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

ucb pharma, inc. - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - tablet - 5 mg - attention deficit disorders (previously known as minimal brain dysfunction in children). other terms being used to describe the behavioral syndrome below include: hyperkinetic child syndrome, minimal brain damage, minimal cerebral dysfunction, minor cerebral dysfunction. methylphenidate hydrochloride is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. the diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. nonlocalizing (soft) neurological signs, learning disability, and abnormal eeg may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. spec

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

bryant ranch prepack - travoprost (unii: wj68r08kx9) (travoprost - unii:wj68r08kx9) - travoprost ophthalmic solution 0.004% is indicated for the reduction of elevated intraocular pressure (iop) in patients with open-angle glaucoma or ocular hypertension. none. risk summary there are no adequate and well-controlled studies in pregnant women to inform a drug-associated risk. in animal reproduction studies, subcutaneous (sc) administration of travoprost to pregnant mice and rats throughout the period of organogenesis produced embryo-fetal lethality, spontaneous abortion, and premature delivery at potentially clinically relevant doses. advise pregnant women of a potential risk to a fetus. because animal reproductive studies are not always predictive of human response, travoprost ophthalmic solution should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus. the background risk of major birth defects and miscarriage for the indicated population is unknown; however, in the u.s. general population, the estimated background risk of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. data animal data an embryo-fetal study was conducted in pregnant rats administered travoprost once daily by sc injection from gestation day (gd) 6 to 18, to target the period of organogenesis. at 10 mcg/kg (60 times the maximum recommended human ocular dose [mrhod], based on estimated plasma cmax ), travoprost was teratogenic in rats, evidenced by an increase in the incidence of skeletal malformations as well as external and visceral malformations, including fused sternebrae, domed head and hydrocephaly. travoprost caused post-implantation loss at 10 mcg/kg. the no observed adverse effect level (noael) for post-implantation loss was 3 mcg/kg (18 times the mrhod, based on estimated plasma cmax ). the maternal noael was 10 mcg/kg. an embryo-fetal study was conducted in pregnant mice administered travoprost once daily by sc injection from gd 6 to 11, to target the period of organogenesis. at 1 mcg/kg (6 times the mrhod, based on estimated plasma cmax ), travoprost caused postimplantation loss and decreased fetal weight. the no observed adverse effect level (noael) for malformations was 0.3 mcg/kg (2 times the mrhod, based on estimated plasma cmax ). the maternal noael was 1 mcg/kg. pre/postnatal studies were conducted in rats administered travoprost once daily by subcutaneous injection from gd 7 (early embryonic period) to postnatal day 21 (end of lactation period). at doses of greater than or equal to 0.12 mcg/kg/day (0.7 times the mrhod, based on estimated plasma cmax ), adverse pregnancy outcomes (embryo-fetal lethality, abortion, and early delivery), low-birth weight and developmental delays were observed. the noael for adverse pregnancy outcomes, low-birth weight and developmental delay was 0.1 mcg/kg (0.6 times the mhrod, based on estimated plasma cmax ). the noael for maternal toxicity was 0.72 mcg/kg (4 times the mhrod, based on estimated plasma cmax ). risk summary there are no data on the effects of travoprost on the breastfed child or milk production. it is not known if travoprost is present in human milk following ophthalmic administration. a study in lactating rats demonstrated that radio-labeled travoprost and/or its metabolites were excreted in milk following subcutaneous administration. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for travoprost ophthalmic solution and any potential adverse effects on the breastfed child from travoprost ophthalmic solution. use in pediatric patients below the age of 16 years is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use. no overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients. travoprost ophthalmic solution 0.004% has been studied in patients with hepatic impairment and also in patients with renal impairment. no clinically relevant changes in hematology, blood chemistry, or urinalysis laboratory data were observed in these patients.

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

medtronic australasia pty ltd - 44074 - programmer, implantable infusion pump - software to programme the synchromed ii pump a device used to change, noninvasive, one or more of the operating parameters (the programmers) of an implanted infusion pump.

Philippines - English - FDA (Food And Drug Administration)

carl zeiss meditec ag - jena germany -

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

state of florida doh central pharmacy - triamterene (unii: ws821z52lq) (triamterene - unii:ws821z52lq), hydrochlorothiazide (unii: 0j48lph2th) (hydrochlorothiazide - unii:0j48lph2th) - triamterene 37.5 mg - this fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked. - triamterene and hydrochlorothiazide tablets are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. - triamterene and hydrochlorothiazide is also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked (e.g., patients on concomitant digitalis preparations, or with a history of cardiac arryhthmias, etc.). triamterene and hydrochlorothiazide may be used alone or in combination with other antihypertensive drugs, such as beta-blockers. since triamterene and hydrochlorothiazide may enhance the actions of these drugs, dosage adjustments may be necessary. the routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. diuretics do not prevent developme

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

nucare pharmaceuticals,inc. - carbamide peroxide (unii: 31pz2vau81) (hydrogen peroxide - unii:bbx060an9v) - earwax removal aid for occasional use as an aid to soften, loosen and remove excessive ear wax.

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

henry schein, inc. - water (unii: 059qf0ko0r) (water - unii:059qf0ko0r) - this parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered. sterile water for injection, usp must be made approximately isotonic prior to use.

Canada - English - Health Canada

merle norman cosmetics inc - avobenzone; homosalate; octisalate; octocrylene; oxybenzone - emulsion - 3.0%; 8.0%; 4.0%; 2.35%; 5.0% - avobenzone 3.0%; homosalate 8.0%; octisalate 4.0%; octocrylene 2.35%; oxybenzone 5.0% - sunscreen agents

Canada - English - Health Canada

prime enterprises, llc. - avobenzone; homosalate; octisalate; octocrylene; oxybenzone - lotion - 3.0%; 7.5%; 5.0%; 2.75%; 2.0% - avobenzone 3.0%; homosalate 7.5%; octisalate 5.0%; octocrylene 2.75%; oxybenzone 2.0% - sunscreen agents

Canada - English - Health Canada

abbvie corporation - carboxymethylcellulose sodium; glycerine; polysorbate 80 - solution - 0.5%; 1%; 0.5% - carboxymethylcellulose sodium 0.5%; glycerine 1%; polysorbate 80 0.5% - artificial tears