (equine) - unii:y605xbm2gl) - coral snake (micrurus fulvius) immune globulin antivenin (equine) 250 [arb'u] in 10 ml - north american coral snake antivenin (equine) is indicated only for the treatment of envenomation caused by bites of north american coral snakes - micrurus (including the eastern and texas varieties). risk summary there are no available human data that establish developmental toxicity related to the use of north american coral snake antivenin (equine). there are no available animal data informing the north american coral snake antivenin (equine)-associated risk. north american coral snake antivenin (equine) should be given to a pregnant woman only if clearly required. in the us general population, the background risk of major birth defects is 2–4% and of miscarriage is 15–20% in clinically recognized pregnancies. risk summary lactation studies have not been conducted with north american coral snake antivenin (equine). it is not known whether north american coral snake antivenin (equine) is excreted in human milk. north american coral snake antivenin (equine) should be administered to lactating women only if

Storbritannien - engelska - MHRA (Medicines & Healthcare Products Regulatory Agency)

alliance healthcare (distribution) ltd - chloral hydrate - oral solution - 100mg/1ml

Storbritannien - engelska - MHRA (Medicines & Healthcare Products Regulatory Agency)

alliance healthcare (distribution) ltd - chloral hydrate - oral solution - 40mg/1ml

Australien - engelska - APVMA (Australian Pesticides and Veterinary Medicines Authority)

elanco australasia pty ltd - calcium as calcium chloride hexahydrate - oral solution/suspension - calcium as calcium chloride hexahydrate mineral-calcium-salt active 13305.0 mg/100ml - nutrition & metabolism - cattle | beef | bos indicus | bos taurus | bovine | buffalo | bull | bullock | calf | cow | dairy cow | heifer | steer - calcium supplement | parturient paresis | hypocalcaemia | milk fever

USA - engelska - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - cyclosporine (unii: 83hn0gtj6d) (cyclosporine - unii:83hn0gtj6d) - cyclosporine 25 mg - neoral is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. neoral has been used in combination with azathioprine and corticosteroids. neoral is indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. neoral can be used in combination with methotrexate in rheumatoid arthritis patients who do not respond adequately to methotrexate alone. neoral is indicated for the treatment of adult, nonimmunocompromised patients with severe (i.e., extensive and/or disabling), recalcitrant, plaque psoriasis who have failed to respond to at least one systemic therapy (e.g., puva, retinoids, or methotrexate) or in patients for whom other systemic therapies are contraindicated or cannot be tolerated. while rebound rarely occurs, most patients will experience relapse with neoral as with other therapies upon cessation of treatment. neoral is contraindicated in patients with a hypersensitivity to cyclosporine or to any of the ingredients of the formulation. rheumatoid arthritis patients with abnormal renal function, uncontrolled hypertension, or malignancies should not receive neoral. psoriasis patients who are treated with neoral should not receive concomitant puva or uvb therapy, methotrexate or other immunosuppressive agents, coal tar or radiation therapy. psoriasis patients with abnormal renal function, uncontrolled hypertension, or malignancies should not receive neoral. although no adequate and well-controlled studies have been completed in children, transplant recipients as young as one year of age have received neoral with no unusual adverse effects. the safety and efficacy of neoral treatment in children with juvenile rheumatoid arthritis or psoriasis below the age of 18 have not been established. in rheumatoid arthritis clinical trials with cyclosporine, 17.5% of patients were age 65 or older. these patients were more likely to develop systolic hypertension on therapy, and more likely to show serum creatinine rises ≥ 50% above the baseline after 3 to 4 months of therapy. clinical studies of neoral in transplant and psoriasis patients did not include a sufficient number of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experiences have not identified differences in response 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.

Kanada - engelska - Health Canada

odan laboratories ltd - chloral hydrate - syrup - 500mg - chloral hydrate 500mg - miscellaneous anxiolytics sedatives and hypnotics