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

oscient pharmaceuticals corporation - fenofibrate (unii: u202363uos) (fenofibrate - unii:u202363uos) - capsule - 43 mg - antara is indicated as adjunctive therapy to diet to reduce elevated ldl-c, total-c, triglycerides, and apo b, and to increase hdl-c in adult patients with primary hypercholesterolemia or mixed dyslipidemia (fredrickson types ii a and ii b). lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see national cholesterol education program [ncep] treatment guidelines, below ). antara is also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (fredrickson types iv and v hyperlipidemia). improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention. markedly elevated levels of serum triglycerides (e.g. >2,000 mg/dl) may increase the risk of developing pancreatitis. the effect of antara t

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

lupin pharmaceuticals, inc. - fenofibrate (unii: u202363uos) (fenofibric acid - unii:bgf9mn2hu1) - fenofibrate 30 mg - antara is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (ldl-c), total cholesterol (total-c), triglycerides (tg), and apolipoprotein b (apo b), and to increase high-density lipoprotein cholesterol (hdl-c) in adult patients with primary hypercholesterolemia or mixed dyslipidemia. antara is also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention. markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dl) may increase the risk of developing pancreatitis. the effect of fenofibrate therapy on reducing this risk has not been adequately studied. fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus [see warnings and precautions

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

lupin pharmaceuticals, inc. - fenofibrate (unii: u202363uos) (fenofibric acid - unii:bgf9mn2hu1) - fenofibrate 43 mg - antara is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (ldl-c), total cholesterol (total-c), triglycerides (tg), and apolipoprotein b (apo b), and to increase high-density lipoprotein cholesterol (hdl-c) in adult patients with primary hypercholesterolemia or mixed dyslipidemia. antara is also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention. markedly elevated levels of serum triglycerides (e.g, > 2,000 mg/dl) may increase the risk of developing pancreatitis. the effect of fenofibrate therapy on reducing this risk has not been adequately studied. fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus. [see warnings and precautions (5.1)]. antara is contraindicated in: - patients with severe renal impairment, including those receiving dialysis [see clinical pharmacology (12.3)]. - patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities[see warnings and precautions (5.2)]. - patients with preexisting gallbladder disease [see warnings and precautions (5.5)]. - nursing mothers [see use in specific populations (8.3)] . - patients with known hypersensitivity to fenofibric acid or fenofibrate[see warnings and precautions (5.9)]. pregnancy category: c safety in pregnant women has not been established. there are no adequate and well controlled studies of fenofibrate in pregnant women. fenofibrate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. in female rats given oral dietary doses of 15, 75, and 300 mg/kg/day of fenofibrate from 15 days prior to mating through weaning, maternal toxicity was observed at 0.3 times the maximum recommended human dose (mrhd), based on body surface area comparisons; mg/m2 . in pregnant rats given oral dietary doses of 14, 127, and 361 mg/kg/day from gestation day 6-15 during the period of organogenesis, adverse developmental findings were not observed at 14 mg/kg/day (less than 1 times the mrhd, based on body surface area comparisons; mg/m2 ). at higher multiples of human doses evidence of maternal toxicity was observed. in pregnant rabbits given oral gavage doses of 15, 150, and 300 mg/kg/day from gestation day 6 to 18 during the period of organogenesis and allowed to deliver, aborted litters were observed at 150 mg/kg/day (10 times the mrhd, based on body surface area comparisons; mg/m2 ). no developmental findings were observed at 15 mg/kg/day (at less than 1 times the mrhd, based on body surface area comparisons; mg/m2 ). in pregnant rats given oral dietary doses of 15, 75, and 300 mg/kg/day from gestation day 15 through lactation day 21 (weaning), maternal toxicity was observed at less than 1 times the mrhd, based on body surface area comparisons; mg/m2 . fenofibrate should not be used in nursing mothers. a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. safety and effectiveness have not been established in pediatric patients. fenofibric acid is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. fenofibric acid exposure is not influenced by age. since elderly patients have a higher incidence of renal impairment, dose selection for the elderly should be made on the basis of renal function [see dosage and administration (2.5) and clinical pharmacology (12.3)].   elderly patients with normal renal function should require no dose modifications. consider monitoring renal function in elderly patients taking antara. fenofibrate should be avoided in patients with severe renal impairment [see contraindications (4)]. dose reduction is required in patients with mild to moderate renal impairment [see dosage and administration (2.4) and clinical pharmacology (12.3)]. monitoring renal function in patients with renal impairment is recommended. the use of antara has not been evaluated in subjects with hepatic impairment [see contraindications (4) and clinical pharmacology (12.3) ].

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

premier brands of america inc. - salicylic acid (unii: o414pz4lpz) (salicylic acid - unii:o414pz4lpz) - plantar wart remover for the removal of plantar warts on the bottom of the foot. the plantar wart is recognized by its location only on the bottom of the foot, its tenderness, and the interruption of the footprint pattern.

Philippines - English - FDA (Food And Drug Administration)

zamira life sciences, inc.; distributor: zamira life sciences, inc. - bacillus subtilis , bacillus licheniformis , lactobacillus plantarum (vet.) - feed premix powder - formulation: each gram contains: bacillus subtilis.......... bacillus licheniformis................................................................*************************** lactobacillus plantarum .............. > 4.10 cfu > 4.109cfu >1 x 108 cfu

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

scholls wellness company llc - salicylic acid (unii: o414pz4lpz) (salicylic acid - unii:o414pz4lpz) - purpose plantar wart remover - for the removal of plantar wart - relieves pain by removing plantar wart - if you are a diabetic - if you have poor blood circulation - on irritated skin or any aea that is infected or reddened

Malta - English - Medicines Authority

proge farm s.r.l. baluardo la marmora, 4 - 28100 - novara, italy - lactobacillus plantarum - vaginal soft capsule - lactobacillus plantarum 17630 cfu - gynecological antiinfectives and antiseptics

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

biorhythm co., ltd - lactobacillus plantarum (unii: qfc21096on) (lactobacillus plantarum - unii:qfc21096on) - kimchi lactobacillus is made to induce the proliferation of intestinal-beneficial bacteria, the inhibition of harmful bacteria and regular bowel movements, and to help immunity by intestinal absorption and normal cell division. it helps to improve eye health. lactobacillus plantarum k-1 probiotics also relieve and reduce constipation, enteritis, rhinitis, vaginitis, atopic dermatitis, acne, liver spots, and freckles. biorhythm guarantees quality and satisfaction. take 1.5g per day

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

gk bio international sdn. bhd. - lactobacillus plantarum -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

janipro (m) sdn bhd - calcium ascorbate; calcium pantothenate; cyanocobalamin; lactobacillus plantarum; nicotinamide; pyridoxine hydrochloride; riboflavin; thiamine hydrochloride; curcuma longa extract (turmeric); dl alpha tocopheryl acetate; folic acid; zinc sulphate monohydrate -