Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

e. fougera & co., a division of nycomed us inc. - bacitracin zinc (unii: 89y4m234es) (bacitracin - unii:58h6rwo52i), polymyxin b sulfate (unii: 19371312d4) (polymyxin b - unii:j2vz07j96k) - bacitracin zinc 500 in 1 g - bacitracin zinc and polymyxin b sulfate ophthalmic ointment is indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria. such infections encompass conjunctivitis, keratitis and keratoconjunctivitis, blepharitis and blepharoconjunctivitis. bacitracin zinc and polymyxin b sulfate ophthalmic ointment is contraindicated in individuals who have shown hypersensitivity to any of its components.

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

lupin pharmaceuticals,inc. - dextroamphetamine sulfate (unii: jj768o327n) (dextroamphetamine - unii:tz47u051fi) - dextroamphetamine sulfate 5 mg - dextroamphetamine sulfate tablets usp are indicated for: 1.         narcolepsy. 2.         attention deficit disorder with hyperactivity , as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 to 16 years) 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. known hypersensitivity to amphetamine products. during or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result). controlled substance dextroamphetamine sulfate is a schedule ii controlled substance. abuse dextroamphetamine sulfate has a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction (see warnings). dextroamphetamine sulfate can be diverted for non-medical use into illicit channels or distribution. abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. misuse and abuse of amphetamines may cause increased heart rate, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness; insomnia; decreased appetite; loss of coordination; tremors; flushed skin; vomiting; and/or abdominal pain. anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed with cns stimulants abuse and/or misuse. misuse and abuse of cns stimulants, including dextroamphetamine sulfate, can result in overdose and death (see overdosage), and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. dependence physical dependence dextroamphetamine sulfate may produce physical dependence. physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. withdrawal signs and symptoms after abrupt discontinuation or dose reduction following prolonged use of cns stimulants including dextroamphetamine sulfate include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation. tolerance dextroamphetamine sulfate may produce tolerance. tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose).

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

nucare pharmaceuticals,inc. - bacitracin zinc (unii: 89y4m234es) (bacitracin - unii:58h6rwo52i), polymyxin b sulfate (unii: 19371312d4) (polymyxin b - unii:j2vz07j96k) - bacitracin 500 [usp'u] in 1 g - polycin® ophthalmic ointment is indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria. such infections encompass conjunctivitis, keratitis and keratoconjunctivitis, blepharitis and blepharoconjunctivitis. polycin® ophthalmic ointment is contraindicated in individuals who have shown hypersensitivity to any of its components.

Տանզանիա - անգլերեն - Tanzania Medicinces & Medical Devices Authority

shelys pharmaceuticals limited, tanzania - glucose anhydrous bp , sodium chloride bp , potassium chloride bp , sodium citrate dihydrate bp - powder for oral solution - 20 gm + 1.5 gm + 35 gm + 2.9 gm

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

laboratoires dermo-cosmetik inc. - zinc oxide (unii: soi2loh54z) (zinc oxide - unii:soi2loh54z), titanium dioxide (unii: 15fix9v2jp) (titanium dioxide - unii:15fix9v2jp) - - helps prevent sunburn. - if used as directed with other sun protection measures (see directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

Հորդանան - անգլերեն - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

شركة جرش للصناعات الدوائية - jerash pharmacutical company - salicylic acid 6.540 gm, diethylamine 3.460 gm - 6.540 gm, 3.460 gm

Հորդանան - անգլերեն - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

شركة جرش للصناعات الدوائية - jerash pharmacutical company - salicylic acid 6.540 gm, diethylamine 3.460 gm - 6.540 gm, 3.460 gm

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

gm pharmaceuticals, inc - .beta.-carotene (unii: 01yae03m7j) (.beta.-carotene - unii:01yae03m7j), ascorbic acid (unii: pq6ck8pd0r) (ascorbic acid - unii:pq6ck8pd0r), cholecalciferol (unii: 1c6v77qf41) (cholecalciferol - unii:1c6v77qf41), .alpha.-tocopherol, dl- (unii: 7qwa1rio01) (.alpha.-tocopherol, dl- - unii:7qwa1rio01), thiamine hydrochloride (unii: m572600e5p) (thiamine ion - unii:4abt0j945j), riboflavin (unii: tlm2976ofr) (riboflavin - unii:tlm2976ofr), niacin (unii: 2679mf687a) (niacin - unii:2679mf687a), pyridoxine hydrochlo - .beta.-carotene 2500 [iu] - escavite® d multi-vitamin with iron and fluoride chewable tablets is a prescription drug product for the dietary management of the metabolic processes of caries prophylaxis, and provides supplementation of the diet with twelve essential vitamins, magnesium, zinc, copper and iron. escavite® d multi-vitamin with iron and fluoride chewable tablets provide 0.25 mg of fluoride in a chewable tablet form for children 4-6 years of age where the drinking water contains 0.3 through 0.6 ppm of fluoride. escavite® d multi-vitamin with iron and fluoride chewable tablets supply significant amounts of vitamins a, c, d, e, thiamine, riboflavin, niacin, vitamin b6, folate, vitamin b12, biotin, pantothenic acid, to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. thus, in a single easy-to-use preparation, children obtain twelve essential vitamins and the important minerals, magnesium, zinc, copper, iron and fluoride. the american academy of pediatrics recommends that chi

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - inclisiran sodium (unii: upc6btx7py) (inclisiran - unii:uow2c71pg5) - leqvio® is indicated as an adjunct to diet and statin therapy for the treatment of adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (hefh), to reduce low-density lipoprotein cholesterol (ldl-c). none. risk summary discontinue leqvio when pregnancy is recognized. alternatively, consider the ongoing therapeutic needs of the individual patient. inclisiran increases ldl-c uptake and lowers ldl-c levels in the circulation, thus decreasing cholesterol and possibly other biologically active substances derived from cholesterol; therefore, leqvio may cause fetal harm when administered to pregnant patients based on the mechanism of action [see clinical pharmacology (12.1)] . in addition, treatment of hyperlipidemia is not generally necessary during pregnancy. atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hyperlipidemia for most patients. there are no available data on the use of leqvio in pregnant patients to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, no adverse developmental effects were observed in rats and rabbits with subcutaneous administration of inclisiran during organogenesis at doses up to 5 to 10 times the maximum recommended human dose (mrhd) based on body surface area (bsa) comparison (see data ). no adverse developmental outcomes were observed in offspring of rats administered inclisiran from organogenesis through lactation at 5 times the mrhd based on bsa comparison (see data ). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%–4% and 15%–20%, respectively. data animal data in embryo-fetal development studies conducted in sprague-dawley rats and new zealand white rabbits, inclisiran was administered by subcutaneous injection at dose levels of 50, 100, and 150 mg/kg once daily during organogenesis (rats: gestation days 6 to 17; rabbits: gestation days 7 to 19). there was no evidence of embryo-fetal toxicity or teratogenicity at doses up to 5 and 10 times, respectively, the mrhd based on bsa comparison/dose. inclisiran crosses the placenta and was detected in rat fetal plasma at concentrations that were 65 to 154 times lower than maternal levels. in a pre- and postnatal development study conducted in sprague-dawley rats, inclisiran was administered once daily by subcutaneous injection at levels of 50, 100, and 150 mg/kg from gestation day 6 through lactation day 20. inclisiran was well-tolerated in maternal rats, with no evidence of maternal toxicity and no effects on maternal performance. there were no effects on the development of the f1 generation, including survival, growth, physical and reflexological development, behavior, and reproductive performance at doses up to 5 times the mrhd, based on bsa comparison/dose. risk summary there is no information on the presence of inclisiran in human milk, the effects on the breastfed infant, or the effects on milk production. inclisiran was present in the milk of lactating rats in all dose groups. when a drug is present in animal milk, it is likely that the drug will be present in human milk (see data ). oligonucleotide-based products typically have poor oral bioavailability; therefore, it is considered unlikely that low levels of inclisiran present in milk will adversely impact an infant’s development during lactation. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for leqvio and any potential adverse effects on the breastfed infant from leqvio or from the underlying maternal condition. data in lactating rats, inclisiran was detected in milk at mean maternal plasma:milk ratios that ranged between 0.361 and 1.79. however, there is no evidence of systemic absorption in the suckling rat neonates. the safety and effectiveness of leqvio have not been established in pediatric patients. of the 1,833 patients treated with leqvio in clinical studies, 981 (54%) patients were 65 years of age and older, while 239 (13%) patients were 75 years of age and older. no overall differences in safety or effectiveness were observed between patients 65 years of age and older and younger adult patients. no dose adjustments are necessary for patients with mild, moderate, or severe renal impairment [see clinical pharmacology (12.3)] . leqvio has not been studied in patients with end stage renal disease [see clinical pharmacology (12.3)] . no dose adjustment is necessary in patients with mild to moderate hepatic impairment. leqvio has not been studied in patients with severe hepatic impairment [see clinical pharmacology (12.3)] .

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

morton grove pharmaceuticals, inc. - doxepin hydrochloride (unii: 3u9a0fe9n5) (doxepin - unii:5asj6huz7d) - doxepin 10 mg in 1 ml - doxepin hydrochloride oral solution is recommended for the treatment of: - psychoneurotic patients with depression and/or anxiety. - depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol). - depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). - psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders. the target symptoms of psychoneurosis that respond particularly well to doxepin hydrochloride include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry. clinical experience has shown that doxepin hydrochloride is safe and well tolerated even in the elderly patient. owing to lack of clinical experience in the pediatric population, doxepin hydrochloride is not recommended for use in pediatric patients under 12