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

bayer healthcare pharmaceuticals inc. - iopromide (unii: 712bac33mz) (iopromide - unii:712bac33mz) - ultravist® injection is an iodinated contrast agent indicated for: ultravist is indicated for: ultravist is indicated for: † specific concentrations and presentations of ultravist are recommended for each type of imaging procedure [see dosage and administration ( 2.2, 2.3, 2.4)]. there are no data on ultravist use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. iopromide crosses the placenta and reaches fetal tissues in small amounts (see data) . in animal reproduction studies, intravenous administration of iopromide to pregnant rats and rabbits during organogenesis at doses up to0.35 and 0.7 times, respectively, the maximum recommended human dose based on body surface area resulted in no relevant adverse developmental effects (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defects, loss, or other advers

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

mylan pharmaceuticals inc. - clobazam (unii: 2mro291b4u) (clobazam - unii:2mro291b4u) - clobazam oral suspension is indicated for the adjunctive treatment of seizures associated with lennox-gastaut syndrome (lgs) in patients 2 years of age or older. clobazam oral suspension is contraindicated in patients with a history of hypersensitivity to the drug or its ingredients. hypersensitivity reactions have included serious dermatological reactions [see warnings and precautions (5.6) ] . there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, such as clobazam, during pregnancy. healthcare providers are encouraged to recommend that pregnant women taking clobazam enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or online at http://www.aedpregnancyregistry.org/. neonates born to mothers using benzodiazepines late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal [see warnings and precautions (5.8) and clinical considerations] . available data from published observatio

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

american health packaging - clobazam (unii: 2mro291b4u) (clobazam - unii:2mro291b4u) - clobazam tablets are indicated for the adjunctive treatment of seizures associated with lennox-gastaut syndrome (lgs) in patients 2 years of age or older. clobazam tablets are contraindicated in patients with a history of hypersensitivity to the drug or its ingredients. hypersensitivity reactions have included serious dermatological reactions [see warnings and precautions (5.6)]. pregnancy registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, such as clobazam, during pregnancy. healthcare providers are encouraged to recommend that pregnant women taking clobazam enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or online at http://www.aedpregnancyregistry.org/. risk summary there are no adequate and well-controlled studies of clobazam in pregnant women. available data suggest that the class of benzodiazepines is not associated with marked increases in risk for congenital anomalies. although

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

biocon pharma inc. - fingolimod hydrochloride (unii: g926ec510t) (fingolimod - unii:3qn8byn5qf) - fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 18 years of age and older. pediatric use information is approved for novartis pharmaceuticals corporation’s gilenya (fingolimod) capsules. however, due to novartis pharmaceuticals corporation's marketing exclusivity rights, this drug product is not labeled with that pediatric information. fingolimod is contraindicated in patients who have: - in the last 6 months experienced myocardial infarction, unstable angina, stroke, tia, decompensated heart failure requiring hospitalization or class iii/iv heart failure - a history or presence of mobitz type ii second-degree or third-degree av block or sick sinus syndrome, unless patient has a functioning pacemaker [see warning and precautions (5.1)] - a baseline qtc interval ≥500 msec - cardiac arrhythmias requiring anti-arrhythmic treatment with cla

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american health packaging - mirtazapine (unii: a051q2099q) (mirtazapine - unii:a051q2099q) - mirtazapine tablets are indicated for the treatment of major depressive disorder (mdd) in adults [see clinical studies (14)]. mirtazapine tablets are contraindicated in patients: - taking, or within 14 days of stopping, maois (including the maois linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see warnings and precautions (5.3), drug interactions (7)]. - with a known hypersensitivity to mirtazapine or to any of the excipients in mirtazapine tablets. severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (dress), stevens-johnson syndrome, bullous dermatitis, erythema multiforme and toxic epidermal necrolysis have been reported following the use of mirtazapine tablets [see adverse reactions 6.2]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. healthcare providers are encouraged to register patien

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

ncs healthcare of ky, llc dba vangard labs - benzonatate (unii: 5p4dhs6enr) (benzonatate - unii:5p4dhs6enr) - benzonatate capsules usp are indicated for the symptomatic relief of cough. hypersensitivity to benzonatate or related compounds.

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teva pharmaceuticals, inc. - lenalidomide (unii: f0p408n6v4) (lenalidomide - unii:f0p408n6v4) - lenalidomide capsules in combination with dexamethasone are indicated for the treatment of adult patients with multiple myeloma (mm). lenalidomide capsules are indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (mds) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. lenalidomide capsules are indicated for the treatment of adult patients with mantle cell lymphoma (mcl) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. lenalidomide capsules are not indicated and are not recommended for the treatment of patients with cll outside of controlled clinical trials [see warnings and precautions (5.5)] . lenalidomide capsules can cause fetal harm when administered to a pregnant female. limb abnormalities were seen in the offspring of monkeys that were dosed with lenalidomide during organogenesis. this effect was seen at all

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

quality care products, llc - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - oxycodone and acetaminophen tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings], reserve oxycodone 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 and acetaminophen tablets is 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 any other component of the product (e.g., an

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

mylan pharmaceuticals inc. - lenalidomide (unii: f0p408n6v4) (lenalidomide - unii:f0p408n6v4) - lenalidomide capsules in combination with dexamethasone are indicated for the treatment of adult patients with multiple myeloma (mm). lenalidomide capsules are indicated as maintenance therapy in adult patients with mm following autologous hematopoietic stem cell transplantation (auto-hsct). lenalidomide capsules are indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (mds) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. lenalidomide capsules are indicated for the treatment of adult patients with mantle cell lymphoma (mcl) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. lenalidomide capsules in combination with a rituximab product, are indicated for the treatment of adult patients with previously treated follicular lymphoma (fl). lenalidomide capsules in combination with a rituximab product, are indicated for

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

dr. reddy's laboratories inc. - lenalidomide (unii: f0p408n6v4) (lenalidomide - unii:f0p408n6v4) - lenalidomide capsules in combination with dexamethasone is indicated for the treatment of adult patients with multiple myeloma (mm). lenalidomide capsules are indicated as maintenance therapy in adult patients with mm following autologous hematopoietic stem cell transplantation (auto-hsct). lenalidomide capsules are indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (mds) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. lenalidomide capsules are indicated for the treatment of adult patients with mantle cell lymphoma (mcl) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. lenalidomide capsules in combination with a rituximab product, is indicated for the treatment of adult patients with previously treated follicular lymphoma (fl). lenalidomide capsules in combination with a rituximab product, is indicated for the