Egyesült Államok - angol - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc. - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam 250 mg - levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older. levetiracetam tablets are indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy. levetiracetam tablets are indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy. levetiracitam is contraindicated in patients with a hypersensitivity to levetiracetam. reactions have included anaphylaxis and angioedema [see warnings and precautions (5.4)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), including levetiracetam, during pregnancy. encourage women who are taking levetiracetam during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or vi

Egyesült Államok - angol - NLM (National Library of Medicine)

zydus pharmaceuticals (usa) inc. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - oxycodone hydrochloride and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings], reserve oxycodone hydrochloride and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] - have not been tolerated, or are not expected to be tolerated, - have not provided adequate analgesia, or are not expected to provide adequate analgesia oxycodone hydrochloride and acetaminophen tablets are contraindicated in patients with: - significant respiratory depression [see warnings] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings] - known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings] - hypersensitivity to oxycodone, acetaminophen, or

Egyesült Államok - angol - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc. - risedronate sodium anhydrous (unii: ofg5exg60l) (risedronic acid - unii:km2z91756z) - risedronate sodium delayed-release tablets are indicated for the treatment of osteoporosis in postmenopausal women. in postmenopausal women, risedronate sodium has been shown to reduce the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures [see clinical studies (14.1) ]. the optimal duration of use has not been determined. the safety and effectiveness of risedronate sodium delayed-release tablets for the treatment of osteoporosis are based on clinical data of one year duration. all patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. patients who discontinue therapy should have their risk for fracture re-evaluated periodically. risedronate sodium delayed-release tablets are contraindicated in patients with the following conditions: -   abnormalities of the esophagus which delay esophageal empt

Egyesült Államok - angol - NLM (National Library of Medicine)

ajanta pharma usa inc. - doxepin hydrochloride (unii: 3u9a0fe9n5) (doxepin - unii:5asj6huz7d) - doxepin hydrochloride capsules, usp are 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 capsules 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 capsules is safe and well tolerated even in the elderly patient. owing to lack of clinical experience in the pediatric population, doxepin is not recommended for use in children under 12 years

Egyesült Államok - angol - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - deferiprone (unii: 2bty8kh53l) (deferiprone - unii:2bty8kh53l) - deferiprone tablets are indicated for the treatment of transfusional iron overload in adult patients with thalassemia syndromes when current chelation therapy is inadequate. limitations of use: pediatric use information is approved for chiesi usa, inc.’s ferriprox® (deferiprone) tablets. however, due to chiesi usa, inc.’s marketing exclusivity rights, this drug product is not labeled with that information. deferiprone tablets are contraindicated in patients with known hypersensitivity to deferiprone or to any of the excipients in the formulations. the following reactions have been reported in association with the administration of deferiprone: henoch-schönlein purpura; urticaria; and periorbital edema with skin rash [see adverse reactions (6.2)] . risk summary: in animal reproduction studies, oral administration of deferiprone to pregnant rats and rabbits during organogenesis at doses 33% and 49%, respectively, of the maximum recommended human dose (mrhd) resulted in structural abnormalities, embryo-fetal mortality and alterations to growth (see data ). the limited available data from deferiprone use in pregnant women are insufficient to inform a drug-associated risk of major birth defects and miscarriage. based on evidence and developmental toxicity in animal studies, deferiprone tablets can cause fetal harm when administered to a pregnant woman. advise pregnant women and females of reproductive potential of the potential risk to a fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and of miscarriage is 2-4% and 15-20%, respectively. data: human data: post-marketing data available from 39 pregnancies of deferiprone-treated patients and 10 pregnancies of partners of deferiprone-treated patients are as follows: of the 39 pregnancies in deferiprone-treated patients, 23 resulted in healthy newborns, 6 ended in spontaneous abortion, 9 had unknown outcomes, and 1 infant was born with anal atresia, nephroptosis, ventricular septal defect, hemivertebra and urethral fistula. of the 10 pregnancies in partners of deferiprone-treated patients, 5 resulted in healthy newborns, 1 resulted in a healthy newborn with slight hypospadias, 1 was electively terminated, 1 resulted in the intrauterine death of twins, and 2 had unknown outcomes. animal data: during organogenesis, pregnant rats and rabbits received deferiprone at oral doses of 0, 30, 80 or 200 mg/kg/day, and 0, 10, 50, or 150 mg/kg/day, respectively. the daily dose was administered as two equal divided doses approximately 7 hours apart. doses of 200 mg/kg/day in rats and 150 mg/kg/day in rabbits, approximately 33% and 49% of the mrhd, respectively, resulted in increased post-implantation loss and reduced fetal weights in the presence of maternal toxicity (reduced maternal body weight and body weight gain in both rats and rabbits; abnormal large placenta at low incidence in rats). the 200 mg/kg/day dose in rats resulted in external, visceral and skeletal fetal malformations, such as cranial malformations, cleft palate, limb malrotation, anal atresia, internal hydrocephaly, anophthalmia, and fused bones. the dose of 150 mg/kg/day in rabbits resulted in external fetal malformations (partially opened eyes) and minor blood vessel and skeletal variations. in rats, malformations including micrognathia and persistent ductus arteriosus could be observed in the absence of maternal toxicity at doses equal to or greater than 30 and 80 mg/kg/day, approximately 5% and 13% of the mhrd, respectively. risk summary: there is no information regarding the presence of deferiprone in human milk, the effects on the breastfed child, or the effects on milk production. because of the potential for serious adverse reactions in the breastfed child, including the potential for tumorigenicity shown for deferiprone in animal studies, advise patients that breastfeeding is not recommended during treatment with deferiprone tablets, and for at least 2 weeks after the last dose. pregnancy testing: pregnancy testing is recommended for females of reproductive potential prior to initiating deferiprone tablets. contraception: females: deferiprone tablets can cause embryo-fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . advise female patients of reproductive potential to use effective contraception during treatment with deferiprone tablets and for at least 6 months after the last dose. males: based on genotoxicity findings, advise males with female partners of reproductive potential to use effective contraception during treatment with deferiprone tablets and for at least 3 months after the last dose [see nonclinical toxicology (13.1)] . safety and effectiveness of deferiprone tablets have not been established in pediatric patients with chronic iron overload due to blood transfusions who are less than 8 years of age. pediatric use information is approved for chiesi usa, inc.’s ferriprox® (deferiprone) tablets. however, due to chiesi usa, inc.’s marketing exclusivity rights, this drug product is not labeled with that information . clinical studies of deferiprone 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 in responses between the elderly and younger patients.

Egyesült Államok - angol - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - deferiprone (unii: 2bty8kh53l) (deferiprone - unii:2bty8kh53l) - deferiprone tablets are indicated for the treatment of transfusional iron overload in adult patients with thalassemia syndromes when current chelation therapy is inadequate. limitations of use: pediatric use information is approved for chiesi usa, inc.’s ferriprox® (deferiprone) tablets. however, due to chiesi usa, inc.’s marketing exclusivity rights, this drug product is not labeled with that information. deferiprone tablets are contraindicated in patients with known hypersensitivity to deferiprone or to any of the excipients in the formulation. the following reactions have been reported in association with the administration of deferiprone: henoch-schönlein purpura; urticaria; and periorbital edema with skin rash [see adverse reactions (6.2)] . risk summary: in animal reproduction studies, oral administration of deferiprone to pregnant rats and rabbits during organogenesis at doses 33% and 49%, respectively, of the maximum recommended human dose (mrhd) resulted in structural abnormalities, embryo-fetal mor

Egyesült Államok - angol - NLM (National Library of Medicine)

zydus pharmaceuticals (usa) inc. - nortriptyline hydrochloride (unii: 00fn6ih15d) (nortriptyline - unii:bl03sy4lxb) - nortriptyline hydrochloride capsules are indicated for the relief of symptoms of depression. endogenous depressions are more likely to be alleviated than are other depressive states. the use of maois intended to treat psychiatric disorders with nortriptyline hydrochloride or within 14 days of stopping treatment with nortriptyline hydrochloride is contraindicated because of an increased risk of serotonin syndrome. the use of nortriptyline hydrochloride within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated (see warnings and dosage and administration ). starting nortriptyline hydrochloride in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see warnings and dosage and administration ). cross-sensitivity between nortriptyline hydrochloride and other dibenzazepines is a possibility. nortriptyline hydrochloride is contraindicated during the acute rec

Egyesült Államok - angol - NLM (National Library of Medicine)

zydus pharmaceuticals (usa) inc. - ketorolac tromethamine (unii: 4eve5946bq) (ketorolac - unii:yzi5105v0l) - carefully consider the potential benefits and risks of ketorolac tromethamine tablets and other treatment options before deciding to use ketorolac tromethamine tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. ketorolac tromethamine tablets are indicated for the short-term (≤ 5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. therapy should always be initiated with iv or im dosing of ketorolac tromethamine and ketorolac tromethamine tablets are to be used only as continuation treatment, if necessary. the total combined duration of use of ketorolac tromethamine tablets and ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see warnings , precautions , dosage and administration , and adverse reactions ). patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine tablet therapy is not to exceed 5 days. (see also boxed warning) ketorolac tromethamine tablets are contraindicated in patients with previously demonstrated hypersensitivity to ketorolac tromethamine. ketorolac tromethamine tablets are contraindicated in patients with active peptic ulcer disease, in patients with recent gastrointestinal bleeding or perforation and in patients with a history of peptic ulcer disease or gastrointestinal bleeding. ketorolac tromethamine tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, rarely fatal, anaphylactic-like reactions to nsaids have been reported in such patients (see warnings, anaphylactoid reactions and precautions, preexisting asthma ). ketorolac tromethamine tablets are contraindicated as prophylactic analgesic before any major surgery. ketorolac tromethamine tablets are contraindicated in the setting of coronary artery bypass graft (cabg) surgery (see warnings ). ketorolac tromethamine tablets are contraindicated in patients with advanced renal impairment or in patients at risk for renal failure due to volume depletion (see warnings for correction of volume depletion). ketorolac tromethamine tablets are contraindicated in labor and delivery because, through its prostaglandin synthesis inhibitory effect, it may adversely affect fetal circulation and inhibit uterine contractions, thus increasing the risk of uterine hemorrhage. ketorolac tromethamine inhibits platelet function and is, therefore, contraindicated in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis and those at high risk of bleeding (see warnings and precautions ). ketorolac tromethamine tablets are contraindicated in patients currently receiving aspirin or nsaids because of the cumulative risks of inducing serious nsaid-related adverse events. the concomitant use of ketorolac tromethamine and probenecid is contraindicated. the concomitant use of ketorolac tromethamine and pentoxifylline is contraindicated.

Egyesült Államok - angol - NLM (National Library of Medicine)

deb usa, inc. - alcohol (unii: 3k9958v90m) (alcohol - unii:3k9958v90m) - alcohol 68 ml in 100 ml - hand antiseptic    hand antiseptic to decrease bacteria on the skin.

Egyesült Államok - angol - NLM (National Library of Medicine)

deb usa, inc. - triclosan (unii: 4nm5039y5x) (triclosan - unii:4nm5039y5x) - triclosan 0.5 g in 100 ml - antimicrobial hand wash cleanse harmful bacteria and dirt from skin