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

mylan pharmaceuticals inc. - miconazole nitrate (unii: vw4h1cyw1k) (miconazole - unii:7nno0d7s5m), zinc oxide (unii: soi2loh54z) (zinc oxide - unii:soi2loh54z), petrolatum (unii: 4t6h12bn9u) (petrolatum - unii:4t6h12bn9u) - vusion ointment is indicated for the adjunctive treatment of diaper dermatitis only when complicated by documented candidiasis (microscopic evidence of pseudohyphae and/or budding yeast), in immunocompetent pediatric patients 4 weeks and older. a positive fungal culture for candida albicans is not adequate evidence of candidal infection since colonization with c. albicans can result in a positive culture. the presence of candidal infection should be established by microscopic evaluation prior to initiating treatment. vusion should be used as part of a treatment regimen that includes measures directed at the underlying diaper dermatitis, including gentle cleansing of the diaper area and frequent diaper changes. vusion should not be used as a substitute for frequent diaper changes. the safety and efficacy of vusion have not been demonstrated in immunocompromised patients, or in infants less than 4 weeks of age (premature or term). the safety and efficacy of vusion have not been evaluated in incontinent adult

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

lannett company, inc. - amphetamine sulfate (unii: 6dpv8nk46s) (amphetamine - unii:ck833kgx7e) - amphetamine sulfate tablets, usp 5 mg and 10 mg are indicated for: - narcolepsy - 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 children with 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 the 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 not be warranted. - exogenous obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patients refractory to alternative therapy, e.g., repeated diets, group programs, and other drugs. the limited usefulness of amphetamines (see clinical pharmacology ) should be weighed against possible risks inherent in use of the drug, such as those described below. - known hypersensitivity to amphetamine products. - during or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result) (see warnings ). controlled substance amphetamine sulfate tablets contain amphetamine, a schedule ii controlled substance. abuse amphetamine sulfate has a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction (see warnings ). amphetamine 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 amphetamine 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 amphetamine 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 amphetamine sulfate include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation. tolerance amphetamine 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).

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

umoja pharmaceutical company ltd, tanzania - zinc oxide plaster 2.5cm -

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

umoja pharmaceutical company ltd, tanzania - zinc oxide plaster 5cm x 5m -

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

umoja pharmaceutical company ltd, tanzania - zinc oxide plaster 7.5cm -

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

umoja pharmaceutical company ltd, tanzania - zinc oxide plaster 10cm -

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

sigma company limited - zinc oxide, quantity: 2.49 mg (equivalent: zinc, qty 2 mg); allium sativum, quantity: 10 mg (equivalent: allium sativum, qty 500 mg); d-alpha-tocopheryl acid succinate, quantity: 86.09 mg; ascorbic acid, quantity: 250.07 mg; betacarotene, quantity: 3 mg; echinacea purpurea, quantity: 20 mg (equivalent: echinacea purpurea, qty 1 g) - tablet, film coated - excipient ingredients: titanium dioxide; colloidal anhydrous silica; macrogol 400; croscarmellose sodium; calcium hydrogen phosphate dihydrate; magnesium stearate; macrogol 6000; hypromellose; iron oxide red; povidone; carnauba wax; iron oxide yellow; microcrystalline cellulose - antioxidant/reduce free radicals formed in the body ; traditionally used in western herbal medicine to helps reduce occurrence of common colds ; traditionally used in western herbal medicine to decrease/reduce/relieve symptoms of common cold

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

sigma company limited - zinc sulfate monohydrate, quantity: 32.92 mg (equivalent: zinc, qty 12 mg); eleutherococcus senticosus, quantity: 100 mg (equivalent: eleutherococcus senticosus, qty 2 g); olea europaea, quantity: 100 mg (equivalent: olea europaea, qty 2 g); echinacea purpurea, quantity: 150 mg (equivalent: echinacea purpurea, qty 1.5 g); curcuma longa, quantity: 40 mg (equivalent: curcuma longa, qty 1 g); andrographis paniculata, quantity: 600 mg (equivalent: andrographis paniculata, qty 6 g) - tablet, film coated - excipient ingredients: microcrystalline cellulose; povidone; iron oxide yellow; magnesium stearate; calcium hydrogen phosphate; croscarmellose sodium; colloidal anhydrous silica; triacetin; hypromellose; purified talc; ethylcellulose; titanium dioxide - antioxidant/reduce free radicals formed in the body ; traditionally used in chinese medicine to aids/assists with recovery from illness/convalescence ; traditionally used in western herbal medicine to relieve weariness/tiredness/fatigue/feeling of weakness ; traditionally used in ayurvedic medicine to anti-inflammatory/relieve inflammation ; maintain/support immune system health ; traditionally used in western herbal medicine to relieve symptoms of mild upper respiratory tract infections ; traditionally used in western herbal medicine to decrease/reduce/relieve symptoms of common cold ; traditionally used in chinese medicine to relieve symptoms of sore throat/pharyngitis

European Union - English - EMA (European Medicines Agency)

h. lundbeck a/s - nalmefene hydrochloride dihydrate - alcohol-related disorders - drugs used in alcohol dependence - selincro is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking-risk level (see section 5.1), without physical withdrawal symptoms and who do not require immediate detoxification.selincro should only be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption.selincro should be initiated only in patients who continue to have a high drinking-risk level two weeks after initial assessment.

Israel - English - Ministry of Health

lundbeck israel ltd. - nalmefene as hydrochloride dihydrate - film coated tablets - nalmefene as hydrochloride dihydrate 18.06 mg - nalmefene - selincro is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking risk level (drl), without physical withdrawal symptoms and who do not require immediate detoxification.selincro should only be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption.selincro should be initiated only in patients who continue to have a high drl two weeks after initial assessment.