ABD - İngilizce - NLM (National Library of Medicine)

pai holdings, llc - amantadine hydrochloride (unii: m6q1eo9td0) (amantadine - unii:bf4c9z1j53) - amantadine hydrochloride 50 mg in 5 ml - amantadine hydrochloride oral solution usp is indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza a virus. amantadine hydrochloride is also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. amantadine hydrochloride is indicated for chemoprophylaxis against signs and symptoms of influenza a virus infection. because amantadine hydrochloride does not completely prevent the host immune response to influenza a infection, individuals who take this drug may still develop immune responses to natural disease or vaccination and may be protected when later exposed to antigenically related viruses. following vaccination during an influenza a outbreak, amantadine hydrochloride prophylaxis should be considered for the 2- to 4-week time period required to develop an antibody response. amantadine hydrochloride is also indicated in the treatment of uncomplicated respiratory tract illness caused by influenza a virus strains es

ABD - İngilizce - NLM (National Library of Medicine)

physicians total care, inc. - fexofenadine hydrochloride (unii: 2s068b75zu) (fexofenadine - unii:e6582loh6v) - fexofenadine hydrochloride 30 mg - fexofenadine hydrochloride tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older. symptoms treated effectively were sneezing, rhinorrhea, itchy nose/palate/throat, itchy/watery/red eyes. fexofenadine hydrochloride tablets are indicated for treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older. it significantly reduces pruritus and the number of wheals. fexofenadine hydrochloride tablets are contraindicated in patients with known hypersensitivity to any of its ingredients.

ABD - İngilizce - NLM (National Library of Medicine)

rebel distributors corp - fexofenadine hydrochloride (unii: 2s068b75zu) (fexofenadine - unii:e6582loh6v) - fexofenadine hydrochloride 180 mg - fexofenadine hydrochloride tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older. fexofenadine hydrochloride tablets are indicated for treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 of age and older . fexofenadine hydrochloride tablets are contraindicated in patients with known hypersensitivity to fexofenadine and any of the ingredients of fexofenadine hydrochloride. rare cases of hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnea, flushing and systemic anaphylaxis have been reported. teratogenic effects: pregnancy category c. there was no evidence of teratogenicity in rats or rabbits at oral doses of terfenadine up to 300 mg/kg (which led to fexofenadine exposures that were approximately 4 and 30 times, respectively, the exposure at the maximum recommended human daily oral dose of 180 mg of fexofenadine hydrochloride based on c

ABD - İngilizce - NLM (National Library of Medicine)

actavis pharma, inc. - amantadine hydrochloride (unii: m6q1eo9td0) (amantadine - unii:bf4c9z1j53) - amantadine hydrochloride 100 mg - amantadine hydrochloride capsules are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza a virus. amantadine hydrochloride capsules are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. influenza a prophylaxis amantadine hydrochloride capsules are indicated for chemoprophylaxis against signs and symptoms of influenza a virus infection. because amantadine does not completely prevent the host immune response to influenza a infection, individuals who take this drug may still develop immune responses to natural disease or vaccination and may be protected when later exposed to antigenically related viruses. following vaccination during an influenza a outbreak, amantadine prophylaxis should be considered for the 2- to 4-week time period required to develop an antibody response. influenza a treatment amantadine hydrochloride capsules are also indicated in the treatment of uncomplicated respiratory tract illnes

ABD - İngilizce - NLM (National Library of Medicine)

wockhardt usa llc. - olopatadine hydrochloride (unii: 2xg66w44kf) (olopatadine - unii:d27v6190pm) - olopatadine 1 mg in 1 ml - olopatadine hydrochloride ophthalmic solution usp, 0.1 % is indicated for the treatment of the signs and symptoms of allergic conjunctivitis. olopatadine hydrochloride ophthalmic solution 0.1 % is contraindicated in persons with a known hypersensitivity to olopatadine hydrochloride or any components of olopatadine hydrochloride ophthalmic solution 0.1 %.

ABD - İngilizce - NLM (National Library of Medicine)

ncs healthcare of ky, inc dba vangard labs - fexofenadine hydrochloride (unii: 2s068b75zu) (fexofenadine - unii:e6582loh6v) - fexofenadine hydrochloride 60 mg - fexofenadine hydrochloride tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older. symptoms treated effectively were sneezing, rhinorrhea, itchy nose/palate/throat, itchy/watery/red eyes. fexofenadine hydrochloride tablets are indicated for treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older. it significantly reduces pruritus and the number of wheals. fexofenadine hydrochloride tablets are contraindicated in patients with known hypersensitivity to any of its ingredients.

ABD - İngilizce - NLM (National Library of Medicine)

bryant ranch prepack - desloratadine (unii: fvf865388r) (desloratadine - unii:fvf865388r) - desloratadine tablets are indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis in patients 12 years of age and older. desloratadine tablets are indicated for the relief of the nasal and non-nasal symptoms of perennial allergic rhinitis in patients 12 years of age and older. desloratadine tablets are contraindicated in patients who are hypersensitive to this medication or to any of its ingredients or to loratadine [see warnings and precautions (5.1) and adverse reactions (6.2)]. risk summary the limited available data with desloratadine in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. there are no adequate and well-controlled studies in pregnant women. desloratadine given during organogenesis to pregnant rats was not teratogenic at the summed area under the concentration-time curve (auc)-based exposures of desloratadine and its metabolite approximately 320 times that at the recommended human daily oral dose (rhd) of 5 mg/day. desloratadine given during organogenesis to pregnant rabbits was not teratogenic at the auc-based exposures of desloratadine approximately 230 times that at the rhd. desloratadine given to pregnant rats during organogenesis through lactation resulted in reduced body weight and slow righting reflex of f1 pups at the summed auc-based exposures of desloratadine and its metabolite approximately 70 times or greater than that at the rhd [see data] . the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data: desloratadine was given orally during organogenesis to pregnant rats at doses of 6, 24 and 48 mg/kg/day (approximately 50, 200 and 320 times the summed auc-based exposure of desloratadine and its metabolite at the rhd). no fetal malformations were present. reduced fetal weights and skeletal variations noted at doses of 24 and 48 mg/kg/day were likely secondary to the maternal toxicities of reduced body weight gain and food consumption observed at the same doses. desloratadine was also given orally during organogenesis to pregnant rabbits at doses of 15, 30 and 60 mg/kg/day (approximately 30, 70 and 230 times the auc- based exposure of desloratadine at the rhd). no adverse effects to the fetus were noted. reduced maternal body weight gain was noted in rabbits at 60 mg/kg/day. in a peri- and post-natal development study, desloratadine was given to rats orally during the peri- natal (gestation day 6) through lactation periods (postpartum day 21) at doses of 3, 9 and 18 mg/kg/day. reduced body weight and slow righting reflex were reported in f1 pups at doses of 9 mg/kg/day or greater (approximately 70 times or greater than the summed auc-based exposure of desloratadine and its metabolite at the rhd). desloratadine had no effect on f1 pup development at 3 mg/kg/day (approximately 10 times the summed auc-based exposure of desloratadine and its metabolite at the rhd). maternal toxicities including reduced body weight gain and food consumption were noted at 18 mg/kg/day for f0 dams. f1 offspring were subsequently mated and there was no developmental toxicity for f2 pups observed. risk summary desloratadine passes into breast milk. there are not sufficient data on the effects of desloratadine on the breastfed infant or the effects of desloratadine on milk production. the decision should be made whether to discontinue nursing or to discontinue desloratadine, taking into account the developmental and health benefits of breastfeeding, the nursing mother's clinical need, and any potential adverse effects on the breastfed infant from desloratadine or from the underlying maternal condition. infertility there are no data available on human infertility associated with desloratadine. there were no clinically relevant effects of desloratadine on female fertility in rats. a male specific decrease in fertility occurred at an oral desloratadine dose of 12 mg/kg or greater in rats (approximately 65 times the summed auc-based exposure of desloratadine and its metabolite at the rhd). male fertility was unaffected at a desloratadine dose of 3 mg/kg (approximately 10 times the summed auc-based exposure of desloratadine and its metabolite at the rhd). [see nonclinical toxicology (13.1).] the recommended dose of desloratadine oral solution in the pediatric population is based on cross-study comparison of the plasma concentration of desloratadine in adults and pediatric subjects. the safety of desloratadine oral solution has been established in 246 pediatric subjects aged 6 months to 11 years in three placebo-controlled clinical studies. since the course of seasonal and perennial allergic rhinitis and the effects of desloratadine are sufficiently similar in the pediatric and adult populations, it allows extrapolation from the adult efficacy data to pediatric patients. the effectiveness of desloratadine oral solution in these age groups is supported by evidence from adequate and well-controlled studies of desloratadine tablets in adults. the safety and effectiveness of desloratadine tablets or desloratadine oral solution have not been demonstrated in pediatric patients less than 6 months of age. [see clinical pharmacology (12.3)]. clinical studies of desloratadine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. [see clinical pharmacology (12.3)]. dosage adjustment for patients with renal impairment is recommended [see dosage and administration (2.5) and clinical pharmacology (12.3)]. dosage adjustment for patients with hepatic impairment is recommended [see dosage and administration (2.5) and clinical pharmacology (12.3)]. there is no information to indicate that abuse or dependency occurs with desloratadine tablets.

ABD - İngilizce - NLM (National Library of Medicine)

marlex pharmaceuticals inc - amantadine hydrochloride (unii: m6q1eo9td0) (amantadine - unii:bf4c9z1j53) - amantadine hydrochloride are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza a virus. amantadine hydrochloride are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. amantadine hydrochloride are indicated for chemoprophylaxis against signs and symptoms of influenza a virus infection. because amantadine hydrochloride do not completely prevent the host immune response to influenza a infection, individuals who take this drug may still develop immune responses to natural disease or vaccination and may be protected when later exposed to antigenically related viruses. following vaccination during an influenza a outbreak, amantadine hydrochloride prophylaxis should be considered for the 2- to 4- week time period required to develop an antibody response. amantadine hydrochloride are also indicated in the treatment of uncomplicated respiratory tract illness caused by influenza a virus strains especially when a

Avrupa Birliği - İngilizce - EMA (European Medicines Agency)

ratiopharm gmbh - desloratadine - rhinitis, allergic, perennial; urticaria; rhinitis, allergic, seasonal - antihistamines for systemic use, - desloratadine ratiopharm is indicated in adults for the relief of symptoms associated with:allergic rhinitischronic idiopathic urticaria as initially diagnosed by a physician

Avrupa Birliği - İngilizce - EMA (European Medicines Agency)

teva b.v - desloratadine - rhinitis, allergic, perennial; rhinitis, allergic, seasonal - antihistamines for systemic use, - desloratadine teva is indicated for the relief of symptoms associated with:allergic rhinitis;urticaria.