Malta - English - Medicines Authority

neopharmed gentili s.p.a. via san giuseppe cottolengo, 15 20143 – milan, , italy - rectal cream - nifedipine 0.3 g lidocaine hydrochloride 1.5 g - vasoprotectives

Israel - English - Ministry of Health

super-pharm (israel) ltd, israel - lidocaine hydrochloride; nifedipine - cream - lidocaine hydrochloride 1.5 %w/w; nifedipine 0.3 %w/w - lidocaine, combinations - treatment of anal fissures and proctologies generally associated with anal sphincter hypertonia.

European Union - English - EMA (European Medicines Agency)

merck sharp & dohme b.v. - sitagliptin, metformin hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes - for patients with type-2 diabetes mellitus:velmetia is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.velmetia is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.velmetia is indicated as triple combination therapy with a ppar agonist (i.e. a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a ppar agonist.velmetia is also indicated as add on to insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dosage of insulin and metformin alone do not provide adequate glycaemic control.

European Union - English - EMA (European Medicines Agency)

merck sharp dohme ltd - laropiprant, nicotinic acid - dyslipidemias - lipid modifying agents - trevaclyn is indicated for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia (characterised by elevated levels of low-density-lipoprotein (ldl) cholesterol and triglycerides and low high-density-lipoprotein (hdl) cholesterol) and in patients with primary hypercholesterolaemia (heterozygous familial and non-familial).trevaclyn should be used in patients in combination with 3-hydroxy-3-methyl-glutaryl-co-enzyme-a (hmg-coa)-reductase inhibitors (statins), when the cholesterol-lowering effect of hmg-coa-reductase-inhibitor monotherapy is inadequate. it can be used as monotherapy only in patients in whom hmg-coa-reductase inhibitors are considered inappropriate or not tolerated. diet and other non-pharmacological treatments (e.g. exercise, weight reduction) should be continued during therapy with trevaclyn.

European Union - English - EMA (European Medicines Agency)

n.v. organon - alendronic acid, colecalciferol - osteoporosis, postmenopausal - drugs for treatment of bone diseases - treatment of postmenopausal osteoporosis in patients at risk of vitamin-d insufficiency.vantavo reduces the risk of vertebral and hip fractures.treatment of postmenopausal osteoporosis in patients who are not receiving vitamin-d supplementation and are at risk of vitamin-d insufficiency.vantavo reduces the risk of vertebral and hip fractures.

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

elanco australasia pty ltd - neomycin base (as the sulfate) - oral powder, pre-mix - neomycin base (as the sulfate) antibiotic active 600.0 mg/g - antibiotic & related - cattle | pigs | poultry | beef | boar | bos indicus | bos taurus | bovine | breeders | broiler | buffalo | bull | bullock | calf - escherichia coli (e. coli) | proteus spp. | pseudomonas spp. | salmonella spp. | scours | including b-lactamase producin | selenium responsive scours

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

neolpharma, inc. - dextroamphetamine sulfate (unii: jj768o327n) (dextroamphetamine - unii:tz47u051fi), amphetamine sulfate (unii: 6dpv8nk46s) (amphetamine - unii:ck833kgx7e), amphetamine aspartate (unii: h527kap6l5) (amphetamine aspartate - unii:h527kap6l5), dextroamphetamine saccharate (unii: g83415v073) (dextroamphetamine - unii:tz47u051fi) - dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets are indicated for the treatment of attention deficit hyperactivity disorder (adhd) and narcolepsy. a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv ® ) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. the symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. the symptoms must not be better accounted for by another mental disorder. for the inattentive type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. for the hyperactive-impulsive type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go;” excessive talking; blurting answers; can't wait turn; intrusive. the combined type requires both inattentive and hyperactive-impulsive criteria to be met. in patients known to be hypersensitive to amphetamine, or other components of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets. hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products [see adverse reactions ]. patients taking monoamine oxidase inhibitors (maois), or within 14 days of stopping maois (including maois such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis [see warnings and drug interactions ]. dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets contain amphetamine, a schedule ii controlled substance. dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets have a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction [see warnings and precautions ]. dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets 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 healthcare 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 saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets, 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. dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets 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 saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation. dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets 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).

Israel - English - Ministry of Health

neopharm (israel) 1996 ltd - glucose anhydrous; sodium chloride - solution for injection - sodium chloride 0.9 g / 100 ml; glucose anhydrous 5 g / 100 ml - amino acids - amino acids - supply of water for administration of electrolytes or calories. vehicle for therapeutic regimen.